# Feedback

comment:
I think the PREV button and grayed out NEXT button should appear here at the bottom.  I might want to go back to the map!


comment:
Prev and next buttons should be here (next grayed out)


comment:
I clicked the PREV button from the weather screen with 6 videos and got here.


comment:
I would like to see the color pictures of the plant throughout instead of the gray washouts. They might need to be faded a little - but I leave that to your judgment.  The gray is depressing.


comment:
Video/narration at 00:30 - "... less than .1 milligram exits the catheter tip." (singular -  milligram vs. milligrams) 
I agree with Sonja's comment - swap the order of the slides.


comment:
If we reorder the slides (placing the video slide before this slide), delete the 1st sentence in the lead-in on this slide. It's repetitive. Just start with "The graph below shows the dose..."


comment:
Video: 00:04 - on-screen text should state "Select the Slider bar." not the arrow button (see Tech manual pg 21). Narration should state, "First, select the Slider bar and access Session Data and Print Reports via the Session Data..."


comment:
On-screen text says to "Scroll down to view the Low Reservoir Alarm Date...", but there is no scroll bar on the image shown.  Once you've made Sonja's requested update there may be a scroll bar and you may not need to change the on-screen text. Please adjust the text, if necessary.


comment:
Why are these interactions different from the ones shown in the Get the Refill Right course (Beta review)?  The interactions in this course are missing steps. Review the Technical Manual (page 99)...need to position the programming head, Telemetry Complete message appears, programmer sounds a telemetry complete tone, and within seconds, the pump sounds the critical/non-critical alarm tone. Let's discuss.


comment:
Back button should show up on this screen


comment:
The resolution of the two guys looks fuzzy. Can you confirm they are high enough res?


comment:
instead of timeframe for completion - change to - when it will be completed. We want to keep our language conversational


comment:
Jen - Both of these pop-ups are really big blocks of text. Jen, please take a pass through to cut down and/or use bullets or tables to make this more readable on screen


comment:
why are we clicking a < arrow to continue within the pop-ups? That seems like that should be a back arrow?


comment:
Jen, where is the video going in this module? We need to at least have a placeholder for it.


comment:
Feedback for all of these scenarios should show the actual consequences of making the right or bad decisions with visuals and stories


comment:
your template is changing here. ON previous screens, the next button didn't show up at all if it wasn't clickable. Now it's there but grayed out. What's the template supposed to be? find out that answer and then doublecheck for all screens


comment:
There's no instructional text on this screen. I would also love to see some of these text boxes with bullets so that they are easier to read at a glance


comment:
where will they find the standard that they are supposed to be referring to throughout the course?


comment:
Ha-Trang - Check your menu and make sure that it mtaches the module titles and screen titles in the course.


comment:
Or did you change up this module? The content in here seems to be more of the content related to Anatomy of a Startup?


comment:
for use checklist and observer - too much text in this box. Figure out a way to manage this content in a way the learner can absorb it


comment:
your intro question here seems like a yes/no question, but you ask them to select a decision point. please clarify


comment:
Alarms pop-up window: 2nd bullet "Program Low Reservoir Alarm Volume"?


comment:
Video (00:50) - update narration "...telemetry in progress" (vs. process). The N'Vision screen actually shows Telemetry in Progress. So for consistency with the screenshot and other courses, as well as the Tech Manual (pg 55), please update.


comment:
To answer Sonja's question, the updated animations (currently being developed) will show a pump orientation of 3:00 o'clock (vs. 12 o'clock).


comment:
Oops... just realized it was Susan, not Sonja.


comment:
When I came back to this screen as an approver, I got the placeholder guy as gray.  Need to update so the character is gray.


comment:
DISREGARD BOTH COMMENTS.  We are keeping this video.  Add a note to Mosaic as follows:  This is a placeholder slide for the Countdown to Startup video  where learners discover how each section of the standard comes into play as startup is requested. Learners progress through the key terms and definitions (including atmospheric conditions that lead to inversion), then choose the next topic they want to see.


comment:
NEW update text as follows: The Production Supervisor is generally responsible for approving startups when:
(bullet) The plant is down > 30 minutes; no shift change  (bullet) The plant is down < 30 minutes

He also determines if inversion is a risk and uses the input of others to determine if startup is safe.


comment:
NEW UPDATE for text:  Change the text to:  The General Manager and Sulfuric Area Manager ensure the Sulfuric Startup Standard is applied at their location, and uphold the requirements of the standard. They approve sulfuric startups when:
(bullet) The plant is down > 30 minutes AND
(bullet) Startup is requested between sunrise and 11:00am OR
(bullet) Shift change is happening


comment:
NEW CHECKLIST & OBSERVER text - At shift change or if there is a risk of inversion, use your plant's pre-startup checklist to meet startup requirements. Field Observers provide additional information on SO2 and stack conditions.


comment:
there need to be directions here so people know they have to click on "MISO focus" - I spent forever looking for a next button


comment:
NEW INFO:  Remove "Is there a risk of stack inversion?" from the orange text.


comment:
This feedback page was never updated from the edits that I sent. We can't legally tell employees who they can and can not connect with on social media. The feedback should read more about while it's fine to connect on social media networks with whomever you want, it's important not to share confidential information that is not already publically posted. This will apply if the feedback wasn't correctly updated on the screen if they got it wrong as well.


comment:
UPDATE:  Correct (no selected) feedback:  Good work! Even knowing that the rest of the plant needs Sulfuric to run, there's no discounting safety. Because of your decision to not startup, you ensured that everyone in the plant was safe when the wind shifted and brought the sideways stack to the ground.


comment:
UPDATE:  Incorrect (yes selected) feedback:  Uh oh.  Because of your decision to start up, you put the workers in shipping at serious risk of SO2 inhalation when the wind shifted and brought the sideways stack to the ground.


comment:
NEW:  Add a sentence after the scenario in a new paragaph:  Click the places and people you need to talk to in order to determine if you can startup.


comment:
Update to Correct (yes selected) feedback:  Right! Because of your decision to startup, we were able to start creating the acid and steam needed in other parts of the plant and not keep them down for long.


comment:
Update to Incorrect (no selected) feedback:  Boy, are you going to hear about this! There was no reason to prevent Sulfuric startup.  Because of your decision, all the other areas were down far longer than they needed to be, and missed precious production time.


comment:
NEW: Add a sentence after the scenario in a new paragraph:  Click the places and people you need to talk to in order to determine if you can startup.


comment:
NEW Correct (no selected) feedback:  Way to go! Safety first! By delaying plant startup, you just saved hundreds of people from needing to shelter and assured the safety of everyone in the plant.


comment:
NEW Incorrect (yes selected) feedback:  You will be lucky if you keep your job. Because of your decision to startup, every worker coming into the plant and leaving the plant needed to be sheltered AND there was no way to account for everyone. Three of your buddies were hospitalized as a result.


comment:
This is awkward wording. How about: Welcome back! I'm so glad to see you again.This second chapter will help me understand the journey of a patient sample. Let's spend some time at the hospital following a sample from start to finish during the testing process. 

Click Play to see the story of my dream again, or Click Continue to start our journey.


comment:
GLOBAL: In Chicago Manual, pre- and post- are closed prefixes. An APA blog post from 10/2016 suggests that APA follows the same recommendation. Change to "preanalytic" and "postanalytic"?


comment:
Change "During" to "In"

Also, should chapter 1 be capped as "Chapter 1" because it refers to a specific chapter?


comment:
GLOBAL: Change "three-phase" to "3-phase" for consistency throughout course?


comment:
GLOBAL: In the steps, add a period to the end of each sentence for consistency with other text?


comment:
In the steps, if the sentences should use articles consistently, change as follows:

A clinician orders a test
A health care professional processes the test request
A health care professional collects a specimen
The specimen is transported to the laboratory
The specimen undergoes initial processing in the laboratory, including specimen accessioning


comment:
The heading "Steps include:" has a different font and color on this page. Please check.


comment:
In the steps, check whether the inconsistent use of articles is okay. For example, change Step 6 to "A microbiologist performs the initial examinatino and workup of the culture:"?


comment:
Should "Inoculate and incubate" have an object? For example, "Inoculate and incubate the specimen"? 

Also, should "Picking and streaking" have an object? Should "Picking and streaking" be parallel with the preceding bullets? For example "Pick and streak the specimen"?


comment:
In Step 7, "Testing to test" seems redundant.

Also, should the verbs change to be consistent with the preceding bullets. So, for example, "Conduct tests to identify the colonies" and "Test susceptibility"?


comment:
In the steps, check whether inconsistent use of articles is okay. For example 

A microbiologist formulates a final report
The microbiologist's conclusions are communicated to the clinician
And so on...


comment:
In Step 10, fix subject verb agreement. s/b "Clinician interprets" (or "The clinician interprets" depending on answer to earlier query about articles)


comment:
note that "examinatino" in query about articles should be "examination" 
Oooops! :)


comment:
In the Notes, add a comma after "initiated"


comment:
In Merriam-Webster's Unabridged, "empiric" is not the standard adjective form, although it is correct. Change "empiric" to the standard, which is "empirical"?


comment:
GLOBAL: Make the use of articles consistent? For example "A health care professional enters an order into the LIS system. . . "


comment:
I think this is the first mention of LIS. Define as "library information system (LIS)" here? If left as is, delete "system" after LIS to avoid redundancy?


comment:
The first bullet repeats the step. Delete the first bullet?


comment:
On the stool specimen slide: delete "causes" x 2 so that the bullet text flows from the intro sentence? If so, cap "Intestinal" and "Loose"


comment:
Delete "Causes" from beginning of each bullet? If so, cap the first word after the bullet as needed


comment:
"minimize time between collection" seems to be incomplete. Should the text say "minimize time between collection and XXXXX"? (where the Xs are a placeholder for the missing term)


comment:
Check the wording of the second/middle bullet. Change to "Use the appropriate collection devices. Specimen containers help ensure optimal recovery of microorganisms." 

OR should this be "Using the appropriate collection devices and specimen containers helps ensure optimal recovery of microorganisms."


comment:
In the third/righthand bullet, delete "must"?


comment:
If you define LIS earlier per earlier query, simply say LIS here?


comment:
"wearing protective clothing to protect" is redundant

delete "protective"

OR

delete "to protect lab staff from specimens containing pathogens"?


comment:
If "presumptive" is another way of referring to a preliminary diagnosis add commas to clarify that and delete the double quotes:

a preliminary, or presumptive, diagnosis


comment:
As written, readers could interpret message for correct answer to mea that the size of the specimen impacts the collection device and transport conditions. If that's not correct (and I think it's not but I'm not sure), I suggest rewriting the correct answer message as follows:

"Good thinking. The size of the specimen as well as the collection device and transport conditions all impact the quality of the specimen. Click continue to keep following the sample."


comment:
Correction to earlier query: 

"Good thinking. The size of the specimen as well as the collection device and transport conditions all impact the quality of the test. Click continue to keep following the sample."


comment:
Should step 7 be capped as "Step 7" because it's a specific step?

Should the first word in "streptococcal pharyngitis" be capped and should the term be italicized per convention for bacterial names?


comment:
Does more than one microbiologist do the workup? If so, correct as is. If not, change 
microbiologists'
to
microbiologist's


comment:
I can't seem to get a correct answer for this question. That might be because I don't know it :) I did try to methodically guess all the possible options.


comment:
Nevermind. I got the correct answer so I could review the rest of the course. Apologies for any confusion :)


comment:
logged in is a phrasal verb. Also, see global query about articles. Change "logged into patient record" to "logged in to the patient record"?


comment:
If you want to be super technical about the first bullet, the clause beginning with "which" should modify medication, not pharmacy. I think the sentence is okay as is, but you could rewrite as follows: "After the clinician orders the selected medication from the pharmacy, the medication is administered to the patient."


comment:
After background, change the comma to a period. Cap "Then." I would delete "let's" because it's not necessary, but it's technically correct and I can see how that word might be part of the tone you want for the course text.


comment:
In the graphic that appears in Step 7, should "gram" in "gram negative" be capitalized?


comment:
In the graphic that appears under Step 9, should stain in Gram Stain be lowercase? Should gram in gram negative be capped?


comment:
change "chapter three" to "chapter 3" for consistency? Also, cap "Chapter" before Chapter 3 and Chapter 2 per earlier query?


comment:
do we need a reveal subtitle (other than/better than 2.0)?


comment:
if amperase does not eliminate false negs then this is technically false...


comment:
its"is" the first to market as it has already launched


comment:
I think this question could be worded better?


comment:
is it possible to change the setting on this part?  having taken the previous reveal it feels too familiar.


comment:
s/b "Flu A/B, RSV"  Also confirm if RSV is stand alone or Flu A/B + RSV


comment:
Can we really run IVD and LDT "at the same time"?


comment:
this could be clearer/tighter on what exactly the xpress issue is.


comment:
To be consistent with the next course, let's capitalize "Standard" whenever it appears.  Can hopefully just do a search and replace.


comment:
I'd rather just see the text all in the same size font and unbolded.


comment:
For the hyphens on this page, make sure there is space before and after.  The one in the paragraph appears as a solid line that starts right after the "t" i incident and the one before Karen's name is two dashes without a space.  Need to be consistent.


comment:
Need to re-name the page in the menu/eliminate the video reference.


comment:
Add to Field observer "...to the Sulfuric Operator or Sulfuric Production Supervisor during ..."


comment:
For Sulfuric Production Supervisor, change "I need to follow the procedure" to "I follow the procedure..."


comment:
When I clicked the Resources button on this screen, as it transitioned back, our learning agent appeared on the right side of the screen for a moment, then disappeared.


comment:
Per Leanne's previous feedback, let's change the language on this screen (and in the menu) to reflect "Quiz".  Maybe also bold the instructions that "You need to get all the questions right to pass"


comment:
Attach/Use David's standard document here.


comment:
Whenever I click the resources button and return to the screen, the Learning agent appears on the right side of the screen.


comment:
When I returned to this screen, too, the next button was available for me to click.  When I did click it, it disappeared.


comment:
When I clicked the resources button on the previous screen and came back, I saw the LA and the next button.  Clicked the next button and it actually took me to the next screen so I didn't have to answer question 3.


comment:
When I clicked the resources button on this screen, it didn't open.


comment:
Change language here to reflect Quiz, too.


comment:
After not passing the quiz, I still got the next button, which worked, and took me to the Wrap up screen.  If they have to re-try the quiz, the PREV and NEXT buttons should be hidden.


comment:
Change Knowledge Check to Quiz on this button.


comment:
The checklist link did not show the checklist. It went to the BLP page and said page not found.


comment:
The subtopics in Help were not in smaller font than the headers. I had to select Shift/F5.


comment:
The Header column lines in the Role table do not align with the content column lines.


comment:
In global button section #4 is Report Examples but the global button is Print Reports.


comment:
In the Certificate area, the second bullet needs a comma. Change to "To create a certificate, type one name or multiple names separated with a comma."


comment:
In Certificate area, the third bullet needs a period.


comment:
The pencil icon is only successfully displaying for the first activity.


comment:
For Hardware Component Label activity, if is necessary to instruct them (in step 1) to gather the labels for the modules in their configuration?


comment:
In Software Review Activity, remove the bullet point in front of Index cards... and move the line up to the top of the box.


comment:
Workflow Guide Review Activity - remove bullet in front of Index cards... and move the line up to the top of the box.


comment:
Note icon is not displaying properly for the "Putting the Analyzer to Sleep with Wash Rack (Non-24 hour operation) activity.


comment:
In the Note for the "Putting the analyzer to sleep...) activities either have Daily Pipe or daily pipe throughout. (consistency with having it all caps or all lowercase)


comment:
Schedule Calibration and QC activity - change list to List in the Materials Needed section.


comment:
Schedule Calibration and QC - ensure "Calibrator and QC Load Lists" is used throughout. Currently there is a mix of capital and lower case.


comment:
In the Operator Notebook, Request Calibration and QC is used instead of Schedule Calibration and QC. Recommend to change Activity name to match Notebook.


comment:
Change to Calibration and QC Load Lists throughout. Stay consistent with upper case.


comment:
Reviewing Calibration Reports/Alarms and Remedies - I would recommend adding Operator Manual/User Assistance Tool to the Materials Needed section.


comment:
Manually Requesting QC activity - In the Notebook, the section is called "Manually Requesting Controls". Recommend changing the activity name to match the notebook.


comment:
Finding Key Information Activity - change Operator Manual to Operator's Manual.


comment:
Ensure Operator's Manual is used instead of Operator Manual.


comment:
Daily Maintenance Practice - Should the instructions have the facilitator demonstrate the maintenance first and then have the participants practice?


comment:
Alarm Screen Exercise - step 2, should "for an alarm" be deleted at the end of the sentence?


comment:
Resolving Data Alarms for Sample Results - change ReageEx to ReagEx.


comment:
The upfront disclaimer and safety info slides would not let me add comments so I will add here:
For the disclaimer- why does it say device data is fictional? 
For Safety Information- Should just say Important Safety Information as the title and we will need to hyperlink the PI at the bottom. The check box was pre-checked and will need to be unchecked so the user actually has to acknowledge. Also we will need a link out to the page on MDT that houses the manuals and all safety information. Think a MDT course had this language already in it that you could pull from.


comment:
I think we either need to delete bullet 4 or we need to go back to the first module where we updated per MDT legal review.


comment:
Resolving Data Alarms for Calibrations - I would recommend adding that additional data alarms will occur with the Std.E alarm.


comment:
The patient data on the video goes very quickly. If we are having this included should we leave it on screen for a couple more seconds? Or if not required for the learner to read should we remove it and just have her picture there?


comment:
Should we add the word chilled to the screen text? This is kind of an important component in gathering supplies that they need to chill the drug and we kind of just gloss over it.


comment:
Installing QC - since the information is not in the Operator Notebook, should the Operator's Manual and User Assistance Tool be included in the Materials Needed section of the activity?


comment:
I thought we discussed the pump location being at 9:00 not 12 or 3? Depending on what side of the body. Is this pump being moved to the other side in final animation?


comment:
According to the list of topics for the Bench Tech Role in help, the Configure Calibrators and QC topic is not covered. It is selected by default on this screen when Bench Tech Role is selected. Recommend it not be default selected.


comment:
cobas c 513 analyzer is listed twice in the first paragraph.


comment:
Recommend reformatting "Roche Diagnostics 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457 1-800-428-2336" the information is breaking at strange places. Recommend Line 1 - Roche Diagnostics Line 2 - address Line 3 - Indianapolis, Indiana 46250-0457 Line 4 - phone number


comment:
Does COBAS E need to be listed since this is a chemistry analyzer?


comment:
Change "All other trademarks..." to "All other product names and trademarks are the property of their respective owners."


comment:
Agree with comments. We need to be clear that a fill is not 20mL and that if you are using a 20mL syringe you WILL need two.


comment:
Disregard my comment about Bench Tech topics. It works correctly. I did not select the Confirm Role button after making my selection.


comment:
Add test alarms or what to do if they hear one?


comment:
agree, feels repetitive. Should we add something about importance of tracking refill accuracy and why? Are these truly the best practices for refills?


comment:
Perhaps add "You can also ask an ICF Template Owner or ICF SME".???


comment:
Add to Quality Review Checklist: This is used to ensure that all required elements are included appropriately in the ICF.


comment:
TCED: change "protocol" to "standard template language"


comment:
When I landed on screen the pop up for critical alarm was already open. Should this be open or does the user have to click on it to have the pop up appear? Strange user experience.


comment:
I agree with TLM about the Risk Profile comment.


comment:
The rationale is not appropriate based on the issue with the revised language presented earlier.  The suggested change is to replace "regulatory authority" with "sponsor".  Due to international privacy commitments, we need to ensure that study participants understand that study data will be sent outside of their country.


comment:
The change is not appropriate.  The proposed revisions needs edits in order to be acceptable.


comment:
I just realized that this is an outdoor shot.  Can you add safety glasses and ear plugs to our people who are outside at the plant?  I will comment on the screens that need this.


comment:
need safety glasses and ear plugs on all three people.


comment:
We need to delete this slide.  It should be the video.


comment:
The Countdown to Startup video.  Same as for approvers.


comment:
In the Sulfuric Operator box, change "make sure" to "makes sure".


comment:
For the guard text, change "traffic into the plan" to "traffic into the plant"


comment:
Jen, I would love if this gal talked some. And then she could say this and then just have a couple of pull quotes to support what she's saying. I don't think she has to talk on each screen, but she could talk on some of them to make this feel like a richer experience.


comment:
in the SAP Startup popup, change "Unsafe" to "unsafe" (lowercase).


comment:
For GM feedback, I'd like for you to get this cut down a bit. IT's a really big block of text


comment:
there's something wrong with her mouth? the black circle over it is covering up her lips?


comment:
instructional text should be above prev/next, yes?


comment:
I think it's click each area in the instructions


comment:
Let's bullet some of this wall o' text.  Change to:

If the stack SO2 is greater than 1000ppm, there are safety impacts to people on the ground. A warning sounds plant-wide on the PA system interlock, and operators take corrective actions such as:
* Reducing sulfur flow * Increasing blower * Verifying acid flows on towers * Verifying damper position (new paragraph) The operator also looks to see if the SO2 ppm is going up fast, going down fast, or remaining steady to help inform decision-making.


comment:
shouldn't click next be under the prev/next button?!? This was the big issue they had with course one, yes?


comment:
It still makes me do this activity again when I return to it.  The screen says "click next to continue" but it won't let me.


comment:
your incorrect feedback on this question only mentions temperature but it's used for all three incorrect options. You need to make it more broad


comment:
there seems to be no right answer - i have clicked all four and can't get past this question


comment:
this would be a good place to have her talk, and use thumbnails of the activity to explain. They'll never read/remember these instructions. At a minimum, the "using your resources" bullet doesn't make sense


comment:
For the "use checklist and observer" popup, need to add a hyphen in pre-startup (1st sentence).


comment:
Ideally, we should have used an image on these screens to explain the issue. Could we at least have some inaages of the wind/stack and what's happening to the SO2?


comment:
Even though it says click next (after I've completed this), I still have to click the last box in order for next to activate as an option.


comment:
I have all checkmarks and screen says click next, but I can't -- it's not active.


comment:
In the Simulator Task list, bold cobas c in the Unload/Load cobas c packs.


comment:
Have either Daily Pipe or daily pipe consistent throughout the program.


comment:
A small matter: the Word .doc for this course (under Resources) seems like an exercise rather than an outline meant to facilitate note taking. The text on this screen indicates that learners should use the .doc to take notes. Also, I found a small punctuation consistency error in the Word .doc. I'll send the doc, with my comment, to Jen C. via email.


comment:
The Topic on the previous page was Daily Checklist - Your Lab but the top of this page says you have selected "Work in Your Lab". Shouldn't these be the same name?


comment:
Does the learning agent need to be wearing eye and ear protection in this setting?


comment:
Why is the Daily Checklist - Your Lab included for both the Key Operator and Bench Tech. Is it a topic that is only covered for someone who has attended training at Indy (I am assuming this is the Key Operator)? I would not think it would be used for someone who would be only trained onsite (Bench Tech). I would think the Bench Tech would only be trained on the Daily Checklist topic.


comment:
In the Recommended Activities section - remove "you" from the first bullet.


comment:
Question 1 - add analyzer behind cobas c 513.


comment:
Do these learning agents need protective eye wear and ear plugs in this setting?


comment:
The menu still makes no sense with the modules that are in the course. Ha-Trang, I encourage you to reach out to Nick for help setting this up quickly this afternoon if you need it.


comment:
Update to:

* Click each building (building image from map) and person you want to talk to  * Review the information  * Click the file cabinet (icon) to review the Standard  * Click "I'm Ready" when you've made a decision about startup


comment:
The subject line of the email currently is "COBAS 513 Onsite Training Facilitator Guide Info:" Please change to "cobas c 513 analyzer Onsite Training Facilitator Guide Info:" and be sure to bold cobas and c.


comment:
The last sentence of the correct answer text box is missing a word: "They also use their phones/radios and information from the Sulfuric Operator TO approve startups when required."


comment:
When I click PREV from this screen, it doesn't go back.


comment:
For the sake of concision in the correct answer text box, revise sentence two to read: "While the Guard does provide information about visitors to the plant, that information does not impact startup."


comment:
If I click on the Guard himself, he changes into a different illustrated character.


comment:
For consistency across the course, should "guard" be capitalized each time it appears in the text box?


comment:
Change series to analyzer in "Point out the core hardware components of the cobas c 513 series". Also in this area, it states Sampling Unit but in the Operator Notebook on page 9 it it the Sampler Unit.


comment:
Will need to review once the lableing is FDA approved


comment:
In the answers for Question 1 on this screen, Granulation still looks like it's not lined up correctly with the other bullets.


comment:
Is it Cell Cleaner or cell cleaner? The Operator Notebook has Cell Cleaner for both 1 and 2.


comment:
this is a really misleading placeholder given that this is a 10 minute module. I'm not sure what you have time to do at this point, but it's almost as if we need to deliver this module in its entirety when we deliver the rest of the course.


comment:
For all of the "Put it all together" section - make sure the headers are using mixed case.  Some are caps and some are mixed.


comment:
In the second pop-up text box (for "Is Stack SO2 > 1000ppm?"), replace "that" for "where" in first sentence: "The Sulfuric Operator monitors levels of SO2 at the stack and the Field Observer monitors SO2 levels at the point *where* he's located."


comment:
Final sentence of fourth pop-up text box (for "Is Stack SO2 > 2000ppm?") is missing a word: "The Field Observer calls the Production Supervisor to have THE plant shut down if levels are too high where he is."


comment:
Should there be the same number of items in "Describe the purpose..." as the index cards in the activity? There are 3 additional items in the activity that are described during the training (Timeout QC, Start Up Calibration and Min).


comment:
Does prinitnig of reports include printing of device log?


comment:
In the pop-up text box for "Instantaneous interlock to shut down sulfur flow & blower: Contact supervisor": second bullet point is in passive voice ("Supervisor is contacted"); should this bullet point be in the active voice to indicate *who* should contact a supervisor?


comment:
Does this learning agent need eye and ear protection in this location?


comment:
Typo in box labeled "Is it morning or evening s[h]ift change?"


comment:
Pronoun inconsistency in pop-up text box for "Supervisor or above has approved?" Sentence one: "The Production Supervisor is the startup approver; the plant cannot startup without *his or her* approval." End of sentence two: "...and cause *him or her* not to approve it." Alternative: Just use "them" in second sentence.


comment:
Typo(?) in box labeled "Use checklist and observe[r]"


comment:
In Pre-Startup Checklist Requirements pop-up text box: Should question marks follow bullet point 6? Toward the bottom of the box, text should read "Other site-specific, critical parameters (plant checklist, etc.)" Note addition of hyphen, commas, and making "checklist" one word.


comment:
Throughout the course we use "start-up" and "startup" interchangeably. Is one or the other the preferred spelling? I would vote for "start-up" or just "start up" in most cases.


comment:
The YES is missing from the arrow connecting "Supervisor or above has approved?" and "Use checklist and observe".


comment:
Remove the comma between "go" and "in" in the sentence "Using the High SO2 Start-up Procedure is the only way to go, in order to keep everyone safe."


comment:
Update to "Click each building (building image from the map) and then each person you want to talk to"; sentence currently suggests that clicking on a given building allows learners to talk to said building...


comment:
Does the learning agent need eye and ear protection in this setting?


comment:
When I click on the Field Observer himself, he becomes a different illustrated character.


comment:
Revise "These are the people that work here" to "These are the people *who* work here." Bullet points in question 1 are smaller than those in question 2. Orange Question 2 text box appears to be clickable when I hover over it, but it's not clickable.


comment:
When I click on the learning agent, he turns into a different illustrated character.


comment:
Not entirely sure about this recommendation, but consider revising "Select all that apply" to "Select the information that your GM or Sulfuric Area Manager will need to know."


comment:
When I click on the Guard himself, he becomes a different illustrated character.


comment:
On the certificate screen, there is no X to click to exit the course.


comment:
Being able to click an option of either True or False would make more sense, even if the response is the same.


comment:
It should be more intuitive of what I need to do/click on this screen


comment:
The numbers on the desk help reinforce there are "5" best practices


comment:
This needs to be more than a click in the right place activity.  Consider a video or something to help visual learners.


comment:
Consider having a consistent # of bullets on the Ask yourself? Some have 2, others 3


comment:
Instead of Round 1, consider a matching activity between best practices and definitions to make it more interactive. Maybe even have a green check to appear if you have it right and red x if wrong and allow you to move them around until you get them all right.


comment:
Explain why people got their answers right/wrong.  Reinforce learning


comment:
TROPHY SCREEN - Different message based on # misses/correct answers? We need to review these statements to make sure they make sense. We missed 4 and the statement had something to do with timing, which made everyone wonder if they were being timed...and then they wanted to see their time. :)


comment:
Ensure it is Reagent Load/Unload Lists through out the program.


comment:
Should the simulator task be Activate Preventive Action instead of Deselect Preventive Action?


comment:
Last bullet for RDU task should be a new line and not included with the simulator tasks.


comment:
Question 3 - Recommend changing run to print.


comment:
Shoudl (if required) be added to the Objective "Address Downloadable Calibrator Found alarm" since it may not always occur?


comment:
Capitalize Workflow in the "Explain when you may be required to backup and delete data..." step.


comment:
Ensure Reagent Status List is used throughout. There were some instances that it was Reagent Status list.


comment:
The "Clean the Cell Wash aspiration filter(s) with deionized water" step in the Replacing detergents and updating volumes is not listed in the Operator Notebook.


comment:
Is it simulator or interactive simulator. Make the same throughout the program.


comment:
Objectives - Shouldn't it be Clean not Check the probes and reaction cell rinse nozzles?


comment:
Ignore edit regarding Checking the probes and nozzles.


comment:
Questions 2 and 3 - change Technical Support to Customer Support Center.


comment:
Change to hands-on maintenance throughout.


comment:
In "Explain that the Daily Hands-on Maintenance..." change to reaction cell rinse nozzles.


comment:
ensure it is Reaction Cell Rinse Nozzles throughout program.


comment:
Should wash rack be added to the required materials for the Maintenance practice activity?


comment:
Ignore comment about adding wash rack to Maintenance Practice.


comment:
Recommend changing Initiate to Start in the Objectives to match Operator Notebook.


comment:
Should "Select the global Start button to display the Start Conditions screen"  be deleted from the "Demonstrate how to review the calibration and QC results..." content?


comment:
Prepare and Load Calibrator and Controls Activity uses the term package inserts but the content uses instructions for use. Recommend using the same term throughout program.


comment:
In the RDU simulator task area, capitalize the C in calibration or calibrator to match the simulator task list.


comment:
Recommend to use the same format for the RDU simulator section. "Perform the following task on the simulator: Load sample racks and initiate run."


comment:
Is it possible that someone would miss the Learning Checkpoints in the RDU section because this topic did not apply to their lab so they skipped the content?


comment:
In the Jump back to section... shouldn't it be Subtopics for Daily Checklist Basics not Maintenance?


comment:
Delete second bullet of Show a reagent package insert since it applies to the calibrator package insert.


comment:
I would recommend moving the "Where you can view package inserts - cobas® e-library or USDiagnostics.Roche.com (US only)." to be the first action and add Show to the front. "Show you can view package inserts - cobas® e-library or USDiagnostics.Roche.com (US only)."


comment:
Should "Explain that the Calibration Status screen is also used to schedule calibrations" be "Explain that the Calibration>Status screen is also used to schedule calibrations"


comment:
In the manual request calibration steps, bold Explain in step 5.


comment:
Make the RDU simulator activities the same format, "Practice the Manually requesting calibration task on the simulator".


comment:
I don't think questions 2 and 3 apply to this topic.


comment:
Page 66 of notebook refers to Active instead of current reagents. Recommend to change so matches the notebook.


comment:
Recommend in the "Explain that when viewing QC results..." include the screen name so they know where there are at.


comment:
Move "QC Result Chart" so that it is in line with Test, Details area and Color scheme. It should not be indented under Color Scheme.


comment:
Is this where the Get Ready for Training access question should be located? It seems out of place in this section.


comment:
Change the RDU simulator format to match other sections. Change to "Perform the Manually requesting QC task on the simulator."


comment:
Is it correct that they should complete the Data Review Learning Checkpoints? I thought that would follow the patient processing section.


comment:
Review and approve I F using an approved TPO template : that's not correct to me or needs clarifiations as we are using Lilly affiliate counrty specific ICFs templates


comment:
Sequence of button is not very smooth and not working (I had to go back several times before beeing able to "rate myself")


comment:
To confirm with SMEs:"you will be handling a lot of country-level ICFs".
Would someone only handle country-level ICFs? Do we need to specifiy that or say "country and site-level ICFs"?


comment:
add what "other information" this may be?


comment:
Where the ICF country-specific templates can be found isn't really mentioned in thsi conversation. Should the new site manager start with syaing "I know where to find my country-specific ICF template"?


comment:
In the instruction:
Let's explore a country-level ICF template"


comment:
textbubble: CS-ICF template. I think we used the abbreviation earlier in the course, so it's ok to use it here?


comment:
Voice over should say country-specific ICF instead of the abbreviation CS-ICF. That's my opinion :-)


comment:
I clicked on the Negotiations Guidance doc and it let to the Communication Tool


comment:
Again, NGD opens up to communication tool


comment:
Would an ERB address the site manager by 1st name?


comment:
Again we wouldn't be on 1st name terms with Regulatory Authorities


comment:
Please change language on exiting the course to prevent technical issues with the SCORM files.
Change last sentence to:
Exit the course, review any associated supplemental material when applicable, then click on the electronic acknowledgment to receive credit.

Alos remove the "Next" button from this screen.


comment:
Should the "Cup on tube and 100 mm tubes are not supported on the cobas c 513 analyzer." note be a note that should be stressed in this facilitator guide?


comment:
May want to add a note stating that only the first part of the slider is functioning for the DP. Unless the rest of the slider should be working (I can't get it to move on my end).


comment:
After the first module, I could not get the second modules to open upon returning to this screen (may have something to do with the slider issue I had).


comment:
Could you add the following note to Citizens somewhere on this screen? "Note to Citizens: Can you provide a number of how many customers you serve for each product/service?"


comment:
Could you add a period at the end of the first benefit sentence?


comment:
Kristen may disagree but is there any way to possibly make it so the audio doesn't replay upon returning to a screen when re-trying? Kristen, thoughts on that?


comment:
Clicking on the Resource icon doesn't got to a Resource window as it should but immediately launches the Standard document.


comment:
It is the same feedback for the Notes and Glossary icons as I gave for the resource icon


comment:
Interactions and Prev/Next buttons don't work correctly if you go forward and then back to the page. I would have expected that the role you selected would have stayed on the screen when you clicked it. Will most likely need to discuss.


comment:
clicking on the field observer takes you to the information on the approver


comment:
I don't think you should give instructions on this page as to what to do and the next page.


comment:
Question for Adriah: Truck Drivers don't wear PPE? Not even gloves? 

Question for BLP: can we add this shirt, pants, and hat to our character library? Please? I'm assuming we already have the guy! Thanks.


comment:
Should the key point be bolded or underlined to encourage attention and retention to the critical information? 

Love the new faces! I would love to have them too. :-) 

Adriah: Should they have PPE?


comment:
Would like to see the feedback given without the pop up hiding the options and something like green checks on the correct and red X on the incorrect. If I return to the page the selection options are hidden the way it is designed right now.


comment:
I want him too! :-) 
Same feed back as no the previous page. 

When developing the training please make sure to retune to the page after it has been visited the first time to make sure the page content still make sense.


comment:
Please check to make sure all the prev/next buttons are visible when they should be and invisible when they should be. I think that anytime there is a "continue" (Which should a return icon as described on the Help page) there shouldn't be the prev/next buttons.


comment:
continue button isn't working as I would have expected.


comment:
Adriah: is the PPE right for the field observer? This is a minerals looking image in the background, so I'm not sure it is a correct image for the Field Observer. That would be way downwind. Should he be holding a respirator (which one?) in his hand. Should he be holding a SO2 looking monitor in his other had?


comment:
Prev button doesn't take you to the correct place. It should be a "go to page" but it is a "return to the last page visited"


comment:
Prev button isn't taking you to the correct place. Program needs to change on this page. The starting question is wrong as well. Wording needs to be corrected - What do you do vs. what do you ask.


comment:
Programing on the "How can you tell?" questions associated with the Has the plant been down for >30 minutes needs to be corrected. It looks like you can "try again" but it doesn't let you when you get the incorrect answer. I'm now stuck and can't continue.


comment:
Should the order of content be reversed to match the order the content is in the operator notebook? Explain the maintenance types first and then the screen. See pages 94 and 95 of the operator notebook.


comment:
Determine case used for maintenance log and be consistent throughout program. I have seen it all upper case, all lower case and also mixed case.


comment:
An additional reinforcement activity could be page 96 of the operator notebook.


comment:
Should it be Sample Probes instead of Probe?


comment:
Change cell rinse unit nozzles to Reaction cell rinse nozzles (per page 96 of operator notebook).


comment:
BD is bringing a new POC with Veritor but it is not molecular it is immunoassay and it is for Influenza, RSV and Strep. I though it was out of training focus. Lets check as a team


comment:
where do I move next? no continue button


comment:
last stop of the slider, can we bring up a green "wrap up" box like you use in Mod2? Something that lets us say "Learners review key points of the module before they move to Module 2."


comment:
instead of video goes here, let's use: "The course opens with a shortened version of the video from your website, meant to engage learners."


comment:
can we have "Click Next to continue." in green at the bottom of the screen, under the player? These people feel too new to elearning not to have directions (sadly)


comment:
needs to say "Learners see a map of Citizens... "


comment:
Can we find the name to the natural gas company for the first popup? (Sorry, should have caught that earlier.)


comment:
can we put the right answer in bold "(2014)" on the cards that don't have an actual description? Probably going to help them out. :)


comment:
for "real" card say "The company formed early, focused on natural gas. But the natural gas fields failed and focus needed to shift."


comment:
Slider doesn't work, so no next button. (Graphically, I love this page!)


comment:
I'm wondering if these boxes should be bigger so we could have pictures? If we did that, they would have to close them which would add some clicks. But I love what you did on the next page with the old pic and text, so I'm sorting thinking about it here. What do you think Matt? Too much work?


comment:
the screen likely needs to reset when I click back. I can't see the map you worked so hard on unless it does.


comment:
can we add a magnifying glass to the images and let you click to enlarge? (I'm cool with it opening the actual PDF in a new window) - you can't read anything when they're this small.


comment:
probably should mix the dropable items up a bit.


comment:
Recommend "Explain that for reagent masking, an individual reagent cassette can be manually masked.
Show the pink bar that is displayed on the test key on the Workplace > Test Selection screen." bullets be indented under the second bullet. See Operator Notebook page 102.


comment:
Should there be an explanation on how to use page 107 of the operator notebook. Is this an activity that should be added?


comment:
Ignore comment. I found the info in the next section.


comment:
is text bolded in correct feedback box for first answer?


comment:
yeah, if we can let them choose replay, that would be good.


comment:
we need to add a note that says "Audio is placeholder only."


comment:
can we make the font all the same size on the responses? otherwise it clearly becomes "one of these is not like the other one..."


comment:
along with the audio replay issue, when you try again, can the answer options just be in place?


comment:
Should the statement "If damaged, replace the S2 CTS probe." be added to results for controls on the S2 CTS probe also affected? "If yes, then clean the S2 CTS probe."?


comment:
we need one of the distractors to be as long as the right answer - so to bubble 1 add "Those employees can help us better help you."


comment:
Recommend using the same format for the RDU simulator task from other topics. Example "Practice the Manually add a new lot number of QC task on the interactive simulator."


comment:
The Configure Calibrator section provides the steps to download a Roche calibrator. Should the same type of information be included here for downloading or manually installing QC or maybe referring to the Operator's Manual?


comment:
The simulator task of Deleting reagent log information for calibrator is listed in the RDU tasks but I did not see the content above.


comment:
I think we need another screen after this that has like the departments at Citizens. For now, it can just have like a blank org chart that says "Learners review more about the structure of the company, exploring the different departments that support Citizens products and services." Then there should be a "Note to Citizens: What additional information should we include on the company structure? Is there an org chart we could simplify and use?"


comment:
menu is a little funky if I skip around. It like starts over on displaying what I should click next.


comment:
I don't think that section north of the city should be highlighted when it's beneficiaries.


comment:
is there any way to enlarge the map so you can really get a sense of it building?


comment:
after they complete the exercise, can we again get that green summary box? Maybe anchor it to the right side - and copy verbage from Mod 2 box as needed.


comment:
after they print, have the same "summary" as in the other modules appear on the right.


comment:
transcript -  "whatever the plan is, it is important..." (right now it still says its before the word important)


comment:
audio cuts off before finished. It says "we will get started. you decide how you" and never completes.


comment:
I believe continue directions likely need to say "Click Continue to get started."


comment:
text bubbles on this screen are in the same spot.


comment:
bubbles are aligned here and I don't think they should be


comment:
This can't be the right feedback. I selected "Good to hear. Sounds like you have things covered." and then "Yes. Janice needs to contact the customer" and wound up getting 6/6 and the "great coaching" feedback. I can't exactly tell from the spreadsheet, but it seems like at most I could have scored 2 and should have gotten something that says "That was some poor coaching!
Good call on having Janice follow up with the customer, but she still does not understand the importance of talking to the right stakeholder."


comment:
I know I've done this activity multiple times so I could test the branches, but I think there may be a bug. It's telling me I scored 8 of 6.


comment:
the little progress bar on the VM gets to the end before the audio ends.


comment:
Explain section: Questioning the following statement: Allowing reagents for the cobas c 513 to be loaded while the analyzer is in Operation or Stand By mode. If you look at assessment question #1 it states the reagents can only be loaded in Standby Mode.


comment:
same scoring issue here - I'm able to exceed 6. I'm going to guess this might be a global thing.


comment:
Explain section: Enabling the following tasks to be performed while the Daily Pipe is occurring: Process green rack, prepare calibrator and controls, record photometer check values, load calibrator and controls, initiate the calibration and QC run, review calibrator and control results.  If the Daily Pipe is occurring then initiating the cal & QC and reviewing the results would need to occur AFTER the Daily Pipe has completed...


comment:
Seems to be a lot of the word "select" especially on the one that reads "select the select button". Could the word CLICK be used instead of select on this page?


comment:
redundancy of the word "select" again particularly where "Select the select button" is used. Substituting the word "Click" for the initial "select" throughout would read better.


comment:
"design standard" should be  "design requirement"


comment:
"design practice" should be "design requirement"


comment:
design standard change to design requirement


comment:
design standard change to design requirements


comment:
Resources "tab"

change "Business Practices Models" to "Business Practices Manual"


comment:
change to "I am part of the MISO Transmission Expansion Plan process."


comment:
Headings

Competitive Transmission Executive Committee
Competitive Transmission Administration Department
Interdepartmental Evaluation Team member

Delete Variance Analysis Team


comment:
Competitive Transmission Administration change to Request for Proposals


comment:
"right team" should be Competitive Transmission Administration department


comment:
change "proposals" to "transmission projects"


comment:
"details of proposals" change to "transmission project details"


comment:
Remove "Additional Communication Protocols"  the document indicates it is a draft document


comment:
"reach out to Competitive Transmission Administration management" rather than Client Relations


comment:
I'd update the graphic that says "Add Unique Course Title" so you can actually put the course title in text. Maybe have HTP photoshop out that text so it can be added in Storyline.


comment:
Maybe rename this "Module" in the provide feedback tool to something like "Top Nav Screens"...Andy had a comment in Alpha about the feedback tool not linking to the correct pages.


comment:
The "Return" button text for the popup when I click the 4th button goes over the bubble text some...also, I'm assuming there's a reason we chose this back arrow versus a close button (x), if so, cool, if not, I think an x would be better....feel free to ignore this.


comment:
The group of people on the right are much lower quality than the other clickable people.


comment:
There's a fade slide transition here, the transitions should be consistent for all slides...to fade or not to fade, we need to pick one and stick with it.


comment:
I think these people should have a hover state...maybe just make it semi transparent (like lower the transparency to like 90%) so there's a slight change when you mouse over them.


comment:
I think you should move the character here, so the "Click Next to continue" text can be in the same place per the Alpha feedback.


comment:
Nice to have, change the stroke color on the 2 black boxes to a lighter gray, so you can see the seperation of the boxes.


comment:
Nice to have - Would it be possible to scale the green box smaller (you should be able to select it and press shift+up arrow) and potentially the top red box enough so the "Click Next" instructions don't overlap the green box?


comment:
Again, I'd move the character so the "Click Next" instructions can be in the exact same place re: andy's alpha gripe.


comment:
Somehow I got to a "Quiz Results" screen with nothing on it...I got stuck... "https://www.dropbox.com/s/t1l9u1bguns2can/Results01.png?dl=1", "https://www.dropbox.com/s/ow6uhkncvlkkbyz/Results02.png?dl=1"


comment:
Also, I'm pretty sure I got every question wrong, and it said "congratulations"...I failed....badly, check your logic.


comment:
There is no previous button here...I guess on this "congratulations" screen, you might have a previous button that takes you to the "try quiz" screen.


comment:
to get this page with nothing, I took the quiz, failed (it said congratulations though), then used the menu to go back to the quiz, I can no longer submit answers, instead I have next/previous buttons, and when I next arrow through the quiz, I get a blank results screen.


comment:
Should users be able to retake the quiz? I think so, but am not sure. If so, on this quiz intro screen, you probably need a "reset results" action, for the results slide. This would allow users to retake the quiz, and would probably fix the issue where I get a blank results slide.


comment:
Just posting one, on quiz questions, if I take it and come back, it's answered, and I can't change it and see my feedback. Consider my "reset results" edit.


comment:
I'd remove the quiz question slides from the top-left menu dropdown.


comment:
This screen doesn't have "Click next to continue" text when you're done, is this ok?


comment:
NOTE section: last sentence..."Processing of the green wash rack at the Daily Pipe both need to be performed daily" should be "and" the daily pipe not "at"


comment:
There are more items that are highlighted in rooms 1 -3 than is mentioned. Is this what is supposed to be?  I see that the items are highlighted but there is not text or sound?  What will the viewer get out of clicking on an item and there is no interaction as a result? Applies to all 4 rooms


comment:
Need to delete "a discuss" as its not necessary.


comment:
Please see this alternate language " The site you are considering for the trial requires a refrigerated centrifuge.  The study coordinator tells you they currently don't have a refrigerated centrifuge for the trial. What do you do?


comment:
bubbles are in same line here - believe they should be staggered?


comment:
audio clips are a little too close together.


comment:
its should be it is in Bob's response on this screen.


comment:
"got" is missing in the coach's text box.


comment:
I got 2/6 on Bob at the end and an "oh no" message from the coach when I got back here. But it showed his confidence meter was at 100%. Seems like that can't be right.


comment:
I selected both red answers - and I still got here. Per the spreadsheet, my feedback should have been "That was some poor coaching!
You need to coach Bob, not do his job for him. Use questions to guide Bob to the correct response. And contacting the customer is Bob's responsibility."


comment:
I somehow got 3 points when I selected both wrong responses. Per spreadsheet, I shouldn't have had more than 2. (And I really would guess I should have had 0)


comment:
on third attempt, I got stuck here. no continue button ever appeared when i put the follow-up item in Friday.


comment:
on replay of exercise, I now have 8 points.


comment:
I choose the yellow option, then the green and got the wrong feedback. Per spreadsheet, this should be "You can do better.
Your message is good, but your approach is off. Do not be so directive. Use questions to get Bob to come to the right conclusion, instead of telling him what to do."


comment:
when you select No - need to change "isn't" to is not in blue text box with try again feedback.


comment:
I thought we agreed to take this process-review out of the course? See line 7 of the alpha-feedback spreadsheet.


comment:
1st question - pop-up:
... may influence study participant safety (instead of care)...?


comment:
Study participant safety instead of "Participant safety" 
(in 1st pop-up).
You can then ignore my other comment as we then mention study participant safety twice.


comment:
adjust the size of the pop-up boxes to the text


comment:
Is it ok to say "lab", or should it be spelled out as laboratory?


comment:
4th pop-up, 2nd paragraph:
I would rephrase to shorten the sentences:
If a site will perform required laboratory testing for a trial at another laboratory, they (? who is they? the site evaluator?) must collect the name of the laboratory. Further documentation will be reqiored, as appropriate, during site activation activities.


comment:
VO:
... last sentence: It is important in the overall assessment...


comment:
VO says more words here than written in the audio transcript. The VO is correct, but want to point it out to ensure the proffesional audio doesn't miss it.
"That shouldnt be a problem at all. Please remember that you are responsible for making sure that Specialty Scanning has documentation and can produce it on request. "


comment:
the submit button is hiding some of the text


comment:
There was no audio on this screen, although I see in the audio-script there is text for this screen?


comment:
I think it's ok to refer to the guidebook, but the link doesn't work for me.


comment:
Something's off with the 1st sentence...
You need to discuss a site's process for...


comment:
VO says SIV.
I don't think we spelled out SIV yet in this course? So say "Site Initiation Visit, or SIV,


comment:
The link to the guidebook didn't work for me. Please ensure this is the url used: http://lillynetcollaboration.global.lilly.com/sites/DCOEHub6/onboarding/SiteSelection/Site%20Selection%20Guidebook/Home.aspx
Also, confirm with Nancy if it is now called "Select and Manage Sites Guidebook"?


comment:
For the process map link, we can't link to the map directly. Please use the link to the user-interface as done for the other courses: http://lillynetcollaboration.global.lilly.com/sites/CDCI/os/SitePages/Home.aspx


comment:
To avoid technical issues with our LMS, please remove the text "Click the next button to exit the course", say "Exit the course, ..."


comment:
audio says "stick with the facts" not to like it says onscreen


comment:
audio clips are really close together here too


comment:
I got 3/6 on Derrik and again his confidence made it to 100%. Capability seems like it's fine.


comment:
I picked the yellow option, then the green option. I believe I should get feedback that says "You can do better. 
Good call on the quick follow-up with Derrick, but you should be more specific on what you can help him with. Derrick should contact the customer to help maintain their trust with him. "


comment:
should service manual be in caps? Service Manual?


comment:
same thing in answer 2 - Service Manual is caps in Levi's edit.


comment:
you can't see the feedback from the coach about the last swimmer because the "recieve the coachy award" text covers it.


comment:
when all made it across the river, I never got audio. I was thinking per line 17 there would be audio?


comment:
change the abbreviation for Investigator Site Evaluation Checklist to ISEC


comment:
revise bullet #2 according to CT Material call


comment:
recent developments have caused us to have to include something regarding ensuring that the refrigerator and/or freezer is the site's and not on lone from another sponsor for another trial; this has caused 2 issues:  during selection the CDC documents the site has said refrigerator and/or freezer and later finds out that equipment will be removed because it wasn't originally the site's and the trial is now finished and the equipment is being taken back; also equipment for other trials is not supposed to be housing specimens or CT Material for another trial; with all of this said I think we can add to this comment; Verification that the refrigerator belongs to the site and not another sponsor is crucial to ensuring the site will have access to the necessary equipment throughout the trail.  Also, verification the refrigerator is properly maintained....


comment:
We an also add my comment below to any slide that has a refrigerator or freezer since it may be a lot of words for this slide?


comment:
we highlighted the temp log on the last slide and it isn't an option for this one- could the learner get confused as to why it is listed in the slide before and not this one?


comment:
The sound effects are louder than the speakers voice


comment:
Just wondering if we need the voice to "read through" the tips.


comment:
Need a photo of one of our guard stations not of a generic looking parking garage.


comment:
This is a new expression for out charters. May I please have his head too? :-) And any others you have developed?


comment:
When you flipped her head you also flipped the logo on the helmet. Oops! Also this is a new pose that would be nice to have in our character library. Thanks.


comment:
Maybe the instructions should say "...outlined in yellow..." not highlighted area. I missed it at first. Also, user the same outline on the word in the instructions to show them want to look for.


comment:
For second question, it is blended the requirements of a local lab vs requirements of the team preparing specimens for central labs. Maybe the answer can be divided into 2 statements and each covers one of the items.


comment:
There is an inconsistent use of clicking compared to previous flowcharts.


comment:
Can't proceed when I got the answer wrong.


comment:
I'm assuming this page will be removed from the menu when if is final.


comment:
When a particular trial has critical imaging equipment, usually the equipment is validated/qualified by a TPO by questionnaires, so a most accurate comment should consider that this requirement must be in place for a central validation in advance to the SIV readiness


comment:
4 pop-up: it is not clear if the CDC only needs to document that local lab name and no further questions need to be asked. Of if the CDC will request if the local lab has been certified by local authorities and any international accreditation is in place like CAPA, CLIA, etc.


comment:
In the ISEC button, for the mitigation plan, we will need to change.. the site could be declared ready for site initiation for the site could be declare enrolment ready as per Activate sites SOP


comment:
I do include that diagnostic services/equipment also are required for the correct management and follow up of the subject, the y are critical to guarantee subjects safety


comment:
Pop-up for SPI. The last sentence reads as .. during an internal or regulatory audit, I would recommend to change it to: during an internal audit or regulatory inspection


comment:
In a standard process the CDC should ask for the critical (and non-common) equipment since the feasibility phase, I do not image a CDC asking in a selection visit for the very first time about a refrigerated centrifuge,  so I suggest to re-phrase the dialog to a confirmatory approach.


comment:
Part of the answer is hidden behind SUBMIT button


comment:
I was able to click on the computer, but there is nothing related to the PC in this section


comment:
We need to have all equipment and calibration certificates for when the site is declared enrollment ready


comment:
I am confortable with this question. the process may be acceptable as long as site staff agrees to select a TPO with a maintenance program etc... So the first answer could also be a YES.


comment:
I think "Significantly faster than other molecular methods" is a strength. In comparison to Liat, they're slower but we listed "Time to Result" as the #2 Strength for Cepheid.

Something around "Requires less hands on time" would be an appropriate response.


comment:
This question might be a little premature from a timing standpoint because cDiff Liat may not be ready by the time this training is rolled out in May/June from a US Standpoint


comment:
Preferentially, I would eliminate the "negatives" wording since it's just false positive.


comment:
In order to avoid misunderstandings; for those highlighted objects which are no basic facility items, I suggest to include how should we evaluate this in the scope of or process

-Reading materials& which are not required
- Pi certification& which is required and should be verified by CDC, but is not part of the equipment/facilities


comment:
Disregard previous comment as the timeline aligns with CE go-live. Thinking too geocentrically.


comment:
Temp Log is not a piece of equipment of a facility, although the conversation is pertinent, I would not listed in the animated checklist


comment:
Not entirely intuitive at the "Good Luck" screen to click to proceed. Each quiz question had a "Continue" button so that was what I expected to see.


comment:
I have never conducted a Rheumatology trial which requires CT scanner, they are really common for Oncology. In Rheumatology, XRays are really frequent and I have worked with MRI, but never a CT Scanner.


comment:
Cepheid should be Xpert or GeneXpert, not Panther (Hologic)


comment:
Because there's only 1 Question on the 2nd option (SO2 Monitoring) it should probably just be open already when you click that button.


comment:
On the quiz start button, there is no next button, therefore the "< PREV" button jumps over....just to be consistent, I'd add a disabled next button, or even a next button that does the same thing "Start Quiz" does...whichever you think andy would like better.


comment:
Does this screen need to have "click next" instructions?


comment:
SA comment - The required question for the evaluation is specific to the site managed lab processes; the only thing we document during the SEC for a non-site managed lab is the name of the lab itself.


comment:
Just a functionality note - when I click the last box and it pops up the extra info, it does not give me a "check" and the Next option until I click OUT of the pop-up box. It would be preferable to provide the check and next option automatically when the last box is clicked.


comment:
Agree with SV comment - 4th box on local lab. Change "they" in second paragraph to the site evaluator, RE: SA comment, it is identified that further documentation is required but that is not something we are capturing in the ISEC.


comment:
Need to mark DEXA as checked off, comments only speak to CT Scanner not being present.


comment:
ARS Comment - I disagree, as any central processes are not covered in this question and also, we are the ones spelling out the equipment, we hear time and again from our CLO partners that the central vendor does not "qualify" anything, they just collect documentation and say if the required steps to be activated on their end are completed. 
Re SA: Comment - using my judgement based decision making, I would NOT allow a site to be declared SIV ready without them having an official plan in place for this equipment....I do not think we should change this, as this is an example of describing the situation for this trial/per CDC judgment. The reason this is a good example speaks to them understanding they won't be able to move forward in the trial.


comment:
Same comment as last screen around DEXA - in this case, it either needs to be checked off as available OR it needs to be added to the reason why it is incomplete - "There is also no description of the situation with the DEXA, even though it is obviously also missing at the site."


comment:
Non-Critical Equipment. "We do not monitor the equipment" should be updated to "We do not routinely monitor the equipment documentation, but it needs to be available as needed for audits or inspections."


comment:
ARS Comment - Feasibility is not a required process and while it is of course best practice to know more details about the site before the live visit, this is looking at the full picture, which could be with the full list speaking without confirmatory processes.


comment:
Where did the wall thing and books come from? I would remove them.


comment:
Clock and laptop - remove those images, why did they get added??


comment:
to NGB comments on ownership - I honestly don't think this is actually fleshed out enough to put it in the training, but would recommend we update language to say "Verification that the refrigerator will be available through the whole trial and is properly maintained..."


comment:
Agree with SV, Guidebook link wasn't working. To ARS Comment on Temp Log - can we have it be "Thermometer with temperature documentation" on the same line, then when they click on the temp log, change the "Temp log" words to bolded or underlined?


comment:
Biohazard bin - be consistent and call it the same between pages. It was biohazard before I am quite sure and should be on the checklist here too.


comment:
Chair pop-up. Add "often" before "Require infusion equipment"


comment:
ARS point is not bad...let's change the first sentence to say "In rheumatology trials, imaging tools like CT Scanners or MRI machines may be critical equipment."
Also, update 3rd sentence to be "Imaging equipment" (not "Scanning")


comment:
The audio didn't match the written, which I think is an error. on the "I'm aware that mistakes can happen..." response.


comment:
Can we have her look more welcoming? Her arms are closed with no smile. Or are we replacing her with the new character?


comment:
Include narrative or instructions to click on the first file and what they need to accomplish to open the next 3.


comment:
No to the HRR comment, as that is not accurate. If it is causing people confusion (it is not for me) then it could be updated to read "The trial you are discussing with the site requires..."


comment:
The left hand path did not update as requested in the ALpha. Please re-review Alpha requests (line 80 in alpha review spreadsheet) and make changes.


comment:
Actually, neither path updated. We need that fixed.


comment:
I would remove the SIV language and instead say something like "before the site is able to enroll patients in the trial"


comment:
Where did the language for the "head and heart" info pop-up come from? I would recommend updating "Does the site staff seem eager to work with us" to "How do the site staff react to expectations and ideas for improvement?"


comment:
The Equipment & Calibration Collaboration Site should also be linked here in my opinion. Link: http://lillynetcollaboration.global.lilly.com/sites/EqCM/SitePages/Home.aspx
ALso, the Site Selection Guidebook link was not working for me.


comment:
I think I heard from some people that they were seeing new trainings REQUIRE that they open each resource link before they could move on. I want to make sure that is NOT going to happen here.


comment:
Heard recently that some folks were wanting to read the transcripts of the voiceover (in case speaker was not working or they wanted to read rather than hear). Can that be added to all screens with audio, a "transcript" button where they can read what the person says?


comment:
Can you bold REVEAL and the 5 words so they stand out?


comment:
Talk slower for learners who are not native English speakers.


comment:
Script change - important to point out that BD is expanding in their Diagnostics space which includes traditional Microbiology and Molecular.

(This will reinforce the point that they have competencies in 2 specific areas.)


comment:
rewrite:

BD is expanding the Molecular business in their Diagnostics portfolio with a new Next Gen platform.


comment:
rewrite script. It sounds like we are implying those menu segments will all be covered in the Next Gen. Perhaps mention that those are part of the existing platforms. Delete viral load.


comment:
-in unitized reagent, include the following point:
'DNA extraction is performed by clicking in the assay specific pre-filled extraction and Mastermix reagents into the reagent strip.'

-Can we reduce the click throughs with hovers instead?

-Sample prep process is longer than 4 steps. Change once confirmed. 

-PCR catridges - incude the following: 
Each cartridge has space for 24 samples. PCR cartridges can be used multiple times

until all used up.


comment:
1. reword title to: BD Max Sample Rack
2. Extract key points from the following:

Only the BD MAX sample rack will fit onto the BD MAX instrument deck.

Sample racks hold up to 12 Unitized Reagent Strips (URS) and Sample Buffer Tubes. Two racks
can be placed on the robot deck in the sample rack station for each run. The racks are comprised
of 3 banks, each of which are composed of 4 adjacent strips and Sample Buffer Tube locations.
Samples within a bank are processed simultaneously by the 4-channel pipette head that moves as
a unit.


comment:
Include a new feature: 
Liquid Handling Head

The liquid handling head performs all sample transfers. It features a pipettor that is used to transfer fluids as well as bar code reader and scanner. The pipette head consists of 4 nozzles that move as a single unit. Each of the 4 channels can be opened or closed independently.


comment:
Did we cover throughput in a previous section?


comment:
No need to repeat 'Random access' in every answer. Include in the question portion.


comment:
Can you clarify if this page will appear in all modules in site selection since these are generic questions.


comment:
There is a lot of TBD for CT/NG and HPV rationale?


comment:
Incorrect Cepheid statement - Panther is hologic, annual calibrations is not considered frequent


comment:
When I select the 3rd answer option, the incorrect feedback text doesn't make sense to me: "Not quite. The ICF protects both study participants and the sponsor."


comment:
Should we add some of the sources of the "stories" presented in this training?


comment:
To avoid the technical issues say "Exit the course, review..."
And remove the next button


comment:
In the description for Create Trial-Level Addendum Informed Consent Form, abbreviate main informed consent form to main ICF.


comment:
IN the second bullet in the Create Trial-Level Addendum Informed Consent Form, should it be trial-level, country- or site-level?


comment:
I would say is a source for ICF creation at the country and site-level for trials with multiple countries vs. multi-country trials.


comment:
where we say affiliates, I think we should say affiliates and/or Third Party Organizations (TPOs)....or we could be generic to say those creating the ICFs.


comment:
capitalize 'she'...she has been asked to participate..


comment:
why is schedule for the trial bolded?  Also, "as a busy mom, it seems overwhelming" is duplicative somewhat with the first sentence.  Not sure you need it.


comment:
I am not sure we really need the bolded words throughout the scenarios...


comment:
In the description for Non-Lilly Investigational Drug/Device Language, capitalize 'investigational'


comment:
capitalize source documents listed in purple in the descriptions (when you click on them)


comment:
For Source Non-Lilly Investigational Drug/Device description - Are they always our business partners...should we say third parties vs. business partners?


comment:
Transitory Document description, I would delete the last part of the description: providing the approximate blood volumes per visit as this is duplicative with what's in the parenthesis.


comment:
IN the response, ...that might impact the study participant's decision of whether to participate.  The doctor will review all criteria for the trial with the study participant before he/she would start taking the drug.


comment:
All of the answers said incorrect for this question.....


comment:
Also after getting 2 wrong, it should tell me the correct response vs. moving onto the next question.


comment:
Ixekizumab should be capitalized.  please check throughout the course.


comment:
To my knowledge, it is only a combo test of Flu A/B+RSV on Xpress versus a standalone RSV option


comment:
"Exactly what should I expect from this trial, and WHEN WILL IT END?"

Please correct grammar throughout.


comment:
This slide does list a couple of incidents that led to current regulations and thinking regarding human subjects research but it leaves out several important ones (Holocaust, Tuskegee...).  Perhaps edit to say that these were among the events that led....because they really aren't the only two.


comment:
I'm not sure Thalidomide is the best example for ICFs.  There are others that are more on point.  That being said, it is fine to leave it as a catalyst for FDA reform.


comment:
What is the link to the public information about this case?  If not public, do not use.  There are other examples of this type of issue that are publicly known.


comment:
Please delete last paragraph.  Negative publicity is not the most important negative effect of failure to obtain proper informed consent, and the way it reads seems to say that is what we think the worst effect is.  Perhaps rephrase:  "Failure to follow ethical guidelines for obtaining informed consent in clinical research can erode public trust in the pharmaceutical industry and the medicines it produces.  In addition, informed consent is one of the most important ethical cornerstones of conducting clinical research and is essential to protecting human subjects."  Also please check numbers.  Press releases I read had a different number of deaths.


comment:
This example needs some discussion.  Please provide your source documents for the facts listed here as they differ from what I was able to find.  The characterization of the fine, its amount, and the outcomes of the trial are all different than what I found.  Please set up some time to discuss.


comment:
I agree that this is one way to make the ICFs better but the ultimate lesson from this case is something different, I think.


comment:
Agree that feedback doesn't make sense.  And is the correct answer "no impact"?  That isn't accurate.  The patients underwent very invasive procedures without providing consent.


comment:
This scenario misses the opportunity to discuss the fact that late stage alzheimer's clinical trial participants would likely need a representative to sign the consent form.


comment:
What is the correct answer?  The voluntary nature of clinical research is such that participants must be able to stop participating without loss of benefits to which they are otherwise entitled, so the first answer should not be correct.


comment:
I am not sure that thesea are really the most important repercussions to these scenarios.


comment:
study participant's vs. subject's participation in the trial in the question.


comment:
check for your formatting for the 'i' in the red circle which provides more information.  in some instances you have it included in the example response in others you don't.


comment:
In the expert version, I think it should be: If you are in the study treatment group....


comment:
Change "opportunities" to "opportunity" in the next to last sentence.


comment:
Make "blueprints" one word instead of two.


comment:
I think we need something additional at the end of the sentence: While you don't have control over the final format of the ICF, you can format content within the TCED by using headings, bulleted lists and shorter paragraphs which will help creation of ICFs which are easier to understand.


comment:
Let's just say "...utility site and see the reasons why it's a good fit..."


comment:
The checkmarks are difficult to see on the blue background.  May want to consider reversing the blueprint image so they show up easier, or could change them to yellow.  :o)


comment:
The ICF is pretty clear Tim.  The number of visits .......


comment:
I am going to participate in the clinical trial Jim.  I think the pros....


comment:
IN the purple box: Pre-screening ICFs occur before the main ICF is signed.  By signing the pre-screening ICF, ......


comment:
In purple box: Optional procedure ICFs...


comment:
...explain that the drug could make them sick vs. trial drug


comment:
doctor, nurse, parent or legally authorized representative (LAR)


comment:
in the question: pre-screening ICFs signed...


comment:
I don't think I would say Dan is an expert yet.  How about "...you are on your way to becoming an expert in both..."


comment:
The correct response says pre-screening assents...it should say pre-screening ICFs are sgined


comment:
Incorrect response for the last response should say Pre-screening ICFs...


comment:
optional procedure ICFs vs. consents - in both question and response(s)


comment:
at the same time the main ICF is signed vs. the ICF is signed


comment:
this response says that optional procedure ICFs are signed at the same time as the main iCF or after...should be after


comment:
check the responses on this one....something seems inconsistent


comment:
If the pre-screening procedures carry any physical risks, what element must be included in the optional procedures ICF?


comment:
addendum ICFs in response..please check throughout course for consistency.


comment:
check formatting of your hyphens and spaces


comment:
Lilly also controls the description of how the data will be used


comment:
I agree with the comment about the second paragraph.


comment:
For children, ages 7-10, the Child Assent template would be used to create the assent, and for children, ages 11-15, the Older Child Assent template would be used to create the assent.


comment:
affiliates and/or TPOs ..or those who create ICFs?


comment:
I'm not sure that "lawsuits" should always be our main negative impact.  Lawsuits occur because someone was injured as a result of our failure to inform.  The most negative impact is subject injury without being properly informed of the risks.


comment:
Tense of verb in first sentence of Check Your Audio Settings section: "This course haS audio."


comment:
I don't see a Resources button in the top right hand corner of the page, even though this page claims that I should.


comment:
Technically speaking, no comma necessary after "rep": "Terry suggests that Dan meet with Cummins sales rep, Gloria Gass."


comment:
This question is true of all Liat assays, and not specific to the Cdiff test.


comment:
Will we be adding the ambient audio from this slide to the first slide of Dan's visit to this utility?


comment:
Typo in Gloria's initial speech bubble: "why some hospitalS"


comment:
Typo in Gloria's speech bubble: "...when she showed Dan that emission regulations ARE one of the gas market drivers."


comment:
In yellow Cummins text box, no apostrophe in "its": "...select its definition."


comment:
On all of the slides where Gloria introduces the customer interaction activity, perhaps we could simply her second sentence as follows: "You should talk with a customer to practice using the terminology related to Learn Burn gensets." This rephrasing sounds smoother to me and uses fewer words.


comment:
The Exit button doesn't seem to work on this slide.


comment:
SAVE acronym.  Not sure how we can get around this thou.


comment:
Correct answer: Cepheid's strengths are the modular expansion of their platforms, rapid time to result, and having the broadest molecular menu.


comment:
Choices:
Fast time to result
Broad menu of molecular assays
Modular design of platforms
Cost effective testing


comment:
Correct answer:
include the Cepheid C diff. specs and remove the Alere reference.


comment:
I thought the purpose of this section was to test your knowledge on Roche products?


comment:
Focus on Roche products in the first section?


comment:
wonder if we can select a better Liat question - will review as a team


comment:
might be a bit too generic  -  other than the reference to 'Xpert' if it was intended that way


comment:
maybe less of a focus on NextGen and more on what they are doing today


comment:
wonder if this would be a good time to mention something like "combining molecular diagnostic synergies with Beckman Coulter" .....as they were both acquired by Danaher and from a sales perspective, DHR will link them together


comment:
I would take this one out.  Focus on micro when we can.


comment:
I could drag multiple selections on top of each other


comment:
team needs to decide if these are the best features to highlight here.  Some of these seem random and not tied to what we will attack later


comment:
can there be a different sound when we "answer" the phone?  Sounds like an old door opening


comment:
get a POSITIVE result in less time with EAT


comment:
include throughput of cobas 4800 as well...closer to Viper LT competition in terms of throughput


comment:
different character possible?   trying to change the look and feel as much as possible from first REVEAL


comment:
are these the same clues as first REVEAL?  can we get different symbols, colors


comment:
we cannot run them at the same time either...may want to move away from this


comment:
on CPHD side, i think we emphasize too much on Early Termination and not enough on broad menu and modular design - maybe the target statements will bring these back in thou


comment:
Any way to change up the objectives on the screen? Normally we don't read word for word what is on screen.


comment:
The specific processes bar is blocking the LA's hand.


comment:
This animation ends kind of abruptly. Can we add an image to the screen or something?


comment:
Second question reads strange. Should it be "Does the investigator understand and are they willing to comply......


comment:
Is there an extra space before Investigator in the 3rd popup?


comment:
Ignore my second question comment - I assume this is pulled directly from the form. Sorry!


comment:
When I go back to this screen, the checkmarks are gone and I need to click through everything to get the next button to appear.


comment:
I think you need a new PF number for this page. My edit is for the SPI page - if we need information from the SME's make sure to highlight it in yellow and add it as a note so they don't think we forgot it.


comment:
Although I like this, I feel like it's missing information on what the purpose of this activity is. Can you add text introducing this?


comment:
Is this a good answer, or a good question?


comment:
The click here text shifted/moved when first on screen.


comment:
The ladies disappeared at the end of the conversation but their names/titles remained.


comment:
The old lady is too low on the slide. She's covering up some of the back/next area.


comment:
Should there be directions on the slider? They use this to review their final answers, correct?


comment:
Can you add a note to the ? popup that we're working on the text for this page and will standardize this throughout all courses?


comment:
Add a note here that we will finalize the text on this screen once confirmed with Lilly.


comment:
warnings and precautions - need to make a new bullet starting with the word "observe" in line 3.


comment:
same feedback for the safety info popup - need to make that new bullet under warnings


comment:
main screen - need to update the graphic per the edits in Refill course. Should expand the graphic to show more of screen so it's clear it's the patient info page, cut off at Interrogate button.


comment:
continue button on the correct popup doesn't seem to work


comment:
at :27, add "basic pump data, notes, and logs and select." need to update audio and the transcript


comment:
starting at :06 - the 40 ml is showing up. I think it should say 0


comment:
when the popup opens for you to insert the value, the graphic of the 1:00 shows up over the open popup. Needs to be behind.


comment:
:39 looks like there is an OS text box that disappears suddenly?


comment:
I think the transcript is double space on this one?


comment:
is this new audio or something patched together? the opening paragraphs sounded a bit different


comment:
when telemetry complete message up, change sentence to say "... and the programmer sounds the critical alarm. Verify..."


comment:
same edit for non-critical, except should say non-critical


comment:
when non-critical alarm starts, need to update page title to say non-critical


comment:
The audio transcript in the word document provided states 'Next, youll practice revising TCED elements so they are easier for study participants to understand'.  
Need to remove reference to study participants.


comment:
In the new audio transcript for the process map, it defines TCED - TCED should be defined in the Overview as this comes first.


comment:
We use the ICF abbreviation before this slide, so should be defined earlier and no need to define here.


comment:
Same re: TCED abbreviation - defined earlier so not sure why we are re-stating here.


comment:
Rather than multi-country trials, which is open to interpretation as to what multi is, can we say for trials with more than one country?


comment:
The last sentence could suggest that study participants read the TCED....could we just say 'The TCED should be written with the study participant in mind'?


comment:
...a complete, accurate TCED with the study participants in mind.


comment:
Second sentence - Re-wording suggestion:  As you create the TCED, remember your goal is to explain the trial in such a way that when the content is incorporated into the ICF, study participants can easily understand it and therefore can make an informed choice about participation.


comment:
'.....to view a good example of a TCED'?


comment:
The ICF is not required to be submitted to the regulatory authorities in all countries and it is not always the country-level one that is submitted to the RA/ERB, it can be the country and/or site-level ICF.


comment:
The word document of the audio transcript states 9th grade not 8th.


comment:
Can ignore my comment re: reading grade on this one.


comment:
In the right-hand side box: Can we change 'Directions' to 'Instructions'.

Also, add 'font' to end of 'Recommended text is normal'.


comment:
Audio - do we need 'of the information passage'?


comment:
On the pop-up for the correct answer, what is the reference to element 3?
Also, change the end to say before the study participant signs the ICF.


comment:
Sorry, my comment was for the previous question, not this one, so you can ignore the question about element 3, but I would still recommend amending the language to say the trial doctor will go through the criteria before the study participant signs the ICF.


comment:
In the response for an incorrect answer, no need to write ICF out in full


comment:
Response - again, no need to write ICF out in full


comment:
Click on the magnifying glass to view the element from a good example of a TCED


comment:
The instructions need to state best answer(s) as the correct response is 2 of the answers.


comment:
Can we change 'passages' to 'information' or something like that?


comment:
And change 'Review Sample Passages' to 'Review Sample Language'?


comment:
Is it a given that trainees will know what to do here to check the reading level?


comment:
To make the content audience-friendly, write it as if you were explaining the trial to a study participant.


comment:
Again, the instructions about the Hint button do not match what happens when you click on it


comment:
Not sure why the payment piece has been added in the expert answer - there was no reference to this in the original wording.


comment:
Instructions should state select the best answer(s) as the correct response is the second and third answers.


comment:
The correct response needs to say that they can be signed at the same time or after....


comment:
Instructions state to select the best answers but there is only one right answer.

Would just talk about the addendum ICF rather than optional procedures ICF...


comment:
States to select the best answers - can only select one


comment:
Need to check the responses to incorrect selections


comment:
Per Louisiana's request, the "Railroad and trucking activity" tab should say "Site railroad and trucking activity"


comment:
Q: When can an "all clear" be called?
A: An all clear can be called when the plant has met the following minimum requirements for a successful startup. Then the tabs.


comment:
Rail icon should read "Site railroad activity"


comment:
Answer should read site railroad and trucking activity.


comment:
The font for the Becky/Phoebe Scenario changed in the upper right box. It became bolded on the screen that says Good morning, Phoebe.


comment:
Is this the first time we reference the Negotiation Document? Shouldn't we include the information Sophie sent us earlier regarding what to call this?


comment:
Ah, okay I see you added it here regarding the Negotiation Document, but I wonder if should go on the page before this. If it stays here, the purple box needs to be a bit bigger.


comment:
TCED Template - Teras edit states "when pulling language from the protocol to create your ICF". Was this edit made?


comment:
Ignore my last comment about Tera's comment. I see JL over ruled!


comment:
In some areas, the transcript goes behind the images. Can this be updated?


comment:
Regulatory Authorities is capitalized here, but nowhere else.


comment:
We just say CRS here. Just confirming we dont' need to say CRP/CRS/CP? I don't think so, but just checking!


comment:
This section also just says CRP. Is this okay?


comment:
Is there an extra space between "little" and "advice" in the last sentence?


comment:
Correct feedback has Regulatory Authorities capitalized.


comment:
You can ignore my comments ab out the CRP/CRS etc.  I see that Tera asked for just the CRP down further in the edit list.


comment:
Incorrect also has Regulatory Authorities capitalized.


comment:
The email is slightly too far to the right in the computer screen.


comment:
Is it okay that this Cover Letter is capitalized in this activity? Just checking!


comment:
DO I have to get this right to move on? In other courses they try 2x and then move on.


comment:
Add the the ICF Collaboration Site link to the Resources page from the main menu.


comment:
Update the script to remove "click the next button" in the last sentence. Make sure the exit button from the menu area works.


comment:
First bullet should say between collection and testing.  The clause is not complete


comment:
For the BSC, indicate that the picture to the right is a BSC.  Either label the picture or insert it into the bullet


comment:
The second bullet should not say "would be streaked", it should say "could be streaked".  I think this goes to Lydia's point.  The aim would still be to have isolated colonies, even on differential agar, in the event that you may need to do further analysis.


comment:
I agree with Lydia.  I am not aware of anyone taking a sputum sample to test for MRSA.  SST or wound but I don't think respiratory.  Confirm with Mike or Beth


comment:
I don't understand the split for the observers and the approvers at this point. Since most of the information following this section is the same, the split should occur only when the content divulges.


comment:
I think this slide may be too soft. It's a little too playful in its language and doesn't convey any information. Is there any way to eliminate it?


comment:
The checklist in the procedure requires multiple sign-offs but doesn't specifically word it as an approval. I would change "approvals" to "sign-offs"


comment:
The procedure says that a plant check list can/should be included on the sites pre startup checklist. Using the wrong answer that says, "site check list" is too close to an actual right answer. It needs to be something different.


comment:
Once I click my answers, they disappear and I can't reference them again to see what I entered and got right/wrong. They need to stay on the screen.


comment:
Background should be different. No mountains in FL! :) He should be wearing/have his respirator on him.


comment:
Please change particles to PPM or parts per million.


comment:
I don't think any of the audience for this module have anything to do with the truck drivers.


comment:
Some of these activities are a precursor for startup and some are done during startup. The downwind field observers must be used during, while some of those are done prior to approval. The screen previously states that all of the following information needs to happen prior to start up/approval.


comment:
Safety Info popup - please pull from Programming course. Title needs to be Important Safety Information. Bottom two sentences in the scroll have to be updated.


comment:
safety screen in the course (sorry, no feedback on that page) - needs a period in the second bullet under the warning sub title. Also needs last two sentences above check box updated. See Programming course.


comment:
need this image without the blue background. Matt has.


comment:
is there a glitch in the audio? Or does Matt just sound that stuffy? It was during the third red box.


comment:
reference popup that you were supposed to add doesn't work.


comment:
remove the body - now that the text covers it, it doesn't work.


comment:
change directions "Click > to continue."


comment:
Please pull page from Programming course. This should have a different opening image.


comment:
when you pull the screen, please confirm that the buttons on the Toolkit popup says Next.


comment:
final bullet still needs to be 7.9. only the calendar dates were to change.


comment:
add an * at the end of the body. Then add a small footnote that says "*The videos in this course are for illustrative purposes only. With the implanted system, the pump should positioned at 3 o'clock or 9 o'clock."


comment:
transcript second line, lowercase volume


comment:
the transcript needs the first line updated to match the audio.


comment:
please delete the bullet that says "Need to call if they hear an alarm"


comment:
change bullet 3 to say "Need to seek immediate medical assistance should they suspect overdose or underdose."


comment:
need to remove the "boo-boop" noise that means telemetry complete. See the programming course (Note: Matt's course has different text, do NOT copy/paste the interaction from it.)


comment:
red header text switches to non-critical, then back to critical. See programming to make it consistent across all non-critical testing please


comment:
non critical alarm is correct, without telemetry complete. only critical needs to be updated.


comment:
Non-critical alarms - the title has moved. Make sure in same XY coordinates


comment:
para 1, increasing needs to be lower case


comment:
they can't just select ok to change the volume to 3. They need to click the 4 and then the screen changes and numbers turn white. Then they click three, then ok. We'll need to talk this thru. Matt knows how to do this.


comment:
will need all new screen shots for the return screen and the summary, since it's now 3.


comment:
none of the changes were made. Here we don't want them updating the critical alarm at all - they should select 10. this means images all need updates


comment:
non-critical - you updated the hotspot, but didn't update instructions. Needs to say 3 hours, not 1 hour


comment:
confirmation screen - I need a new screen shot that has 10 minutes and 3 hours


comment:
tube set interval, delete second sentence


comment:
can you make it so I don't have to click close? but that the buttons can be clicked in any order and I don't have to close the popup to open the next? Let's discuss


comment:
we need to fix the new images with the scroll bar - it changes width and it can't do that


comment:
can we check the directions - I don't think line 96 got made from the spreadsheet.


comment:
ok, figured it out. needs to say "Enter the patient's new dose of Remodulin (treprostinil) Injection. In this example, enter 67 ng/kg/min."


comment:
cath puncture - they want the blue dot on the line to the left of where you placed it


comment:
bullet two, add "(treprostinil) Injection" after Remodulin


comment:
last bullet, I think there's an extra space before the D in Determine


comment:
sub bullet 1, change to "...function; program..."


comment:
opening line, add comma after pocket fill


comment:
update last bullet to say "... performed; contact..."


comment:
this page will need to be updated with the reference that gets added earlier.


comment:
this page will need to be updated with the reference


comment:
references popup will also need to be updated


comment:
Not sure I love the image of the patient treatment room on this screen. It doesn't really highlight the ERB-ness of this and the more administrative part of things (Even if they are overseeing the ethics of patients. Maybe another logo like this or something? http://www.lssu.edu/irb/logo/irb_logo.jpg


comment:
These shouldn't be titled Correct/Incorrect (as they are just examples and a lot of things could be correct or incorrect). Maybe Good Example? Poor Example? Also, I feel like there should be something in the header that speaks to "documentation"


comment:
This is probably my fault, but I am hoping you can fix it. In the "Incorrect" example, Q3 should probably have an answer - can you add a "No" on top of the drop down box area?


comment:
VO, toward end..."without access to an APPROVED ERB..." I would have it say ACCEPTABLE (broader and would include specific regions that have required "Approvals")


comment:
VO- remove the word "process" after institutional early in the recording. it said "Institutional Process ERB" and the process was extraneous.


comment:
I would change the language of the CDC to say something like "What is your usual timeframe to get approval to use the Central IRB" - whatever it was before was very duplicative of other language just before or after.


comment:
I know #2 was a little wordy, but was there no way to fit all three on the same screen?


comment:
Same comment...the patient room is not the best use here. It might be better to show an office space with computer and files? something more administrative?


comment:
Same for the GM/Area Manager. The previous screen says that these are the people who provide information to determine startup. The GM/Manager are the approvers. They don't provide information. And change Sulfuric Area Manager to Area Manager. Mack had deviated from the procedure.


comment:
I selected "Was the plant tripped with high SO2" first, both it and "Use checklist and observer" boxes marked complete and the text for the "Use checklist and observer" was displayed, not text for the "Was the plant tripped with high SO2"


comment:
This page (and the earlier one with the same graphic) need to have labels under the images to know what they are supposed to represent. One looks like a house, one a school, there are 2 trucks and 2 factories. That's what I see.


comment:
For the GM question, I don't think that the information funnels this way. I believe that the sulfuric supv gathers all of the information and then calls the GM. I don't think that the operators call the GM for approval.


comment:
The prod supv needs an approval exception on there for sunrise-11am.


comment:
I got this wrong, but can't tell what the right answer is supposed to be. The setup may be incorrect.


comment:
I don't understand the phrase "they must report an all-clear for startup to occur in the sulfuric area". The procedure says that "there must be a contact record startup confirmation from all depts. that have been notified of startup"


comment:
The wording is correct, but the guard's actions are done prior to startup, after the plant has been approved.


comment:
you can't put the stack and field observer measurements in the same context. at the stack it has to be less than 1000ppm, in the field it has to be less than 2 or 3 ppm. wildly different. if it's 1000ppm in the field, we're all in the hospital!


comment:
The instructions are a bit confusing because 2 of the three red boxes don't pull up anything.


comment:
The wording is a little squirrely on this "the plant trips (the sulfur valve closes/ interlocks trigger). It should say "the plant trips and triggers the sulfur flow and blower interlocks"


comment:
Once you hit 2000ppm, the decision to shut the plant down is no longer in any person's hands. The interlocks for the sulfur and the blower will force shut down automatically. Better verbiage is "...,the plant shuts down, a warning sounds plant-wide on the PA system, and the operators/supervisor take corrective actions to solve the problem. The high SO2 procedure, field observer, pre startup checklist and approvals will be needed to restart.


comment:
Last box - change density to concentration. Some of my previous comment may be better suited here.


comment:
High SO2 (top)- The plant is always full of SO2. Better verbiage is "different procedures have been developed for startup if the plant tripped on high SO2.


comment:
Use quick trip startup- "if not tripped with high so2 AND down for less than 30 min, the quick trip startup procedure is used." The procedure actually says "no field observer is necessary if the plant supervision approves"


comment:
High SOs startup procedure - This procedure is used when the plant was shut down for high SO2. This startup requires the Pre Startup Checklist, field observer, and approvals. High SO2 procedures should exist for each plant.


comment:
Risk of stack inversion - Inversions bring stack plumes (and SO2) to the ground where it can harm people. If there is a risk of inversion, Production supervisors may err on the side of caution and delay startup until the risk has passed.


comment:
Stack inversion - instead of production supervisor, put "leadership". If theres a risk of inversion, the production supervisor isn't the one making the call on startup.


comment:
Supervisor or above has approved - the verbiage "unloading of a large shipment" is a little odd. Recommend change to "outside factors, such as operational or maintenance work on another part of the plant, are things that supervisor is aware of that may....


comment:
Use checklist and observer - the conditions for this are actually risk of inversion, shift change AND anytime the plant has been down longer than 30 min.


comment:
As you can see, there are a lot of smaller decisions that go into figuring out if and how we can startup a plant.


comment:
This scenario needs to say who "you" is. The steps change whether "you" is a production supv or an area manager...


comment:
stack inversion risk - "Jack said there is a risk" is too close to correct. Needs to be something more incorrect.


comment:
Risk of stack inversion - I did the incorrect answer, now I'm stuck. It won't let me go to previous or change my answer.


comment:
The supervisor doesn't grab the pre startup checklist. The sulfuric operator fills it out.


comment:
Lines are blurred again between the decision to startup and the actual process of starting up.


comment:
Downwind field observer has a limit of only 2 or 3 ppm. His readings would need to be 0-1 to be ok or 3-4 to not be ok.


comment:
there's not a question to answer. I think it's supposed to be "select all of the information to supply" or something like that.


comment:
Technically, the procedure says "area manager" instead of sulfuric area manager. Since the SME's didn't answer that question, let's stick to the procedure and say area manager.


comment:
Response from the GM is not correct. They are the one who says yes or no. They will not refer it back to the supervisor.


comment:
This question isn't exactly correct. The time of day and stack direction supplement the risk of inversion, but the high risk of inversion or inversion present is really the only cause.


comment:
The selection "other area managers" isn't correct. you'll consult the departments, not their managers.


comment:
I think that the weather information needs to come before the scenarios. Most people have no experience/exposure to the concept of inversions at all.


comment:
Remove old course name from the note (Diag Services...) Also add a question about whether they still want the link to the full SPI form even though there are no SPI questions in this course.


comment:
Remove sentence in note about 9 questions and 9 slides. We'll put in as many examples as Erin provides. It probably won't be 9


comment:
Remove all the content in the feedback boxes. Those are from the old course.


comment:
Remove Ethical Review Board from note and replace with CT materials. May want to do a search for all references to Ethical or Diagnostic to make sure no old content is still there.


comment:
In the audio, "Once youve determined that a Trial Consent Element Document, or TCED, is required...", should it be "Trial Consent Elements Document" ("Elements" should be plural)?


comment:
Add a sentence at the beginning of the note stating "The learning agent refers to the restaurant analogy used at the beginning of the course and explains why some key questions..."


comment:
In the audio, "You may also need to create trial-level assents and addendums", would it be helpful to clarify that "addendums" are "Trial-level Addendum ICFs"?


comment:
If the SPI tab is disabled, why even show it?


comment:
Soo...I know the voice here is for DP, but we really won't make someone try to sound foreign for the real course, right?


comment:
Do we not have content for this area? Normally for DP you program one of each activity with content.


comment:
This is missing the slider text about scrolling back up to see the answers.


comment:
I realize this is templated, but this is the same thing in a few courses now. We need to change this up. Especially since this was slated as a 45 minute course. This is all tell. Is there something that happens if they don't answer? Can this be more conversational?


comment:
For field observ/ops button - give two people on the button so that they know it covers both


comment:
for this one - keep the answers up and use the buttons to give the feedback rather than a larger text box. Apply across the course


comment:
Move this into "mod 1" all three audiences, and do it early so that they have it as context for scenarios/decisions.


comment:
Change this interaction so that this is one slide and when prev is hit, it goes back to seeing the initial information about the mgr/supv


comment:
trigger on bottom green box isn't working properly


comment:
"highlight" might not be the right term and make it more obviously which one they need to select.


comment:
Same situation here. Field limits are 2-3 upper limit.


comment:
I clicked share information to see what it means. I don't want to share information and want to go back but there's no previous button.


comment:
I'm not sure yet where this scenario is taking me but the GM response is not ok. The GM shouldn't be contacted if it's outside of morning/shift change. If he is contacted, he's the final say so for startup.


comment:
I don't understand the concept of "share information" here. Who are you sharing information with? It's confusing on each screen.


comment:
Should this screen call out that "Evaluating a Site" is a "Group" of trainings? It seems like there are only six courses, but there are like 5 in the Evaluating Site bucket.


comment:
Should have a "Process Map" button here linked to the whole process map in BW Live.


comment:
"go ahead given by area leaders" isn't accurate verbiage. "All departments notified" would work better. The time of day and SO2 levels are a condition of inversion and approval level, not of acceptable startup.


comment:
The line is blurred again here between content before approval and content after approval. The downwind field observer is used during startup, he doesn't give information used to determine if you can startup.


comment:
2nd bullet...Start the evaluation documentation process in Trialforce
3rd Bullet...Ensure any required confidentiality agreements are in place
Last bullet - I don't like the use of basic two sentences back to back. Not sure which synonym to use, but please think of another term. :)


comment:
In this scenario, I don't think the GM would be called. He is only called for morning and shift change. The option should be whether you call him or not, not a given.


comment:
CDC pop-up - not in love with Patient Pool (too colloquial imho). I might suggest "patient availability and enrollment potential of those sites."


comment:
CDC Pop-Up - "You inform monitors..." should be "you will work with the sites and other site managers (Such as site activation or monitors) on any unresolved..."


comment:
Sheltering in place during sulfuric startup is not a requirement of the standard.


comment:
COM pop-up is entirely wrong, not sure where that language came from at all. COMs don't approve any ISECs anymore. I would refer back to the language in the overview course about what a COM does and maybe duplicate that here for us to tweak later.


comment:
For all of these pick the answers sections, you need to highlight the correct answers after the fact. Trying to pick them out of the paragraph and match to the selections is difficult. If an incorrect one is chosen, it should be x'd out and the correct ones highlighted.


comment:
Need to update the intro text on this slide, it refers to equipment. I would highlight in this situation that these are expectations of the ROLE (we are not expecting things of the site enough to call out here, these are the "how to be prepared" parts of the training).


comment:
Shift change doesn't happen at 11AM. Shift change is around 6. Scenario should call out the 6PM time and state that it is shift change.


comment:
Also, the GM/Area Manager doesn't help with the decision. He makes the decision. The supervisor just feeds him information. During the morning or shift change, this decision tree falls to the manager.


comment:
#3 Why it Matters - Change the language to (others might tweak, but I don't love what is there) "You have the power to push back when something being called out as a requirement is not realistic or is a "nice to have."


comment:
#4 - Not in love with "interact appropriately". What about "Represent Lilly in a positive fashion"? (or something else?)


comment:
#5-Why-"Both are..." should be more like "Both types of information are important to consider, but objective documentation is best.


comment:
I think eventually we may need to have a 4th bucket here with the "starting" parts of the documentation, starting with the Add a Member TF video.


comment:
2nd button - It is Investigator Databank (in caps).


comment:
Debarment Lists - Definition needs to be updated. This is the "definition" from the actual site: A disqualified clinical investigator is not eligible to receive investigational drugs, biologics, or devices, and is not eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA (including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products).

This can be shortened up, but I would think using and identifying it as an available list to reference would be best.


comment:
This is missing the intent of looking at whatever medical licensure boards are in the area (somewhat regionally specific). In the US, it is typically a state medical board website that licensure can be verified against. I am thinking maybe include it with the Google Search box? Google/Medical Licensure search box?


comment:
DNU List - I would comment that this MUST be reviewed prior to site evaluation.


comment:
Audit Reports - that text doesn't match the box. It needs to speak to reviewing any available audit information, including previously conducted Lilly audits, which can be obtained through the audit organization.


comment:
Where did the "Future concerns from an investigator" language come from? I think perhaps this means "areas to pay extra attention to when evaluating the site in the future"? Don't think 2nd choice is correct as is and needs updates or needs to be removed.


comment:
Question update: What information might you find from this resource...?


comment:
The slide is titles just as "Site Websites" (Even though button to get here says "Site Websites/Publically available info". Users won't remember that part and will think that you are saying "Audits against a site" would be on the site website, which isn't true. I would remove that as an answer.


comment:
Comments on initial screen with these resource types would also apply here.


comment:
Update the correct answer to explain it per the FDA Definition. It isn't exactly an action against their medical license, it's against their allowed research participation.


comment:
It says Click Next on the first screen, but it really means click the purple arrow to review next page. (there is no next button from the first page).


comment:
All of these things technically COULD be asked for again, depending on what the CDC wants to do. I would leave the following as correct:
Audit/Debarment statuses
Updated SPI Form
Check for updates on med license
and add the following as incorrect:
Fully completed 1572 form
Complete list of lab reference ranges


comment:
This is a VERY specific email example with all the trial details. I don't think "is anything missing" is the right question (most people won't have a clue if there are "details" missing and might think they are supposed to). Perhaps, "Aside from the trial specific questions they need to focus on, can you think of anything else I should ask for right now?"


comment:
Technically, the 1st option would also possibly be applicable, since nothing prior said that site has already expressed interest and there is nothing in the email that says "I appreciate your interest in discussing this trial further..."


comment:
The intro text references a CV, but I think you mean e-mail.


comment:
Not sure I love the background here...we are talking about pre-work and it looks like she is standing in a site lobby. Might suggest an office image.


comment:
I am still not sure what the "right" answers are here. These aren't really things that need much follow-up, although Donna as manager would lead to more verification questions about roles and responsibilities.


comment:
There are lots of other things that would go in here too...maybe update to 3rd bullet of "Discuss all expected roles/responsibilities with the site, including the new study coordinator"
And then add another bullet that says "review ISEC fully and prepare for the visit" ? (That would provide the "rest" of the coverage pretty well).


comment:
Update LOC to confidentiality agreement (some call it other things and may be regionally dependent).


comment:
Change question to "to get good starting information"


comment:
scenario: "need from them TO BE PREPARED."


comment:
I would take the audit option out, maybe add "Copy of all laboratory reference ranges" as a NO option. Change Robust Feasibility form to "Trial Feasibility Information" (since it may not be an official form, but the CDC should have an idea it is a feasible patient pop for the site before going to them)


comment:
The Feasibility form thing is my bad. Maybe update the language in the email to say "return to me the attached document asking about the feasibility for your site"?


comment:
In the pop-up, I would say that he would like to receive site information from the site profile form rather than he NEEDS info (since this step is best practice, not required).


comment:
Last sentence...sorry, its a little cheery. :) Might recommend, It will be interesting to see if the information they provide looks reasonable for the trial.


comment:
Update to "feasibility info" in the body of the email, OK to leave it as the file name it is though.


comment:
In wrong pop-up (I picked two of 3 right) I think it should say, good job, but you may also want to think about ...and then give the one that was missing. 
For #4 - Follow-up with them on the biopsy experience prior ASAP, as it is a required part of the protocol.
For #5-They said they have the staff, I will need to get more details about that during evaluation.
For #6-I will need to know more about their plan, especially as they have an ongoing Psoriasis trial.


comment:
I might remove bullet #1, as it overlaps with #4.


comment:
I think we need to identify that bullet #2 (biopsies) would need to be clarified BEFORE a site evaluation visit.


comment:
The name of the trial site was identified in the SPI/other forms sent. Make them match between documentation and these scenario screens (Applies to both).


comment:
Maybe also at the end something like "If I schedule a visit with the site, I'll also have all the rest of the ISEC questions to review with them..."


comment:
We need a couple screens in here for TF demos. Specifically, documenting activity with the site (logging a call/creating an event) will be one demo and Adding Trial Site Contact Roles to the Trial Site is another one (both relate to the "What do I need to document in TF" FAQ.)


comment:
I would add the following resource links:
FDA Clinical Investigators - Disqualification Proceedings: http://www.accessdata.fda.gov/scripts/SDA/sdNavigation.cfm?sd=clinicalinvestigatorsdisqualificationproceedings&previewMode=true&displayAll=true
Investigator Databank: https://dqs.investigatordatabank.org/login
Transcelerate BioPharma: http://www.transceleratebiopharmainc.com/

There may be more, but that is it for now. :)


comment:
It would be good at this point to show a quick TF demo walking through the SPI creation steps. (Find [or create if needed] the site in Trialforce, scroll to the SPI area and click Create for a new form, or Edit to update an existing form).


comment:
I was thinking that maybe a "TF Documentation" resources button running throughout this module might be good, where screenshot walk throughs of the demo could reside. Just a thought.


comment:
Steps could for each phase could be reworded to be stream lined. Some  steps need rewording ie : Microbiologists conclusions are communicated to the clinician" to "Laboratory Report is available in the EMR"


comment:
The order is placed in the patients Chart not the LIS.


comment:
Does Health care professional need to be specified?


comment:
Reword Step 5:Specimen is accessioned at the laboratory and specimen processing begins.

What is essential data that is entered into the LIS?


comment:
Again Why do we need to say "Health Care professional" collects specimens? Same comments for step 5


comment:
Step 2 I don't understand? Once the test is ordered it is in the system. Is step 2 supposed to be accessioning in the laboratory? if so it is in the wrong place.


comment:
Specimen size is not correct. Perhaps what is meant is an adequet specimen collection ie volume for blood, tissue vs swab of the tissue?


comment:
Even with Chrom agar you need isolated colonies to be able to read and interpret the plates.


comment:
A respiratory specimen could show pneumonia due to MRSA but it would be a sputum for a respiratory work-up not for MRSA. Also this container could be used fro other things ie urine, tissue.
Also the stool specimen would be collected in Cary-blair transport medium which should be stated.


comment:
GAS & pertussis PCR typically are not part of the respiratory bench.


comment:
This needs some work. 
Plates are examined, Suspecious colonies may be Gram stained which not only identifies it a G-/G+ but also as cocci in cluster, pairs, rods, etc. Then Biochemical analysis for identification which may include spot tests, vitek or MS then AST.


comment:
See previous comment on last page this needs to be reworded.


comment:
Culture work-up is logged into the LIS. Prelim reports maybe issued until the final report is released to the patients chart. In some cases reports are called ie a positive blood culture with a Gram Stain result.


comment:
See previous comments. The info on the LIS has to be released to the patients chart by the technologists.


comment:
Sometimes the results need to be discussed with the laboratory as well.


comment:
The attending Provider may also need a consult from Infectious diseases of the Antimicrobial stewardship team if one is in place.


comment:
Perhaps need to change example. A blood culture would make more sense to illustrate points to be made.


comment:
I don't understand Step 2. 
Also can you find a picture of blood collection with a butterfly.


comment:
Step 1 sounds funny "based on your symptoms you are developing sepsis" 
Reword to something like - Patient developed fever and blood cultures were drawn to rule out sepsis.


comment:
Reword as stated before specimen is accessioned in lab - specimen processing begings


comment:
Not all specimens have to be processed in the BSC during specimens processing.


comment:
Initial work-up is subjective to the specimen type.


comment:
Reword- Gram stain provides a preliminary work-up towards the identification of the organism. Gram stains are very important this makes it sound like they are not. Often times the Gram stain is when soon antibiotics start or are adjusted prior to the final ID and AST.


comment:
Reword to make more positive. Don't say "there is still alot I don't know". Say something about how much it is helping to understand the processes or steps in the microbiology laboratory.


comment:
Agree with Tera on the double use of the word "overwhelmed". Replace with "Carole is stunned"?


comment:
1st paragraph:
... copy and pasted into...


comment:
Since there are only 2 choices, I think it makes sense to only allow 1 attempt.  The incorrect response should be adjusted to say what is correct&..so mirror the correct response.  You can also use the section which they would have found the information.


comment:
Incorrect feedback:
Is the Key Element and Information to be used to complete the trial-specific Informed Consent Form (ICFs) the title of the section?  If yes, I would capitalize the full title of the section.  If not, I would just say read [insert section] section.


comment:
Correct feedback:
The doctor will review all criteria with the study participant before he/she would start the drug.


comment:
So there are 2 incorrect responses&.there should only be 1 if they select yes.  Need to look and update this in the course.


comment:
Same comment as above&.Since there are only 2 choices, I think it makes sense to only allow 1 attempt.  The incorrect response should be adjusted to say what is correct&..so mirror the correct response.  You can also use the section which they would have found the information.


comment:
Incorrect feedback:
I think capitalize the section title to make it easier to read.


comment:
Incorrect feedback 2nd attempt:
I think it would be better to include in the answer what the answer was&.like what was element 6, 8, 9&.


comment:
Correct answer needs to be revised: The Concomitant Therapy in the protocol would be reviewed as well as Medical would be consulted.


comment:
I think if this is the second attempt and they get it wrong, we should provide them with the correct response&please reword to align with suggested wording above.


comment:
Is there a way to get the original version on one screen. I don't think a learner will scroll through and type in a complete new section.


comment:
Under principle 2: "bq"
what does this mean?


comment:
Pre-screening addendum ICFs. in correct answer feedback


comment:
Pre-screening addendum ICFs
in incorrect feedback at 2nd attempt


comment:
When 2nd answer is selected, you get the incorrect feedback saying Optional procedures are signed during or after the main ICF is signed.
While the answer selected really is correct.


comment:
incorrect feedback:
Should this be try again or something like that since there 2 attempts are allowed?


comment:
Correct feedback:
Optional procedures addendum ICFs

This should be are signed at the same time and during according your correct responses checked above&..


comment:
2nd attempt incorrect feedback:
Optional procedures addendum ICFs


comment:
Since there are only 2 answers, I think you really only need to allow 1 attempt


comment:
Incorrect feedback:
If the pre-screening procedures carry any physical risks, treatment and compensation elements need to be included in the optional procedures addendum ICF.


comment:
Correct feedback:
You must include treatment and compensation elements in the optional procedures addendum ICF if there are any risks associated with the pre-screening procedures.


comment:
2nd incorrect feedback:
Use addendum ICFs
Say "Use the TCED language when appropriate"


comment:
Are the younger and older child links the templates?


comment:
Here or on the previous slide, I would propose to mention that there is an "Alternative Word" list in the resources tab that the learner can use to complete this exercise?


comment:
It was not clear to me that we are supposed to finish the lab worker's sentence


comment:
2.5 hour PCR test?  maybe a range of TATs is better?


comment:
In the "Addendum box", remove "or addendum ICF" in the 2nd bullet and change "optimal" to "optional" in the 3rd bullet.


comment:
The study schedule actually looks to be the "good version"?


comment:
Just another thought...  in the second sentence for the correct answer...  revise to also include that the criteria should be those that the typical study participant would know about as well...


comment:
I would remove 156 weeks and just say 3 years.


comment:
Instead of "new medication", say "study drug".


comment:
Remove "you will be paid for these visits" from the expert version.


comment:
Why does it say no competitors to the MRSA screening test?


comment:
To be consistent, section 3 should say "Identification for Diagnosis Methods"


comment:
I like how the competitors come in one section at a time.


comment:
why mention Biorad and Remel here specifically?


comment:
There shouldn't be 2 bulletpoints for BD BBL CHROMAagar


comment:
Do people use Cepheid's MRSA / SA SSTI and Xpert MRSA / SA BC for screening as well?


comment:
It's easy to get lost on where we are.  It would be helpful to have labels help along the way.  For example, competitors should say "PCR competitors to the MRSA screening test".  "PCR competitors to the C.Diff Diagnostic Tests."  In other places, it should say "Culture-based competitors....," etc.


comment:
Why is selective agar here under C. Diff? - I thought this was about PCR competitors?


comment:
Is it true that lower volumes are also cost effective for the 4800?


comment:
Labels are wrong.  This is still molecular methods


comment:
I feel like we need better separation between culture based, molecular, and antigen testing sections.  It's even more confusing because the labels are wrong.


comment:
Where did HOlogic Panther HPV come from...?  This should be Cepheid


comment:
Is high sensitivity really a strength?  Can't we emphasize low cost and fast TAT?


comment:
Some of the columns in resources appear to be centered while others are left aligned.


comment:
When talking about the competitors, I would bold or highlight in some way the Culture or Molecular part at the top of the page.  It gets confusing and hard to understand why similar info is being presented


comment:
The wording here needs a bit of work.  I had to read it 4 times to understand the answer.  Also, should we be highlighting the benefit of antigen testing up front?


comment:
"When preparing addendums.." and "When preparing addendum ICFs..." seems duplicative.  Suggest removing the second phrase, as well as specifying "addendum ICFs" in the first phrase.


comment:
Would it be helpful to specify where the templates are located (ICF SharePoint)?


comment:
Since this module also includes trial-level addendum ICFs and assents, would it be better to name this course "Writing Accurate Trial-level ICFs"?


comment:
In the audio, "Finally, youll identify the requirements for creating addendums and assents", should you specify "addendum ICFs"?


comment:
Audio, should it be "at or below a 9th grade reading level"?


comment:
I don't believe that green text is being used in the new template.


comment:
Would it be helpful to indicate where this template is located (on the ICF SharePoint site)?


comment:
The voice over script is different from the bullets- did we agree that they would be different?  For bullet #1 it notes documents since the information in the system isn't considered a "document" won't this be confusing for the learner?


comment:
Revise - Do some basic research to Gather additional investigator and site details by reviewing internal and external resources & for the last bullet suggest something like:  Review the information as requested from the site in preparation for the evaluation visit


comment:
Scenario details box - 1 has a period on it. Put on all or none.


comment:
Why do we have a box behind the charge codes on this screen and not on others? And the box isn't big enough to fit all 4 charge codes in it


comment:
Charge code 491 seems to have a bunch of spaces before it


comment:
same edits as previous screens apply here


comment:
Transcript, paragraph 2 - extra space between the and LMP


comment:
Audio ends but no next button/directions appear


comment:
From this point on, we need to show some sort of timeline.  Building an account plan is an evolutionary process that happens over time (maybe we say that?) and show at the bottom of the screen (or right or left side) a timeline that stays on screen for the rest of the eLearning. We have the components that we need but haven't shown how this is taking place over time and not in one fell swoop.  We need to associate some of our online chunks with a timing component to show the evolution.


comment:
This shows as the last screen in the module in the dropdown menu but i don't believe it is?


comment:
Maybe this happens over the next two weeks so we can move the timeline marker?


comment:
Maybe this moves the marker to the end of the first month?


comment:
change directional text to match module/button name


comment:
Move the timeline marker ahead half a month.


comment:
Is there a reason there is a resources button on the player on this screen?


comment:
On the next screen, looks weird how there's no top to the box on the left


comment:
Move box down so it matches up to the teal/green pattern footer like edit on mod 2 to the scenario details box


comment:
I would add in the end :
all the infos /answers that a CULTURE could give
all the infos that a ID test can give
the infos/answers related to the AST testing

I would change few questions (more on results handling)


comment:
I just realized this now - step 4 is developing the training material, so at this point the traning material cannot be finalized. Step 1 is determining risks, step 2 determining needs per audience and step 3 defining methods, step 4 developing material based on methods agreed. 
change first sentence to: When risks have been identified and priorities for audience been determined, ....


comment:
Can we change the question to Do you need to have it approved? 

otherwise the answers might be confusing...

1. answer choice  - stays
2nd answer choice - No, protocol-specific traning does not need to be approved, but ....


comment:
Storyline shell: change Design Proof to Alpha


comment:
Course title on airplane banner: For all courses, the banner text should be centered over the "Click to enter" text; i.e. move the plane and banner over to the left to center text above each other


comment:
Directional text: Change to "Rollover each module to see what you'll learn. Click Troubleshooting in BAAOP to get started.  (bold "Rollover" and "Click Troubleshooting in BAAOP")


comment:
Troubleshooting in BAAOP rollover text: add a hyphen between "market" and "related"


comment:
Intro text: per alpha script, add a new sentence (as a separate paragraph) "The input timeframes shown here are approximate."


comment:
Ignore the addition of the new sentence, I expected to see it in the intro text, but see it as a footnote onscreen. Duh.


comment:
STUC popup box text, 3rd sentence: Change "evened" to "even". 4th sentence: add a comma after "STUC picks up outages"


comment:
RTD popup box text, 3rd sentence: "RTD looks at the same inputs that RTPD does, but doesn't make commitment decisions." (changed a couple of words, and removed an extra space)


comment:
Directional text: Add a sentence "Incorrect answers won't "stick" if they don't match the description."


comment:
We may get a comment back from the alpha review on providing feedback when they make an incorrect choice, but let's leave that for post-alpha review.


comment:
Recommend a wrap-up feedback box onscreen here once all 4 options are dragged to the correct place. "That's right! Knowing how each infeasibility indicator relates to the market helps you determine the best troubleshooting path when you encounter a market issue."


comment:
ETSR limits graphic: still says "ESTR" but should say "ETSR"


comment:
Need instructional text above the directional text. "The BAAOP landing page is the primary resource for identifying local and global issues. This graphic represents the different sections of the landing page."


comment:
Top left popup box (includes MCP text): To mirror the other popups: The DOT and RTD boxes are used to identify global issues." Also, I know the text came from the source, but I don't know what "Market?" means. Recommend removing the question mark.


comment:
Infeasibility tests popup box: add a period at the end of the sentence.


comment:
Dispatch Instruction Review popup box: to mirror the other popups "Dispatch Instruction Review summarizes external DOT instructions to identify local issues."


comment:
Need instructional text above the directional text: "Let's look at the first of the two possible troubleshooting paths. This path is used to correct issues that impact single resources or BAAs."


comment:
Resource parameters popup text, 2nd point: Change the first "MSG" to "multi-stage generator (MSG)"


comment:
Resource parameters popup text, 1st point: It looks like there are 2 spaces between "in" and "the"; please confirm one space between these words.


comment:
RTMO popup box: Change title to "Real-time Market Operator (RTMO) desk".


comment:
RTMO popup box: Change text to "If no logical solution is found, contact the RTMO desk."


comment:
Question text: add hyphen between "market" and "related"


comment:
Answer options text: add periods to both to be consistent with previous answer options.


comment:
The bolded text is the only thing different between this scenario and the previous one (in fact, only the words ON vs. OFF). I don't think learners will see that. Change font color to red for the words "ON" and "OFF" in these 2 scenarios.


comment:
Priority #4 text: "Notify your internal RDT submitter to correct parameter inaccuracies." (I don't think there's a "group" per se for these)


comment:
Need instructional text above the directional text: "Let's look at the second of the two possible troubleshooting paths. This path is used to correct issues that impact multiple resources or BAAs."


comment:
Directional text: change "resource-specific" to "global"


comment:
Contingencies popup text, 1st sentence: "You check market runs to see..." (pluralize "run"; I think it should be a specific market run [RTD, RTPD, etc.] but I don't know which one, so we'll be generic)


comment:
Market suspension popup text: Add a period after "suspended" in the first sentence.


comment:
Market suspension popup box, bullet #2: change to "If base schedules are balanced for the following hour..."


comment:
ETSR limits text: It looks like the text in the parentheses was directional text to us for scripting; please remove.


comment:
ETSR limits popup text, 3rd bullet: "ETSR limits may be adjusted as needed. For example, if they are too restrictive, those changes need to be communicated to the RTMO." (cleaned up punctuation and grammar)


comment:
I'm thinking we should not have any pictures of current Citizens employees as they tend to out date themselves or need to change when people change.


comment:
Also, I'm not sure this is the title we want.  I like Citizens Energy Group Ambassador but not sure about the word "Becoming".  Maybe the word "Being" is better.  Let's brainstorm the title with the team.


comment:
Would need to see exactly what segment you are considering from the video.  It is a great video and I like the emphasis on the word Trust.


comment:
I should have caught this sooner- might want to spell out percent


comment:
For the next slide since it won't pull up anything when I clicked on provide feedback- the primary reason this question is in the ISEC:  This question meets the following compliance requirement:  Investigator assessments must be performed prior to selection to verify the investigator has access to the required number of suitable subjects or required data within the agreed research period


comment:
the feedback box came up after going back 2 slides and then forward.  In addition to the comment on the previous slide which pertains to this one- we can keep the information associated with the question just add my statement on the prior slide or a version of it


comment:
Can you not take a screen shot of the ipad program and send it to BLP and upload it into the presentations?  We will have to come up with something other then the MQS since that isn't applicable


comment:
Comment for complete response:  1st sentence doesn't make sense consider:  Preliminary EMR searches came up with 122 patients that could possibly match trial inclusion criteria. add The to the 2nd sentence and for the last sentence...does not see any potential barriers to enrollment


comment:
This question is no longer an ISEC question so we can't use as an example.  I don't know how the 2nd question is regional specific; how about this if it isn't used later on:  Is your site located in Belgium?  If yes the following traceability questions need to be answered.


comment:
The enrollment Question is not an ISEC appropriate question as it isn't a qualifying question;  You could keep the example and just change the NOTE:  add and the total enrollment for both parts cannot exceed 12 subjects.  Then remove the please describe....to Provide the number of subjects the investigator will enroll for each part, not exceeding a sum of 12.


comment:
#8 is not a qualifying question how is this one: PI has confirmed availability of the following facilities to conduct the trial: Facilities to conduct 4-hour MMTT; Adequate storage facilities for large volume of insulin, lab kits & MMTT supplies; due to short enrolment period, large amounts of supplies will be provided to cover this
short, fast enrolment.


comment:
Should we add CT Material & Equipment examples?


comment:
ARe we using the same example as the slide before for a reason vs. using a different example?


comment:
). Does the trial require further preparation/manipulation of the product at the site or pharmacy? Refer to the Investigational Product (IP) and Non-IP Preparation at the Site or Pharmacy (MQS442-001) procedure requirements.
If yes, continue below:
a.	Is the site or pharmacy qualified and approved to perform the further preparation and manipulation as classified above? 
b.	For operations classed as manufacturing, does the site or pharmacy fulfill all local regulatory requirements (for example, in Europe, a manufacturing authorization and a licensed qualified person [QP] or access to a QP)?


comment:
Can we have a man's voice for the Doctor please


comment:
Do we have any other options for the SC she looks silly


comment:
the box that went across the screen wasn't for CT material but equipment and facilities


comment:
When you click on ISEC the diagnostic and facilities portion of the ISEC comes up and not the CT material


comment:
This definition associated with the 1st question will be changed before we finalize in May please put a place holder so we don't miss it


comment:
need to replace ISEC pic with right section


comment:
Revise the comment box for the 2nd question to:  The CDC needs to asses if the site has a documented process on how they will work with the TPO, and that process includes the TPO providing evidence that the materials (any drug supplied by Lilly) are destroyed.  Evidence is things such as:  certificates of destruction, a receipt, etc.Destruction of everything else  (including containers, needles, gloves, cotton swabs, and etc. ) should follow local procedures and laws. 


comment:
revise to read:  In this instance, the site has a documented process in place and that process includes evidence that the materials (any drug supplied by Lilly) were destroyed. Evidence is things such as:  certificates of destruction, a receipt, etc.
Destruction of everything else  (including containers, needles, gloves, cotton swabs, and etc. ) should follow local procedures and laws. 


comment:
on each day not daily or do daily and not each day


comment:
don't think the statement/question matches the answers


comment:
Is it possible to add the function of rewind?
Or we may need to click "Back" and go through the whole conversation again.


comment:
Help screen - global buttons
3rd line needs a period


comment:
activities section - hardware and software 
activity icon isn't linked properly


comment:
Second pop-up: the question is related to verify if the PI has been disqualified... the other items are reviewed by other questions.. this in particular asks about debarment by regulatory agencies, readers may lose the objective of the question by providing the other information. You can add that the information can be consulted in the regulatory agencies' websites for those that publish this information (for example US FDA, MHRA)


comment:
Review second bullet, I suggest "Ask the right questions in your conversation with a site"


comment:
The process maps URL directs to a IBM platform


comment:
To address Nancy's point, I would recommend adding to the first paragraph on the first question pop-up: "...to successfully run the trial, as GCP requirements state that a site must have reasonable expectation of being able to enroll subjects".


comment:
Last slide mention GCP, this on ICH-GCP. Both are correct but I suggest use the same


comment:
I will send an image that could be used, the header of the form. The MQS thing definitely had to go away.


comment:
Disagree with Nancy's comment for last sentence - all trials have some barriers, hence identification of extraordinary in this commentary.


comment:
Complete pop-up - 2nd bullet, update to "Includes number of initially identified patients who may meet enrollment..."


comment:
Nancy - these are questions that would ONLY go in the Protocol Specific section of the ISEC. Other sections are covered with example questions in their respective modules.


comment:
2nd pop-up 1st paragraph: Verify if the investigator...


comment:
To Nancy's first comment points, take out first question of Regional specifics pop-up. Second question, change answer to a check box next to Electronic and one next to Paper and don't have a free text example. (This is a regional specific question from a recent SEC Nancy, electronic wasn't an option outside the US and we asked US sites that question).


comment:
Nancy, I really don't agree on your comments about removing or changing the other questions under Enrollment Initiatives or Additional Protocol Design topics ...I know there are these pushes to just not ask anything in the ISEC if it isn't exactly GCP qualifying required, however, we do ask if they can enroll as part of GCP and the extra questions are REAL examples that MAKE SENSE To document against as extra specific information around site's ability to enroll. Same with the procedural comment, sometimes we need more info on how they plan to handle an oddity and the ISEC is our site evaluation documentation. PLus, these are JUST EXAMPLES. Just giving evidence that they may see other questions in this area.


comment:
I'm struggling with this, because knowing what the objections are to sharing the account plan isn't an objecive of the course.  I think I would change this to say "Digs points out that you've got a reasonable bit of information in your account plan so it's time to share it with the customer."  Change to "Click Next" and move the timeline up a month.


comment:
Maybe we should stress that Mas was lucky that he received an organ so quickly  - many patients can wait years... actually have to go back to his story because I thought he had waited several years to a point where he needed the LVAT procedure and then 4 months after that procedure he received a heart....let's discuss on the call.


comment:
rewrite: This allows greater testing flexibility to labs.


comment:
Different pose for the doctor...this makes me think he it not sure of what he is saying...could be just me..:)


comment:
so just to confirm, we  aren't adding anything to the Review the Form from comment 37 and 38?


comment:
Maybe we can add a footnote about autologous - I think some affiliates might include this population as potential for CMV. It is good to remind them we do not test this population. 
Also - comment on HLA testing is interesting...we don't mention this for SOT.  Should we add there for consistency?


comment:
agree with Eveline. Can we add more detail to differentiate types of maintenance?


comment:
Shouldn't the first bullet be Sponsor's?


comment:
This is meant to be a summary of what they learned from the patient stories correct?  
Seems like there is some new information here. 
Also - is SOT more common than HSCT??


comment:
Good that we have numbers beside the colors. Maybe the instructions should say...click on each color beginning with blue (1.) in order....


comment:
Need click next to continue instructions.


comment:
The hover over bars are covering up text of the other answer.


comment:
We should use metric here - KMs...

Also - not sure about this patient...is it possible to change him?  Maybe someone more European looking?

Would say just that he had to stay in a hotel - not sure about having to cover the costs etc.. as this might be different in different countries based on insurance or national payer programs.


comment:
Reword question: Cepheid offers some of it's tests with the Early Assay Termination feature to get the result as early as 30 minutes, but it only applies to ___results


comment:
We should mention other infectious disease markers testing with serology - see slide 6 of module 2.


comment:
Does this one have any other poses? I don't know that she would talk with her hand on her face.


comment:
Maybe we can work on the patient dialogue ....

I was added to the waiting list for an organ. The list is very long and the clinician could not tell me how long I would wait on the list. In the end it was two years before a match was found. During the waiting period I was on dialysis which was very restrictive. (maybe we need input from MSA here...)


comment:
Not sure about the "conducted a serology test to learn about donor status"..check with MSA


comment:
Throughout the patient perspective should we say who the doctors are in each screen to demonstrate the different "titles" the doctors will have that are involved?  Just to make it more clear.


comment:
I think we are setting up the scenario to show that patients and clinicians have challenges when they have an organ transplant in a hospital and then return home to a different location for testing. The point Jessica is making will become clearer as we move through the modules.  Is this the intent?


comment:
Need MSA to answer the questions on side-effects.


comment:
screen with currency symbols. Please add a variety to represent different parts of the world including APAC (yen), LATAM (R$) and other EMEA (euros, Lira, chf), etc.


comment:
I thought we had eliminated 'poc' device.


comment:
change to 'Enteric Bacterial Panel' testing.


comment:
Agree with Ellen's comments. 

Maybe we should outline on the call what the most important points are from the patient perspective section and then this will help define the matching points?


comment:
Maybe this should be a bounce back if the answer is not correct rather then waiting until the end to find out...


comment:
After viewing the entire course and revisiting the menu, the last paint spot (purple) is still greyed out.


comment:
rewrite last sentence: Each PCR cartridge can only be used for 2 runs only. There is no indicator on which wells have been used.


comment:
List should show ranking of most common and those of most concern:
CMV
EBV
BK
HSV
Adenovirus

If you just want 4 we can discuss as a team with MSA which 4 to choose.


comment:
rewrite:

1. Transfer sample from collection tube to Sample Buffer Tube.
2. Break swab in Sample Buffer Tube.
3. Place pierceable Septum cap on Sample Buffer Tube.
4. Scan barcode
5. Vortex multiple samples.
6. Place sample tube on rack and ensure barcode is visible.
7. See steps for preparing Unitized Reagent Strips.


comment:
Capitalize Unitized Reagent Strips throughout course.


comment:
rewrite last sentence:

The reagent strips are prepared by snapping in 2 components: Master Mix Reagents and Extraction Reagents into their respective color-coded slots.


comment:
rewrite first sentence:
DNA extraction occurs in the Unitized Reagent Strips which combine...


comment:
We need to change to a global statistic vs US statistic for CMV infected rate...will try to find for our call on Thursday


comment:
rewrite:
Each BD MAX" System Rack holds 12 Unitized REagent Strips and 12 Sample Buffer Tubes. Two racks (Rack A and Rack B) can be used with each run.


comment:
Let's discuss what to include in the list on the call...should it be just the tests we may offer someday or the most common testing for transplant patients or just the most common that they can become infected with...probably good to use common names vs getting too technical..


comment:
Now we will review some questions that you may receive during a discussion with your customers relating to transplant.


comment:
Second thought...maybe these are not actual questions that a customer would ask them...they are more concepts that customers will discuss so it is good for the rep to recognize the terminology and context.


comment:
We didn't introduce the concept of "grafts" in the module...maybe need to add this word to the very beginning when describing what transplant means...

Agree with Ellen's comment too


comment:
Agree with Ellen's comment.

Maybe we should decide which side effects?  Are these consistent throughout the module and with what Mas says as a transplant patient in the video?


comment:
The Annette (both scenarios) and Ronald screens - if you choose the incorrect answer, the impact of that decision is explained, but there is not any direction as to what Annette/Ronald SHOULD DO instead. Offer an appropriate/acceptable status for the situation (state this instead), guide people to avoid posting things about work in general (what things about work should they avoid posting), or provide qualifications for when they should/shouldnt post something so that the person who chose the undesirable answer understands why they shouldnt, and what to consider before doing something like that in the future.


comment:
Annette (both scenarios) and Ronald screens  if the user chooses the undesirable answer, they move to the next screen  they dont get to try again like they do on the John, Mark, and Jill screens. Consistency to make them "try again" on all screens, or for these screens, providing the instruction as to what should be done in instead of the undesirable scenario are preferable.


comment:
Annette (both scenarios) and Ronald screens - if you choose the incorrect answer, the impact of that decision is explained, but there is not any direction as to what Annette/Ronald SHOULD DO instead. Offer an appropriate/acceptable status for the situation (state this instead), guide people to avoid posting things about work in general (what things about work should they avoid posting), or provide qualifications for when they should/shouldnt post something so that the person who chose the undesirable answer understands why they shouldnt, and what to consider before doing something like that in the future.


comment:
If the user chooses "Forward" - the "Wait a Second!" screen button is "Next" - it should say "Try Again." When the user clicks "Next" it takes them back to the scenario so they can choose the correct answer the next time.


comment:
Formatting Inconsistency - If user chooses "Post Status" - the "Next" button has a period (.) after "Next." Formatting on other buttons has not included a period beside "Next" or "Try Again" .


comment:
Clarity on Next Step Needed - I wasn't clear that the course was finished or if I needed to look/click somewhere to continue to another phase of the course. Make it obvious that I am done and am not looking for something else to click on to continue.


comment:
It took me a minute to realize that the top left character was "highlighted" and I should click on him.  I agree with JH comment - either click on anyone or make it obvious - Bright red or yellow around the entire character's space (across the top of the character's scene, down cube wall sides, across bottom of the character's scene)


comment:
opening video:
Our BD MAX System offers a highly efficient path to improved clinical outcomes through flexible molecular solutions.

Next slide:
To reach this "flexibility", you will need to purchase multiple systems including a 3rd party equipment to meet your routine molecular testing needs.


comment:
Add to this note that the analogy is about moving to a new home.


comment:
not getting a next button on this screen


comment:
Please move the first bullet to the bottom. The PI change should be the first one.


comment:
Change first bullet to: Recognize the important considerations for the five change categories.


comment:
Correct pop-up. I am not 100% sure if this is referencing Lilly audit history or asking the site about other audits and inspections. Not sure who asked for this, but think it should be discussed. I would Rephrase to "While it is not REQUIRED to ask for audit/inspection history now, it is recommended to discuss it at some point prior to the live visit, as the outcomes of an audit or inspection may impact the decision of a CDC to conduct a full evaluation."


comment:
Might update last sentence to "which ones you think are important to follow-up on right away?" (since there were more things in the forms that do need follow-up, we only call out some of them in this exercise).


comment:
First sentence "follow-up on only one item IN THIS AREA of the Site Profile Information."


comment:
"SPI information" is redundant. SPI is site profile information, so it currently says "site profile information information"....I would just take information out or update to "any required questions on the SPI form"


comment:
First sentence doesn't match now (Reflects one item when there are two). Update to "There are a couple things in the email that likely should have further discussion." (or something like that.


comment:
I couldn't get it to give me both "correct and incorrect" answers. Why do we need f/u on statement 1? The site already confirmed they have the specialty testing, there is no follow-up there to be had that I can see. I would think if anything, Statement 2 will deserve more discussion, since that would be around their enrollment potential.


comment:
3rd from bottom purple button says "SEC" - update to ISEC.


comment:
4th from top (What documentation) pop-up. Very last bullet, Historical should be capitalized for consistency


comment:
2nd from top, pop-up - can we reduce the all caps to normal size with bold maybe?


comment:
There will also need to be a "Trialforce Collaboration Site" (they may retitle that) placeholder for the link to the Trialforce area that houses system specific training.


comment:
2nd bullet I suggest saying as agreed upon with your COPM & COM or the COPM & COM


comment:
Last Bullet how about through to study close out?


comment:
The attachments aren't working here. Will send to you.


comment:
Don't agree with NB comments, that would be trial specific but included in the CT Material section, which we are not addressing here.


comment:
Gotta change the "surprise" expression on the CDC face, looks a little crazy.


comment:
It is ok to swap between two reasonable expressions, normal, happy or pondering maybe? CDC expressions throughout this screen just look crazy to me.


comment:
Correct pop-up, update to "...sense to discuss and confirm with the site the number of participants they can commit to enroll for the trial."


comment:
I'm assuming the question in the gray box is an example question the CDC can ask the site.  In which case, I will reword to "Is there a distinct....related to your site's defined processes..."  Add the "your" in the sentence.


comment:
Bold the word "not" in the question (just need it to stand out a little more).


comment:
It references "following conversation" when it really means "prior conversation" didn't notice if this was on other screens too, please double check.


comment:
I view the SAE requirement as three parts:
1.) PI must review and acknowledge the safety mailing report within a reasonable timeframe.
2.) Sites must report AEs/SAEs to Lilly within a specific timeframe.  Furthermore, sites must report SAEs that occur at their site to their Local/Central IRB.
3.) In certain regions, Lilly does not submit safety mailings to the central IRB.  Those sites are responsible for reporting safety mailings to the central IRB.  All local IRB sites must report safety mailings to their IRB.


comment:
Update the "document" header image across the training course. If you aren't comfortable with the image I send, just make sure to remove the MQS logo and simply put the "ISEC" language up.


comment:
Last bullet - might suggest "Does not repeat information or provide details that should be in other sections of the ISEC"


comment:
In the NOTE section, type out "Do Not Use" prior to using the DNU acronym.


comment:
The ISEC question is confusing because I initially thought it was in reference to communicating staff changes when it really is in reference to communicating "study changes to site staff."


comment:
Regarding the "Considering the site personnel's experience" "correct" answer...could the correct for that be EITHER option with the chosen item reflected in the end results? It is fine to enter that with the better wording, but it would also be fine to omit it all together.


comment:
Yes, patient language is fine. It is ONLY when we refer to the person already IN the trial that we want to switch it to participant or something else (Even though real world...we all say patient then too!)


comment:
Incorrect for "Tell the site" answer...might say that "more information is needed before making a decision and the CDC should always be respectful in their conversation." (wordsmith as you wish, just want that to be a better instruction in pop-up


comment:
Answer logic is not working. I chose the wrong answers and it gave me the "Correct" pop-up.


comment:
Correct Pop-Up. Change to "That's right! You would not want to give a trial to a site that does not have the ability to enroll participants when other sites may be available and you do not need to complete ISEC documentation in Trialforce for a site you will not Selecting, although you can enter the ISEC information if the site will be a back-up site. You should discuss..."


comment:
For this to really be an acceptable response, the SC needs to specifically state their standard TAT for signing off on the safety mailing.  She only indicated the sign off occurs during business hours.


comment:
Both options are right.  The second option is only slightly better than the first, but it's really subtle.  Let's have a conversation about how to modify this so that one option is clearly better than the other.


comment:
We probably should list in the Correct pop-up that we expect reasonable to be 30 days.


comment:
Update first answer "PIs are required to review Safety Mailings within...."


comment:
Talked through this with SP. Only change needed is add last sentence from final pop-up to end of 2nd pop-up.


comment:
For SV comment, update to "She should have confirmed how frequently the PI signs off on safety mailings."


comment:
Discussed further with SP. I think that we really should just take out this "why did you choose that answer" screen and make sure that the "correct" feedback is given at the first level response.


comment:
I suggest yo clarify that this is an example from a protocol-specific requirement


comment:
I am sure the answer is good, however, the question also asks if an ERB has conducted and audit and CDC did not provide information on that. A complete answer should clarify if an ERB or any other sponsor /CRO different from Lilly has conducted additional audits


comment:
VO - "inject, ingest, or apply to person" - don't think IV is well covered with inject. Maybe "take into or apply to their body"?


comment:
1st bullet: Change "protocols" to "trial requirements"


comment:
Same comment on VO as prior screen. (ingest, inject, apply)


comment:
Don't like title...SIte evaluation is not like the restaurant, it is like the health inspection group responsible for restaurants. Maybe title it something like "An everyday analogy"?


comment:
I have an ISEC pic I will send, but am going to wait until I clarify something with Nancy.


comment:
R/T NGB 1st comment, remove "C" under the 1st question about Central Qualified Pharmacy.


comment:
Need to confirm with Nancy, but I believe the Controlled Substance question is removed in total and only to be used for Trial specifics.


comment:
Add to red box and VO: understand the "site specific details"


comment:
Update 3rd box (or create 4th if you think it is better) and update VO to include "requirements that CT Material be stored properly ASAP upon receipt by the site and acknowledged in the appropriate system"


comment:
Biohazard pop-up. "What is your biohazard waste disposal process?" isn't a terrible question, although not necessarily a REQUIRED question or topic. I would remove that from the answer choices and maybe add "Do you have larger biohazard bins?" as a wrong choice (cause who cares about size of bins. :)


comment:
The feedback on this one was a little weird, since I got the "Incorrect" same answer for all, even if I DID select the right answer. I think if the right answer is included with wrong answers, there should be a "Almost" feedback box that says You're right...lab samples should never be stored with CT Material, however XYZ is not an issue because XYZ...


comment:
Site response for CDC option of "Do you have a plan..." box isn't in the right flow, as the question from the CDC doesn't ask for anything WRITTEN, it asks if they have a plan. That VO needs to update to reflect the response to the question specifically, by referencing not having an "official plan" and "I am sure we could just handle it" type of statements.


comment:
See comments on prior screen - this response needs updating.


comment:
Update Good answer on this to "I understand. However, we want to make sure that there is a plan, preferably written, to ensure that you will be able to handle it IF something does happen."


comment:
Update site response to something like " I guess being prepared would be wise. We can go ahead and put something more formal into place."


comment:
Update site response to "...in order for us to be approved to destroy drug here?" (want to be clear that they can still be allowed in trial and this approval is relative to destroying drug).


comment:
they all are System and assays for the cobas 4800 System, c6800/8800 Systems and cobas Liat System, the way it is written it is only c6800/8800 assays


comment:
2nd paragraph. "If the site agrees to put a plan into action that would meet Lilly requirements, document the plan and determine prior to selection if the process now meets requirements to be authorized now, or if authorization will occur later when changes by the site have been implemented(documented in Change Form)."


comment:
Site response: "...prepares the CT Material and the study coordinator picks material up for trial participants when they are being seen for their visits."


comment:
Update feedback to include "proper receipt of material" along with the storage conditions statement.


comment:
Intro text references wrong module, update to CT Material


comment:
change whether to if in first sentence of scenario.


comment:
bit ambiguous.loading and unloading specimens may be considered 2 interventions not 1 - in that case would be 5


comment:
Temp monitoring and proof of accuracy are true, but Lilly also requires Min/Max documentation, which isn't addressed here. Need to include that in CDC responses.


comment:
Please go back to original content for this. SCenario provided was that CDC questions about the EXISTING temperature monitoring process accuracy verification - namely, do they calibrate their thermometers. The way it is currently written is a huge red flag, since it acts like the site NEVER monitored temperatures and that is flat out not acceptable for any trial, any sponsor.


comment:
Update the "For this topic" on screen and VO


comment:
only daily and weekly ? that's a lot of maintenance to me. Can be considered an objection.  
Maybe adding how many minutes if it is little comparing to competitors


comment:
I think Q2 would be more head than heart


comment:
Include the Transcelerate Biopharma link included in the other modules.


comment:
We have decided to change sample prep on cepheid to 1 minute per sample


comment:
Cepheid has a 30 minute test with Early Assay Termination feature to get results as early as 20 minutes


comment:
We have agreed to use 1 minute processing time for Cepheid


comment:
Cepheid 30 minutes with early assay termination of 20 minutes


comment:
Reagent Registration is inconsistent - does it need to be capitalized?


comment:
I feel like manage setup and provide granularity text should be larger to increase legibility of script font


comment:
2nd to last paragraph, 1st sentence: This may be what you're referring to in the DP edits, column M, but there is no audio for "CIDI is used to manage your business interactions with the ISO." Ignore if that if that is what yu meant by no new audio yet.


comment:
The highlighted Cummins employee wasn't clear. Perhaps we can say click any employee below to begin? Otherwise I would suggest making it more clear which employee to start with.


comment:
should the resource also be available from this screen for context? like if people want to refer to it now?


comment:
Typically, we provide 2 distractors for this interaction. Is there a reason why we went with 1?


comment:
I would remove the introductory text onscreen since it is also part of the audio/transcript.


comment:
instead of having the 2 sentences "Refer to the MRI-S..." and "The Resources tab will be..." in every popup for people to read multiple times, can we just put it below screenshot?


comment:
Since 3 of 4 popup boxes say "For more information on X task, see the MRI-S user guide", I would remove that from the popups and put it in the intro text.


comment:
Versioning popup box: Since the #'d list is only 2 items long, I don't think you need to number it. I would just put "...last two versions of your data: Current and Previous."


comment:
Change title to Directive Overview instead of Standard Overview


comment:
Change "Sulfuric Acid Startup Standard" to "Sulfuric Acid Startup Directive"


comment:
Change all instances of "Standard" to "Directive"


comment:
Ensure menu is updated to replace Standard with Directive as well.


comment:
For GM/AM popup, change first sentence to:  I am an Area Manager.  Change the last sentence to:  ...between sunrise and 11:00am, at shift exchange, and if there is a risk of inversion.


comment:
change "site pre-startup checklist" to "site Sulfuric Pre-Startup Checklist"


comment:
Change Sulfuric Prod spvr text to:  I am a Sulfuric Production Superisor.  It's my job to contact the GM or Area Manager during morning hours, at shift exchange, or if there's a risk of inversion to approve startups. I approve startups that happen any other time by looking at plant conditions and considering requirements for safe startup according to the Sulfuric Acid Startup Directive.


comment:
Didn't we make the User Guide available in the Resources tab early for the OMS courses? Maybe we should do that for this course as well, so they can hop over now rather than wait til the very end.


comment:
image: this looks pretty blurry to me - do we have anything else to use, or is this it?


comment:
2nd last paragraph, add comma after User ID


comment:
Meter Write popup text: 2nd paragraph, last sentence: Recommend changing to "They can also use the Manage User Filters function." I had to re-read the sentence a couple times to pick up what it was saying.


comment:
I don't know if there's a way to change this but this is SOO long


comment:
Under the Demonstrate section - second to last bullet list needs a hard return before "Select the Options button."


comment:
If you click onscreen while the audio plays, the Meter Data tab image from the click to reveal interaction appears over Edwin and the other animated objects.


comment:
Step 9/14: feels weird that i have to click the dropdown to select Excel when that is what is already selected


comment:
Step 7/25: when you click 8 on the calendar it doesn't show as being selected so it doesn't seem like i'm ready to then press OK


comment:
Step 4/11: Same thing as earlier about selecting Excel when it is already selected


comment:
screen 7/9, popup box text: says "Id" instead of "ID" 2x


comment:
Make sure all references to the application are consistent. It should be MRI-S throughout, but I saw MRIS on this screen. Do global check.


comment:
Ive seen Batch ID and Batch Id - I think it should be ID? Make consistent either way


comment:
13/18: same thing about excel dropdown as prev mentioned


comment:
Same thing about clicking dates on calendar as prev mentioned


comment:
Same thing about selecting excel in dropdown as prev mentioned


comment:
Why is selecting open incorrect in this task and correct in previous? Green note box says i can open or save as?


comment:
Ignore my previous audio comment, it works fine now. I agree, this is super long. We can just bring it up to CAISO to ask if these tasks have to be bundled or if we can split them up sequentially.


comment:
The transcript popup box has a yellow border when you scroll up or down within it.


comment:
The See it in action rollover appears in a visited state on this menu page. Shouldn't both See it in action and Make the connection be visited and unclickable here?


comment:
Payment Calendar hasn't been capitalized throughout the rest of the course, so I would make it lowercase in the intro text here.


comment:
Make the connection rollover button is not in a visited state but See it in action and You try it are.


comment:
Question on whether the SQMD file will be rejected: answer option #1 has "Id" 2x instead of "ID"


comment:
Appears to be 2 spaces between "Filters" and "in"


comment:
The Resources link says "MRI-S Settlements External User Guide" but the resource is referred to as the "CAISO MRI-S Settlements User Guide" onscreen. We should match up throughout the course with what is onscreen, in audio, and what the resource is called in the dropdown Resources tab.


comment:
in the 2nd paragraph, add "work" after "upwind."  Should be Upwind work may continue...


comment:
??"the important difference Roche is making for CMV testing" ?? what are we saying here? Perhaps better:
"... what I've learned about the importance of accurate and consistent CMV testing for transplant patients".. (or whatever adjectives marketing thinks are most important to emphasize.)


comment:
.....with Operation REVEAL 2017: BD and Cepheid

or
....with Operation REVEAL: BD and Cepheid

(up to the team...but use throughout all materials)


comment:
I'm not sure I agree the message that transplants are a blend of art and science" is appropriate. This is usually a life-or-death situation for patients, and doctors try the best they can to take the art out of it.


comment:
Do we want to add in that HSCT can either be allogenic or autologous?


comment:
I think we don't need a separate page for this if we just put it onto the preceding one.


comment:
OPTION TO REPLACE

The cobas(r) 4800 System offers the ability to perform mixed-testing across which assays?   [answer 1 is correct]

(1) HPV, CT/NG, MRSA/SA, Cdiff plus virology and blood screening assays 
(2) MTB, HPV, CT/NG, MRSA/SA, Cdiff
(3) Virology HBV, HCV, HCV-GT, HIV-1 only
(4) CRE, HPV, MTB, Flu A/B, RSV


comment:
Is it worth putting "allogenic in the heading: "Patient#2: Allogenic Hematopoietic Stem Cell Transplant (HSCT)." I would take out the first sentence of the dialogue (With an autologous stem cell transplant, post-procedure CMV infection is not a concern because we will be restoring the patients own immune system")


comment:
I would put this before the patient stories.


comment:
---would need to add G&O to answer 1 as well

THEN
Correct!  Mixed-testing of cobas 4800 System CE-IVD assays for MRSA/SA, C. diff, HBV, HCV, HCV-GT, HIV-1, HSV 1&2, HPV, CT/NG, BRAF V600, EGFR v2, and KRAS is possible.  LDTs can be run separately.


comment:
For the yellow paint-audience might be wondering why you put him on suppressive therapy if he were CMV neg. do you want to mention if the organ was CMV+ or CMV-? the risks of CMV disease for both cases, versus the risk of reactivation if he were CMV+?


comment:
now I see why 30-60 minutes was an answer...we can leave it.

Also, do we want to remove Alere...or not?


comment:
These are not intuitive to me. the red items go in a very logical order, but the comments on the right don't seem specific to them. (i.e., long term patient impacts could also go to "could last months or years). Patient Placed under care of local medical team" could also go with "requires coordinated care between transplant team and local care providers, but its not the first chronological step... or is it...?


comment:
need to rework this section - there is not just one right answer. example: "Patient can be placed under care of local medical team" could be before or after transplant.


comment:
cobas 6800/8800 System CT/NG test has the largest number of specimen claims for clinical use of any molecular diagnostic test on the market.  How many specimen claims does it have?


comment:
HSV encephalitis is a herpes virus (#3 is a flavor of #1)


comment:
Instead of "risk of infection" we need to mention that these can also latent infections that are reactivated to cause disease.


comment:
What is unique about the cobas 6800/8800 System CT/NG test that no other competitor on the market can claim?


comment:
Can we put the percentage questions in numerical order (least to greatest) and keep the scale the same on all the pages? (i.e., make them all like CMV?)


comment:
do we want to remove the word "batching" in one of the answers?


comment:
This list should match the viruses mentioned in the slides that follow. EBV, BK and JC aren't listed yet they each get a quiz question. The quiz doesn't have HSV encephalitis.


comment:
How about MRSA, Cdiff?   Now sure what is loaded for these but good to double check.


comment:
I finally got this to answer by holding the shift key, but it wasn't clear that this was highlighting all 3 items. Perhaps this is just a matter of changing the color? maybe give people a hint that they need to hold down shift?


comment:
Counting the three _____ assays and HPV, the cobas 4800 System offers 12 CE-IVD approved tests.

Answer is: Microbiology


comment:
What about Rhinovirus? most deadly virus for transplant patients. We don't test for it, or influenza. 
Also, in looking at this, i see we should be more precise with our nomenclature. Perhaps first slide should not have herpes, hepatitis, HSV, and CMV. but rather:
Herpesviruses (e.g., HSV, VZV)
Hepadnaviridae (e.g., HBV)
Cytomegalovirus (e.g., CMV)
polyomavirus (e.g., JC, BK)


comment:
The preceding slides do give evidence that CMV is the most prevalent, but it didn't give any evidence that its "one of the highest risk infections"... Is that evidence in an earlier module? if not, we either need to provide it or strike this out of the conclusion. (I'd prefer the former, not the latter)


comment:
Abbreviations SOT and HSCT include the word transplant, so sentences should be rewritten so this is not repeated; e.g., currently, first sentence says Solid Organ Transplant transplants..."


comment:
Its not that they "also weaken the immune system." its that the way they prevent rejection is by suppressing the immune system.


comment:
I got same glitch as JEB with last brush


comment:
NEW OPTION TO REPLACE The cobas(r) 4800 System offers the ability to perform mixed-testing across which assays? [answer 1 is correct] (1) HPV, CT/NG, MRSA/SA, Cdiff plus virology, and G&O assays (2) MTB, HPV, CT/NG, MRSA/SA, Cdiff (3) Virology HBV, HCV, HCV-GT, HIV-1 only (4) CRE, HPV, MTB, Flu A/B, RSV

Correct! Mixed-testing of cobas 4800 System CE-IVD assays for MRSA/SA, C. diff, HBV, HCV, HCV-GT, HIV-1, HSV 1&2, HPV, CT/NG, BRAF V600, EGFR v2, and KRAS is possible. LDTs can be run separately.


comment:
Correct! Mixed-testing of cobas 4800 System CE-IVD assays for MRSA/SA, C. diff, CT/NG, HPV, HBV, HCV, HCV-GT, HIV-1, HSV 1&2, BRAF V600, EGFR v2, and KRAS is possible. LDTs can be run separately.


comment:
Around 1:05  1:11 of video, can we replace:
Money is no object for Sylvie Spuhn.  She will spend as much as it takes to make her labs the best and most efficient in the world  

OPTION:  Despite her enormous wealth, Sylvie Spuhn is financially clever. She aims to select the best diagnostic partner to ensure her labs are the most productive and efficient in the world.


comment:
Were we going to have a different character than Jakob (the guy on the right)?   BL- do we have some options to replace him?  Anyone look like Dewi?  ....I know right?


comment:
Nice Work!  Cepheid was instrumental in changing the way Mycobacterium tuberculosis (MTB) diagnostics occurred in high burden countries.


comment:
28 CE-IVD tests:  HAI (10), CID (6), Virology (3), Sexual Health (5), and Oncology & Genetics (4)


comment:
change this one to 

"The patented cartridge holds sample, reagents, processed samples and waste solutions."


comment:
GeneXpert Infinity-80

This applies everywhere.


comment:
First answer:   Change to 80 tests  (not >80 tests)
Second answer:  Change to <1,000 tests  (not >1,000 tests)

otherwise there are multiple correct answers


comment:
where did the normal phone ring go?  Is it my computer...?   Applies to all the calls


comment:
Cepheid has a 30 minute Xpress Flu/RSV test with Early Assay Termination (positive results in 20 minutes)


comment:
to the CPHD team, do we want to highlight here the other EAT tests?  6 in total I think?  Or put this in the dossier?


comment:
IDEA:

DEBRIEF:   Quick thinking Agent!  Cepheid offers additional Early Assay Termination tests: MRSA, C. difficile, Norovirus, vanA for VRE, TV, GBS & GBS LB and Flu only or RSV only tests.


comment:
FOR THE ANSWER DEBRIEF:

 Each GeneXpert®
thermocycling module
requires calibration every
year or 1,000 tests, whichever
comes first.


comment:
For Interlock Q1 -update A 2nd bullet to say ...and main air blower at no greater than 2000PPM.


comment:
BETTER OPTION:

Each GeneXpert® thermocycling module
requires calibration every
year or 1,000 tests, whichever
comes first.  For an Infinity-80, this would required a minimum of 80 calibration cartridges to be run.

Comparatively, Roche platforms do not require this added calibration time or cost to the customer.


comment:
Interlock Q2 - update A to ..."Startup - High SO2" in this procedure.


comment:
Startup, Q1, A change "plant personnel" to "facility personnel"


comment:
REWORD

Is the BD MAX a random access system?

NEW correct Answer: No, it is not a random access system.

Nice work Agent!  The BD MAX system is not random access because during an extraction run, the system is locked down and not able to accept additional samples on that side.


comment:
Announcement systems, Q2, A - update "site to site" to "facility to facility"


comment:
I know there is Side A and Side B so technically, Side A could be locked down and Side B could be "random access".....I suggest we put his in the facilitator guide.


comment:
BD MAX   <---all caps (everywhere through all training)


comment:
Startup Q1, A - update 3rd bullet to:  PA system announcing the imminent startup of the plant or high SO2


comment:
Feedback 

Very smooth Agent!  The BD MAX System offers an average hands-on time of less than 1 minute.


comment:
can we make the summary statement a bit stronger?  BD is using LDT's and third party developers.  

OPTION:   BD claims the BD MAX System is flexible and enables standardization for the laboratories benefit.  In reality, BD outsources essential laboratory menu needs to Third Party developers and refers to this as BD MAX flexibility.  Core Virology menu is the customers burden to develop and validate as an LDT. This leads to a fragmented menu for customers to figure out.


comment:
is it supposed to provide an Error message on the phone/ipad?


comment:
For cdiff:
"Strain Coverage:  23 toxinotypes"


comment:
For MRSA/SA

Assay = MRSA XT
Sample Type: Nasal Swab
Control:  Recommended but not provided


comment:
maybe replace Cdiff Strain Coverage with Cdiff Sample Type.....then both use sample type

Cdiff:  "Sample Type: Unformed stool sample"


comment:
Ask that BD team come up with a strong final statement that pops up on the phone at the end.  The current one doesn't really relate to the goal of the training.


comment:
not sure if we have this much room - thought is to have two categories (Sample type and Control).  The control part may be a guess for them but reinforce that Cepheid don't include external controls....

Xpert C. difficile
Sample Type: Unformed stool sample
Control: Sample Processing Control (SPC), Probe Check Control (PCC); no external positive or negative controls provided.

Xpert MRSA NxG
Sample Type: Nasal Swab
Control: Sample Processing Control (SPC), Probe Check Control (PCC); no external positive or negative controls provided.

Xpert HPV
Sample Type: Cervical specimens collected in PreservCyt
Control: Sample Adequacy Control (SAC), Probe Check Control (PCC); no external positive or negative controls provided.

Xpert CT/NG
Sample Type: Male: Urine; Female: Urine, Vaginal Swabs, Endocervical Swabs
Control: Sample Adequacy Control (SAC), Probe Check Control (PCC), Sample Processing Control (SPC); no external positive or negative controls provided  ZeptoMetrix vendor recommended.


comment:
Take Away message:  While Cepheid offers internal control strategies, external positive and negative controls are left to the laboratory to source and QC.    (is this true?)


comment:
Cepheid offers additional Early Assay Termination tests: MRSA, C. difficile, Norovirus, vanA for VRE, TV, GBS & GBS LB and Flu only or RSV only tests.


....but only one Xpress test.  Yes?  If so, this is fine.


comment:
Feedback OPTION:   Nice navigation!  Cepheid's Xpress Flu/RSV provides results in 30 minutes.  For positive results, it can be as fast as 20 minutes with Early Assay Termination.


comment:
Feedback OPTION:

Nice move!  Cepheid Early Assay Termination (EAT) for Xpress Flu/RSV returns a positive result in 20 minutes.  Other EAT tests include MRSA, C. difficile, Norovirus, vanA for VRE, TV, GBS and GBS LB; however, these have longer thermocycling profiles.


comment:
Another option is to change the 3 hours answer to something broader.  

Example:  30 minutes to 2 hours depending on the test


comment:
2nd link: change to select and manage sites procedure in Quality Docs


comment:
include link to Select and Manage Sites process map on this screen


comment:
In all the pop-ups on this page, a couple requests.

Update header of the pop-up to "Example Section Questions"
Highlight the word "Example" somehow. Maybe make it red or all caps?


comment:
VO - there is no "singular 'right way' to have this discussion"


comment:
Item #2, How to say it: If there is room, add "and required training for the trial" to the end.


comment:
VO: "Something changes about a site" does not work well, as that sounds like it is discussing true site changes (Which it is not). I recommend "something specific to the ability to use the site for the trial changes..." (or something like that, to identify that it isn't necessarily a SITE change, but a realization of something you previously expected that is changing).


comment:
The highlighted sections are going beyond where they should. The "Dr. Jordan stated...." area extended all the way through most of the "Pharmacy was contacted" sentence.


comment:
It's happening all the way through. Check the formatting to make sure the specific sections are being called out appropriately.


comment:
The answer logic isn't working here. I selected the two correct answers (Discuss site commitment and Consider other potential sites) and it told me "Incorrect, remember you can't select a site that doesn't qualify...". CHECK ALL ANSWER LOGIC.


comment:
Ok...so just realized why I had my first comment...the question says which would NOT be appropriate. Discuss with the group, but I think I would prefer this to be select which WOULD be appropriate.


comment:
In regard to my COM popup, just remove the random period. (not bullet, sorry!)


comment:
Your audio says we're going to learn about accessing and navigating the system. Shouldn't it be introducing the video so editing and creating contacts?


comment:
Gather Information box isn't aligned with the other layers.


comment:
Some of these logos are covering up or too close to the text in the red bars.


comment:
Remove the "for you" in the last sentence.


comment:
Check all of these Q&As. All are too close to the icon for me. (I'm using Firefox).


comment:
All of this text is covering the icon too. Do others see this too, or is it just me?


comment:
I'm wondering if for all of these videos, is the LA needed on screen? Can we just add the text about the video on the screen, remove the LA and then make the videos bigger? I just feel like we're adding even more narration to this already long course. Thoughts?


comment:
Document and Plan Follow-up has a strange hover state. It keeps glowing.


comment:
Fix the second bullet "information" isn't aligned.


comment:
When I revisit any trialforce demo screen, I can't play the demo.


comment:
I can't select the Answers PDF. Am I supposed to be able to?


comment:
Let's say "As I read Dr. Poe's email, a couple of questions....


comment:
update directions" Review the statements below and select the statement I should follow-up on with Dr. Poe and select submit. Review the email by selecting the Email button.


comment:
This activity is confusing. You say I need to follow-up on only one statement, but there are two? Update my directions in my comment above. This activity wasn't easy to navigate. Once I selected something it was hard to deselect. Could just be me though.


comment:
Guy's text in the box is covering up the image.


comment:
The incorrect text hides the form so I can't see the answers.


comment:
Make the directions clearer for these activities.  I think we can easily shorten them up. Also for this one we tell them to click sections and I think it should just be a section.


comment:
Documentation popup complete state has black font. I can't click it again once I viewed.


comment:
Pending action items popup - Appropriate is spelled wrong. Please run a spell check for this course to see if we can catch any of these.


comment:
The resources button from the menu needs to be updated with the correct links from the course.


comment:
Can we use bullets when listing out assays and/or platforms? Easier to read.


comment:
I count 6 for female (unless items in parenthesis counts as 2). Confirm.


comment:
Copy text and title from storyline file here.


comment:
Please bold the phrase "running two Lilly trials right now" in the text


comment:
I think it's Dr. Poe? Please confirm and change globally


comment:
Site evaluator defend and/or explain why a site is the best choice or fits the necessary qualifications. 
Use 'defend or explain' why a site is qualifed to conduct study


comment:
Interviewer is looking at the resume and the job is regulated. A pilot job. Needs specific schooling and training to take the job. A couple of candidates meets all the requirements. Check all the boxes. You might have four pilots but you only need two...


comment:
Fourth item change to: "What documentation should I have with me during an Evaluation Visit?"


comment:
Since the end-user may take these out of order, I suggest saying the full name vs. abbreviation since this is 1st slide.  (i.e, say: Investigator Site Evaluation Checklist)


comment:
Audio - suggest removing "this is the 5th of 6th..."  Doesn't add to the content and somebody might take in a different order.


comment:
When I select Field Observer/Operator, the guy on the right - his ear protection does not gray out.


comment:
After selecting a role, the eLearning should advance to the next screen (without selecting Next).  Right now, it stays on the same screen regardless of the role selected.


comment:
Documentation Requirements should be the correct answer.  Correct feedback should say, "Correct! Documentation Requirements is where you can find the four documents required by each site as part of the Directive."  Incorrect feedback should say, "Sorry.  Documentation Requirements is where you can find the four documents required by each site as part of the Directive."


comment:
Control Requirements should be the correct answer.  Update both incorrect and correct feedback to indicate "Control Requirements" instead of "Controls and Warning System Requirements."


comment:
We need to change StandardiZation to StandardiSation throughout.


comment:
This pages provides options for additional system training for all platforms except for the Liat. Please add this, which should link to existing pre-learning modules created for Liat.


comment:
Love this! Sounds awesome!  One small note-- it might be distracting to hear that Sylvie Spuhn would spend as much as it takes to make her lab the best. Can we focus more on the competition instead of stating that money is abundant?


comment:
menu buttons are slightly off... may just need a republish


comment:
There is a heavy focus on MTB during the Cepheid call. Suggestion to make this one of the many menu items they offer, as the training focuses on addressing this and its top of mind for affiliates.


comment:
looks like you have the space to match font size in bubbles as intro text


comment:
There are no arrows for the GeneXpert 16-door instrument versus the GeneXpert Infinity.

Also please match menu items to modules questions for target statements


comment:
shorten directions text box so it goes to 2 lines and move out away from purple bar a bit


comment:
im not a huge fan of the checkmarks, but feel free to leave in. i would change them to green though


comment:
can you have the instructions come up when audio complete?


comment:
just want to call out i can skip this video at any time. that may be intentional though


comment:
For semi-automation, we discussed yesterday to change the <2 minutes to ~


comment:
i would ditch the normal audio controls once you get to the video part. then move the replay button on top of the video.


comment:
spelling error for BD Max... "utilized" should be "unitized"


comment:
"Holds two individual racks of 12 each, allowing 1-24 samples to be loaded"


comment:
i can confirm all of the instances sharon has mentioned


comment:
Spelling and Grammer....should be: "The platform enables any sample to be loaded at any time, provided capacity (an open module) exists."


comment:
"Add-on Modules Sets can be additionally purchased to expand up to 48 or 80 total samples, depending on base system"


comment:
extra space in speech bubbled before "trial-specific" at the end


comment:
seems like directions are almost always in speech bubble. make consistent


comment:
i think this can be reworked to a similar layout as the others (not sure why it's so different?) i think the paper can probably take up a similar space. then bring the character back in and use speech bubble, especially if the intro text is shorter. it was weird having it be first-person without a character on screen


comment:
Change the hover on the last paint spot to say "Gallery Walk" to be consistent


comment:
Agree with Jessica and Ellen - let's say...

I would like to share with you what I have learned about the accurate and consistent CMV testing and the important difference Roche is making for transplant patients.


comment:
when I hit the transcript, other text showed up on screen.


comment:
Investigator is spelled wrong in the first box.


comment:
The goal for this video is to provide an overview of the Transplant Academy and what we will focus on as well as why this is important for affiliates to learn about CMV testing.
Can you send us the script for the video?  Maybe we can provide edits this way?
Thinking it needs a bit more about the Academy itself and why we have built it as well as link to the patient video - we plan to use the videos in advertising for the Academy prior to its release...


comment:
Need to add the "halos" around the color they are supposed to click on ...if color blind greying out the other spots won't help.


comment:
Popup 1 - last bullet paper documentation is missing a period.


comment:
Good suggestion Ellen.  We should also say that SOT can be living donors (ex: Kidney) and deceased donors...unless that may come later.


comment:
Is there an extra space after the word "Remember"?


comment:
Transplant replace organs or tissues that have been...


comment:
Is there a space before the word "Is" in the first box?


comment:
1st popup text is covered with the close X.


comment:
Looks cool, a little frustrating that answering correctly doesn't always show that you get closer.


comment:
4th popup, add a space after assets. and before If.


comment:
Whoops. I can't count. I meant third popup :)


comment:
The reference for HSCT is 
Bone Marrow Transplantation (2016) 51, 778785
Niederwieser et al.
Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey


comment:
Did you want add the 20 min for Cepheid EAT assay?


comment:
Can we add HPV ie cobas CT/NG and HPV or all cobas assays on the cobas 4800, 6800/8800 systems


comment:
Should we say inspections for the 3rd one as audits are what Lilly does and inspections is what is done by other outside regulatory bodies


comment:
do we intend to show how to access the SPI?


comment:
Not to keen on this question I think we should list out the interventions


comment:
We should remove this slide since the last sentence is not so true and Hologic is the only manufacture with and mRNA test and BD & Cepheid are DNA


comment:
Since this is about ease of workflow and efficiencies can we something about this


comment:
When we hit continue can we go right into the voice without hitting play


comment:
Is it "up to 12 racks" and are we calling these Unitized reagent strips


comment:
Unitized Reagents Strips: the Extraction reagents and the Master Mix tubes are added to the strip. this is not clear in the verbiage


comment:
I do not believe that all the BD MaX assays have swabs, what about urine, CDiff uses a Loop


comment:
The feedback here is wrong.  Correct feedback should be "Right! Controls and Warning System Requirements provide information on what workstypes should be suspended during startup, as well as what interlocks and notifications are required."  Incorrect feedback should be "Not quite. Controls and Warning System Requirements provide information on what workstypes should be suspended during startup, as well as what interlocks and notifications are required."


comment:
Audio: Instead of "We get data on our tax forms", suggest: "We enter data on our tax forms" or "We received data for our tax forms".


comment:
Is this example of using tax forms too US-centric?


comment:
Still need to update images for A, B, and D to match the style we have for C.


comment:
Last sentence: Recommend changing "Lilly may lose the submission" to "the submission not be approved by a regulatory agency and may not be able..."


comment:
Checkmark still appears before I watch the video.


comment:
This prevents the plume from rising screen - need more fumigation clouds.  Needs to be like where we mention type 1 fumigation.  Let's go through Fumigation together.


comment:
checkmark appears before I watch the video


comment:
Remove the comma after "The heavier inversion on top"


comment:
The checkmark appears before I watch the video


comment:
the checkmark appears before I watch the video.


comment:
If the 1st "A" in ALCOA is "Accurate" please switch the order of the vertical gray boxes (i.e., Accurate is 1st and Attibutable is last)


comment:
Pop-up - contemporaneous paper expectations - didn't quite understand the last bullet. What is meant by "have many blank document forms available"?


comment:
It looks like the speech bubble on this screen is sitting on top of another one.


comment:
The mosaic logo on his shirt is backwards.


comment:
Click Next to Continue should not appear until after all of the text has appeared on screen.


comment:
The first response makes it sound like Omni is suitable for PoC. This is not necessarily true. Suggestion to change end of the the sentence..."...will have to reduce TAT on their current tests to address true PoC locations."


comment:
This is great!  Much better in terms of keeping the mystery of the painting until the end.

Also..no contractions please :)


comment:
Can you make it more obvious they should click on the plaque?  Maybe have an Halo around it appear or blink a few times?


comment:
When they click on Exit where will it take them?


comment:
Does it make sense to even put 6800 in here? Do we not want to add something about Liat?


comment:
Capitalize Country-level at the beginning of the 2nd sentence.


comment:
Note: Make these corrections throughout - 
barcode reader
Sample Buffer tube
Master Mix tube
Extraction Reagent tube


comment:
incorrect for BD - 4-step sample process is truly a multi-step sample process.


comment:
Can you include a portion of the answer in the question:

The GeneXpert IV can run...


comment:
Do we add the caveat that this is what is stated in their materials? Although it is more than 1 minute.


comment:
change answer to: 'availability of LDTs'


comment:
In commentary, change 'develop' to 'enhance' their core testing....


comment:
BL - in the answer, can you add a third column with Roche so they can compare?


comment:
Change Cepheid to BD in green box.

to CN - I would keep strain coverage fo performance (vs sample type). It's what we highlight in BD vs cobas materials for Cdiff.


comment:
Please also out to the counter...There should be some focus also put on how the Xpert system is not suitable to be put outside the lab. There is no integrated screen for their 1-door instrument. 

Roche counter: 
In comparison to the Cepheid Xpert System, Roche's cobas Liat System has an integrated Graphical User Interface (GUI), which provides definitive results for all assays in under 30 minutes, making it ideal for PoC (urgent) settings. Additionally, the workflow does not require use of 3rd party equipment.


comment:
Dossier links not working, please correct


comment:
rewrite: His build is large (strikeout pretty)


comment:
rewrite:
'give flexibility and standardization to labs, ...'


comment:
pre-warming only applies to certain assays?

to team: should we delete pre-warming and make it a generalized approach


comment:
rewrite:

...perform some of the following steps for specic assays: pre-warming, aliquoting, recapping.


comment:
in answer recap box, add the following at the end:

'part of sample preparation for a few assays'..

(Team - need your input if this is misleading by highlighting only a few assays. Perhaps we should generalize the steps and remove the 'pre-warming step'


comment:
update the text in the incorrect example red box to say incorrect example instead of incomplete.


comment:
Sorry also change it in the text at the top to say incorrect.


comment:
Please re-word (team review):
Cepheid's claimed <1 minute of manual sample processing must be repeated, for each sample, so "ease-of-use" efficiencies are not realised as volumes increase.

Dewi insists on British English everywhere please!


comment:
Can we simplify the text and reduce it is easier to read?


comment:
Match up the resources popup to this page (process map text)


comment:
delete 'off-board heating step' as that is particular to a few assays only.


comment:
(Team review)
The counter claim here does not tie to the statement. Please delete.

Please replace with: 
Every sample being placed on the GeneXpert System must undergo the same manual sample preparation time. There are no efficiency gains with hands-on time. 

Roche's cobas 4800 System, and cobas 6800/8800 Systems leverage economies of scale for hands-on time, providing increasing efficiency and productivity as volumes increase.


comment:
(Team Review):

For the BD rep might say oart... Myra will send revised wording. We don't want it say random access.


comment:
(Team Review) 
Myra will also send revised wording for BD Revealed..


comment:
(Team Review)

Please change the Cepheid rep statement:
"We offer Early Assay Termination, giving you results as early as 20 minutes!"


comment:
(Team Review)

Change the Cepheid Revealed to: 
"Our Early Assay Termination feature is only available on select assays, and only applies to positive results. You have to wait for the run to end to see true negative results!"


***BLP: Please add to ILT more info on the 20 minutes being only for Flu/RSV Xpress positives when in Flu only or RSV only mode


comment:
FIRST RESPONSE, take out the word "conservatively"

SECOND RESPONSE, GeneXpert Infinity


comment:
SCREEN 2
STATEMENT: Whoa!  Let's do some math.  At 1 minute of sample preparation time per sample multiplied by 2,074 samples....that 34.5 hours!  How can that be?

FIRST RESPONSE, change "batching" to Mixed-testing"


comment:
SCREEN 3 STATEMENT: I really need to consider the full workflow of my laboratory as my costs are more than just reagents and consumables.


comment:
LAST STATEMENT:
change "see the efficiency to be gained with batch processing" to "see the efficiency to be gained with mixed-testing"


comment:
Choosing all the wrong answers:

OPTION FOR FIRST WRONG RESPONSE: You do realize the platform is semi-automated, meaning that your staff will need to perform individual sample preparation and load the unitized strips?

OPTION FOR SECOND WRONG RESPONSE: Since the throughput of the system is low, you will be required to set up multiple runs. Because of this, your dedicated staff will have time to complete the extra sample prep after your first run is started

FINAL CUSTOMER STATEMENT OPTION: Well, that is not ideal.  I will need to go back to BD and get some clarification prior to making a decision


comment:
Choosing all the wrong answers:

OPTION FOR FIRST WRONG RESPONSE: Did the Cepheid rep talk about the increasing hands-on time when loading the GeneXpert Infinity?


comment:
FINAL CORRECT STATEMENT OPTION (last sentence only) 

..........Tests meant for Poc and the Omni platform will need to be modified to meet the PoC requirements for TAT"


could delete the middle sentence if we have space issues


comment:
The final summary statement needs to be revised for BD statement 1.  Unrivaled and unmatched will not pass regulatory.

OPTION:  Roche is the established leader of PCR and aggressively invests in projects to advance Molecular Diagnostics.  RMS continues to expand its menu with strategic focus relative to urgent and non-urgent testing to improve patient outcomes.


comment:
We need to firm up the response.....we say BD and LDT's is bad but cobas 4800 and UDF is good.  


Something about Roche developing high quality assays with our in-house expertise, providing controls and enabling automation for a true walk-away solution.  Additionally, we empower laboratories to run LDT's for niche (<----different word) tests to improve patient care.....


comment:
OPTION: At Roche, the LDT option complements the core CE-IVD menus of cobas 4800 System and cobas 6800/8800 Systems.  We empower laboratories to supplement their menu offerings through in-house developed tests.  

Conversely, Cepheid does not allow this flexibility on GeneXpert platforms requiring the customer purchase a second platform while BD places the full burden on customers to build and validate LDTs in order to offer routine testing (Virology).


comment:
OPTION FOR RESPONSE:

Point-of-Care and Centralized testing environments have different needs that are not fully addressed with a single platform design. When the same platform design is forced into both urgent and non-urgent laboratories; one laboratory experiences efficiency, productivity, and economic losses. (Imagine a cobas 6800 System in an emergency room running STAT Cdiff. or a single cobas Liat System in a Centralized laboratory running 300 CT/NG per day  the same applies to GeneXpert random access system in the two settings)


The cobas Liat platform strategically released CE-IVD tests specifically designed for a rapid turnaround time based on the clinical utility gained from a faster result. It is critical to have the proper technology (platform) and the proper menu that delivers a fast result in the PoC setting.


comment:
How do I put an X in Global Edit???   I want to X people.  :)


comment:
RESPONSE FOR THE MODULARITY ONE:
Different throughputs (urgent vs. non-urgent) require different platform designs or lose aspects that are important to the laboratory such as efficiency, productivity, and cost effectiveness. 
Roche understands this concept. The cobas Liat System is specifically designed to meet the laboratory requirements in a PoC setting.  Likewise, the cobas 6800/8800 Systems are specifically designed to meet the laboratory requirements in a high throughput setting.


comment:
agree.  need a stronger BD - hit a target statement topic..


comment:
expand, expanded, expand.....too many expands


comment:
Our BD MAX" System provides maximum flexibility and efficiency by allowing you to optimize your workflow through its true walkaway automation!

Next slide: 
You must complete an extraction cycle of up to 24 samples before you can load another sample on the system!


comment:
PCR Cartridge can only be used twice I thought? uses one row for the first run (regardless of sample 1-12) then the second run would use the second row?


comment:
Loading the racks onto the BD Max are you referring to unitized reagents in the rack and the sample rack? just confused


comment:
Still concerned about the four step sample prep


comment:
I would like a voice here if the phone is going to ring


comment:
The question is more about scalability, should the question be addressed with adding multiple units


comment:
Should this address workflow and not annual calibration


comment:
The workflow response could cover the time of calibration and if a  high volume could calibration several times per year


comment:
can we change the correct answer to something including efficiency?


comment:
In the correct response mention that you need to load the reagents onto the instrument


comment:
The BD OnClarity HPV test offers extended Genotyping. The present guidlines supports genotyps 16, 18 (with or without 45) and extended genotyping could lead clinicians to confusion and diminish clinical utility. 

Second Slide
Most BD MAX assays lacks  a contamination control and the requirement......


comment:
The 6800/8800 are not really competing with Omni and the LDT are not needed for Cepheid since they do have a broad menu


comment:
Last bullet, should it be "trial-specific" rather than "protocol-specific"?


comment:
Second sentence, I would replace "trial protocol" with "trial requirements". The COPM doesn't only base their questions on the protocol, but rather the requirements or needs of a trial. At least that's how I understand it :-)


comment:
1st pop-up, 1st paragraph: replace subjects by study participants.


comment:
Question for Nancy or the COPMs in this group:
The regional-specifics example question doesn't seem like an appropriate ISEC question (with the new process). It asks for preference. Replace it with an other example?


comment:
I don't believe we have spelled out SC before. If not I would say "Study Coordinator" here.


comment:
typo in correct feedback: trail vs trial


comment:
The sample slide deck wouldn't open for me


comment:
2nd popup: Just got off the phone with a really tough customer. It was challenging to hear them because they were so frustrated. We ended up finding a solution for him. He just wanted to know what went wrong. I'm ready for lunch. Are you?  Make this text more conversational throughout.


comment:
Remove the typing sound. It is distracting.


comment:
Is that the correct order of modules? I was thinking Managing Satellite Locations would come after the full round of "Evaluating/Qualifying/Selecting Sites" since ultimately, it is an EXTRA thing that may or may not occur (sort of like Site Changes).


comment:
I think the #4 expectation is reading weird. If others agree, I think the sentence needs to be swapped. "Acting as the representative of Lilly, you will establish partnerships with investigator sites."


comment:
Capitalize Clinical Operations on screen.


comment:
Trial Records Pop-Up, need parenthesis at end of Member List statement.


comment:
2nd sentence in VO: "When learning about sites known to Lilly, but WHICH are new to the CDC..."


comment:
Sites video should come first, followed by Contacts.


comment:
Text at top of screen. Update to "Let's take a look at Adding a Member, which is one of the first official steps to start documenting during the Site Evaluation process." (I get that may be too long - point here is that I want them to realize that we've moved from the "general" info in prior videos into the "This is part of preparing for a site evaluation visit"


comment:
There was previously a brief VO that intro'd this video, but it isn't here now - is there a reason for that? I took a look at it again and I still think it works to intro the video (doesn't alter what the video says). Can that be added back in? (with following change to first sentence "for a site visit, it's THE RIGHT time to begin documenting...")


comment:
Debarment list pop-up, extra period at end of sentence.


comment:
Don't love the correct answer here. We aren't going to find the ACTION on the debarment list, we are going to find a statement that they ARE debarred. Perhaps update to "Information that would prevent a PI from working on a trial"? That can be wordsmithed, but I just don't like actions, unless it includes "regulatory actions"


comment:
Correct pop-up - update last sentence to say "regulated by the applicable regulatory body (e.g. FDA).


comment:
The voice placeholder is missing the last sentence that is in the script. It says "The SPI form is created at the SITE level in Trialforce, as it is not trial specific, and is easy to fill out."  (That should be included in final for sure).


comment:
I don't think SPI has been defined before now. I would suggest slide header be updated to say "Create the Site Profile Information Form" and then the VO also include the full name the first time - "Site Profile Information Form, commonly called the SPI"


comment:
I am going to send you a Screenshot to include with the "SPI" words on the computer. Think it would be good to use that here, as we don't demo it officially.


comment:
I think there needs to be some intro into the Creating a Trial Site screen as well. If you can't do a VO intro on the next screen (the verbiage in the VO script would be fine if you CAN include a intro commentary on the next screen), you could include it here, with this being a "Start your Trialforce documentation" slide - highlight the SPI on screen as planned, but then also comment in the VO something like "When you have started further discussions with a site specific to potentially including them in a specific trial, it is also a good time to Create a Trial Site in Trialforce. This usually occurs as soon as you have a Confidentiality Agreement for a Trial and they have expressed interest, but can occur earlier if needed. You will have the opportunity to see this process demonstrated on the next screen."


comment:
See comments on prior screen. I think the VO either needs to come back here (As it is still in the VO script) or the prior screen needs updates to introduce this page.


comment:
1st bullet say "Identify, Evaluate & Select Sites process"
2nd bullet: link symbol to be on same hight as text

Are we referencing the procedure here in the other modules?


comment:
the site evaluation slides do not open for me. i get the error message 'The proxy server isn't responding".


comment:
As there is a lot of audio in this course, should we add something here to say that audio transcipt is in the menu button?


comment:
Voice Over:
its Global Clinical Operations, not "the" Global Clinical Operations


comment:
Another thought for this screen:
Should we add a sentence explaining that 
- Trialforce videos are provided in this course to provide the full pictue of peparing for site evaluation
- That based on individual learner needs the learner can move forward in the course
- that these videos are created by a CDC and therefor the voice is different

.... just a thought


comment:
2nd red box pop-up: why only Citeline bolded as header text? I would remove that


comment:
Title of this slide, should only Citeline be mentioned?


comment:
The incorrect feedback after 2 tries gives text about history of audits, but that isn't in the answer options.


comment:
st sentence I would propose to replace "this" with "the": Based on the information from the site, ...


comment:
Title of the slide "Review Site Profile Information"?


comment:
CV and Site Profile mention Dr. Ford, but it's dr. Smith in the scenario.


comment:
Font in correct feedback seems smaller than usual. Can this be corrected?


comment:
It's Dr. Poe on the scenario on the previous screen. Please correct.


comment:
Should it be "Click on the attachments" (plural)? And if yes, the Answers attachment doesn't work. It doesn't seem to be hyperlinked.


comment:
1st FAQ pop-up. Allowances for virtual visits are no longer defined in the procedure. Remove that wording.


comment:
3rd FAQ: would propose to replace SEC visit with site evaluation visit as the SEC is the tool, not the visit.


comment:
Last FAQ: confirm the wording of action item with the SMEs


comment:
What is Trialforce?

Update the 2nd bullet point as:
Is Lilly's source of information on site, contact and trial


comment:
So much text. Leo is doing something like this, but he's personalizing it a bit more with people, and then you see the impact. Might be visually more appealing.


comment:
How Does a CDC use Trialforce?
Keeping site, contact and site evaluation and selection information up to date within the system

Allow other roles and functions to access the information


comment:
Let's try to have these like we do the other TF videos. Full screen. No learning agent.


comment:
learning about sites known to Lilly the bullet list item should remain staying


comment:
The title of creating site are wrong.  Agreed to EB that this site creating video need to be before contact video.


comment:
IF the training topic is "Introduction of Trialforce"  We should also introduce the trial and trial site record here as the overall picture has already mentioned that.  Feel incomplete by ending here.


comment:
Oh the next TF video only show after Gather Information which is a wrong sequence.


comment:
SPI is tied to site, not trialsite.  

I would move creating trialsite earlier as part of Introduction of TF.  So you can focus on SPI here.


comment:
SPI video is missing.  Erin, you will need to do that from Sandbox as SPI UI change a lot.


comment:
Can't click the arrow to move on form this screen


comment:
I see the purple arrow now.  Why does that different than the regular arrow at the bottom.


comment:
it took very long time to open up SPI and it is the wrong PI name


comment:
Answers.pdf not clickable.

Also this SPI is not the standard TransCelerate SPI form.  Different than Mark's


comment:
Need to leave a placeholder for TF detail training materials when we move them to success factors.


comment:
Di's prior comment a couple screens ago went here - I think she is saying that all of the bullets should stay on the screen and just be added to, if possible (rather than having first screen of bullets be replaced by second screen)


comment:
To Di's last comment, we already did a general intro to what the areas of Trialforce area in the navigating video. The CDCs only use the Trials page really for the Member area, which gets called out later in this module. There is not going to be a "Trials" demo, it isn't necessary. And the Trial Site was also identified in this section around text and the general navigation video, so it technically was covered and there is a more detailed demo on it later in this module. I think it is fine as it is titled.


comment:
I am not doing an official SPI video as the way the form looks has changed, but not enough to actually matter. People don't need a demo in formal training just to see a new look to the form. The SPI shows up in later videos and the new look is visualized there.


comment:
The first sentence should say "EIM participants use the Market Results Interface - Settlements application, or MRI-S, to work with meter data and settlements files."


comment:
The RDT section should be labeled "pre-market" not "market".


comment:
Master file feeds all the applications, but it feeds the RTM as well. There is no ball going to the RTM box.


comment:
CIDI is not necessarily post-market.  It can be done anytime.  Please remove it.


comment:
Change "Do you know what it can do for you?" to "What can you use it to do?"


comment:
For the "Submit meter data" comment box remove the "Meter Data/".  They cannot use the Meter data tab to submit meter data.


comment:
On the validate meter data comment box change the second sentence delete ", and then validate that it will pass."


comment:
On all the comment boxes change "Always use..." to "You can use..."


comment:
On the View/export meter data comment box add "/Batch Status" between the words "Meter Data" and "tab".
Change the last sentence to read "They can also export meter data from these tabs."


comment:
Instead of the words we deleted in the comment above, add "by viewing the Batch Status tab".


comment:
Change "the EIM" to "EIM" in the sentences on the top of the screen.


comment:
At the end of this screen it would be better to have a right arrow, rather than clicking on Edwin to go to the next screen.


comment:
Delay the "Click on Batch Status tab" until user has clicked on all the yellow arrows.


comment:
By yellow arrows, I mean orange markers :)


comment:
On Manage User Filters button replace the "a" with the words "your own" before "custom list".


comment:
On the Toolbar button remove "in CSV format".


comment:
Please delay the "Click the Settlements tab to continue" until after they have selected all the orange markers.


comment:
spreadsheet says the creating a site video should come first, followed by contacts


comment:
We need to be able to get the titles of each of these changes on this screen. MAybe they could sit to the left of the icons if we got rid of the learning agent on this screen?


comment:
on already selected - Bold *use the Investigator Site Change Form* 

On site not selected - Bold "update the original ISEC"


comment:
Right arrow should not show up until they have finished looking at the Settlements tab (unless they have been through the screens before).


comment:
Suggest having the "Resources tab" show up on this screen rather than waiting until the end.


comment:
In the Upload File button, remove the words "for API or UI".


comment:
Change "MRI-S Submitting Meter Data User Guide" to "MRI-S User Guide for SQMD Submission".


comment:
Can you move the Error Codes box above  the  Batch ID file with the  orange marker pointing down.  It's a little busy where it's located now.


comment:
Move Meter Write to the top and follow with Meter Read.


comment:
Meter Read - Move the first sentence to the end.


comment:
Need to get you information regarding User Roles for Settlements Tab.


comment:
On Meter Write tab delete the words "via API or UI."


comment:
Make the 2nd and 3rd paragraphs one paragraph.


comment:
In the "Begin" box change the word "from" to "into".

Note - Do we usually say "Begin"?  Please check and make this consistent with other CBTs.


comment:
Please change the text box and the script to say "Your view of MRI-S is based on your provisioned user role."


comment:
Need to state that they have selected the Meter tab in MRI-S rather than the Settlements tab before launching in to the demonstration.


comment:
Since they are in the UI let's discuss how we can reword it so that it doesn't sound like they can get to the API from this application but that there is a way to provide meter data using an API outside of this application.


comment:
At then end when you talk about the Batch ID, please use an orange arrow to show where the Batch ID is located.


comment:
Change the second sentence to read "You can export meter data to save offline or troubleshoot errors and resubmit your files."
Delete the third sentence.


comment:
In the Begin box, change it to read "In this demonstration, you'll learn how to validate and export your meter data."


comment:
At 11/32 add the word "only" between "MRI-S" and "keeps" in the comment box.


comment:
Please add the word "only" in the script (align with the comment above).  Also add "Please note, MRI-S only maintains these two versions; therefore you will want to store historical meter information outside of this application."
Also the information about versioning begins in the Success bullet on the script.  It should be with the versioning information.


comment:
Let's remove the section where we show them how to filter for the Warning status.  We do the same steps later for the Error status.


comment:
Regarding the export wizard and the "All Rows".  The box should say "You can use this drop-down to export all data within the selected range or the page that is displayed."
Change the script in this area starting with "Notice in the bottom right, you also have the option export all data within the selected range using All Rows or the just the page that is displayed using Grid View" (we need to verify if Grid View is correct).


comment:
Change the Click here to continue box to say "You did it!  You successfully validated and exported your meter data."


comment:
Change "Meter Data/Meter Data tab" to "Meter Data tab"


comment:
On the You've learned how to: change the last bullet to say "Export meter data from the Batch Status screen".


comment:
There are leftover lines after text boxes go away.  This happens throughout the presentation.


comment:
Change the second sentence to read "To export meter data, you'll follow the same process that you used on the Batch Status tab."


comment:
Keep this section - but we may want to remove the exporting explanation under the batch status section.  It's redundant.  Let's discuss.


comment:
Bill determinants - I need to provide you with a better description than what is at the top of the screen.


comment:
Invoices - I need to provide you with a better description than what is at the top of the screen.


comment:
Do not capitalize settlements in the phrase "...specific settlements files quickly..."


comment:
Change "Batch Status grid" to "meter data".


comment:
In the Begin box change "Batch Status grid" to "meter data".


comment:
We have to click to the left and then click to the right for no apparent reason (to the learner).  Let's discuss how to correct this.


comment:
In the "You did it" box change it to read "You found the file with the errors and exported it."


comment:
The first comment boxes tells them two times to look at the green and orange boxes.  Let's take one out.


comment:
After entering the resource information they will need to press Apply to do the search.  Next you are going to create a user filter.


comment:
Add to You did it that they also created a user filter.


comment:
Remove Administration from the question.  Have only three options.  Also the Administration tab pops up from time to time in the demonstrations and screenshots.  Please review and remove it everywhere.


comment:
See previous regarding the meter data grid.


comment:
Downstream-impacts are internal and external. Audio


comment:
Could add differences about satellite locations-info screen. Location changes


comment:
so...it probably doesn't need to be actioned on, but the VO artist said "ConDUHct" (i.e. how I acted) versus CUNduct (I performed this). Just wrong emphasis; if others think it matters or agree, maybe consider redoing that, but if no one else agrees, maybe I am just a crazy person.


comment:
The voiceover I heard had a full set of the whole conversation running all on this screen. It also had the voice over actor stopping and restarting, going "ugh". It is clearly not a clipped file. :) Needs to be corrected.


comment:
To SV comment...I don't think it is the hugest deal in the VO if it doesn't say ICH GCP, if it would require full redo of the actor work. So long as it shows properly on screen I doubt it will be an issue. Not my final call though.


comment:
if there is room, in the site response pop-up, spell out the first instance of ICF [Informed Consent Form (ICF)]


comment:
I feel like we made a decision to take out IEC on another screen...thinking it should maybe come out of the first question here too.


comment:
VO - "making sure source documentation PROCESSES are acceptable" the way it is phrased now sounds like CDCs would be expected to actually review source docs, which we are not.


comment:
Correct Pop-Up for Microsoft Word Answer. needs to read "In this case the printed document is the official record, not the word program used to create it."


comment:
Last question, need a dash or something in first sentence between "SAEs" and "via"


comment:
Correct answer..."How do you handle THE SITUATION when documentation..."


comment:
First question, update to "..contain ALCOA+ principles?"


comment:
Update the Transcelerate link to Transcelerate BioPharma Site Qualification & Training and use: http://www.transceleratebiopharmainc.com/initiatives/site-qualification-and-training-sqt/


comment:
Debarment spelled wrong in the >> menu drop down for this slide (line 41 edit)


comment:
Slide looks/sounds incomplete and it's the last one in my deck???


comment:
Minor -  similar comment - once completed, should the buttons be gray so that the new area to click stands out as the only purple?


comment:
Minor: could be a missing a word after potential. Should this say: discussing as a potential study for your site


comment:
Minor - not sure of the purpose of the Email button.  Nothing wrong to leave it here -  just doesn't seem related to the activity and is a duplicate to previous screens.


comment:
For the directions section on this page and previous 2 exercises, the first sentence provides the number of items for f/up. Instead of stating "take a look at this page and let him know if he should follow-up on any of the items below" this could state "take a look at this page and select the items for follow-up".  You've already told the learner there is f/up needed (and how many items)


comment:
Not sure why pointing the learner to the emails is helpful.  It's ok to keep but seems extra since there isn't new information in the emails (same emails for each exercise)


comment:
The 1st question on ICF is identified with a red x as incorrect but the pop-up answer states it's actually a good idea to ask about the ICF process.


comment:
All questions within the ISEC are driven by the COPM and would keep as is


comment:
revise correct comment to read: The site has participated on 3 trials with similar patient populations over the last 2 years meeting or exceeding their enrollment commitment.  PI does not foresee any enrollment barriers resulting from the current inclusion/exclusion criteria.


comment:
for the 2nd example it should read please provide the site's enrollment commitment for each part of the trial:


comment:
if this is captured elsewhere great otherwise is there a way to highlight that if there is a subsequent question asked if answered "no" the CDC must provide additional information- we are already seeing CDCs documenting no comments when the if "no" comment comes up


comment:
2nd question should read:  Does the site have qualified personnel who can perform and interpret 12 Lead ECGs?


comment:
Update the "to this topics" in all the boxes.


comment:
First bullet (And corresponding VO) update to "store and handle"


comment:
Global edit, update GCP to ICH GCP everywhere


comment:
Answer for Example 3, update to reflect "it is not appropriate information for the ISEC" (rather than site evaluation- it is actually appropriate discussion material, just shouldn't be in the form)


comment:
VO - would update regarding last item on destruction. ISEC doesn't fully document the criteria necessarily, it asks the questions. I would figure out how to rephrase that to reflect it better, but need to VO Script to do that.


comment:
VO - Swap out the "Perfect!" for something like "Thanks" or "OK, that sounds acceptable"


comment:
I would make the last item the 2nd item and make the current 2nd item last. (so swap box two and 4 from this screen)


comment:
In the answer pop-ups on the thermometer, you may also want to say something like "checking calibration data would also be important" or something to all out they should be looking for calibration info when possible and/or asking about it.


comment:
Box pop-up answer. Might update to "These boxes that are clearly meant to be refrigerated are sitting out, so it would be appropriate to ask about their CT Material receipt processes. This could be a red flag if what you are seeing is evidence they don't follow an appropriate process."


comment:
Update the "for this topic" header, VO, etc.


comment:
Update Transcelerate link to match the other courses (Site Qualification & Training Initiative).


comment:
I would bold CE-IVD and LDT here not test type


comment:
LLast bullet: Established by the "trial planner". Isn't it COPM? Or there is someone else who can do the planning?


comment:
Should we be more specific about what we can do with TF? For example, how data is utilized?


comment:
Will we change the voice of Dr. Shah to a male one?


comment:
Is it contain ALCOA or meet ALCOA principles?


comment:
2nd bullet add "Identify, Evaluate & Select Sites" before process map


comment:
second line - why it matters

I think we should not refer to LIlly expecataions only as these are regulaotry requirements


comment:
second question refers to Electronic health records - please be consistent with the use of EMR


comment:
first question to be changed into:
Do original source documentation and certified copies meet ALCOA attributes?


comment:
please add GCP in front of the word requirements in the second question


comment:
The module start as SPI but I don´t see any about this. If is possible I think that we can include the demo of  the process to create a SPI in trial force. 
We can include this here or in a  previous page when the video demonstrate as create a site in trial force.


comment:
The words "universal guidelines" appear in bold in the green spot pop-up. No bolded words appear in any of the other pop-ups on this menu. Should we remove the bolding from green spot text?


comment:
Add ":" after title in Immuno-response markers pop-up layer. Add "is" between "that" and "useful" in 2nd and 3rd lines of text on Antigenemia pop-up layer. Also, text in second and fourth pop-ups starts by repeating the title of the pop-up layer (i.e., Immuno-suppressive drug monitoring: Immuno-suppressive drug monitoring is XYZ)--is that repetition and additional text necessary?


comment:
Typo in first sentence of learning agent's speech bubble: "fact" should be "facts."


comment:
For the four menu topics, it's not easy to determine which I've completed and which should be the next on which to click (because in both conditions, they are purple).  Suggest using one color when the topic is complete and a different color to indicate the next topic to choose.


comment:
Once I clicked on all the folders, the system would not allow me to click on them again to review a second time.


comment:
Missing word in first sentence of correct feedback layer: "alternative". Also, spacing between second and third bullet points on flashcard seems slightly greater than spacing between first and second.


comment:
In serologic status pop-up layer, revise beginning of second sentence as follows: "D+/R- represents the highest risk for patients"


comment:
In Underlying Health pop-up layer, double check spelling of "comorbities"; shouldn't it be "comorbidities"?


comment:
In Underlying Health pop-up layer, should we end by saying "are at higher risk for CMV disease"?


comment:
Add Trialtrove/Sitetrove to the list of resource websites in the 2nd red box.


comment:
In the correct feedback layer for High-Moderate Risk, we need a comma between "recipient's" and "which".


comment:
Add intro text before instructional text: "There are five primary methods used to screen and monitor for CMV in transplant patients."


comment:
Add to end of PCR statement: "...contamination than antigenemia."


comment:
In the incorrect feedback layer for Patient 3 (high-moderate risk), we need a comma between "recipient's" and "which".


comment:
Move period to after the closing parenthesis at the end of the text in the pop-up layer for Antiviral Prophylaxis. Also, "antiviral" is misspelled in the clickable box for Antiviral Prophylaxis.


comment:
In the pop-up layer for Hybrid Approach, revise first sentence as follows: "The hybrid approach begins with antiviral prophylaxis followed by preemptive therapy."


comment:
This is a tricky question b/c the correct answer requires you to remember they are referring to an internet search of the PI's name with the terms "audit," or "fraud."  You might include those search terms in this slide header or in the red box in the previous slide.


comment:
Replace first bullet "Is a post-transplant test" with "can be used to diagnose clinical disease"


comment:
In introductory text under Treatment Comparison, replace "which," with "that" and be sure there is no comma after "that".


comment:
Delete "pp65" at the beginning of the first sentence.


comment:
When returning to this slide a second time, the radio buttons show my previous answers and I cannot click submit nor advance to the next slide.  I would like the radio buttons to be blank so I could try answering the question again.


comment:
In Antiviral Prophylaxis pop-up layer, revise first sentence under Use Case as follows: "...putting Mark at high risk for CMV disease."


comment:
Could make second radio button choice a correct answer by changing to "He should ask for their audit history now."


comment:
Functionality note: I completed the interaction incorrectly the first time by placing an incorrect dragger under each heading, then I tried again and arranged all the draggers under the correct treatment type. When I submitted the interaction, a green check mark appeared next to each of the draggers, but the feedback box contained the following text: "Sorry, that's not it. These are the correct features of each treatment model. Click Continue."


comment:
In the lab director's first speech bubble, I would argue that "test results could be" should also be bolded.


comment:
Would change to "learned about accurate and consisten"


comment:
Would say that SOT is used to replace organs that have failed. Examples include lungs in cystic fibrosis, heart after heart attacks, kidneys after diabetes, or liver after chronic hepatitis.


comment:
There is no discussion of why transplanted patients need to be immunosuppressed.


comment:
Add my QuickServe content from slide 24 to stop #1


comment:
The X doesn't stand out to me. Maybe we need to add a button on each stop that says "Continue the Tour" or something like that


comment:
If time allows, please do a global check for contractions. I'll generally let "Let's" slide if I can't write around it, but otherwise just spell them out.


comment:
Edit intro text: At the end of the tour, one of the technicians stayed to talk to the group. Listen as Mike shares a story about his experience in the service function.


comment:
It MUST be the year of the sexy learning agent! What a fox. Where do you find these people?!


comment:
I'm going to say no on the music. I can help you find an alternative, and hopefully a free one at that.


comment:
Cummins should never be punctuated - delete the apostrophe


comment:
I don't have Daphne's storyboard edits at my fingertips: did she want to take out EVERYTHING about how they improved their ability to respond more quickly? He says more about the JSA than he does about the fix - feels wrong.


comment:
2 concerns - a.) The graphic just doesn't look very nice, and b.) when we actually have content it's going to be jam-packed. Not sure what a good alternative is... maybe we just write it on the seat? or the windshield?


comment:
This will go into my hall of fame for poor quality scripting. Sigh. Edit the blue convo: It sounds like you just had a bad experience today. In my new role in the service function at Cummins, I hope to deliver an excellent experience for every customer.


comment:
I know you're looking into the Thursday/Friday programming - FYI it actually wouldn't LET me click thursday without clicking Friday first.


comment:
Please highlight which question is being answered.


comment:
Keep the distributor bkgd on this screen


comment:
for 2nd comment could include Qualified personnel as per local laws and regulations.


comment:
Add after the last sentence.  Remember to consult with your COPM and COM to ensure that the allocation strategy is being met prior to final selection.


comment:
add to first statement:  prior to qualifying the site


comment:
requalified is addressed in site changes as that is where it is applicable


comment:
should there be a comma after Each, What If....


comment:
should the 2nd sentence read a site with qualification exceptions only exceptions is plural?


comment:
for the 2nd one revise to read:  with nine years of clinical research experience who has worked on four insulin titration protocols over the last 2 years


comment:
for MRI comment recommend revising the last sentence: Being onsite could make the MRI more convenient for patients.


comment:
add to first statement:  access to the patient population and their potential enrollment capabilities.


comment:
Bold "only one item" in the slide instructions.


comment:
Bold "three items" in the slide instructions.


comment:
Add question mark at end of final bullet list item in learning agent's speech bubble.


comment:
Remove extra space between final two words of clinician's speech bubble (i.e., between "variability" and "details").


comment:
Back arrow doesn't work on clinician's third speech bubble.


comment:
Good call, Nick. Please bring back the testing methods easel from the first screen in the section, and pull in a few icons from the "Risk Factors" screen - either on the easel, or just let them float about. Sophie says: "Again, these are the primary testing methods related to our focus on infectious disease. Each patient has unique risk factors that guide clinician decisions about how long to continue treatment and monitoring. Next, we will take a closer look at some of those treatment options."


comment:
Back arrow on clinician's second speech bubble doesn't take learner back. It takes learner to the next screen/speech bubble just like the forward arrow does.


comment:
I've hopped around a bit, so not sure if that impacted this, but please double check that the "Congratulations!" text does not appear on the red dot menu.


comment:
Instead of bolding the first part of the first sentence in the clinician's speech bubble, why don't we bold "limits clinicians' ability to manage CMV patients being monitored by two different institutions." That latter statement is a clearer answer to the question "How does a lack of standardisation affect clinicians?"


comment:
Question for you, Nick: Is it possible to add a magnifying glass/zoom feature to just the graphic portion? If that's easy, let's do it so they can see that text a little bigger.


comment:
Please add each patient's name to their profile pic - i don't care where (Mark, Marta, Martin)


comment:
As a distractor, should Immunosuppression be capitalized ? No sentence-initial blanks appear in the answer to the question.


comment:
I assume we're aware that the brushes are possessed and fly off the screen when clicked whilst a series of magical numbers appears at the bottom of the screen?


comment:
1st FAQ: I disagree that a live site visit is "HIGHLY recommended in any situation."  I would remove the entire first sentence and start the paragraph with "A combination of both..."  You could also reference the Site Selection Guidebook outlining Site Evaluation by Telephone.


comment:
In learning agent's third sentence, make the following revision: "...but in health care, basic rules are critical..."


comment:
In the learning agent's speech bubble, shouldn't the title of Monet's painting be italicized?


comment:
The instructions on this screen indicate that learners should return to the course palette to revisit a section of the course again, but to do so they must click on Module Menu at the top of the screen. Should the instructions be revised to read "Click Module Menu to return to the Course Palette and visit a section again"?


comment:
Text revision for third challenge in plaque pop-up: First two lines are quite similar and should simply be replaced with "Challenge 3".


comment:
Shouldn't the "immuno-suppressive drug monitoring" dragger read "immuno-suppressive drug therapy"?


comment:
Some of this question are in the ISEC not in the SPI.


comment:
Territory is not a common concept among the regions


comment:
The question "What do I need to document in Trialforce"?  I would like the formal evaluation documentation bit to come first.  Trialforce is the documentation of record for site qualification and it is the system that provides our "control"/compliance with our standard requirements.  Feel free to re-word, but I'd like a stronger connection to documenting the requirements and I would like to see it mentioned first in the FAQ response.


comment:
the term 'territory' is not standard for all regions


comment:
For source documents pop up: It is not clear that source documents are, it is mixed with the idea that source records show how the study was conducted.. one of the key messages should be that source documents are any record that includes information pertinent to the patient (e.g. patient records, lab results, ECGs) and records created to demonstrate that clinical research activities have been conducted according to sponsor instructions or protocol (e.g. drug accountability, product complaint forms, pharmacy notes).


comment:
ALCOA principles are now also part of GCP E6 R2, we can also reinforce that ALCOA is a regulatory expectation


comment:
Certified copy: one key element of certified copies is that there is documentation that the certified copy process was followed. Not sure if it is the intend of the second sentence, if yes, the validated electronic process is not clear... what do we expect CDCs to verify?


comment:
Is this the final audio? I notice a lower volume some slide ago.


comment:
I dont like the question related other colleagues. Other colleagues should never be a source. The information from other colleagues should be stored in a valid repository. If info is not in a valid repository (system dashboard etc) we should discuss the PI and the staff rather than other colleagues.


comment:
the feedback regarding history of audits have not sense with proposed answers


comment:
Third bullet, I suggest change "SEC visit" for selection or evaluation visit


comment:
Browsers - why is Google Chrome listed? I thought Lilly computers all use IE.  Is it necessary to list browsers?


comment:
Last sentence - this is first time SPI is mentioned. Provide full name during 1st reference? (Site investigator profile information)


comment:
Recommended rewrite: 1st sentence - Per ICH GCP requirements, the investigator site should have appropriate personnel to properly conduct the research activities of the trial. 2nd sentence in 1st paragraph: Suggest rewording this - currently isn't clear (run-on sentence and order is confusing)


comment:
1st question, last sentence in this section: recommend rewriting for clarity. Consider dividing into 2 sentences.


comment:
2nd question - recommend re-writing 1st sentence (consider dividing into 2 sentences) as current sentence isn't clear as written. e.g., It is an ICH GCP requirement to report all AES and SAEs.  If a site is not willing to comply....


comment:
3rd question, 1st sentence: too long, consider dividing into 2 sentences so it isn't a run-on sentence.


comment:
1st question, 1st sentence: Do you mean "potential quality findings" or "previous quality findings"?


comment:
2nd question - 1st sentence: not correct as written (example - "to verify if the investigator has not been debarred" should be "to verify the investigator has not been debarred"


comment:
3rd question, 1st sentence: recommend re-write, as this rationale isn't clear. What is meant by "risk assessment for monitoring purposes"?  Monitoring of what?


comment:
4th question, last sentence: Suggest removing "unless necessary".  (i.e., "Stick to the facts and do not draw conclusions.")


comment:
Example text: suggest removing 3rd sentence about being invited into Alz. portfolio program.  Suggests a "perk" for high enrollment, which is not allowed.


comment:
answer pop-up: 2nd sentence: Is this referring to safety mailings? Doesn't seem to match with 1st sentence.  Also, is 30 days really a reasonable time frame? That seems late, given this is a safety communication. How was 30 days provided?


comment:
Maybe Test Type is confusing...can we call them testing options?
Also it is not just CE-IVD and LDTs, there is a continuum of testing and we should capture that complexity in this question. Also, more than just features...there are advantages and disadvantages as well as definitions. 

What are the differences across the continuum of testing options for CMV, from LDTs to CE-IVD/FDA approved tests?

Something like this?  Should discuss with the group for consensus.


comment:
For the resources tab, will the table on slide 2 of the PPT for Module 3 be included?  This is a nice summary and we should refer to it somewhere in the training


comment:
Not sure if it is the difference between testing plasma vs whole blood.  

What is the difference between using plasma vs whole blood as as sample type for CMV testing?


comment:
Disregard James' edit, it's correct as-is


comment:
please replace the ; in the last sentence: "...of CMV infection, but ________ can be used..."


comment:
Add label to bottom of whiteboard: "Unique Skills Gained in Service Function"


comment:
Change screen title: Working Together for our Customers


comment:
Keep the TM tied to INSITE; also, delete the comma after himself


comment:
Delete "Celebrate ...Hooray!" from the notebook. Sigh.


comment:
1. I'm pretty impressed at how quickly you got this together
2. I appreciate the little sarah touches that make it better. You're like our closet graphic designer.
3. My greatest concern for this course is the level of content - it's very inconsistent, based on the source content - which makes the course feel less cohesive.
4. I am not loving the gray intro text, plus speech bubble text. I know I set it up that way, so I'll lie in that bed, but the screen text may as well be invisible.


comment:
we try to avoid the term "sales rep" in the affiliates. The feeling is that "account manager" is more empowering and drives a sense of professionalism and ownership.


comment:
Agree with KSB. It is better the sequential order of ALOCA being identical with previous page.


comment:
Contemporaneous paper SD: It is not clear in definition regarding what is "Have good document design" and "blank forms available"


comment:
I noticed that in the Mod2 alpha that the popup associated with where we are in the course (in this case, on the orange spot) appeared automatically, not requiring the learner to hover to see it. The rest of the spots have the hover state. Which way are we wanting this to be done, across the four modules?


comment:
I love what you did with the continuum. Yay!


comment:
Update the screen directions (currently refers to Flashcard #4).


comment:
Switch the draggers to the opposite landing pad--Experience, Performance, Workflow and Clinical Relevance match with CE-IVDs and Operational Efficiency, Result Integrity, Clinical Validation, and Cost-Effectiveness match with LDTs.


comment:
I think the way that you changed the format of this conversation works just fine!


comment:
Make sure cobas(R) is bold throughout the branching--I noticed an un-bold cobas in the feedback for the BBB branch.


comment:
I know they don't yet have info, but, do we want to size the plaques for Mods 3 and 4 the same as Mods 1 and 2? Could we get the info from HT for the Mod 3 plaque?


comment:
should "The Challenge" be on a white rectangle like other sections?


comment:
Change slide layout so there is a back button


comment:
Do we need to remove the contraction (it's) from the first sentence of Sophie's speech bubble?


comment:
On the very first Course Palette slide, I clicked Gallery Walk. I was taken to the Gallery Walk as expected; however, when I arrived here the painting for this module was already visible. It shouldn't be until the module is completed.


comment:
Should the URL for the first reference in the pop-up be clickable? It's not currently.


comment:
The text on the easel could make better use of the easel's space. It could also be spread out a little. An extra space appears before "Accuracy" in the final bullet.


comment:
Accurate: I am not clear the purpose of first bullet... it is related to a type of record. Please review and determine if it is accurate to keep it in this section


comment:
consents are source documents, normally the site keeps the original and the patient gets a copy of the signed consent. there are countries where it is needed to signed 2 originals of the consent. In addition to the consent, the PI or delegate should document that they provided the subject with a copy (or original) of the ICF.


comment:
some additional data that is captured in patient files when patients are consented are:

Obtained prior to any study procedures
In an ethical manner (subjects had adequate time to review the ICF, were not coerced, had their questions answered etc)
In compliance with ICH GCP 4.8 and local regulations
Describes the process used when an impartial witness is required


comment:
Please modify the consent example as we expect that site keeps the original.


comment:
I would recommend to add some different examples as compared to what was included before, for example:
Patient history documents
Medical charts with progress notes
Laboratory/Pathology reports
Investigator interpretation of results
Other Ancillary reports (ECG, Scans, chest x-ray, MRI)
Informed Consent Form (ICF) and HIPAA authorization signed and dated by subject
Diaries, questionnaires (paper or electronic)


comment:
First pop-up, it is not clear the sentence that starts with: Potential harm to research subjects...
in general EMR has to be compliant with CRF 11, it is not included here. As a sponsor, we do not do a full assessment, our review is not equal to confirm that the EMR is compliant with CRF 11 requirements, this is a site responsibility


comment:
Last box states.. Select all that apply: this dos not make sense as there is no multiple choice option for readers.


comment:
In some cases there are further topics which are discussed during the evaluation e.g. satellite sites. Site specific questions are the last discussion point but this is not always on the sixth courses.


comment:
site specific questions are also discussed during the feasibility process and documented in the feasibility questionnaire. Should that mentioned here?


comment:
As far as I know the CDC is not allowed to create PowerPoint slides for a site evaluation. The CDC can use an approved presentation by the study team.


comment:
As far as I know the CDC is not allowed to create PowerPoint slides for a site evaluation. The CDC can use an approved presentation by the study team


comment:
The bullet point simplicity is not clear for me.


comment:
1st pop-up: bullet point competing trials could be added


comment:
The documentation of an audit or inspection is in almost all cases not available for CDC review as least in Germany.


comment:
SAE reporting is an ICH GCP requirement too. This information could be added.


comment:
Sorry for not seeing before, but in the VO "evaluation GCP requirement" sounds strange.
If possible, can the word "evaluation" be cut out? If not, it's fine to leave as is.


comment:
2nd sentence I would propose to remove the word "Central" and say "We need to get commitment that the site is willing to comply with any ERB requirements."
As we're not limited to only central ERB requirements.


comment:
Remove the wording SUSARS as we haven't defined this earlier in the course? I think it's ok to just say Safety Mailings (SMEs can confirm)


comment:
Remove text shadow in the green bubble globally.


comment:
There's a red 0 shown up at the bottom :)


comment:
Then a red 3 appears after the painting is done.


comment:
I thought the client doesn't want to see how the painting going to look like at the first step. They said it's too obvious, Sarah had to edit hers differently.


comment:
Remove" to the objection" form the top line.  Can we add one of the "team" characters to the screen so it appears they are saying this?


comment:
Change View Next Objection to Click Next


comment:
Same feedback as previous screen.  Add character and remove "to the objection."


comment:
Feedback button on previous screen doesn't work


comment:
Previous screen - not sure why we use a continue button on the last of the various activities for each scenario and a next button the other times?


comment:
I think to wrap up the last interaction, we need a screen to show how the information changed based on meeting with the customer.  Click the tabs to see the revised information in red.  Something like that.  THEN, to set up this page, we need to maybe hold a quarterly meeting with the account team where you notice that there's a blank page...


comment:
Introductory sentence: add a space between "market runs" and the parenthesis. Add a colon at the end before the list of charge codes.


comment:
Remove the comma after "RTM BCR EIM allocation". Start the next sentence with a capital letter. Ideally, I think it starts with "This animation provides..."


comment:
Yellow popup text for T+40 animation explanation: Change this into a bulleted list for easier reading.


comment:
Need to fully build out one example on this screen.  So, for Customer Website, let's say "A customer's website is a great place to dig into the customer's business.  Here you can find information about what they do, how they do it, and what's important to them."


comment:
Change the yellow callout box text to bulleted lists instead of blocks of text.


comment:
Make "Flexible" lowercase in the introductory sentence.


comment:
Need to have info for one correct role and one incorrect role here as a fully refined and functional example.  Ping me and we can figure out who these should be and what they should say.


comment:
Note to Cummins needs to move up on the screen.  Part of it is off the bottom.


comment:
Note to cummins off the bottom of the screen.  Move up a smidge.


comment:
The button says "Grid Management code" but the popup says "Grid Management charge" - stick with one or the other. Also, I assume this is "grid management charge (or code)", lowercase.


comment:
Need to include "final level of refinement" info on one of these flags.  Maybe yearly to confirm strategic alignment and identify initiatives and opportunities for the year ahead.


comment:
Change intro text: "The forecast fee is a charge..." lowercase F if not the first word in the sentence.


comment:
Add space between "fees" and the parenthesis. Capitalize the first word of the sentence below the bulleted list. Most likely it's "This video provides..."


comment:
Need to find a picture we could use of a customer here. Maybe another Digs person but with a face and no mustache?


comment:
I like the directional text at the beginning. Once you move the slider once, I would make the directional text "Click the market time points to learn more. Drag the slider to see the market time points in the next market segment." Then when the last market segment's time points are revealed, change text to "Click the market time points to learn more. Click the right arrow to continue." (and activate the right arrow)


comment:
Why did we use a notebook here? The key points are usually the slide out bars that come over from the left and are timed to the VO.


comment:
For "full refinement" instead of saying what learners will do, let's have them do it.  Update the instructions to what we would have the learner do "Review the account plan information about the customer, then decide whether or not to share it with them.  Click the Executive Summary tab to start."


comment:
Yellow callout box: "Need your input on the most important..." missing the word 'on'


comment:
The buttons are not in the same place on each menu screen.


comment:
I agree with Christa's comment - I think we can use the icons to represent market conditions, and the italic script text onscreen, instead of the notebook here. Other items to consider are the clock going from 12 to 1 to represent 1 hour on a trade date. Simple stuff that we've already got on-hand


comment:
Transcript: scheduling coordinator is lowercase, as is fifteen-minute market


comment:
Make False button an image, not a clickable element.


comment:
Add spaces between transcript paragraphs for easier reading.


comment:
"Flexible ramping" if starting a sentence, "flexible ramping" in all other cases.


comment:
The highlight used on the market timeline isn't readily visible, and blends into the blue above the timeline. Recommend using a different color and making larger/darker


comment:
"Real Time" always has a hyphen between it. If it is the proper name of a code, report, etc. it's OK that both are capitalized, but otherwise should always be lowercase.


comment:
scheduling coordinator is always lowercase. Only use capital SC if it is in an acronym "EIM Entity SC", "PRSC", e.g.


comment:
For all of these scenario walkthrough screens, I see that the relevant market condition icon and information is highlighted. Recommend using a more obvious highlight, and having it come onscreen at the beginning and stay throughout the audio. Otherwise, I missed it coming up on a few of the screens.


comment:
Is there an image or something we could use to represent "Offsets"?


comment:
There does not appear to be a debrief/key points slide at the end of Module 2 (it isn't in the Menu). I can't advance from this screen since there's no right arrow, so can't check - but there needs to be a debrief to wrap up module 2.


comment:
Need to add an information slide for CAISO here - they won't have any idea what this module 3 is about without some kind of explanation. I would inform them that Module 2 was like a See it in action module, and this one is like a You try it module. This whole module covers the key 6 scenarios they provided to us, and learners will interact with true/false, multiple-choice, and select-all-that-apply questions to come to the same types of conclusions Javier showed them in Module 2.


comment:
Remove "Checklist" from the Resources tab throughout module 3.


comment:
The next screen says "Foundational Scenario"


comment:
We need to re-title these scenarios from #1-#6 and instead call them something similar to the names provided in the source PPT file Cindy sent over. Alternatively, include in the information slide I indicated in my other comment the 6 scenarios that learners will go through in this module.


comment:
The pop-up / light box for Constant Bias lacks a title (i.e., Constant Bias). Compare the pop-up / light box for Proportional Bias.


comment:
Note contraction (let's) in first line of Sophie's speech bubble.


comment:
Delete "must" from first sentence of Sophie's speech bubble.


comment:
Perhaps not a major concern, but when I clicked Continue on the previous screen and came to this screen, the diamonds on the chart disappeared for a moment and then reappeared just before the animation began. Just fyi.


comment:
I just noticed that the spelling of "standardized" on the y-axis of the graph is not the British spelling that RMS wants: "standardised".


comment:
See my previous comment about spelling. X-axis has same issue.


comment:
Let's make the URL for the final reference in the pop-up clickable. It's not currently.


comment:
Remove contraction (doesn't) from second sentence of Sophie's speech bubble.


comment:
The final four bullets on the tablet should be indented. They are sub-bullets.


comment:
Include yellow callout box to CAISO indicating that we will need their help to identify the key points to include at the end of the course. Also, change the #ing here to say Key point #1, Key point #2, etc.


comment:
Why does Javier change positions if there's no audio yet?


comment:
Sorry I didn't ask before as I hadn't noticed- why are we including the TransCelerate website as a resource


comment:
I understand John's suggestion, but I think we should be consistent with whatever color we have used for all the other training courses.


comment:
I don't see "SPI" text here, I only hear it from the narration.  Since this is the gold master, I don't know that this is worth re-recording.  The intended audience should already be familiar with this acronym.


comment:
Don't use "investigator site".  You can either use "investigator and site" or just "site".  But we no longer use the terminology of "investigator site".


comment:
Yes, reporting AEs/SAEs is an ICH GCP requirements, but the requirements for SAEs is "immediate" in the regs and the requirements for AEs is "according to the reporting requirements...of the sponsor". Lilly has said 24 hours.  Since this is the gold master, I don't think we have time to fix this and provide all the clarifications, etc. That would probably be best for a safety or site training course.


comment:
VO starts by saying "Qualifying a site's CT Material storage capabilities is critical".
Is it only the storage capabilities we're qualifying a site for though? Maybe the statement should be broadened by saying "handling and storage"?


comment:
Voice over states "Diagnostic Services, Facilities and Equipment section of the ISEC".
Please correct to CT Material section of the ISEC.


comment:
1st pop-up, should we say instead of "... who is not supposed to have the material."
"... who is not supposed to have the medicinal produt".?


comment:
3rd pop-ip: to understand to ensure" reads funny... remove the "to understand" words?


comment:
1st pop-up, we use CT Material and IMP - these are not the same thing.
CT Material is the umbrella term for all materials in the trial
IMP is the medicinal product being tested.
To confirm with SMEs.


comment:
st pop-up:
Is it only a Lilly business requirement? Do we then really require it? If so, maybe only say "Per requirements" and leave out the Lilly business?


comment:
1st pop-up: again, using different terms (CT Material and IMP)


comment:
Is the next button supposed to be clickable even when I haven't seen the 3 examples?


comment:
Say"... need to discuss with the site staff"? As it may be someone else than the study coordinator?


comment:
2 boxes question:
What is the correct answer? I clicked on all and always got the incorrect feedback.


comment:
question for the SMEs:
Could unauthorized access also be the problem here? Clearly patients seem to come in to be examined...


comment:
In the feedback, should it say "why inaccuracies from improper temperature control..."?


comment:
1st text balloon:
"trial drug materials" - is this an ok term to use?


comment:
2nd pop up: Change to "Is the site able to store CT Material (remove the "s" in Materials) according to STUDY REQUIREMENTS, ICH GCP GUIDELINES, AND LOCAL LAWS AND REGULATIONS (i.e. label, pharmacy manual..."


comment:
2nd and 3rd pop up:  Change "i.e." to "e.g."


comment:
Do we want to say "CT Material" or "CT Materials" (note the "s" at the end).


comment:
1st pop up:  In the brown box, we do not address what to do if the site uses a TPO to destroy IMP.  There has been a lot of confusion around this.


comment:
1st pop up: Disregard my comment about using a TPO to destroy IP.  We address this in the 2nd pop up.


comment:
3rd pop up: In regards to the difference between CT Material and IMP, we should rephrase to "When extra material are used as part of IMP ADMINISTRATION, verification of appropriate...as those materials will not be returned with IMP."


comment:
Example 1: The question, "Will the Site be destroying CT Material material..." - was it intentional to type material twice?

Also, it's not clear if this question refers to actual drug (or placebo) and/or ancillary supplies needed to administer drug, as CT Material encompasses everything.  I sense that this question pertains only to drug.  In reality, most sites will destroy ancillary supplies (used needles, syringes, tubing, IV bags) but not drug.


comment:
VO when the SC states "We record the temperature daily,"  the script should be modified to "We record BOTH THE MIN AND MAX temperatures daily DURING CLINIC HOURS."


comment:
Change "We monitor and record the temperatures daily" to "We monitor and record BOTH THE MIN AND MAX TEMPERATURES DAILY."


comment:
I clicked on the first 3 options but am getting an "Incorrect" response because it's not registering that I clicked on the 2nd option.


comment:
Identify, Evaluate and Select Sites process map


comment:
The process map provided is Manage Site Information.  Is this the correct process map for CT material?


comment:
2nd pop up.  Add "and storing" to the sentence "Local regulations will dictate extra licensure/requirements for handling and storing controlled substances...".


comment:
3rd pop-up can be updated by the following GCP statement: "Per ICH GCP requirements, the investigator should have available an adequate facilities for the foreseen duration of the trial."


comment:
Use the Identify, Evaluate and Select Sites process map as opposed to the Manage Site Information process map.


comment:
What about temperature monitoring outside of business hours (such as, evenings and weekends)? I think it should be mentioned in the dialogue as well.


comment:
This is a note for alpha, not dp - Digs has no face and never changes position. This makes this course pretty graphically "the same" from page to page. I think we need to talk about whether we do something with him for this course and the manager one.


comment:
I agree with Jen, even with the explanation after this, I don't know what those images are. If you aren't going to have on screen text or audio, you're going to have to add more images to make sure the story comes across. 

Recommend adding a note to cummins on the flashback screen: Additional graphics will be added to tell the story of feeling like account plans don't add value.


comment:
stronly suggest reorienting this screen and using photos to represent each of these items and make the focus less about the shovels. This course is so brown and the graphics are fairly unvaried. I think it will help with learner focus to give some more visual interest throughout.


comment:
I'm not sure how the executive summary update is related to digging into the customer data. Wouldn't that be more related to the customer analysis section?


comment:
This feels like a non-sequitur between the set up screen talking about assembling your team and then activity to actually do that. Is this screen in the right spot?


comment:
two of the roles are titles and the rest are placeholder. I assume the rollover will be bigger than just a title, but will also be a description? 

Also, maybe in the rollover, they see a photo of a cummins type person to connect the dig site into the business world?


comment:
i don't get how the flags are related to how often to meet? The visuals don't connect with what we are talking about


comment:
This storyline illustrated person is an odd choice given that he's not the same illustrated style as the rest of the course. I recommend going photo here.


comment:
How'd I get from sharing content with the customer to this updated notebook?


comment:
If there is no regular temperature monitoring on weekends, Id suggest to update the statement accordingly:  we monitor and record the temperatures daily except weekends


comment:
I'm assuming that the opening recap automation will be refined once we finish module 1.


comment:
Do we need to say ...+ or - status for the presence of CMV antibodies?


comment:
for immunosupporessive drug monitoring - do we need to say "...method for tracking markers for transplant patients to determine if they are responding well to the levels of immunosuppressant drug levels to prevent organ rejection"


comment:
for immuno-response markers:

is this meant to communicate that they are tracking inflammation markers and other markers to determine potential risks for transplantation failure?

the description here seems a bit too vague for me.


comment:
for antigenemia:
isn't q in QNAT lowercase?


comment:
Option 3 "Do you keep food..." can be a relevant question.  I realize it's a wrong answer here b/c the graphic does not show any food, but that's kind of tricky and not easy to see.  I suggest removing this answer.


comment:
when you click on PCR the other green windows pop up a little too fast and it's a little distracting.  Can these be slowed/delayed down a bit please.


comment:
for PCR - maybe we should say also known as real-time PCR instead of qPCR so that we can continue to take this marketing message away from Abbott???


comment:
for Sophie - do you think she should say "today we are focusing on real time PCR detection of infectious diseases, and only a few targets."


comment:
first sentence could be reworded

suggestion:  Serology testing is essential pre-transplant for DMV determination in both donor and recipient


comment:
Roche offers a CMV IgG test, which detects latent infection and is the most important test for transplant patients.


comment:
are we going to have problems with regulatory on the "Prevention".   our tests don't really prevent???


comment:
really like how the icons are incorporated and colored when you click on them. nice!


comment:
for type of immunosuppression: should we maybe think about having the exclamation mark icon??? not sure if the DNA icon communicates our message strong enough


comment:
do we need to have the easel paint swipes clickable on this screen - i clicked on them and they changed colors but if feels like something should happen and we just want them to hit continue...


comment:
Correct answer feedback: It looks like there are 2 spaces between "microbiology" and "assays"


comment:
Incorrect feedback box: per RMS Comp 2 Branding Word doc, "BD MAX(tm)" should have the word "System" after it.


comment:
Furthermore, the right standards should be used and other calibrations may be necessary.  Communtability could actually worsen considering the amount of variables that need optimization.


comment:
I feel like the response to the incorrect answer should provide them with the rationale but then allow them to try again????


comment:
is there a reason why the hexagon image on the right changes colors to orange? not sure this correlates to the copy on the left in the green bubble.


comment:
I wonder if we need to add a halo to the dot that users are supposed to click. We already did this for the Course Palette to accommodate color blind users.


comment:
Ignore my previous comment. Just remove the first  bullet point and allow that text ("Think of LDTs...") to stand by itself.


comment:
Remove the vertical bar from behind the double-headed arrow


comment:
Revise second bullet for Extraction Method: "Studies have shown that the extraction method contributes..."


comment:
Remove vertical bar from behind double-headed arrow.


comment:
To reduce complexity and keep this at a level 1, make it so that they only have one chance to get it right. Make the feedback tell them the correct answers and make it the same for Correct/Incorrect pop ups.
This applies to all interactions using this template.


comment:
suggestion...

treatment for CMV infection leads to fragmentation of the CMV genome and can cause variability in PCR performance

not sure if this is right?????


comment:
The C should be uppercase in TransCelerate.


comment:
The SEC questions don't include the question about controlled substances was this not included by design?


comment:
I had asked to remove the comment in () that says for network sites only as this is not a true statement


comment:
The definition of a central pharmacy has been changed to:  A central pharmacy is a company/facility that receives initial CT-Material shipments and holds CT-Materials for a site until requested by the site.  The site is responsible to perform the necessary steps to randomize and assign CT Material for all applicable study participant visits and will notify the central pharmacy of the appropriate CT-Material to distribute to them.   We need to include this somewhere within the training


comment:
Can we include that the CDC will document this follow up item in Trialforce through until resolution? or something similar? (First example)


comment:
Example 2 also has a follow up item which needs to be documented within TF and resolved prior to enrollment readiness is declared- we should highlight these points for any follow up items in the modules


comment:
Please spell IMP as there are other acronyms that are also used in medical like integrated monitoring plan (IMP)


comment:
There Is no authorization letter anymore, I think it is important to raise that the only document will be the one registered in the ISEC regarding this topic. Can we clarify if we need to assess how all CT Material may be destroyed or only what it is considered investigational medicinal product?


comment:
I do not know if it is possible to add something about the check to how the site documents the destruction, we have had problems with sites that do not have proper documentation, although the destruction process was correct.


comment:
Incorrect feedback - It should be a period at the end of the list following "Males" instead of a semi-colon, to match the layout of the "Females" list. I would also indicate the # of specimen claims in the feedback since the question asks the #, not the type.


comment:
Feedback text, last sentence: Add a comma after "Currently"


comment:
The last answer option ends with a period, but the other 3 do not. Some question sets all have periods at the end of answer options, others do not. I would check this out globally for these questions sets and follow one format.


comment:
Question text: don't see it differently in the style notes, but usually "hands on" is "hands-on" since it's an adjective for the word "time"


comment:
Basecamp writeboard indicates "AmpErase" should be "AmpErase Uracil N-glycosylase (UNG)"


comment:
Feedback text uses "hands-on" instead of "hands on". I'd pick one and stick with it.


comment:
Feedback text: the last bullet ends in a period, but the other 3 do not have one. Add periods to the other 3 or treat this as a serialized list by adding commas to the first 2, and "..., and" to the 3rd bullet.


comment:
Answer #3: Change to "ready-to-use", which matches question #1 text.


comment:
Feedback text: remove "only", per beta feedback, rows 36/37.


comment:
Question text: the last sentence tells you the correct answer (not suggests, tells!) :)


comment:
Question text says "Microbiology" is the correct answer, but "Virology" provides correct feedback.


comment:
Feedback text: change "C. diff" to "Cdiff" per Basecamp writeboard.


comment:
Agent speech bubble: since "and" is part of the REVEAL acronym, I think it should be bolded as well.


comment:
Agent Sharpe speech bubble: "...help you with your..." change 'your' to 'you'


comment:
Dossier link does not go to an active URL. Should it?


comment:
There are a lot of acronyms used in this course that aren't defined early on. This may be fine for this audience, but I want to call it out.


comment:
PCR cartridges popup: Image blocks the last line of text.


comment:
Sample prep loading popup: The text is blocked by the directional text bar.


comment:
The directional text bar at the top obscures 2 of the popups once clicked. Recommend bringing the popups to the front when they're onscreen.


comment:
Semi-automation popup: Change "<1 minutes" to "<1 minute"


comment:
Click Continue directional text is obscured if the last popup is still onscreen. Recommend moving directional text box to the left side.


comment:
Some features have periods at the end, others do not. Pick one layout for all.


comment:
I noticed that the feedback screen includes only features without periods at the end of the sentences. Recommend aligning the drag and drop to this approach.


comment:
Incorrect feedback: Recommend changing "Quick thinking Agent!" to something like "Not quite, Agent." I thought I had the right answer, but the background was red, and the phrase confused me.


comment:
Are the debrief questions debriefs? They just feel like a new question to me, but I am not a pro on the content. They didn't feel like they were reinforcing things I already learned.


comment:
C.diff should be Cdiff per Basecamp writeboard


comment:
When the last answer is dragged over, it remains larger than the answers that 'settled' into place, making the table a bit off. Consider letting it settle in before advancing to the text message feedback.


comment:
<1 minutes should be <1 minute (singular)


comment:
Four-step sample process: per beta edits, rows 75-76, not sure that a correction was made?


comment:
Correct feedback: "C. difficile" should be Cdiff per Basecamp writeboard


comment:
Correct feedback: still missing the ending of it that starts with "Cepheid only communicates hand"...probably need from client.


comment:
Not sure where beta edit fixes for rows 97-99 appear in the course.


comment:
Correct feedback: I assume this is a wordsmithing of the edit in cell 108F. Just want to call out that it doesn't match 100%.


comment:
3rd answer option: beta edit row 110 says this answer option should be 'availability of LDTs'


comment:
Question text: per beta edit, row 125 change to: BD claims to "give flexibility and standardization to labs", but they rely heavily on what type of testing to make that claim?


comment:
Correct feedback: change "give" to "gives"


comment:
Per Basecamp writeboard, Women's health should have both words capitalized.


comment:
C.Diff should be Cdiff per Basecamp writeboard


comment:
First answer option: "Mixed-Testing" should be "Mixed-testing" per Basecamp writeboard.


comment:
Customer character is pretty close to the text onscreen, perhaps move her over 1/2 an inch.


comment:
2nd answer option: Should "unitized strips" be "Unitized Reagent Strips" per beta edit row 60?


comment:
Missing a period at the end of the 2nd answer option.


comment:
First answer option: "Poc" should be "PoC"


comment:
Recommend including directional text that says "Incorrect answers won't 'stick' in the blank spaces."


comment:
This is duplicate feedback, same as the 1st answer.


comment:
The top secret dossier covers up the text in the feedback box here.


comment:
2nd answer space isn't centered and overlays some of the text.


comment:
Top secret dossier overlays text here as well. Confirm for all feedback boxes.


comment:
Text doesn't match text provided in beta edits cell 166G.


comment:
The question bank doesn't auto-advance to the feedback once the 3 words are placed correctly.


comment:
Sophie's dialog is a good introduction to the module,but not the slide. I.e., she mentions "only a few targets" but all we are taking about on this slide is 1 target -CMV. Maybe add a sentence at the end, "first lets look at CMV"...


comment:
Hm. The first bullet isn't really true of all serology - need to specify in transplant setting and you're talking about CMV serology. (For example, you also use CMV serology for congenital CMV..."serology is used before transplantation." Or maybe substitute a different bullet to say what serology measures? (i.e., its not detecting CVM Virus, but immune response to it?)


comment:
The second sentence of the answer Sophie gives after you correctly fill in the blank with "both donor and recipient tested" is actually more related to bullet 1 than bullet 2.


comment:
I don't feel like the double helix is the right icon for immunosuppression


comment:
When it said review the patients file, i tried to click on the file folder, but nothing happened. Stan's name is cleaver, but we're talking about risk not standardization. I think it might be nice to have different responses when you click the "wrong" answer. Maybe give an example of each risk category (e.g., high-moderate risk - organ is +, donor is +).... lowest risk is -/-?)


comment:
Is this the right list on the easl for this slide?


comment:
The 3 names are too similar- perhaps a way to make the association is to match the first name with the first letter of the model? I.e., Antony-Antiviral Propylaxis; Paula-pre emtive therapy; Harold-Hybrid approach???


comment:
Graphic for Antiviral prophylaxis should be more like the other two - otherwise hard to distinguish between 1 and 3.


comment:
For disadvantage to Antiviral prophylaxis, do we want to mention drug resistance, or is that so rare that we don't need to?


comment:
For Disadvantage of preemptive therapy, should we also mention higher risk for severe illness and DEATH from the infection itself?


comment:
For Preemptive therapy - Use case- is it really appropriate to mention "control drug costs"?


comment:
Don't we need advantage and disadvantage sections for the Hybrid approach?


comment:
Not really accurate to say, "no guidelines". Maybe "universal guidelines??"


comment:
maybe put the last line of the correct answer as the opener for that answer?


comment:
Hm. this graph (showing limited commutability of the WHO) required more explanation. we did a whole seminar and pubalert on this (and it only has CAPCTM not cobas). we should discuss options.


comment:
It seems all the wrong answers go strait to ROCHE selling. Can we perhaps have one wrong answer without the direct sell?


comment:
My suggestion is to talk about fragmentation when we show the Patient commutability (Preksaitis paper?) slide a few slides earlier.


comment:
The second fill in is kinda weird bc/ its the drugs that actually prevent rejection, not the drug monitoring... Maybe you can say help the physician monitor whether therapies are sufficient to prevent organ rejection. (also, there is somewhere in this deck where we use the term "graft"... I'm not sure the audience will know this is the same as organ transplant. And it made me wonder if we might use more precise terminology - "GVD = graph versus host disease"


comment:
Do we want to just say PCR, or RT PCR? (qNAT, or whatever we were calling it before?)


comment:
Did we mention the frequency of the qNATtests in the earlier section? (here we say weekly). I believe they can also be more frequent, given clinical presentation/patient history.


comment:
"Shared" also logically fits into the last blank. Can we make that a different wrong answer?


comment:
The gray boxes for dropping words don't line up with the blanks here.


comment:
I don't understand how the feedback here ties to the completed sentence.


comment:
Beta edit row 180: not sure what the decision was on how this Operation title format should look, but what's in the course doesn't match the listed edit.


comment:
It looks like the edits in rows 182-183 apply to the video when the BD rep says X, the real thing they are saying is revealed right after. The 2 edits in the two rows conflict though (or are at least different) so need to be reconciled.


comment:
Cepheid rep statement REVEALed: "You have to wait" (missing the word 'to')


comment:
Remove the word only after can in the last sentence of the PCR cartridge pop up.


comment:
Cartridge pop-need a space between GeneXpert and Infinity


comment:
Agent isn't disappearing on this screen when all dots are revealed.


comment:
Replace "four-step process" answer with "Offers a pierceable septum cap to cover the Sample Buffer Tube."


comment:
put a dash between flu-only and RSV-only in feedback


comment:
looks like a different font on the MRSA dragger after the word control


comment:
Delete the word labs before flexibility. Put the comma inside the quotes after second use of the word labs.


comment:
Remove all the contractions on this screen and spell out (It's should be It is, etc). Remove the first sentence of the second paragraph entirely "There are 3 different..." It's redundant.


comment:
Global edit for all these scenarios: Now that we are at GM, let's mix up the order of the right responses. We don't want the top choice to be right on every screen. Randomly swap the position of the statements on about half the screens.


comment:
I chose 20 minutes and it gave me incorrect feedback


comment:
in both feedbacks: change will have to has


comment:
capitalize virology in both feedbacks too (this is global)


comment:
Genotype coverage answer is wrong here. This goes with Cepheid. Change this dragger to- Strain Coverage: 23 toxinotypes


comment:
Change Strain Coverage to Genotype Coverage


comment:
capitalize all testing types here: Women's Health, Enteric, Respiratory Tests


comment:
After the word but in the question change: "...that only applies to which of the following..."


comment:
in correct answer, put a comma after 2 hours


comment:
BD question 4- (can't get it to stay on the screen) the dragger said LTDs and should be LDTs


comment:
Use this feedback: Different throughputs (urgent vs. non-urgent) require different platform designs or lose aspects that are important to the laboratory such as efficiency, productivity, and cost effectiveness. Roche specifically designed the cobas Liat System to meet the laboratory requirements in a PoC setting and the cobas(r) 6800/8800 Systems to meet laboratory requirements in a high-throughput setting.


comment:
Remove this yellow note and all the placeholders. Duplicate the links/buttons that are used on the Quiz Fail screen and put them here. Also, here is the link for the guru game: https://www.theknowledgeguru.com/REVEAL_workshop2/game.cfm


comment:
Agree with comments made by Jessica and Ellen

QNAT is the format used in the International Consensus Guidelines for SOT (Kotton et al).  Can leave as is.

Real-time PCR is fine to change to - we should be consistent throughout


comment:
Like Ellen's suggestions

Also - from previous slide comment from Jessica to add antibody


comment:
Maybe mention for the last sentence of Sophie's feedback that IgM and IgG tests are not applicable to transplant 
Double check with Ellen on the call.


comment:
To Jessica't comment regarding regulatory - we will probably have to footnote somewhere that even though PCR is used for all these purposes, Roche only has claims for initiating treatment and monitoring (CE-IVD tests) and monitoring only for US-IVD.  

Let's discuss to finalize on the call.


comment:
Should "can" be capitalized in the first bullet?


comment:
Not sure about stating - antigenemia is used when PCR is not available.  This was also earlier in the module.  

The guidelines for SOT state that either could be used and list disadvantages and advantages. It most cases it may be used because the institution sees no real clinical advantage of PCR; PCR can be more expensive.  
Maybe we can briefly look at the guideline paragraph about this with Ellen on the call.


comment:
Should clarify what the risk factors are for in this section....
Risk factors for transplant recipients
Or
Establish risk stratification for transplant recipients

Ellen?


comment:
Maybe need a better explanation for immunosuppression as well...introducing new terms like lymphocyte depleting antibodies and everolimus - don't think participants will know what these are...


comment:
To replace DNA icon - maybe use the flask icon


comment:
When I advanced to Reggie Ulation the D+/R- folder under "higher risk" from Stan was still showing


comment:
Oh...tried the 3rd patient ...see the folders remain under the category after you complete the risk for each patient....ignore previous comment


comment:
This was great!  Very creative with the names :)


comment:
Agree with Jessica - maybe the paint swipes should be static

To Ellen's point - I think these are the correct tests  - this takes us back to the beginning to complete this part of the module


comment:
Would modify Sophie's dialogue...the test methods are used to treat CMV...the test methods are used to guide treatment or maybe associated with treatment models?

Let's discuss with Ellen for the best wording here.


comment:
Very creative Ellen :)

In terms of the graphics - let's discuss and clarify how to modify.


comment:
Should we also comment that there are no universal guidelines that dictate the frequency of viral load testing and as such this can fluctuate for each model and patient and institution?


comment:
This only discusses SOT patients...

HSCT patients also have treatment models - is it mainly pre-emptive for them?

We should also touch upon why one method is chosen over another...
This can vary country to country as well.


comment:
Agree with Ellen's comments....we need to look at guidelines again to clarify some points.

We should briefly discuss and take these as action items to clarify following our call Thursday.


comment:
To Ellen's point on previous section - let's discuss the cost aspect...


comment:
Overall - really like how this was presented :)


comment:
We probably should add a footnote about thresholds here - there are no established universal thresholds for pre-emptive therapy....will vary by test, sample type, institution etc...let's discuss how best to work this in..


comment:
Agree with Ellen...there are actually too many fragment attempts at guidelines :)

Lack of universal guidelines would be more appropriate I think


comment:
Maybe instead of saying...don't try to sell them yet...

This is an opportunity to demonstrate what you know about CMV testing with a lab director and clinician.  It is important to build relationships with these key stakeholders first. We will discuss our cobas CMV tests in later modules.  

Or something like this.


comment:
it would be better if the lab director talks about standardization - this is about aligning the analytical performance of assays and the WHO

Commutability comes later with the clinician when we talk about patient samples.  

The questions from slide 40 are really good to define the differences between these two concepts.


comment:
This dialogue is good and does a nice job to summarize the challenge but somehow we need to separate "standardization" from "commutability" at the beginning to ensure the concepts are clear, then bring them together.  Maybe we can talk through this?


comment:
We need to change the image on the right. Maybe just make them all the same color...the shape was also a concern for Ellen because it looks like what is in the middle might be more important than the others...This is really just a list of factors and we tried to show it a bit fancier...


comment:
Maybe in his dialogue say 1st WHO International Standard for CMV...just to be more accurate. After that we can just say WHO standard..

Also "mL"...vs "ml" - first answer box


comment:
Agree with Jessica's comment during this dialogue - if they get it wrong...or half right/half wrong...do they get a chance to see the correct path or best example?


comment:
As you can see, calibrating an assay to the 1st WHO Standard for CMV can be difficult and time consuming for the lab and variability can arise from numerous sources, including the calibrators themselves.


comment:
Lack of standardisation between CMV tests means results are not comparable across institutions so universal thresholds for decision making can not be determined.  This raises many questions for clinicians..

Ellen do you agree with this re-wording?


comment:
What is the required sensitivity for a quantitative CMV test?


comment:
Here is where commutability matters...need to changes this questions in white from the clinician and doctor and modify.


comment:
This lack of universal guidelines limits clinician's ability to optimize CMV patient management.  This becomes especially challenging if patients move and are tested in different institutions.

Ellen - thoughts on re-wording?


comment:
Not sure we need to bring this back into the discussion -clinicians don't understand PCR tests...keep it clinical.

The question in white should also change. Let's discuss.


comment:
This graph would be better in the lab director part to show the variability in the performance of different calibrators..

Some of what was said with the lab director might be better with the clinician.


comment:
This is better with the lab director discussion.

To Ellen's point - we don't have data yet for cobas so this is why just CAP/CTM here...

Perhaps we should walk through the opening dialogue for clinician and lab director together on the call to re-work...this will probably take the most time.


comment:
Good ending...probably can delete alot of the clinician dialogue and just get to this point...

We should also say why this matters..this is what clinicians want the most - treatment guidelines!


comment:
Bottom dialogue....It is calibrated to the WHO standard, reporting in IU/mL with full automation


comment:
It is not the WHO standard that recommends lab report in IU/mL...
Slide 10 of module 3...
The community is moving towards IU/mL due to the availability of the WHO standard.
International consensus guidelines recommend that all labs report in IU/mL,  EQA in Germany, CAP in the US...

Let's discuss best way to re-word this.


comment:
Let's talk about how to incorporate this...better with clinician or lab director?


comment:
Maybe we should refer to the guidelines mentioned by proper names and then reference them in the bottom as foot notes?

1. Updated International Consensus Guidelines on the Management of CMV (2013) (ref)


Kotton, CN, Kumar, D, Calienda, AM, Asberg, AA, Chou, S, Danziger-Isakov, L, Humar, A.. Updated International Consensus Guidelines on the Management of Cytomegalovirus in Solid-Organ Transplantation.Transplantation. 2013; 96: s1-28


etc..


comment:
Generally check for contractions throughout...saw several examples


comment:
Agree with Ellen - this is really no defined frequency...it varies by institution and for numerous reasons

Maybe just say..which requires "frequent monitoring" with

Will also have to adjust "cost" if we change this a key point in the module


comment:
Here is where standardization and commutability play -if we are clearer in definitions in the module then maybe we can test that here as well...ensure participants know the difference.


comment:
I believe that if i view and screen and come back to it, the next button should be unlocked? It's not on this screen. please check in course.


comment:
Matt - We have oportunity on this screen to make the graphics more relevant and to include more so that it's more engaging to the learner.


comment:
Capture files are used in Power Generation, this is an automotive engine scenario, the request should be for a INSITE job image in eif format


comment:
I'd caution telling anyone that level 3 has "a lot of great resources available to them" that no one else does. Level 2 should have all the same resources except they aren't on site


comment:
Since when did we allow level 1 24 hours before escalating?


comment:
I agree with RLK. If it is on it's way to Singapore it should be fixed. I'm not sure what you want me to do? I should verify my fix is in the troubleshooting steps.


comment:
Who is Global Solutions? Who is Service Events Solutions?


comment:
May want to double check the edit on line 2 of the spreadsheet. I'm unsure if the audio change was made.


comment:
fix the click next text box so it's all on one line


comment:
did the client ask for labels under the icons? they seem a little off as is. if they want them there, i would make sure they're all similar size icons, and have ALCOA text under the clipboard icon like the others


comment:
Ignore my edit. I just saw another note further down that negated my edit. Sorry about that!


comment:
have the popups cover the entire area for all of the icon clicks. some are shorter than others, i would just make the same


comment:
will send graphic for here. lots of text


comment:
not sure if i had this edit before, but i would make sure the source and not source are bigger so that when icons are dropped, they aren't overlapping... i also think you should make the icon descriptor text purple so it's clear that text goes with the icon


comment:
actually, i would just reuse the EMR graphic that we use on the next screen. put it centered above the text


comment:
elongated the "now it's time..." state so there isn't the orphan word


comment:
can we have line separators so it's easier to follow which checkmarks go with what?


comment:
Per line 12 in the spreadsheet, should "+" be removed from ALCOA? This may not be the case but I just wanted to verify.


comment:
elongate the "Correct answer:" box so "it" isn't cut off


comment:
when i hit back to return to this page, it locked up and I couldn't click anything


comment:
Attributable Popup: First Bullet: I think there may be an extra space between the bullet point and "H".


comment:
Accurate Popup: Second Paragraph: Suggest adding "are" between "but" and "not".


comment:
Third Bullet: Suggest changing "version" to "versions" here as well.


comment:
next button changed to normal before audio ended. also dont we normally have images before the red bars come out?


comment:
First Box: It appears there may be an extra space at the beginning of this sentence.


comment:
First Popup: You got the language right from the spreadsheet here so you can take or leave this comment. :) That said, I'd suggest maybe adding, "when" after "helps" in the third sentence.


comment:
Why is this...popup: Should "good" be bolded here as well to match the other screens?


comment:
Closed Captioning: Should "judgement based" be "judgement-based" in the captioning as well?


comment:
First Answer: It appears there may be an extra space at the beginning of the sentence.


comment:
Correct Feedback: It appears there may be an extra space between the comma and "original".


comment:
This may be more of a nice to have at this point but the characters seem to sometimes be floating a bit. They may need to be moved down slightly.


comment:
This may be more of a nice to have at this point but sometimes the characters seem to be floating a bit. They may need to be moved down slightly.


comment:
CC: Third Line: Should this say, "Ensure the site understands" instead of "understand"?


comment:
Head and Heart Button: This may be nice to have as well but the button appears before it's mentioned in the audio whereas I think in other courses it appears as the audio mentions it.


comment:
I'm guessing here, I have nothing to tell me what the right choice is. I could be learning by failure.


comment:
Is this related to the previous slide? Is the "Best Auto Shop" and MHC dealer?


comment:
Neither of these are what we are telling Cummins Care Level 1 to do. At this stage we tell them to escalate to Cummins Care level 2. I don't see that option here.


comment:
Transfer the call should say "escalate" the call.


comment:
Ask the technician for all documented troubleshooting they have completed and a job image in eif format.


comment:
Do we open workorder for our dealers or Distributors at Cummins Care. I believe we don't. Incase we don't open the work order for dealer as a Cummins Agent we should understand what customer is looking for a authorized Cummins repair location and we would help him to find one.


comment:
Level 1 can check CSS or EDS if published troubleshooting steps are completed and if any answer is available before escalating to Level 2.


comment:
Review EDS /CSS and get all the details of troubleshooting which has been completed. This will help to get into the roots of the issue. In this scenario if tech has run the test, we would ask for log file for the tests instead of capture file.


comment:
agree with matt - need to be consistent in whether icons are labeled and make them the same size and lined up


comment:
origional pop-up - don't let your 2nd lines go under the bullet. line them up under the 1st line to be consistent with other pop-ups


comment:
will there not be any references in this course? If so, what are you guys doing globally with the reference button? WE shouldn't direct to a blank screen


comment:
Put a space between Male: and 3 in the 3rd option, make it look like the others.


comment:
Edit sentence 2 on HSCT side: "HSCT can be either autologous/autografts (from oneself) or allogeneic/allografts (from someone else)." Delete the last sentence.


comment:
Just a compliment - you've done a great job catching britishisms. Thanks, Sarah!


comment:
Edit last HSCT bullet, sent 2: "It is also often used to treat autoimmune diseases."


comment:
I like the reference idea; we probably need to mention it somewhere toward the beg of the course? I'm fine to hold off on the reference doc til we're ready to launch megacourse


comment:
Add text to Sophie's bubble, "Here are a few other facts about BK."


comment:
Edit sophie's text: "Well done! Did you know these facts about EBV?"


comment:
AGH! a new issue I haven't seen before. Paintbrush hopping around/2nd brush never disappeared. Please troubleshoot.


comment:
incorrect: Change "No Quite, Agent" to "Not quite, Agent!"


comment:
Maybe start with "Now that you've determined you need a plan, you need to figure out where you can dig up some information to start filling it out."


comment:
At 3:49 of the intro video animation, if possible, when the narrator says "CMRI, OASIS and ADS", those should populate the computer screen at that time, and then the emphasis of each application (from dull to bright), should be made when the application name and description appear on the right hand side of the screen. If this is too much of a change, it is not a make-or-break, we can save that for future edits. But, it would be more impactful to have the visual display coordinated better with the narration.


comment:
change course title here to Operation: REVEAL-BD & Cepheid


comment:
I've changed my mind on this one. Let's spell out AmpErase like Dennis said. It's the only question that has it, I think. Question and Feedback both please.


comment:
I wanted to click the box because it's in a row with the other stuff. Since it's not clickable, I think we need to remove it or gray it out or something to indicate that it's not part of the list.


comment:
reconstitution solutions pop-up - can we make the bottles bigger to fill up more of the white space on the pop-up?


comment:
really for all of the pop-ups - the graphics look pretty small shoved in the bottom corner. Can Katherine adjust to make it look a little more balanced?


comment:
For step two in pop-up - Capitalize "Cover" and add period after area.


comment:
pop-up - i think the first bullet "characteristics" can be deleleted? Check against script that this all got copied over correctly.


comment:
what have you guys been doing with animations in these courses? are there any player buttons? this is a really long one to not have any control over.


comment:
i'm just going to say it again - the timing on the stopwatch makes no sense based on what's happening on screen. i know that's the time that roche gave you guys....


comment:
This screen isn't working completely correctly. I just kept tilting and saw an incorrect feedback box that popped up for a second, but i just kept tiling and then I got the correct final feedback


comment:
update the fade on time of the arrows with the bubbles. have the process arrows and bubbles animate on simultaneously


comment:
have these animate on in time with audio? that's what we normally do


comment:
replay didnt come on when audio finished... also bold "button" in instructions


comment:
Move "These solutions..." line to a separate line as  in the other pop ups


comment:
The boxes in this picture are all still labeled HCV. They should have the name/style of the CT/GC assay.


comment:
Boxes all still say HPV in the see it. They should have the CT/GC assay name.


comment:
HPV Internal Control reagent-the letters spill off the vial


comment:
Delete one of the "You have spent..." sentences.


comment:
remove question mark from last sentence in paragraph. Just  period is fine.


comment:
In other course i saw this week, the "this course has audio" was a separate screen. MATT - what's the rule they should be following?


comment:
i won't be suprised if lilly requests you have at least one non-white option


comment:
agree with matt - this is a good example where the visuals moved enough and were relevant to the voiceover. nice!


comment:
"hard documentation" is an odd term. what do you really mean by this? I'm not sure that ESL learners will know that term.


comment:
Beth, let's talk through this when you're at the office tomorrow. You have them think of themselves as the student...but really, they are the teacher recording grades for the students, right? I think we need to clarify this a bit for it to be meaningful...and to connect why accurate documentation is important.


comment:
add a header to all of your pop-ups on this screen so we know what this step on the timeline refers to


comment:
first timeline stop, first sentence - i have no idea what this sentence is about.


comment:
for all of your bullets in pop-ups, check that they are parallel structure and end in periods.


comment:
add captions on images so they know what screen that is in trialforce


comment:
chage video screen to a title screen with play button when it hasn't been clicked yet


comment:
what are we doing for these screen captures? should there be player buttons?


comment:
The Next button doesn't seem to be activated upon replaying this screen after viewing it once.


comment:
Original Popup: Suggest lining the bullet points up like you have in the other popups (not having the second/third lines go under the bullet point itself).


comment:
I believe "good" should be bolded in the text box popup as well. Whatever matches the other screens.


comment:
suggest to add explanation to the 6months cycle put on the slide. it doesn't have to be 6 months, even though it might be common for the customers we as Cummins usually handles, but it is up to the account team to decide what is the right cycle duration


comment:
in my opinion, executive summary shouldn't be the simple aggregation of all info. collected based on all other tabs. it is the "so what"


comment:
these images are too close to each other. it makes it hard to tell where one starts and one begins.


comment:
Beth - when you grab me today about the analogy, let's also talk about this screen. have they learned any of these things in the course already or are we using these multiple choice questions to teach them?


comment:
The mosaic logo on his shirt is backwards here too.


comment:
Add instructions to this screen "Click each location to find out about the Sulfuric Acid Startup team members and the tools they use."


comment:
The sulfuric plant looks like it is cut off on the right side.  I can also still see a little bit of the smoke coming out of the sulfuric stack (not a clean coverup).


comment:
When I clicked the sulfuric plant, it turned gray and shifted on screen before I got to this screen. Should it actually turn gray when I click Continue on this screen?


comment:
The operator image changed (got darker?) when I advanced to this screen.


comment:
The instructions should remain on the map (see comment below).


comment:
Image on the previous screen turned gray before advancing to this screen. This should only be visible as gray after the section has been completed.


comment:
field observer image turned gray before advancing to this screen.


comment:
The guard is not a Mosaic employee.  Need to remove the logo from his shirt.


comment:
Add eye and ear protection to these guys.  Since they are outside, they need PPE.


comment:
The GM grayed out before advancing to this screen.  He shouldn't be gray until I complete this section.


comment:
Add a bullet to the end of the list "There is a risk of inversion."


comment:
Prod Spvr turned gray before advancing to this screen.  Should not be gray untill after this section is completed.


comment:
Change 1st bullet to:  Approves all startups after 11:00am UNLESS there is a shift change or risk of inversion.


comment:
Let's talk about this section.  The popups aren't matching up correctly and I still don't like the "highlights" for where to click.


comment:
Need to update the menu.  This really isn't a "Countdown to Startup".  In the menu, let's re-title this to "Startup Considerations"


comment:
Last paragraph - Electronic Word documents that are printed....  Is this limited to Word? Is it correct to remove Word and just say Electronic documents...?


comment:
Let's change the speech bubble here:  Now that you've seen what it takes to start up a Sulfuric Acid Plant, let's see if you can put all the pieces together in one big scenario.


comment:
Let's make "You're a Production Supervisor" bold.


comment:
The sulfuric plant picture has changed from previous versions.  Can you fix?


comment:
Can you lengthen the plume coming out of Other pLant Departments?  It can even cross over and go on top of the plant office building.  I'd like to exaggerate it so learners pay attention to it.  Maybe we make it a different color?  White would stand out for sure...


comment:
After clicking Other Plant Departments and returning to this screen, the plume is still that rust color.  Should be gray.


comment:
Need to fix this on all screens:  When I clicked field observer, the object turned gray before it advanced to this screen. The learner should not see this as gray until they return to the map screen.  Check ALL clickable objects that turn gray to indicate progress.  It's not working right.


comment:
Before advancing to this screen (in addition to the shack turning gray), the plant office turned orange.  I shouldn't see that either.


comment:
Update text to:  ...He will ask you about the inversion risk, plant condition, and stacks.


comment:
Update feedback (for incorrect and correct) to say "...what the current plant conditions are in Sulfuric. The Sulfuric Operator can provide you with this information."


comment:
Review menu again for consistency in capitalization.


comment:
When I hover my mouse just to the right of the journal, I get a pointer instead of the arrow head.  But I know it's not clickable!


comment:
Popup box for the dude in the top left is covered by the end of the tool of the guy standing opposite of him.


comment:
The menu is out of whack here.  Missing the introduction to this final challenge.


comment:
This screen should not be titled "End of Course".  It shoud be "Final Challenge - Introduction"


comment:
If the user selects the incorrect answer, can they try again? This automatically moves on to the next example -is that what the team prefers?  I tried to test both answers but wasn't able to go back to add feedback to individual examples. The 1st example and one towards the send weren't clear to me that the question was about the actual system.  If you have these examples written out, can you send via email to me since I can't get back to the examples to add on the correct page?


comment:
Suggest remove napkin example. only source if that is 1st place recorded.  I think enough other examples that reflect what a CDC might see at a site.


comment:
Change the question to:  Such a nice, sunny day!  Any concerns about the weather? (Select the correct answer) ------------the answers remain the same.


comment:
Update correct feedback:  "Yes! You need to call for approval. Even through it's not morning when inversions typically happen, the looping plume is cause enough for weather-related concern."  Change incorrect feedback to, "Actually, you DO need to call for approval. Even through it's not morning when inversions typically happen, the looping plume is cause enough for weather-related concern."


comment:
Change the label to "Area Manager" only.


comment:
This is the wrong text for this screen still.  The text should be "The plant has been down a little over an hour due to high SO2. It looks like the plumes are looping, too."


comment:
The text on this page is correct.  Weird!


comment:
Update Matt's correct "feedback" to "I agree. Why don't you give me a call in a couple of hours and we'll see if the weather is cooperating then." What is currently appearing on this screen is the feedback for an incorrect answer.


comment:
Add a label to the filing cabinet that says "Livelink" in the white space.  Needs to be readable though.  If the white space doesn't work, just add "Livelink" to the drawer wherever it works.


comment:
Weather image in background should be normal plumes rising (almost) straight up into the air.


comment:
Update instruction to "Click the Livelink filing cabinet to get the documents needed for startup.


comment:
update clock to 3:40 and weather picture in background.


comment:
Fix clock, Livelink on filing cabinet, and weather background.


comment:
There is no highlighted person on the phone.  Need to add the red boxes.


comment:
May need to re-orient this screen.  Since David is talking, I feel like the speech bubble should be coming from him rather that from the person on the phone.


comment:
When I click the last "return" button, I should advance to the next screen instead of clicking next to continue.


comment:
Would love to have the phone buzz here, too.


comment:
Change 2nd bubble to "Thanks. Go ahead and startup."


comment:
change text to:...We're starting up the Sulfuric Acid Plant.


comment:
The shadow from the PPE is inconsistent from screen to screen.  That is the difference.


comment:
Whe I click "List/log of visitors" the "o" in log moves.


comment:
Is this the image we've always been using?  Its the same as field observer and shouldn't be.  If you need a different image, let me know.


comment:
Microsoft word file example was one I was confused about on previous exercise.  I wasn't clear that the question was about the system itself. (Microsoft word file). now that I read it again, I think it's ok.


comment:
Last sentence of 2nd question. Suggest removing "unless necessary".  Sentence can be Stick to the facts and do not draw conclusions.


comment:
In the feedback for incorrect answer, change "General Manager" to "Area Manager".


comment:
In the feedback for incorrect answer, change to "...did not approve your recommendation to startup. Because of the risk of inversion..."


comment:
Next does not take me to the certificate here after completion as field observer/sulfuric operator.


comment:
4th question, 1st two sentences - I would like to confirm with Laura Ludwig. 1st sentence  - reword - sounds funny to say "sites have been found".  2nd sentence: If the site has a certified copy process in place, they can destroy originals. Not sure why this says to keep originals.  I will get back to you on this comment.


comment:
Agent needs PPE (eye and ear) since she is outside.


comment:
Picture is gray instead of in color.  Need color to be consistent with others throughout the eLearning.


comment:
1st answer - possible to shorten or divide into bullets for ease of reading?


comment:
2nd answer - another training module changed IRB/IEC to ERB.  Make consistent across? Need to consider OUS audience.


comment:
2nd answer: is the last part taken directly from ICH? Sounds a little out of order. Suggest change to: investigator should make all requested trial-related records available for direct access.


comment:
Last answer - I think clear enough to say "regulatory authorities"  (ie., plural is ok)


comment:
The additional comments on the form weren't clear to me. Can a SME reword this? Which is the convenience copy? 1st sounds like paper, then sounds like electronic.


comment:
I just noticed this but do you want to refer to "study participant" instead of "patient"?


comment:
the photos of applicants that scroll by quickly - grumpy lady, big group of young professionals, etc. is an odd mix that don't seem related to each other.


comment:
Top banner should say:
Why is assay standardisation important?

Text should read:
Achieving standardisation of assays would mean results are comparable across institutions. It is the only way to enable development of international clinical practice guidelines for CMV viral load testing to support better patient management.


comment:
Banner should say: 
What are the obstacles to achieving standardisation?


comment:
Note to BLP: Need to add another screen to cover the WHO IS and guideline requirements for IU/mL that currently exist...

Banner would be:
What does it take to achieve standardisation?
In 2010, the 1st WHO International Standard was released as reference material to enable labs and manufacturers to calibrate their assays and report in IU/mL. This is referenced in the 2013 International Guidelines for SOT and has begun to appear in proficiency testing (CAP & INSTAND) which send samples in IU/mL.


comment:
Let's say.... lack of universally applied guidelines that include treatment thresholds.


comment:
Text under banner:

Converting an LDT to report in IU/mL can be challenging as laboratories usually do not use the WHO IS directly but purchase secondary derived material from manufacturers (ex: Seracare). Studies have shown that such "calibrators" may actually worsen the agreement between assays rather than improve it

REF: Hayden et al:  For the College of American Pathologists Microbiology Resource Committee. 2017. J Clin Microbiol 55:423 430. https://doi.org/10.1128/JCM.02044-16


comment:
Banner needs to change to the same as the previous screen  (no commutability here!)


comment:
In addition to the challenge posed by calibrators, other aspects of assay design can be obstacles to standardisation. (some are shown in the graphic on the right)
Viral load treatment thresholds developed in one institution based on their test remain specific to that test at that institution.


comment:
Banner can stay as is..

Text:
The lack of standardisation prohibits universal viral load treatment thresholds which in turn limits  CMV patient management. This becomes especially challenging if patients move and/or are tested in different institutions.


comment:
Banner text to be?
What is commutability?

Text:
Commutability means that the reference materials used to standardise the assays (ie WHO standards and/or calibrators) behave like clinical specimens. Therefore, for test results to truly be comparable across different tests/institutions the assays must demonstrate the same performance with patient samples as with reference materials.


comment:
Banner Text:
What aren't standardised assays commutable?

Text:
A recent study across 10 labs with different assays showed improved agreement when using reference materials (graph 1) but poor agreement when using patient samples (graph 2).  REF
Preiksaitis, et al.  Clinical Infectious Diseases. 2016 Sep 1;63(5):583-9

Note to BLP: Will send slide with graphs via Basecamp


comment:
Banner text:
What can impact the ability to compare results, ie: the commutability?

Text:
CMV DNA is a very large virus and can be fragmented by a patient's immune system. On the contrary, reference materials are intact constructs. This means CMV assays that have different amplicon sizes will have different amplification efficiency with patient samples even if they have the same efficiency on reference materials!


comment:
Banner Text:

In the end, how do these challenges impact patient care?


comment:
How are these test methods used to guide treatment decisions for CMV?


comment:
This may be nitpicky, but sentence is a bit of a run on.


comment:
Is standardization spelled with an "s" or a "z"


comment:
Not sure if this applies but in general when discussing organ donation, there is a lot of sensitivity around specific language. E.G. using the term organ donation instead of body parts, etc. so may consider a bit of rewording in the SOT section where you discuss bodies. This may not matter as much for this audience, but just wanted to highlight


comment:
SOT: examples would use instead: end stage liver disease, cystic fibrosis, end stage heart failure (would not use diabetes, hypertension, etc.)


comment:
HSCT for solid tumors is pretty rare so would leave it to: Leukemias, lymphomas, and some non-cancerous disorders like severe immunodeficiencies.


comment:
Is there supposed to be sound on each page?


comment:
2 years plus four months is a bit confusing. Do you mean in total from the time of diagnosis of end stage disease it took 28 months?


comment:
Not sure if need to see the patient one fact sheet again


comment:
Maybe in bullet points discuss why she needed a transplant (e.g. underlying malignancy). Spelling ? hospitalization vs hospitalisation. Consider:
Prior to transplant:
1st bullet: 5 months of twice weekly chemotherapy (maybe highlight a few side effects)
Transplant
Inpatient procedure, requiring 18 days in the hospital
Felt ill throughout stay with fatigue, decreased appetite, weight loss, and hair loss (? if this was also a symptom during chemo)
Many medications to prevent infections, and required blood transfusions
Discuss infection prevention (isolation)
Post transplant
Continued debilitating fatigue
Continued isolation to prevent/minimize infection risk


comment:
HLA typing is done to determine the match (who can be a donor for that particular patient). Serologies are performed for a number of infections including CMV to determine whether or not a patient has been exposed in the past and may be at risk for recurrence of disease post-transplant, when they are immunosuppressed. Also not sure if you still need the fact sheet here


comment:
Similar comment regarding terminology. Additionally, SOT also has increased risk for reactivation of infection, and most patients will get CMV serology prior to tranpslant


comment:
Sophies speech bubble is hidden in the blue paint strip of "PCR"


comment:
Syntax and grammar need work in sophie's bubble. efforts is plural.
Also, do we want to say, "calibration" instead of "recalibration"?


comment:
do you think we'll lose them on the first sentence? its correct, but is it too technical?


comment:
conventionally, you put the reference comparator on the x-axes and the experimental on the Y... But here we have the experimental (lab tests on the X...) Don't know if we can change this...?


comment:
well, technically, you apply a conversion factor to correct proportional bias, its just not a linear function...


comment:
I don't understand the title "+/- WHO Traceability"... or the green arrows.... Sophie should tell us what the arrows are...


comment:
And,voila! when i click continue, she tells me... LOL


comment:
Hmm.. the dotted line represents 100% concordance R2=1. y=x. "best fit" implies that the curve has been fit to the data, which it hasn't....


comment:
this graph shows a type of non-correlation that is neither proportional or constant. I think the first slide sets up a false dichotomy of bias - they can be non-linear and non-proportional.


comment:
We haven't yet defined commutability, which makes the first sentence hard to understand. Maybe we can say, "...improves inter-lab correlation, but doesn't ensure that patient results are directly comparable between labs..."?


comment:
Maybe give a little more explanation: patients who have both diabetes and end stage renal (kidney) disease do better if they can receive a kidney transplant rather than dialysis. Because of Bill's diabetes, I referred him for transplant evaluation


comment:
Do we want to say something about how some centers place someone on prophylaxis and some on preemptive therapy?


comment:
May be nice to put in chronological order


comment:
Would spell out all viruses on the easel


comment:
Second sentence: In addition to acquired, opportunistic infections, these patients are at risk of reactivation of latent infections, e.g. from pathogens that may have infected the patient many years ago. Something like that


comment:
Would maybe give a stat on morbidity and mortality


comment:
Compare the spacing (i.e., leading) between the bullet points on this screen with the spacing of the bullet points on the Connect the Dots screen for LDTs. The leading for the bullets on this screen needs to be increased.


comment:
In Sophie's speech bubble, shouldn't "CE-marked reagents" be "CE-Marked Reagents"?


comment:
Update the text in the advantages and disadvantages boxes: e.g., Advantages of CE-IVD/FDA-Approved Tests


comment:
Update the green instructional text: "Click each highlighted dot to learn about the strengths and weaknesses of CE-IVD and FDA-Approved tests and to reveal the image."


comment:
Update the green instructional text: "...weaknesses of LDTs with CE-Marked Reagents..."


comment:
Increase the space (i.e., leading) between the bullet points. See my comments on the previous connect-the-dots screen.


comment:
Remove extra space at end of Sophie's first sentence (before the period). Also, capitalize "approved" in her first sentence.


comment:
On this table and on the table for LDTs with CE-Marked Reagents, the Examples row is slightly misaligned with the rows above it.


comment:
This screen and the table should be labeled "CE-IVD / FDA-Approved Tests"


comment:
Probably not necessary, but should the pop-up bubble for the red spot extend over the center of the palette so that it doesn't obscure the instructional text?


comment:
Change "color" to "colour" in green instructional text. Also remove extra space between "a" and "key".


comment:
Hyphenate "end point" in lab director's speech bubble.


comment:
In Sophie's speech bubble, remove extra space between her first and second sentences.


comment:
Change title on easel to Lab Director's Perspective.


comment:
Revise Sophie's speech bubble: "...HSV 1/2, and Adenovirus can..."


comment:
Make "cobas" bold in lab director's speech bubble. Capitalize "approved" in Sophie's speech bubble.


comment:
The two buttons on this screen didn't fade in like Sophie and her speech bubble did when I advanced to this screen.


comment:
Center title on easel. Capitalize "considerations", "utility", "children", and "considerations" on the buttons on the easel.


comment:
These buttons also have no hover state. All other buttons in the course have multiple states.


comment:
On this and the other question screens in this section: remove the contraction (There's) from the incorrect feedback layer.


comment:
In the first response option, replace "That is true" with "Some studies do." In the second response option, replace "That is true" with "Some studies do, and yes".


comment:
Edit Sophie text: "You are doing great! Would you like to keep learning about post-transplant CMV test types and standardisation?"
Click play to review..."


comment:
The reference on this slide (Mengelle 2016) is correct for Sophie's feedback on the correct feedback layer. However, it's not correct for the second response option on the main layer. That response option should have the following reference: Kraft et al. CID 2012:54 (15 June), 1793. Also, the URL for the first reference should be clickable.


comment:
Do a global search for contractions and british. Sarah did a great job with the british search in module 1, ask her how she did it.


comment:
URL for reference 3 should be clickable.


comment:
Remove unnecessary space at beginning of first bullet before "Lack".


comment:
No reference is necessary on this slide.


comment:
Edit sophie: "To illustrate... results, here is a theoretical example. In this scenario, we apply a conversion factor... reporting in IU/ml."


comment:
In previous modules, didn't the draggers become plain text when they were properly placed?


comment:
Let's use title capitalization for LDTs with CE-Marked Reagents (sic) throughout the course.


comment:
Let's use title capitalization for FDA-Approved tests (sic) throughout the course.


comment:
The way the painting fades in is great! The brushes disappear behind the canvas, however, when I drag them to start painting. Also, in Sophie's speech bubble, italicize "A Sunday on La Grande Jatte".


comment:
The .pdf available via the Resources tab contains one minor "typo": there's an extra space beneath the text in one of the cells. See the second row (CMV), third column (Patient Population Tested). This extra space is making the text appear off center.


comment:
Add below sophie's text: "Note to Roche: Can you help put this explanation into layman's terms?"


comment:
Need to update the audio on this screen.


comment:
make "have a conversation" purple in red bubble 2


comment:
need to bold "button" in click next instructions


comment:
first question box changes on the finished state. i think the first sentence gets bulleted.


comment:
make the rollover words purple and bold too


comment:
same issue of the state change for first question bubble.


comment:
finished state for question 1 is messed up


comment:
check the speech bubbles on all these layers aren't hidden or wait to show until audio is done playing. make sure they are always visible.


comment:
This is not realistic because patients who are getting on the transplant list would already be under the care of a nephrologist for advanced renal failure. As AK said, the referral would be for kidney disease, and the nephrologist would recommend transplant rather than dialysis.


comment:
when i click down the rightside path, it ends up with bubbles on the left side. the boxes at the end look similar to the rightside ones, but they're slightly different and it looks like i followed the left path.


comment:
hovers are new and also off (hover for 2nd bullet covers the third as well). remove


comment:
The story is confusing a live donor vs a cadaveric donor match. If you get called with an "organ available" that means the donor is dead and you go urgently for a transplant. In the case of a live donor, it would either be an elective procedure with a relative who is HLA-matched (say a sister) or else a non-matched relative (say a wife) who is a match for another patient--in that case, sometimes simultaneous elective procedures are done after computer matching the various donors and recipients.

In either case the patient (future organ recipient) would go for an evaluation in a separate visit before the actual transplant once the "organ is available." The patient would not stay in a hotel for the transplant.
The donor would not be tested for BK serology.


comment:
The halo (i.e., hover state) should be active for the spot that the learner is to click next. So, in this case, the halo should be visible on the orange spot.


comment:
At the very beginning of the module, I clicked on the Gallery Walk spot on the Module Menu (i.e., Course Palette) and was brought here. That's correct, but the place holder / painting for the current module should not be visible when a learner visits the Gallery Walk (that is, not until the learner completes the current module).


comment:
The text on these slides will change, but we'll want to look out for contractions. RMS wants none.


comment:
This is a really cool interaction/graphic. My only thought is that the yellow pop-up text (LDTs) is difficult to read against the whitish background of the slide.


comment:
Correct speech bubble typo: Learning agent explains...


comment:
As JL noted, some of the draggers seem out of place and the instructions are wrong, but this again is a cool interaction/graphic!


comment:
The instructional text that appears after section one has been completed is partly in black and partly in green. It should all be green.


comment:
I know that we are at DP and content will change, but I recall RMS saying previously that the AmpliPrep and Taqman tests are obsolete.


comment:
I know these are only placeholder screens, but the green speech bubble reads "Placeholder patient statement", and this is supposed to be a clinician we're working with here. Also, after clicking through a few slides, the clinician changes into the lab director from the previous conversation.


comment:
Replace "color" with "colour" in green instructional text.


comment:
Revise second paint swipe: "It was the first FDA-Approved/CE-IVD test."


comment:
On the second incorrect feedback layer, the last part should read "FDA-Approved/CE-IVD test."


comment:
In correct feedback layer, the last part should read "FDA-Approved/CE-IVD test."


comment:
Revise speech bubble: "At Roche, we are..."


comment:
Instructional text is again partly black and partly green after the third section of the course has been completed. All instructional text should be green. Also, in addition to having the hover state active by default on the spot that learners should click next, the pop-up bubble for that spot should remain visible at all times, not only during hover.


comment:
If the easel reads "Placeholder", do we need the yellow call out box for Roche?


comment:
We have removed Exit from the UI in all three of the other transplant modules--are we doing that here as well? I would think that, even if we are, the exit button should appear on the Gallery Walk at the end of the module. If we do remove it from the Gallery Walk, the green instructional text needs to be revised.


comment:
Delete the first "a customer" from second challenge question on pop-up plaque for Module 4.


comment:
This VO needs more happening on screen to support it


comment:
Can Sophie be a bit more energetic - the voice is mono-tone on occasions


comment:
IS this spoken or does it need to be read?


comment:
Not sue what the * at the bottom means / trying to say(some affiliates may test both....)


comment:
Would it help having a really easy short test before the affiliate can move on to the next section? - could be applied to each section


comment:
Agree with Amanda - spell out the virus names. Would be nice to also include somewhere pronunciation of the virus names


comment:
Change storyline setting so that course title in the internet browser tab is correct


comment:
in script - change update persons to update people and don't say BMV, say department of motor vehicles. Or alternatively, think of something that would work for EU...Not sure what they call it over there.


comment:
can we be consistent in the imagery and use the same black couple throughout to represent the new homeowners?


comment:
watch that images don't look too US-centric


comment:
it's odd that there are just empty boxes on screen?


comment:
Matt - this text needs to be re-written. The first bullet isn't even coherant. Check if Beth or Erika have time to edit it. If not, I will on Monday


comment:
Matt - Cut off the audio when she starts listing the types of changes. It's too much words with nothing happening.


comment:
change onscreen text (after showing where course fits in) to: 

Changes impact: 
* whether a site continues to be qualified to participate in a trial
* Lilly's ability to support and communicate effectively with the site.


comment:
Can you animate the second half of the outline before populating the "innards?"


comment:
Add header to tablet: LDT with CE-Marked Reagent Description


comment:
Change intro sentence to: In this course, you'll learn what to consider for the most common site changes and how to document those changes in TrialForce.


comment:
Change page title: Creating an LDT with CE-Marked Reagents


comment:
Change the first module name to Change Considerations. I know this impacts the menu and UI, but the button name doesn't make much sense given the content in the module.


comment:
Puzzle pieces should end up closer together to show they don't fit; hopefully that will leave a little more room for the speech bubble text, which feels too small right now.


comment:
Matt - ignore earlier comments related to script. I've updated and rerecorded. Can you just check imagery to make sure it all works and that there's enough?


comment:
I actually do NOT think "Marked" (in CE-marked) should be capitalized. It's been correctly capitalized in page titles, but it's not a product name or anything, so in narrative text it can be lower case.


comment:
Add tablet header: "CE-IVD/FDA-Approved Test Description"


comment:
Matt - Could we have icons for each of the changes instead of these empty boxes? You might have to rearrange screen, so if you don't have time, that's ok


comment:
New onscreen text (notice that there are two categories now): 

Click each icon to see a description of five common changes.

Require Re-Evaluation

* Personnel Change - The site has a new PI or Study Coordinator whose qualifications must be evaluated.
* Site Location Change - The site moves after it has been selected.
* Process change - The site makes a significant process change such as implementation of an electronic medical records system or how they handle CT material distruction changes.
* Protocol Change - Only significant protocol changes require re-evaluation.

Requires Action, but Not Re-Evaluation
* Information Change - Examples of these changes include name changes of personnel or other changes that don't impact the site's qualification.


comment:
Flexible ramping product - please look at the verbiage the we used in the script for flexible ramping product to adjust this wording (I don't have the wording available to provide it to you....)


comment:
Additionally, this introduction does not mention the Greenhouse gas settlement, which has nothing to do with flexible ramping product.


comment:
Replace "in the market" with "during the dispatch intervals"


comment:
Change the title from "Meter and e-Tag allocation" to "Meter and e-Tags"


comment:
change "for services provided" to "to cover the ISO's administrative and capital costs"


comment:
In Sophie's speech bubble, "FDA-approved" should read "FDA-Approved" and IU/ml should read "IU/mL". These are global edits.


comment:
Underline disappears on rollover of central pharmacy.


comment:
Change the description of 4575 to "Scheduling Coordinator ID charge"


comment:
Please bold the word good in example 4 feedback


comment:
Forecast fee - correct this to say "The following charge code is triggered:"


comment:
change feedback to read "This is an incomplete answer because although this information may be good for discussion, it is not appropriate for the ISEC."


comment:
I'm having problems with the arrow buttons and moving between screens.  For example I just completed the "Validation basics and timeline" and am back to the main screen. Normally I would choose the next option "the basics of charge codes" but instead I wanted to check out the "Validation" section again.  It would not let me choose that option.


comment:
Also, when I was on the summary screen of the Validation section, I pressed the left arrow to return to the previous screen.  I could not get a right arrow once I was done to move to the next screen.


comment:
Replace "Before the market runs Base schedules are submitted at T+75 and T+40" with Before the market runs base schedules are initially submitted at T+75.  The EIM Entity has until T+40 to adjust the base schedule to pass sufficiency tests run by the ISO."


comment:
Change this to read "Using the base schedules that were available at T+40 a test is run to compare the base schedules to the ISO's load forecast.  If the base schedules are not within 1% of the ISO's load forecast, charge cost 6045, Over and Under-scheduling Settlement, is triggered.  We'll have to wait until we receive the meter data to see if the EIM Entity actually receives this charge because the ISO checks the meter data.  If it is within 5% of the base scheduled amount, there will be no charge.  However if it is outside of that amount, the Entity will receive a charge and the money received will be allocated in charge code 6046 Over and Under Scheduling Allocation."


comment:
On the screen, remove the parentheses from around (Settlement) and (Allocation)


comment:
Please refer to the script that we provided to update this verbiage.


comment:
The ISO is a non-profit PUBLIC benefit corporation.


comment:
Charge code 4575 is the Scheduling Coordinator ID charge.


comment:
I think we talked about something the learners could have that described the scenario, like a printout or something so they could remember the details of the scenario.  Do you remember this?


comment:
Instead of "dispatched" use "scheduled through the"


comment:
I wrote a comment here before but I see that it is gone - perhaps it will show up elsewhere.  Change the wording to read "At T+40 if the scheduling coordinator is using the ISO forecast and the base schedules are not within 1% of the forecast, this charge code will be triggered.  Also, this charge code will be triggered if the EIM Entity scheduling coordinator is not using the ISO forecast.


comment:
Instead of "Dispatching a resource" use "This"


comment:
It may be easier to give you these points after we see the animation.


comment:
Just a general comment - should we really go through every charge code in every scenario, or only talk about the charge codes  that apply in the specific scenario.  It seems like this will become very repetitive if we run through the list of every charge code in every scenario.  Let's discuss this concept - perhaps that's not your plan.


comment:
The graphics that I have for the offsets are contained in the EIM Settlements 101 materials that I provided to you.  Please let me know if you need me to send them again.


comment:
All of the fees ARE triggered by market events - awards, dispatches, flows, metered energy, bids, etc.


comment:
Consider only talking only about the charge codes that apply, not the ones that do not apply.


comment:
throughout, check that next button works right away if i've viewed the screen already


comment:
Matt, please find out from Sharon - in the content outline, it refers to a screen before this that talks about the process map and where it fits in. I haven't seen that in many of the courses, so i'm not sure if that's appropriate to add in or not.


comment:
replace text for remaining roles with: 

CDC: 
"	Uses judgement-based decision making to decide whether the changes requires the site to be re-evaluated.
"	Notifies the right people of the change.
"	Documents new information in Trialforce.
CRA: 
"	Communicates change to the right people at Lilly.
"	Manages the timing of the change onsite.
CT Material Team:
If change impacts CT Material or shipping of CT Material, this group adjusts processes and documentation as needed. 
Site Activation Team: 
"	Ensures any new site personnel have access to systems.
"	Updates required systems, such as IMPACT.
Financial Team:
Updates financial documents as needed depending on the type of change. 
Study Team: 
Determines whether the change will impact enrollment or study conduct and takes action as required.


comment:
It doesn't show up well in PF tool, but if the role has more than one thing in their pop-up, then the items should be bullets, not paragraph form


comment:
IGNORE THE PREVIOUS LIST OF CHANGES. USE THIS INSTEAD: 

Require Re-Evaluation 
* PI Change - The site has a new PI whose qualifications must be evaluated. 
* Site Location Change - The site moves after it has been selected. 
* Process change - The site makes a significant process change such as implementation of an electronic medical records system or how they handle CT material distruction changes. 
* Protocol Change - Only significant protocol changes require re-evaluation. 
Requires Action, but Not Re-Evaluation 
* Information Change - Examples of these changes include personnel changes or other changes that don't impact the site's qualification.


comment:
Put the table on the easel; Change Sophie's text: "Before moving on, take a moment to review these key differences between plasma and whole blood samples."


comment:
Add instructional text: PCR has some distinct advantages over antigenemia. Click each factor to learn more.


comment:
Edit last line: "...viral kinetics,(5) mathematical models that describe viral infections."


comment:
End of previous section did not take me back to the menu, went straight to this page


comment:
first sentence, very end should be: "....building in a month."


comment:
I found this very hard to get these to stick. Is it set up where they will only stick in certain rows? Is that why it cared where each box went? Please test.


comment:
Can we make it so that they can see that three things need to go on the to-do list? Nice to have is to make it graphically look like a to-do


comment:
for all three of these video screens, I still think the first sentence is a different color than the remaining ones. Is that how it's supposed to be?


comment:
How are these screen titles supposed to be written in the menu? Right now it's Use Your Resources; XX. If that's correct then ignore. Seems like it should either be a colon or a dash (like on the actual screen)


comment:
title - I think it should be SPI instead of SPF. If so, update in dropdown menu as well


comment:
per line 75 on edits spreadsheet "only one item" should be bolded


comment:
per line 77 - bold "three items" at top of slide


comment:
Change "extraction methods" option to "cost"


comment:
Edit last line of statment: Instead of "...and complicate <troubleshooting>" say "...and require a specific <platform>."


comment:
Make sure any changes to statements get applied to the wall plaques in the gallery


comment:
No edit - I like how you broke this up into the 3 phases. :)


comment:
Update onscreen text to: Sometimes site personnel have contact information specific to a trial. Click and watch the video below to see how to update TrialForce with trial-specific information.


comment:
Screen title - Change to: Change Trial-Specific Contact Information in TrialForce


comment:
Move this ahead of the first demo. This one should be first in the module.


comment:
Change onscreen text: In the first module, you learned that many changes are documented in the Investigator Site Change Form. Click and watch the video below to learn how to update the Investigator Site Change Form in TrialForce


comment:
In onscreen text and in screen title fix spelling of TrialForce


comment:
first sentence of onscreen text is wrong color


comment:
Matt - Just make this the standard list. I am not sure we need the note to Lilly?


comment:
Investigator Site Change Form screen goes AFTER this one. See script for text.


comment:
For the timeline of the six months at top, put '...' or some indicator of time continues beyond this 6 month example.


comment:
I am not sure it is much more detail, but we should call out those people are selected to be on the team based on the key needs/initiatives with the account.


comment:
This may be an aspect we can cut since I don't recall us wanting to get into how they direct customer interactions as assignments / direction to others.


comment:
This can be more about what key information can be gained from the email and moved into the account plan.


comment:
I think moving into a real photo versus animation is jarring from the overall look and feel so far.


comment:
Lets say "share this information" versus page to move away from attachment to format of how account plan information is stored/managed.


comment:
For the script...we should change "sales rep" as well to match the comments from the opening page


comment:
In the painting:
Transplants = Art + Science..I would just put "Art + Science".
The selling process is the Art and Science vs...transplants which is scientific...


comment:
She says " especially the CMV assay"...not sure if this will remain in the new script but we have more than one assay... maybe say just in general.."selling CMV assays"


comment:
Good points from AK..let's make this adjustment


comment:
Please make the changes to SOT as per PB edits
Changes HSCT as per AK edits


comment:
Agree with AK's comments...better to say 28 months...


comment:
Should say...3 months isolation post surgery to avoid infection and remains cautious years later due to ongoing immunosuppression..

Maybe not so wordy but the point is to ensure they understand immunosuppression is for life!


comment:
Can we look at different options for patient #2..she looks angry.


comment:
Like AK's edits...can you incorporate? Do we need to discuss?


comment:
Let's discus this page based on AK's edits.
Also confused by the footnote.


comment:
Change the terminology regarding "body" - should check this throughout

Agree with Serology testing..this is done for SOT and HSCT but only listed under HSCT


comment:
PB brings up a very good point about why immunosuppression is needed.
Can we add this during the patient cases?  Maybe the doctor can explain this for both SOT and HSCT?
Let's discuss


comment:
Based on the earlier comments from AK - should we choose a different reason for Bill to need a kidney transplant?
Let's go back to the list from the introduction and discuss


comment:
Let's discuss the adjustments to this section based on the feedback from AK and PB


comment:
Agree. if we want them to understand the process then maybe the answers in the end should be in order.  
Would that make it too easy?


comment:
Not sure about the second bullet on the easel. 
Change to...CMV infection can reactivate other opportunistic infections

Would put the second bullet first.


comment:
If we don't spell out the full names of all the viruses then just use short forms for all

Alternatively if this is meant to match the easel a the beginning then whatever changes are made there based on feedback we can also make here.


comment:
Good point from AK...think we have this in the section on CMV in Module 2. Maybe we can introduce it here?


comment:
Need a space before the start of the last sentence in her dialogue


comment:
Sophie's dialogue box covers the painting...can we move her a bit to the left and maybe make the box skinnier?


comment:
As per our discussion on the Mega version with all the modules, can you change "Module 1" on the Gallery plague to Transplant Academy Basics" - if we agree this is the final name for Module 1. 

We also talked about labeling the paintings..?


comment:
Go ahead and add the certificate template at the end for a conclusion and in case they want to print.


comment:
1st red box and narration script - sounds like a word is missing after "meet requirements about data" Is is accurate to replace "data" with "source documentation"?  Or add another word after "data" - data generation? data creation? Or could reword to say "sites who meet data requirements"


comment:
This example ties back to my comment in the know the goal section. I would keep this here but remove the napkin example from the earlier section (around 1st place to record data is the source) Otherwise it seems like is ok in earlier section but now not ok. If this comment doesn't make sense, call me!


comment:
Even though not the "correct" answer, I would suggest changing "strongly prefers" to "recommends" or "prefers".


comment:
The text under the correct answer is written well. See the comment above. I think it's helpful to be consistent all throughout the course because technically a site CAN destroy the originals if they have a process in place. Seeing the recommendation worded in the same way throughout the course helps with reinforcement.  I don't think we should be training CDCs to repeat "Lilly strongly prefers"


comment:
Text when "maybe" is selected: I disagree with STRONGLY in caps around Lilly's preference. If the site has an approved process, this is fine and a common practice, especially in sites with limited storage. OK to state "Lilly recommends" but the back and forth with the "STRONGLY" is confusing and I feel is overstated.


comment:
Tex when "yes" is selected: The last sentence doesn't seem to match the 1st part. If the site explains the process and it's acceptable, why the emphasis on loss of data?  This makes it sound like unless the site agrees to keep all original paper wet signatures (even if using acceptable process) the CDC shouldn't select the site.


comment:
Same as in other sections.  Remove the STRONG and be consistent in the rationale of a documented process describing control measures. This answer seems biased and overstated to me  - no need to state "significant critical judgment".  This implies sites can't destroy originals, and that isn't accurate.  (if have acceptable process in place)


comment:
Text in incorrect answer: typo - "the" should be "that"


comment:
Audio: This is the first time I remember hearing "singular source data locations". Has that been defined previously? If not, consider reword (e.g., identify source data locations)


comment:
Might be nice to have a different color for the topic to be covered next.


comment:
Recommend rewording the statement "You started the conversation in a confrontational way" to something less harsh to the learner.


comment:
Starting with "This could have gone better" is a good way to start.  Same comment re: confrontational - is there another way to state this to the learner?


comment:
2nd example sounds more like a head/lightbulb question vs. heart. (EMR)


comment:
Site selection guidebook link works but went to page that said not ready until 4/7. Checked link on 4/9 but content not posted.


comment:
ALCOA - attributable and accurate are switched in the pop up box.  Attributable is the first "A" in "ALCOA".


comment:
re: ALCOA - my 1st comment is incorrect. The 1st "A" is attributable. So, this list is correct but the text in the slide previously needs to be switched.


comment:
suggest rewording from "Key points from the process get documented" to "Key points from the process are documented"


comment:
Audio - consider removing "COPM" from the sentence to keep more general. Is it possible the additional questions may also come from the study manager? Not critical to change but avoids the need to update if a role changes.


comment:
Audio and on screens: I noticed "trial specific" and "protocol-specific" are used interchangeably. Is that what the team intends?


comment:
2nd red box - remove the word "including"? Do you mean "Key points get documented within the iSEC, in the Trial-specific section"?


comment:
Pop-up to question 1 - consider another word besides "run".  Consider breaking this into two separate sentences.


comment:
Same comment as on previous slide - OK to state COPM but if the role name or task  changes in the future, the course loses some flexibility.


comment:
Pop-up box to 2nd question: Suggest removing "unless necessary"


comment:
1st topics: Some examples are place holders so can't comment until gold master version. (note that new example from John will be used)


comment:
CT Material - please confirm with quality systems consultant Michele Ball (contact for CT Material) on reference to MQS442, as this may not be the best way to point people to the information. Moving forward, CDCs should be referencing the process maps in Blueworks Live in conjunction with procedures that are streamlined in the CDOS.  The old way of finding all the information in procedures has changed and procedures only contain the requirements. Full picture is maps plus quality docs (& training).


comment:
Text in picture of complete answer: Please check with Michele Ball and Brian Schrock on accuracy of referring to MQS 442-001.


comment:
Gray-out "Know the Goal" since that section has been completed and then the purple section for "Have the Conversation" stands out more.


comment:
Audio - it is very common to call the principal investigator the PI but I don't know that saying "SC" instead of study coordinator is common. Please confirm with the SMEs - not sure we want to start using "SC"


comment:
I couldn't get the Sample Slide Deck link to open the slides.


comment:
PI is called Arif on this slide but Dr. on the next slide. I would keep consistent - probably call Dr. vs. 1st name Arif.


comment:
Watch and Learn 1 - seems overly long. Can this script be shortened?


comment:
Text under the correct answer: Suggest remove last sentence. "These questions should have been answered" is too strong for an example conversation flow. OR change "should" to "could"


comment:
At this point in the course, suggest you gray out the completed sections and leave the purple for the yet to be completed section "Determine Next Steps"


comment:
Audio: I suggest saying study coordinator instead of SC


comment:
A small suggestion for the first stop:
Statement about confidentiality agreement should be updated to Complete the confidentiality agreement and store it in Trialfoce at the Trial Site Level


comment:
I feel like we need the journal to be available if they want to refer to it when choosing their team.  Is it possible to add it as a reference tool for this page?


comment:
Pop-Up - electronic source documentation - Don't understand the addition of the first bullet - link the user to actions that create, modify...Deleting data is not allowed. Could be misunderstood


comment:
Suggestion for the third pop-up (red circle):
A space between complete and before is required.


comment:
Last example: For me it is not clear why this example is not a source. If the file is not electronically saved then the signed printout is the source, or not?


comment:
I understand the principle of this section, but as its unfinished not sure on what the "correct" selection would be, and what types of roles you wouldnt include, etc.


comment:
Could we revise the sentence: "PI stores archived files in HER basement". For me this archive option is not okay. Sounds like the PI stores the files at home, or?


comment:
Please ignore my comment. Later on it is mentioned that this archive option is not acceptable


comment:
I think that the demonstration should pay attention on completing not only Trial Site Contact Roles, but also on entering shipping locations addresses before selecting a site. Some counties have an external vendors for delivering of ancillary supplies. I think it is important to stress that in this case suppliers contact information is to be entered accordingly.


comment:
We need to match the text of the Skype conversation here with the original options.


comment:
audio still says "Study Coordinator" instead of "Site Staff" Can you re-record this line and drop in with Site staff instead?


comment:
DISREGARD my comment here! Cache issues! Sorry


comment:
I think we have been literally putting "Is that site qualified for this topic?" as the header. Let's confirm with Beth/Leo on the other courses. But I think that's the norm


comment:
I think re-qualification of a site should be explained as well


comment:
There is a mistake in Monica's possition. Should be changed to Clinical Development Consultant


comment:
The middle guy disappears after I click him. He should slide to the side.


comment:
check the size of the font in the feedback


comment:
Images of dishwashing? Do we need to find a picture or can it just be lab background


comment:
Looks like we need to update their product name to CT/NG http://www.hologic.com/products/clinical-diagnostics/assays-and-tests/aptima-combo-2-assay-ctng


comment:
OK... maybe fade the dishwashing images in when this msg appears


comment:
line 82 - reduce all caps to normal and bold the word instead


comment:
Put random access in quotes in the first "think about" box (as in Hologic's so called Random Access)


comment:
Is "items" in bold? or is it a browser thing?


comment:
double check the edit on line line 89 - it says to remove the first sentence, but there isn't a comment from ryan as to whether that edit was accepted


comment:
What do I need to document in TF - seen line 90. Wanted the sentence about formal requirements to come first.


comment:
So... instead of These solutions must be paired, change to: The target capture reagent must be paired...


comment:
Add final statement to indicate that both bottle  barcodes must be matched to the master lot barcode sheet


comment:
Add final statement to indicate they must be matched to the barcode sheet


comment:
Can you add the bleach corrosive warning symbol to the bleach bottle. It's the diamond and exclamation mark shown here:  https://goo.gl/images/jtRT22


comment:
Not glass vial; One of the target capture vials need to be Target Capture 'B' (both visual and VO). 
Mixing:  need to up-end little vial onto the big vial before mixing (got to get everything into one tube)


comment:
The refrigerated Target Capture reagent is "B" (both visual and VO)


comment:
Can we have an ending visual show all of the paired vials with the writing on them... not just the one to show the magnatude of what the lab is dealing with


comment:
Still not clear what to click. e.g. in this case, we're clicking the barcode - visual vs. copy instruction unclear


comment:
Remove "glass" (not all of the vials are glass)


comment:
This assumes there is room in the REAGENT LOADING BAY for the HIV-1 reagent rack...


comment:
Same reagent bay vs. reagent rack wording as wrong answer


comment:
... if they are considering buying or retaining their Panther. Some of these point points might be invisible if manual reagent prep is all they know.


comment:
Questions on the left are bold font... inconsistent


comment:
On the next screen, it says HCV instead of HPV at the bottom but the feedback button isn't working.


comment:
Link back to the beginning where you asked yourself those 3 questions: worth it, efficient use of time, better way to use staff?


comment:
Can you mention that the TCR and TCR-B need to be mixed by pouring TCR-B into TCR and mixing... gently. There is no collar needed for this process. This isn't obvious in the visual since we are only mixing 1 bottle. For HPV, the bottles are TCR and IC (IC goes into TCR and is then mixed).


comment:
I agree with comment change "lost the submission". We can performe the submission but if some issue is detected and we don´t have the documentation to explain this... we have a problem...


comment:
I don´t find the audio narration for this page.


comment:
Sorry, the document has an incorrectly order, wrap up will need to move after section It is Qualified?


comment:
I struggle with this concept as it is suggesting that account plans are ancient and out dated rather than something "live" and evergreen that is not living in the past. I agree experience is useful but account plans are not something you can "dig up" and use again they need to be relevant to the present day.


comment:
Account plans are about looking forward .. planning next steps less so about looking into the past, however you do need to understand the background and the customer .. but nothing stands still e.g. it is an ever changing environment


comment:
Sample slide deck bottom doesn't work. Worked before.


comment:
The comparison of an account plan with an archaeological dig feels inappropriate ... I think people will struggle to relate to this .. a more business relevant scenario would work better or even mountaineers climbing towards a target/peak ...digging something up feels like it has always been there rather than you need to create it ...


comment:
the last bullet could be expanded with trial specific requirements


comment:
I am not sure this is a "one size fits all" answer on what to share and what not to share from the account plan - it really depends on the type of account and what your plan is ...


comment:
As per previous comments I really don't think "digging up an account plan" gives the right impression of what an account plan is and how you create one...


comment:
one more negative fact that could be mentioned in regards to site 1 - no number of potential patients was mentioned; PI has not used the internal databank to get an estimation of suitable patients.


comment:
We need to revise the audio for this screen with the SMEs as it still refers to the protocol specific section of the ISEC, which we agreed was no longer the only section in scope here.


comment:
I would add more information regarding CDCs concern in regards to site 1. PIs attendance of 2 conferences in the first 4 months of enrollment does not necessary have to be a big issue.


comment:
suggest re-wording the 1st sentence of 1st pop-up to:
"...., as ICH GCP requirements that an investigator must have adequate resources to conduct the trial. This includes a potential for recruiting the required number of suitable study participants."


comment:
Let's put the 3rd option as the 2nd and not that she has partnered with an endo as a Sub-I on....; the one which will be the 3rd comment will read the PI has no enrollment concerns related to the HbA1c criteria and would add the comment about the Sub-I referring patients to the 2nd comment that speaks to the Sub-I


comment:
MRI comment- has the site worked with this MRI?  May want to revise to say:  access to an MRI center within 5 miles of the site who they have partnered with on prior clinical trials; associated comment could be - it's good they have an established relationship with an MRI center; it's hard to say if 5 miles is convenient so not sure if we should keep that ?


comment:
epro- revise to say something like: the site's experience and lack of issues with ePro is a benefit.  This could lessen the number of errors, increase data integrity and patient compliance.


comment:
1st site summary- bullet 1 should say met with the COPM & study team and confirmed they were comfortable ....experience with ePro without any issues...I'll need to partner with both the site and the site activation rep....


comment:
2nd site: add to first bullet additional discussions revealed....bullet 3 we should add I will document this as a follow up task in Trialforce that must be resolved prior to enrollment readiness


comment:
need to be resolved seems to read better?


comment:
for the correct answer may want to revise to read: the site may not be able to participate in the trial; also #3 is also correct as the CDC needs to initially document the follow up itme and then the follow up calls that were made to discuss resolution so may want to have check all that apply?


comment:
prior to qualifying a site the CDC documents any follow up items in Trialforce


comment:
Did we have a button to the actual ISEC on the other courses?


comment:
2nd pop-up : Should we define Lilly's record retention period?


comment:
4th pop-up: Is it "medical product" or "Medicinal Product"?


comment:
Does that last question fall under the "Source Documentation" section of the SPI?


comment:
Should we specify which ALCOA attribute the napkin example doesn't meet. As it can be legible, contemporanous, original and accurate


comment:
2nd pop-up use "internal and/or external"


comment:
on the 1st ISEC question, should the Mini-mental state exam be capitalized?


comment:
In the 1st sentence, replace Protocol Specific with Trial-specific.


comment:
Question for the SMEs: should this be a trial-specific question in the example as in the comment section it is mentioned that the trial doesn't require further preparation or manipulation?


comment:
Audio: last word, replace "protocol" with "requirements"?


comment:
Audio:
I am not sure peppered would be understood by non-English speakers. Replace with scattered?


comment:
I don't think the order matters here as long as they take place either before or after the move. So I think these should be able to be dropped anywhere in their respective columns.


comment:
Can we add a note somewhere here-either a footnote or in parentheses before the click next instructions: "Note: In this case a location change refers to standard/primary sites. See the Guidebook for information on handling satellite location changes."


comment:
After this screen, can we add one more Trialforce placeholder screen called Trialforce-Creating Views. Add the following text: "You can use Reports, Dashboards, and Views in Trialforce to save time. Click to watch the video below to learn how to create views and other tips for using Trialforce effectively." I don't believe we have this demo, so we may need a note to Lilly asking for it.


comment:
It looks as though there is an extra space between the  super-scripted 1 and the comma that follows it at the end of the easel title. The space should appear between the comma and the super-scripted 2.


comment:
The animation that occurs on the current slide should actually not occur until the learner advances to the *next* slide. The graph on the current slide should look exactly the same as on the previous slide.


comment:
Do a global search to replace "ml" with "mL".


comment:
In pop-up for Detection Instrument, correct misspelling of independent in the second bullet (independent, not independant).


comment:
On easel, missing period at end of US-IVD entry.


comment:
Change "ml" to "mL" in Sophie's speech bubble.


comment:
Title on easel should consistently read Lab Director's Perspective. On step three it currently reads Patient Perspective.


comment:
Final part of second sentence is wrong. It should not read "and and require a specific []." Edit final part of second sentence to read: "and complicate [maintenance]. Also, "troubleshooting" dragger should be relabeled "maintenance."


comment:
As LF indicated in her feedback, "LDTs with CE-marked reagents" should not be in title caps in the plaque pop-up for this module (see the second question in the pop-up).


comment:
I just saw that LF asked that the end of the second sentence be changed to "and require a specific []." Still, the extra "and" at the end of the second sentence needs to be removed.


comment:
Should it be "There ARE lots to learn?"?


comment:
I agree, continuum looks great. Please edit The middle category: "LDTs with CE-Marked Reagents"


comment:
Replace "reagents/kits" with "LDTs with CE-Marked Reagents" - both in Sophie's text and header to index card


comment:
Move this screen to precede clicking the funnel levels. i.e., both sophie bubbles occur on top of the funnel background, but the funnel isn't clickable; after speech bubble 2, user clicks "See it in action" and can then click the 3 levels. Let me know if this isn't clear, should be a very basic change.


comment:
Besides the number, please list the title of the sub-function.


comment:
How is this page different from the previous one? Also it needs to capture all seven sub-functions instead of three?


comment:
Update last course of the 6 to "Trial Specifics". This needs to be double checked in all courses.


comment:
Editing the bubble:" I drove 3 hours to Tom's location. The first thing I did was to conduct a Job Safety Assessment (JSA), which includes checking surroundings, making sure everything was in a safe place, and that things are secure. I was able to fix Tom's problem. Although he was frustrated about the long wait, he appreciated it that we arrived there on schedule."


comment:
1. Self-introduction of the Cummins guy; "Hi, my name is XX at the XX branch. How may I help you?" 
2. In the end, the Cummins advisor should say "I don't have any technician to send you right now; but I can do some rearrangements to send you someone in 3 hours."


comment:
Remove "Sophie meanders across the screen" animation when screen first loads.


comment:
JG is right - instead of using the long name, just call it the "cobas(r) CMV test"


comment:
ALCOA pop-up: 
Can we re-phrase the sentence starting with "In addition, ...". ?
Maybe something like, "In addition, ALCOA+ indicates source documentation is complete, consistent, enduring and available when needed.


comment:
Did we mention at alpha to also add the EMR definition here?


comment:
Ignore my comment - just saw it later in the course :-)


comment:
FYI - it appears feedback ID on final feedback screen is linked to course 2.


comment:
Speaking of course 2, on our recent feedback call, client preferred to have a scrollable recap of the best answer options. Can we incorporate that here, or at least a placeholder for it?


comment:
Add "Note to Roche: We would like to create an infographic representing the subfilters within each level of the funnel."


comment:
Need to get down to the competitor level in the CE-IVD layer. Let's discuss the best way to do this.


comment:
Add the placeholder funnel graphic from Sophie's previous convo to the top right corner of these branching screens - learners can click to view the infographic.(Can be non-functional for DP)


comment:
I believe the red C is against the branding standard


comment:
Need to spell out VPI.  And need to explain it as well


comment:
The blue box response seems a bit odd.  Not a natural response.


comment:
Blue box is out of order?  Again, does not seem like the right response.


comment:
For the Diagnostic box, key processes should say something more like "defines what is needed to diagnose the issue and how will the channel do the diagnosis. Creation of the diagnostic logic, fault lamp strategy, etc."
"


comment:
For the voice over, need to think about translation of this.  May get expensive very fast to record other languages.


comment:
The Service Advisor video got me thinking about Cummins Guidanz.  Should we be promoting this process within this training as well?


comment:
Not sure I understand how we fixed the customer issue of 3 hour wait time, its not explained.


comment:
The response is not appropriate.  DBU does not service Ram trucks in warranty. Dongfeng, Foton, Tata are self servicing in their domestic countries.  The HCEC JV is no more.  GCIC is just a manufacturing JV.


comment:
Another section were we should be showcasing Guidanz now.


comment:
Should the facilitator introduce the video?


comment:
Need to change CSS to Guidanz...  Might apply to more screens, not sure yet until I get there.


comment:
Need to add the new Eaton Cummins JV to the Components BU list


comment:
Global Remanufacturing Centers are not part of the support network.


comment:
Make sure the trucks in the video are Cummins powered chassis.  I could not tell, but certainly someone will be able to.  Also, the field scene, tool being used is not a Cummins tool, needs to be.


comment:
Again, "Cohort" does not seem like the right word.


comment:
Shouldn't this be QuickServe Online (instead of QuickServe)?


comment:
The last frame is weak.  'We quickly come to their aid' can be improved.  Might try something more relevant from what they've already learned (i.e. 'We did a project using COS Practice 10 to improve...)


comment:
Echo tvd's comments.  This list is all of the largest customers who DON'T use our channel for purchase and service.


comment:
good place to also showcase Cummins Care (instead of just a generic 'support specialist)


comment:
Guidanz needs to be the process, not the individual tools.


comment:
There are too many 'TLAs' (three letter acronyms) in the text.  These need to be spelled out with the TLA in (TLA)


comment:
There's a yellow engine in the video, looks like a CAT engine.  Need to all be RED engines.


comment:
This question is misleading.  You also learn about product design and financial analysis in the Service function, it's just indirect learning vs. direct learning on communication and problem solving.


comment:
Consider rewording: They already cooperate with Lilly... to They have previously worked with Lilly...


comment:
Consider rewording - "they already cooperate with Lilly" isn't clear. Do you mean previously worked with Lilly? They are currently working with Lilly?


comment:
The "right" answer sounds subjective to me. (e.g., the site can probably conduct the trial - doesn't sound factual and 2. the site can probably be successful - doesn't sound factual. This is in the answer to 1st radio button as alternative language and also the answer to radio button 2 (listed as correct answer)


comment:
Minor: at this point in the course, since the "Know the Goal" portion is completed, should that be gray instead of purple?


comment:
Audio: say study coordinator instead of site coordinator


comment:
the text in the purple box "... but they don't ever let the CRA into it".
Would replace with "... but they don't ever let the CRA acces it".


comment:
Slide header to read "Is the site qualified?" (as in the other courses)


comment:
The transcelerate link should be this one: http://www.transceleratebiopharmainc.com/initiatives/esource/


comment:
Maybe we should make this table simpler. Does this have more information than a CDC would need?
How about just a short definition with an example next to each ALCOA letter?


comment:
Add an additional resource:
- Directive 2005/28/EC (url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2005:091:TOC)


comment:
The volume of the presenter in this slide is louder compared to the previous slides.


comment:
Attributable/paper records: It is not clear what it means the third bullet. it is enough to have a signature, not required to have a seal...not sure if seal also meant signature/initials


comment:
should there be any guidance for when a  site with eSD does not meet all requirements? and what back-up process should the site have in place for eSD?


comment:
I still have concerns with the ICF example. If the site only keeps a photocopy of the ICF, then this is the source document for the consent. If the site keeps the original and in addition a copy of the ICF, then the photocopy is not the source.


comment:
Depending on the example that will included in the previous exercise, this can be changed here. We need to be clear that the site needs to have an original or for some circumstances a copy of the consent that the patient provided. The question now with certified copies is if that copy will be the certified copy


comment:
Not sure why IMPACT got mentioned here??  Site Activation also need to work with CDC on any site personnel change.


comment:
this feel repetitive from the beginning.


comment:
Should there be an introduction before this screen.


comment:
why creating views here?  I thought this is about documenting changes in Trialforce.  

Areas of changes are:
1. trialsite contact role 
2. trialsite shipping location
3. ISEC change Form


comment:
Please review the Molecular sections for the testing methods. things are missing from screening & Therapy guidling


comment:
May want to check the Continue buttons on the feedback layers. Some of them seem to be thinner than normal.


comment:
May want to check the Continue buttons on the feedback layers. Some seem to be thinner than others.


comment:
May want to check the Continue button on the feedback layers. Some seem to be thinner than others.


comment:
Same comment about the Continue button on feedback layers.


comment:
change wording to eliminating the need for additional "identification" steps


comment:
Pause and replay buttons seem to be hard to click on this screen. Not sure if it's just my computer being weird though.


comment:
First Popup: May want to check edit on line 4 of the spreadsheet. I'm not seeing, "&at the Trial Site Level." at the end of the sentence.


comment:
After all the popups have been visited, should there be, "Click Next" text? I'm still seeing the "Click the last stop" text at the moment.


comment:
Description of Alere - perhaps needs to state detects antigen & toxin. Can be confusing if they don't understand the antigen is a screen.


comment:
Check demos - have the next button active the whole time.


comment:
Depending on the sample type Nanophere is PCR or Probe. Ie Probe with Blood Cultures


comment:
This may just be my internet connection but the animation seemed to pause at the book image and suddenly jumped to the head/heart questions about 10-20 seconds later.


comment:
Same comment about the Continue button on the feedback layers. May want to check this throughout the course.


comment:
Do we want to say the Accelerate is currently approved for blood cultures? 
for NAATs do you want to use an example of a Resistance marker test? Ie biofire or nanosphere?


comment:
This C diff culture comment does not make sense to me. Most labs would not do this.


comment:
These are not complete lists of competitors do you want to say top competitors?


comment:
IS this Hands on time claim correct vs Cepheid?


comment:
The wording does not make sense. you only need to confirm if GDH +/toxin- as shown in the table. Nice table.


comment:
Competitor testing shows the only cards with both GDH & Toxin. Do you want to mention the EIAs that are the individual test for GDH and Toxin?


comment:
under limitation say higher cost vs high cost


comment:
what is measuring range? Do you mean assay dynamic range, or Linear range??


comment:
perhaps we should say linear range instead of dynamic range?


comment:
This slide animation doesn't flow well for me - perhaps this first box shouldn't say anything about the conversion factor? First, I would just articulate the problem... that there is not a 1-to-1 relationship between measurements of the same samples across these two assays. If duplicates run in the 2 assays were the same, you would see all the points on the dotted line. Then point out that the x-axes is the reference test (BTW, I would make the reference test on the x axes TEST "A", and make the experimental test "B" on the Y axis...)


comment:
Maybe,'if the two tests gave the same results, all the points would lie on the dotted line".


comment:
I haven't heard the term "point conversion process". Should we reference it?


comment:
I don't think the normalization coefficient is ever selected using a single point.. (I understand we are trying to make it simple, but we don't want it to be inaccurate...)


comment:
Replace with "So the issue had to do with our limited capability, capacity and coverage.  We did not have the right amount of capable people in the right place to support the customer's need."


comment:
Replace with "I drove 3 hours to Tom's location. The first thing I did was to conduct a Job Safety Assessment (JSA), which includes checking surroundings, making sure everything was in a safe place, and that things are secure. I was able to fix Tom's problem. Although he was frustrated about the long wait, he appreciated our arriving when we said we would. Our branch then worked to improve our ability to respond faster and better serve the customer."


comment:
Replace "Our branch then worked to improve our ability to respond faster and better serve the customer." with "Using COS practice #10, our branch completed a Six Sigma project to improve our responsiveness to our customers."


comment:
"There was a lot of information to absorb today. Take a moment to reflect on how you would apply these processes for your job. Click Next..."


comment:
Need a different scenario that more people can relate to other than day care center. i.e. gas station etc.


comment:
1. Take out "BPE" from the correct answer;
2. "Good job! The following are all examples of Service function critical processes:..."


comment:
1. take out "company-owned";
2. take out "behind the service counter"


comment:
1. second bullet: take out "factory-trained";
2. Missing a bullet for the last one;
3. Needs consistency with periods at end of sentences.
4. Last bullet: "to ensure an excellent customer experience when interacting with our network."


comment:
1. Change the wording: "The Cummins Support Network is comprised of over 600 distributor locations, 7,200 dealer locations, plus many additional resources.";
2. will provide a new map to replace;


comment:
Change the content to reflect discussion of certification standards (bullets of requirements in certification process)- will provide.


comment:
1. add "in over 190 countries worldwide." to the end of the paragraph.
2. map - change it to a world map;


comment:
cobas in the Legal Language needs to be bold.


comment:
1. change the title to "who are our biggest partners?";
2. Remove bullets 2 and 3;
3. Getting a list of customers using Cummins network - will provide.


comment:
Please remove cobas from the answer. That will make it "You can troubleshoot modules."


comment:
Can the zoom function in Storyline be added to the image so the learner can make the image larger if they need to?


comment:
Can the zoom feature in Storyline be used for the image so the learner can enlarge the image if necessary?


comment:
1. Replacing "support specialist" with "technical service support specialist";
2. JSA comment: reword the training part conversations to reflect confidence that the tech is trained and experienced.
3. Need to improve the repair example per DD comments - will provide.


comment:
I prefer the pop-up box displaying all the text vs. the two-line scrolling at the bottom.  I fear information may be missed.


comment:
I think there is a mistake in the CRA sentences.  Seems to be missing information.


comment:
Change "ethical" to "ethics", ERB is an Ethics Review Board


comment:
I don't think we use the term "study drug" any more.  I would suggest removing study drug and just using CT material without the parenthesis.


comment:
Just a subjective observation, but not obvious the lady with pick axe is a point of reference to select, as I assumed that depicted me searching the tend (could be me being slow though!).


comment:
Quite vague for an Exec summary, and should link and summarise the key points


comment:
I believe the previous page should explicitly state to carefully read the details, as you will be expected to propose an account team.

Based on the selections, its not fully clear to me why external suppliers would potentially be a good choice for the account team (in this customers example)


comment:
Needs to be restructured slightly as the correct answer suggests that account managers cannot make arrangements or discussions with their account without first getting approval from the team. As the account manager, they should be empowered to agree to a meeting and then get the insights from the team etc. Just an observation, but I believe its important to not create the feeling of needing allapproval to discuss any topics with the customer.


