# Feedback

comment:
From the Alpha Review: title was updated to add 'Clinical', however, in BWL it just says 'Manage Trial Change'


comment:
I agree we should share Metrics, however we shouldn't share with the customer how much GM Cummins makes on their account!


comment:
There is a typo in teh first objective: 'its GOALS'


comment:
I would change the format of this slightly to have a more specific as "lack important information about the customer for developing a better plan" doesnt suggest the need for technical people to talk to technical people. Alternatively, the correct response could be "leverage existing internal relationships with customer to gain insights about needs"


comment:
should be e-CTMS

But I would strongly recommend to remove system reference here as there are many other systems NOT listed here.


comment:
From ALpha review we decided to add the role to the character vs. a name. I see 'Study Manager' but I would like it to be more visible, maybe move it to the top? Or by the middle of the character?


comment:
I would remove satellite location do not have their own SPI statement.  

The system is design in a way that SPI associated to ANY site.  Satellite location today in TF has to associate to a site. (right or wrong that is how system works today).  However today the system is NOT required satellite location ISEC must have a SPI.  Sorry it is a very long explanation on removing that statement.


comment:
This change from the Alpha review has not been addressed:
Change the last sentence of the second paragraph to " This likely means the protocol needs to change so I need to perform and assessment."


comment:
From Alpha review: roles- where did you see the Regulatory Representative or the SME roles? Sorry I may be missing something but I don't see them in the process map


comment:
Same as before, where do you see the Business Approver and the Quality Approver in the Revise section?


comment:
From Alpha review: for Level 3, third bullet point, word 'trial' has a typo


comment:
Need to add a back button to provide learners a way to go back!


comment:
After someone has completed the course, they should be able to download a transcript of the information presented -- much easier for reviewing as needed!


comment:
continue button appeared after I got through the first seven items (top row and most of middle row).  Should only appear after all items are clicked.


comment:
In other courses there is red text that appears if you click start without typing your name


comment:
Is this the same page as in course 1? I remember it differently. Should the other ui icons be explained?


comment:
There is difference in the voices and quality of the audio beteween this slide and the previous one. Is OK at this point?


comment:
second pop-up: we know that Lilly requirements for site record retention are more than the GCP expectation. Maybe we also add to the resources the link to the Lilly Record Retention Schedule


comment:
Last statement first paragraph: should we include that CDC needs to understand if the site meets Lilly requirements for certified copies?


comment:
Last pop-up. Depending on the trial, SAEs may be reported electronically (eSAE through Inform) or paper. The 2 bullet points are not clear.
 For eSAEs, Sites should have a back-up plan to report SAEs in case the system is not available or the site cannot access the system, then the back-up plan is through fax. For paper SAEs, the CDC should assess that the site has capability to fax the report, depending on the trial the report should be sent to a designated safety hub (e.g. Safety) or local affiliates.


comment:
First bullet: missing a "comma" before etc.


comment:
In the Diagnostic Services, I suggest to include in the TB testing. Does the site have a dry incubator to QuantiFERON - TB Gold test?


comment:
I suggest to inlcude the examples (regional-specific and recrutiment) also in the text of the content


comment:
I believe the preparation/manipulation IP question in the iSEC has a drop down "yes/no" answer option.  Only a "yes" answer triggers a comment box to open.  Therefore, a "no" answer is complete without any additional comments.  I also believe this may not be a standard iSEC question any longer, so may want to consider replacing it with something else.


comment:
There are no questions and answers.  Delete this text.


comment:
Need to add the link for the Sulfuric Acid Startup Directive.  See Jackie's course.


comment:
Need to include Nick's video.  If you don't have a link, I have one.


comment:
Add a final line to the text that says "Click the Play button to watch the video."


comment:
Click Next to continue should not appear (and the next button should not be active) until the video finishes playing.


comment:
Fix typo in feedback:  Control Requirements (not Controls)


comment:
Actually, the feedback needs to be fixed for both.  Change to:  Exactly! (or Not quite.) Control Requirements outline field observer tasks, tools, and the requirements for the Sulfuric Pre-Startup Checklist.


comment:
Center text on "Back to meteorology" button.


comment:
The fumigation animation is still not right.  The slide that says "This prevents the plume from rising" is a good one.  The slide that starts "with little to no wind" should look like that one.  We need SMOKE!  That's the point of fumigation.  Too much smoke fills the air close to the ground.  Any slide that is showing what fumigation looks like shoud have lots of smoke.  If you want to go through this one, let me know.


comment:
Looping video - shorten timing on slide that says ...causes the plume to loop to the ground.


comment:
After I watched all 4 animations, I clicke Aerodynamic Downwash again, watched the animation, and returned to the meteorology screen.  My Next button is doesn't work and isn't active.


comment:
This is nit-picky, but I'd love it if we can do it -- I'd like to see "How high the plume will rise" come in from the bottom of the picture and rise to the top; I'd also like to see the "Turbulence or mixing of the plume" swirl in to illustrate turbulence or mixing.  If it's too much, leave as is.


comment:
In the last sentence of the text box, remove "one of the"


comment:
I tried to click on the heads, but they weren't clickable.  Can we extend the click area to make it include the body and the label?


comment:
The GM still shows gray, then reverts back to color when his info screen appears.


comment:
The Production supervisor image still changed to gray before his info screen appeared and he changed to color again.


comment:
Let's remove the inversion rollover for the definition since they've already seen the video.


comment:
Remove the period at the end of the first bullet


comment:
SAP Startup box should not be highlighted.  The request to start up is a trigger to start going through the process.


comment:
This popup box "As you already know, what can make..." goes with "Is stack SO2>1000ppm?" box


comment:
This popup box "If SO2 levels are acceptable, the Sulfuric operator continues..." goes with the block that says "Continue with startup following checklist & SOP"


comment:
This popup "The sulfuric Operator monitors levels of SO2 at the stack to ensure ..." goes with the "Is stack SO2>1000ppm" box.


comment:
Need to update the "If there's no risk of inversion..." box to add at the end "as long as it is after 11:00am.


comment:
"Night time" should be "Nighttime" I think


comment:
In the "Any time the plant is tripped with high SO2" box, fix the 2nd SO2 to add the subscript.


comment:
Need instruction to click next to continue.  We see the text box that ends with "Ready?" and there's no way forward.


comment:
When I click a box, is there any way to show that I've clicked it so I know where I am in the process?  I don't think we need a checkmark.  Maybe a highlight?  Same for all in this scenario section.


comment:
Why does the sulfuric plant on this map look different than the one earlier in the course?


comment:
On this map, the plumes should be obvious and going sideways.  Need to make them big, white, flat, and drifting over as far as the plant office.  I had a mockup in the ppt document I sent you earlier, but I can screen print it if you need it again.


comment:
Sulfuric operator needs PPE for eyes and ears.


comment:
Other plant department peeps need eye and ear PPE.


comment:
I'm not sure how to make this work.  Technically, looking at our instructions, learners should be able to click on the plant office AFTER the sulfuric plant has been clicked. Thoughts?


comment:
Our learning agent does not need eye and ear PPE here.


comment:
Should the button say "Back to the Meteorologist"?


comment:
First statement, please add Trial Specific.. The COPM may create additional trial specific questions for the ISEC ..


comment:
When I clicked PREV to come back, the submit button appears, but I have no chance to click it.  Once I select an answer, I get feedback without clicking submit.


comment:
Same feedback on this screen.  the submit button isn't clickable since I get feedback based on whatever the first item is that I click.  I never have a chance to click Submit.


comment:
Learning agent needs PPE for eyes and ears.


comment:
Thinking in non-English speakers, can we spell out SC?


comment:
Please change Investigational Product for Investigational Medicinal Product as well as for any other reference to IP.


comment:
This screen should come after the next section.  This is a two-part scenario with a little quiz in the middle. They've just completed this little quiz and now they need to finish the second part of the scenario.


comment:
If we are removing periods... remove the one after second bullet too


comment:
SC is not a common acronym while speaking


comment:
Once the folder is opened I could not see the fisrt text of the slide.


comment:
This screen should be the start of the section that only approvers get.


comment:
Fix typo on menu for this section/screen - Introduction


comment:
I'm stuck.  I can't click either of the answers to the question.


comment:
when a constant correction is applied to adjust data that are not co-linear, while the data will shift towards the dotted line, but the relationship between results from the two assays will result in over quantification of some results, and under quantification of others. In this example, a static correction factor applied to test A means it gives lower results at the upper end of the data distribution, but higher results at the lower end.


comment:
This isn't accurate - first sentence says it possible to "correct bias" by 2 step process of calibrating to Who, then applying a conversion factor.  The last sentence says its not possible.


comment:
We need to be more precise with the language throughout.  What we are talking about the ability to normalize values from two assays, with or without colinear assay distributions...  Its not correct to talk about conversion factors. (in fact, the example given shows correction of an offset by addition of a constant, not multiplication by a factor)... Also, the proportional bias might be removed with a higher order polynomial function describing the data (perhaps the data aren't colinear, but coplanar?)....i have no idea how the WHO calibration is applied, but i'm sure it could be done even if the data aren't colinear... we might want to ask biostats for help...


comment:
Can we look to see what language the consensus guidelines use? Do they suggest we "convert" to IU/mL or do they ask us to "report" in IU/mL?


comment:
First sentence is awkward. Can we say, "LDTs are often referred to as "homebrews", because the test is built from scratch by the laboratory"


comment:
Hm. well, its not as tedious as clicking through all the dots, but I have to say I looked at the bullet points even less this time, when they came up all at once in 2 clicks... :( Not sure how to get this information though to the audience... I still would like the clicking and the words to be closer together....somehow...?


comment:
reword to take out "kits" in the second half of sentence 2. Perhaps something like, "Labs can also create LDTs using CE-marked reagents.  While these commercial reagents are often bundled and referred to as "kits," they are used in combination with other regents and consumables. This creates a test that must be validated and QC'd by the lab. The more components to the process, the greater the complexity, cost, and risk."


comment:
Do we want to put these two examples somewhere on the continuum?


comment:
Need to modify. Can't view reagent temp on the 502. Possibly remove reagent temp or specify for 701/702. We will let you know which version we want during the review meeting.


comment:
Please use the zoom function for the image.


comment:
There is a blue highlight when hovering over the e 801 module.


comment:
change the cobas c 701/c 702 modules to cobas c 701/ cobas c 702 modules


comment:
Correct the branding in the correct feed back.


comment:
1. Replace "ECM with INSITE" with "engine";
2. It should be period after "no-start complaint"; 
3. "His next step is to:" for choices use a.trouble shoot with Cummins Electronic tool;
b. guess the issue based on previous experience; 
c. ask the technician next to him for help.


comment:
Need to change the correct answer. The labels do not necessarily need to be applied just positioned correctly.


comment:
EcoTergent will need to be changed. Will provide the correct terminology.


comment:
1. "Right! The technician should use the tools to troubleshoot the complaint. After following the troubleshooting procedures, the problem was still not resolved. At this point, the best option is to call a level 1 agent to:...."
Change the first answer to "Help with the troubleshooting" - correct answer;


comment:
After picking the second option, it should be "in the scenario".


comment:
Update text here to add a first sentence:  Market Attractiveness contains many open text fields with character limits.


comment:
Change the instruction here to say:  Now that you've entered some Market Attractiveness information, let's take a look at P&L.


comment:
Please align terminology from protocol-specific to trial-specific


comment:
However, when I clicked submit (and got the feedback that I needed to click an answer), the next button activated so I could move forward.  Need to fix this so that next button isn't active until feedback is delivered.


comment:
Update the text box to say "After waiting for a few hours, the weather is back to normal.  As the Production Supervisor, you've approved startup.  Click the Livelink filing cabinet..."


comment:
Can't click on the documents to select.  But again, clicking submit unlocked the next button.


comment:
I don't like like the No -but ... answer


comment:
The answer doesn't read right. Maybe remove the word "a" before "complete"?


comment:
Remove the Mosaic logo from the Guard's shirt.


comment:
Same comment as previous slide, remove the word "a" before "complete"


comment:
Can the voice of the PI be changed for a male one? or change the picture for a woman


comment:
Guidebook under revision, Just check that URL will not change


comment:
All responses gave me an incorrect answer. Something is not right when selecting the correct answer


comment:
Please ignore my comment, I needed to select 2 answers and I read now that the instruction states, select all that apply.


comment:
Add a period to the first bullet under During Startup


comment:
SAP Startup: "when the ins running"? is that correct?


comment:
In the last pop-up, subscript the 2 in SO2


comment:
Can we change patients for subjects? this is the prefer term in the quality system


comment:
When you highlight one category, gray out the rest


comment:
Take out "Other Direct Detection Methods" entirely.


comment:
Add click next text to correct feedback layer?


comment:
Change "Culture Using Conventional Media (Including Automation)" to "Culture (including Automation").  Please make sure to change this on the summary slide in Test Types.


comment:
Under "Description" change "Culture using Conventional Media" to "Culture (including automation)


comment:
Change first sentence for API strips:  "Standardized strips with a panel of substrates for biochemical reactions used to identify bacteria in pure cultures."


comment:
Under Mass Spec, keep first sentence, replace second sentence:
"The sample is vaporized and molecules are ionized.  Molecules move towards the detector based on their mass-to-charge ratio.  The "time of flight" of each molecules establishes a profile that is used to identify the bacteria."


comment:
Under Mass Spec "Common Use Scenarios", take out the second sentence.  just keep the first one.


comment:
for Automated ID / AST Systems first sentence:  "Instruments using biochemical panels..."


comment:
Change "way to identify bacteria" to "diagnose infections"


comment:
Broth microdilution use scenarios:
"CLSI or EUCAST consider manual broth microdilution as one of the reference methods by which commercially available tests are compared."  Replace the first sentence with this.


comment:
For Disk Diffusion, replace first section:  "A McFarland standard is streaked onto an agar plate, and antibiotic disks (at specified concentrations) are distributed onto the plate.  Bacteria are grown over 18-24 hours.  At the same time, the drug is diffusing outward from the disks."  
New paragraph:  "The larger the zone of inhibition..."


comment:
Under "Description" of E-test:  Change "distributed" to "placed" and change "point of no inhibition" to "point of intersection between growth and inhibition."


comment:
Under Disk Diffusion, change "distributed" to "placed."


comment:
Please say "examples" of nucleic acid competitors across all clipboards.  Also, the clipboard here does not look like


comment:
Put "When compared to PCR alone" as part of the question, not as part of each answer.


comment:
"of positive results" in the introductory green box.


comment:
third pop-up - why it matters - second part of the sentence is not clear for me. What doesn't make sense?


comment:
Glossary lightbox, the space after the words "Click here" is underlined...please remove the underline on the space.


comment:
I think links should have an underline, like in the glossary popup, for consistancy.


comment:
From "what is your roll", I click the 2 guys on the left. I then come to "A Day in the life of an Approver"....the main character moves a lot...nit-picky but can we make the main character positioned more similarly on the 2 screens so the "jump" in position doesn't happen?


comment:
This looks different than any other question I've seen...are we ok with this...as an outsider, I didn't immediately realize I was supposed to click the text. I'm fine if Jen is fine.


comment:
Wow, I love the cleanness though...especially with the feedback and the checks and x's...I think it's ok.


comment:
Yes, I'd move the feedback and add click next text to same location as other pages.


comment:
When I answer the question, then come back, the next button is still locked...they need to be able to click next automatically if they've already answered...this is for all 4 questions in this section.


comment:
Need next button to be automatically active when I return to this interaction after completing, sarah recently trained james on this and could help you, or I could help you on Monday.


comment:
I'd remove the visited state on the image of inversion, it looks kind of strange that it grays out and then I leave the screen.


comment:
This is very very nice Ha-Trang....I like it a lot!!


comment:
Nit picky, make the green box with word "inversion" 1px wider so it's the same width as the image.


comment:
So...this one is a little complex. On this page (with inversion box and play button)...I think it should work like so 1) next button jumps to page AFTER inversion animation. 2) next button is disabled until they user has watched the inversion animation. 3) if the user returns to this screen with the inversion rectangle and play button AFTER having watched the inversion animation, the next button should be automatically enabled, which means they can click it, and it jumps to the page AFTER the inversion animation, allowing them to skip the animation if they return.


comment:
The next button should be active when returning to this slide after I've watched this all the way through one time.


comment:
The next button should work kind of like the page with the 4 videos, if that helps.


comment:
Same comment as Sarah, I know she's a pain in the butt Ha-Trang, but sometimes we have to suck it up and listen to the girl.


comment:
The "Left" position of the question text bounces around...the answer options should always start about the same position (maybe slightly indented from the question text), instead of having differing amounts of left space. This is for the 4 questions.


comment:
Same next button issue as JC...It works (becomes active) the first time I complete all 4, but if I leave the page and then come back to the page after completing all 4, it's disabled again...check your logic, hit me up if you need a hand.


comment:
If I come to these animations (all 4) and then click previous button, they are still marked as watched. Instead of updating your variable on timeline start, you should update the variable when the animation is done, so the user MUST watch the animation.


comment:
Note, my comment around the variable is for all 4 of these animations.


comment:
The "Prev" button on this page takes me to the menu if I've already been there...make sure ALL prev buttons jump to the right place and not just "previous slide"


comment:
I just confirmed using the menu dropdown, the prev button is using the "previous slide" action...we can't do that, save this for last, but go through and manually link the previous slide buttons to go to the slide that makes the most sense. I know it's a pain, but this client is too.


comment:
If i click a building, and then don't complete the interaction and click the "prev" arrow, the building is grayed out like I've completed it. It shouldn't gray out until I actually complete the interaction. This is for all the building interactions.


comment:
Confirm with Jen C. But my impression is that this question should reset and they should be able to answer it again. This is how all interactions should work.


comment:
This interaction actually resets, the others just don't seem to, and the checks and x's show up when I return, do what you did here to the other ones.


comment:
Same as Jen, should be able to click their heads, I'd cut the action, group the head & body, then paste the action on the group.


comment:
There's some nice logic here!!! Kudos on making this work HTP! A nice to have is that I'd prefer the people not gray out until I return from completing their interaction. It looks like you have a visited state, which means they're changing to black and white immediately when you click them, which is distracting...I typically do a "completed" state when I want to do something to an image after something happens, and don't use a "visited" state so you don't see the state change immediately, but rather when I trigger it manually.


comment:
My comment on the prev button completing the buildings applies to: Sulfuric Plant, Field Observer, Guard Shack. "Other Plant Departments" is ok because it's a text screen, "Plant Office" is ok because you have more complex programming.


comment:
Nice to have - I'd lean to having checks on these people, when I've completed and come back, without the check on the completed state, I forget they're grayed out because I've done them.


comment:
I think adding "checkmarks" to the completed states of these things would be nice to have.


comment:
Nice to have - Some of the boxes are rounded, some are hard rectangles...I think you can just click the shape, format shape, and then use the shape dropdown to change.


comment:
I completed this interaction, then came back, and the next button was disabled, after completing, the next button should be automatically enabled (switched to Normal state with a trigger).


comment:
Again, rounded rectangles & squared rectangles...once I complete and come back, the next button should be enabled.


comment:
NICE TO HAVE...because it'd take a long time probably, but I feel like these buttons should have hover states...like, they get slightly lighter or something when hovered over, right now it's just the cursor...I'm fine if we don't do it, but hover states should be on most buttons in stuff (for the future).


comment:
When I click "is there a risk of inversion" I get incorrect feedback, but "Is there a risk of inversion" has a checkmark...I think it needs to be changed to an x.


comment:
I also think that once I've completed these questions, the next button should be active so I can quickly pass through these screens.


comment:
This is the only one I don't get a "Try Again" message, the others I keep picking until I get it right...this one, I get it wrong and the next button comes up...is that how it's suppose to be?


comment:
Change the question to "What temperature do the cobas e 602 module reagent packs need to be when loading them into the reagent compartment."


comment:
Need to clarify more upfront what is the role of the manager versus seller (account manager).


comment:
Add a yellow note to Roche that all screen prints will be cleaned up to reflect project-specific information as learners build the information throughout the course. Screen prints currently in the course are placeholders.


comment:
Add a yellow note to Roche that we will need appropriate marketing business case information for our Purple Fever Assay to use for this activity.


comment:
Add a yellow note to roche that we will need Finance business case information for this screen as learners would see it for our Purple Fever Assay.


comment:
I would just leave the previous button as normal.


comment:
I answered this, came back, and the next button was disabled...it should be active once I've completed this screen when I come back.


comment:
I'd removed the submit button because it's a pick 1.


comment:
Next button should be active when I come back after completing.


comment:
Submit button enabled next button when clicked, delete submit button.


comment:
The previous screen has checks and x's, this one should too. all questions in this section should have checks and x's for constancy.


comment:
I got to this screen, and there was nothing except for the learning agent character, no feedback or anything, just the character and the next button. If this is going to be graded like a quiz, then we might need to disable the previous button on the questions and hide the menu button, so they have to go through these linearly.


comment:
The next button didn't do anything...maybe that's because I broke it and got a screen without feedback.


comment:
Again, I've completed this, came back, next button is disabled...I haven't caught every screen, but this is how every screen should work.


comment:
The folder cabinet opening happened after about 2 seconds...maybe it should happen immediately.


comment:
If I don't click any docuemnts, and click submit, the next button is enabled...make the next button show on feedback layer, not on clicking submit button.


comment:
Should the date show up in the date field? Should there be a print button? Maybe talk to Jackie to make sure we're doing this right.


comment:
Change last course of the 6 courses to Trial Specifics


comment:
We use CT Material and Investigational Product intermitently - review with SMEs if the different terms are used correctly


comment:
I'm wondering if the 2nd 'answer' could be worded a little differently maybe (??).  Maybe something like "A tough customer just called.  The conversation started out pretty challenging because they were so frustrated.  We found a solution though.  Ready for lunch?"


comment:
In the main sentence on the screen, 'Your' should be 'You're'


comment:
"...that included steps for fixing the issue and steps to fix the issue"
This is somewhat confusing


comment:
1st pop-up:
Propose to re-phrase 2nd sentence
"Authorization would need to be reviewed if the site themselves is directly destroying IMP (...).


comment:
Should we also include "equipment" as something that would be in the mix for using CE marked reagents?


comment:
Maybe broaden the bottom right box - detection instruments are more than just the PCR instrument... Other equipment that can detect are capillary electrophresis machines (e.g. ABI 310) - used after thermocycling? Or isothermal tests?


comment:
what if we put the advantages on one side of the graphic, near the first dot that is clicked, and the disadvantages on the other side of the graphic, where the 2nd dot is clicked? Maybe make the advantages dot Green, and the disadvantages dot RED?
 I'm still struggling to connect clicking with the text and concepts...


comment:
Can we put images of lab reagents, consumables, and instruments in the gray circles on the octopus arms?


comment:
you can say, "all components necessary to perform the test" instead of "reagents"


comment:
This isn't working for me - It needs column headings. I don't know what the questions are ... What is the content in the right-most column? I suppose the one on the left is the attribute of the test type (Design, Strength, Weakness). Which column (left or right) is supposed to cue me? I go down different rabbit holes if I look at one versus the other.
Example: If I look at the left-most column, bottom row:
Why doesn't "lab sources all reagents" go in the limitations box?
Also, if I look at the right-most column... why doesn't design flexibility go next to "lab designs assay primers and probes?"

What if we just make this a simple "strengths and weaknesses" sorting exercise for all the different assay types?


comment:
if we transpose rows and columns, it might help establish these as categories for which there are two examples (1 populated and 1 not populated?)


comment:
if low cost reagents can be a strength for the previous slide, why can't it be a limitation here?


comment:
Open system for troubleshooting an also be a strength..


comment:
Assay design answer doesn't seem right - (includes controls and calibrators - we don't have calibrators...)


comment:
Nix the Lab directors answer.... There is a better way to answer this - maybe focus on the fact that the signal from a PCR assay using whole blood comes from both integrated virus and actively replicating virus, but the signal from plasma comes only from replicating virus. This doesn't mean the blood result it wrong, but it does mean that you cannot compare measurements from the two sample types.


comment:
Fix syntax/grammar of lab directors answer "... using either sample type that a clinician prefers..."

Better is "..using either sample type, but using plasma helps us..."
or "...To accommodate physician preference, my lab can perform assays using either plasma or whole blood. But using plasma helps us..."


comment:
remind me if commutability has already been defined?


comment:
that list of variables could be longer...are those the ones we prioritized


comment:
measuring range = linear range or lower level of detection to upper range of detection.

do you want to say it this way?


comment:
took me to this punchline to get the point of the storyflow...maybe too technical...not sure of the solution here


comment:
Suggestion:

with enough expertise, you can build a custom solution, but it takes a lot of work, involves risk and maintenance.


comment:
is there a package insert or some documentation to go with the examples mentioned???


comment:
when we write things like "studies have shown..." we will most likely need to reference that


comment:
"A full IVD approved test includes all...."

with the Roche example should we use the most recent approvals:  cobas(R) CMV on the cobas(R) 6800/8800?


comment:
Suggestion:

These tests remove the QC and maintenance burden providing the lab with more time to focus on other things.


comment:
I thoughts Calibrators and controls may be in kit was for assay design

and

lab conducts calibration was the answer for strengths


comment:
CAP/CTM will need either the full trademark name or an asterisk to a footnote somewhere with the full name


comment:
cobas(R) 4800 needs System after it

cobas(R) 4800 System


comment:
I'm struggling with the coffee cup being the thing that we expect the lab to focus on now that they don't have to do QC....


comment:
I don't think you need the "however" in sophie's statement. I actually don't know if you need that sentence on this slide at all...


comment:
I'm wondering why sophie has more information than the lab director on some of these... Shouldn't he seem a bit more "scientific"...


comment:
Can we use some other wording than "market trending" in the question?


comment:
in the lab director's bubble- I think it should be testing for other transplant infections, not markers?

 "test for CMV and EBV simultaneously" sounds like he's running a multiplex.?


comment:
Don't we want the take home message here to be that they are both OK, but don't forget that whole blood includes integrated virus, and may run hot?


comment:
why is this optional? why don't we want everyone to go through the antigenemia info?


comment:
the "correct" answer doesn't seem to answer the question. I would think the reason the results don't "match" is that you cannot compare the output of the two assays for the many variables mentioned in the earlier section on standardization and commutability. Moreover, its because you cannot legitimately compare the results among assays that you cannot establish the thresholds for treatment, (not visa versa...)


comment:
His question needs to be rewritten because it now doesn't follow the answer of the preceding question....  Do we want to make him ask:
"I just read a study that adhered to specific viral load thresholds for treatment. Should I be reporting out Viral Load results relative to this threshold?"


comment:
Sophie should also mention that you should pay attention to the patient, not just the numbers....


comment:
the first bullet is a consequence, not a cause of interpretation difficulties.
The next two bullet points need work- neither of them give the reasons, and they seem to overlap. 
I would say the reasons its hard to interpret are:
lack of standardization
lack of commutability
heterogeneity of CMV clinical course


comment:
the lab must perform all validation as well as QC. both answers are possible...


comment:
I don't know if i agree with the first blank - lower cost relative to what? They are not lower cost than LDTs withOUT CE marked reagents, for example.


comment:
you might also put "closed" in the slot where 'higher cost" fit - this actually makes more sense because the last blank is "troubleshooting"


comment:
E-mail is asking for Dr. Smith's CV - should it not be Dr. Ford's?


comment:
Given that the audit/inspection history is not required I do not think we should list it as a "mandatory" correct reply, i.e. that if only SPI is selected the response is incorrect.


comment:
File name for cv should be "DrFord_CV.pdf".


comment:
Robust Feasibility pdf when opened still mentions Dr. Smith - This should be Dr. Ford.


comment:
Typo in "Dermatology" - says Dermatologu on the CV screenshot (and on actual cv file)


comment:
Nice job on the video! It looks really nice.


comment:
I think that this video needs some player buttons given the length.


comment:
Add 2nd sentence to instructions: The words won't "stick" if they are placed in the wrong spot.


comment:
Especially beceause there is on screen text, I think this needs player buttons. Applies to all weather animations.


comment:
In final postivie feedback, I don't think that you've been capitalizing sulfuric just when it's by itself?


comment:
Should correct-feedback also mention the PI's availability for the trial, given that 's a correct answer too? Or should that not be a correct answer?


comment:
plant office only became clickable for me after I had reviewed all of the other stuff. The instructions are to click the ones I think I need to talk to, but it seems like you want me to click all of them. Easiest thing would be to clarify your instructions rather than reprogram


comment:
Can we look at this question with the SMEs? I think I clicked on incorrect answer, but got "correct" feedback.
I would think number 2 and 3 are the things to follow-up on...


comment:
again, instructions aren't clear. Technically, i should be able to move on once i've talked to the right people. But programmatically, I can't move on until I click all of these items. AGain, recommend adjusting instructional text rather than programming


comment:
I came back to the map after clicking all of the items to make my comment. The next button is clickable, but nothing happens when I click it.


comment:
i selected that I was not an approver at the beginning of the course. But I got to this screen that refers to me as an approver. Not sure if it's pointing to the wrong screen or if we just need to make some text edits to not cause confusion.


comment:
Having taken both paths, this screen is the wrap up for both. That's fine; just adjust your text so that it applies to both roles.


comment:
Per review call of course yesterday, Site Selection Guidebook link should change to http://lillynetcollaboration.global.lilly.com/sites/DCOEHub6/onboarding/SiteSelection/default.aspx


comment:
The Trialforce materials link (last bullet) leads to DNU site. What should it link to?


comment:
maybe here there could be that easel with the complexity continuum and the types of products on them with their examples and company name???  idea


comment:
or we could use this graphic on the first easel to set up the following pages with more information


comment:
I like the funnel idea but feel like it needs some labels or further information to better understand.  like at the top is IU/mL - what about that?  and then we move to LDTs followed by IVDs (not just CE-IVDs) is that to communicate decreasing levels of complexity?  what does IU/mL have in common with LDTs and IVDs


comment:
okay so this animation helps but on first appearance it is hard to understand.  maybe a bit of this in the introduction


comment:
do we need to have something in LDTs to address sample types?


comment:
i'm guessing we are going to work through this conversation in an excel sheet?


comment:
are we working through this conversation with an excel sheet for editing


comment:
are we using one of our CMV masterpieces here?


comment:
I agree this made my brain go nuts perhaps dont show the labels in the funnel until you click on the color band to animate it?
other small issue, considering you haven't finalized text: Are you filtering OUT things, or filtering IN things? If you are filtering out, you should call the first one copies/mL to be consistent across these bins.


comment:
why is result integrity in the ldt? it wont goto ce-ivd...


comment:
This is a critical module as we are moving to more practical information that is needed to better position Roche products in module 4. 

Can we include something like this in the introduction?  In order to keep them interested it would be good for them to know that they will use this information in a way that helps them win...


comment:
Change the first part to: 

Remember that the WHO Standard enables laboratories to report results in IU/mL for CMV viral load,  which improves...use Ellen's edits for the rest.


comment:
To Jessica's point...maybe and a bullet at the end of the list of variables that impact PCR
- Others

This will infer that this is a list of the biggest ones that it is not an exhaustive list


comment:
Reference formats should be the same:
Author last name, title of article, Journal, year, vol, pages, hyperlink (if available)


comment:
This should be an introduction of the next several screens...we are going to walk them through why it can be a challenge to calibrate to the WHO standard 

Sophie should say:

It is recommended that all PCR based CMV tests report in IU/mL and therefore labs must calibrate their LDTs to the WHO standard directly or to standards purchased from manufacturers.  Since the WHO standard can be difficult to obtain directly, most labs will use standards from manufacturers.  Once the assay has been calibrated, the performance characteristics of the assay must be redefined. 

So how does a lab perform calibration to convert their test to report in IU/mL?


comment:
Agree.. we can use Linear range instead of measuring range

(although measuring range is how it is referred to by CAP and ISO 15189)


comment:
If we use linear range on the previous screen then be consistent throughout....dynamic range = linear range


comment:
These graphs are from the Hirsch publication - to Ellen's comment we can't change the axis


comment:
Yes we can explain this a bit more. How about:

The goal for conversion is for the assay to be co-linear to the WHO standard across the linear range. This means that the results generated by the assay from the lower limit of quantitation to the upper limit of quantitation fall along the dotted line on the graph.


comment:
For the second sentence...maybe we can say at the end...

..can demonstrate that would need to be corrected in order to achieve co-linearity to the WHO standard.


comment:
Reference for the graphs
Hirsch et al. An International Multicenter Performance Analysis of Cytomegalovirus Load Tests CID 2013:56


comment:
Delete the +/- WHO Traceability as per Ellen's comment.


comment:
Green box dialogue:
To illustrate the challenges in converting to IU/mL here is a theoretical example.  
In this scenario, that there is not a 1-to-1 relationship between measurements of the same samples across these two assays. There is proportional bias between the assay reporting in copies/mL to the one reporting in IU/mL.


comment:
Agree with Ellen, we can flip the axis labels


comment:
Test A (x axis)  Test B (y-axis) in the text if we flip as per Ellen's comment on previous screen


comment:
The last sentence.. The dotted line represents the best fit line and the diamonds represent test results should be described in the previous screen since you are seeing the graph for the first time then


comment:
If these two tests gave the same results, all the points would lie on the dotted line.  Because there is proportional bias, if a conversion factor was applied to Test B so results were reported in IU/mL the results from this test would still not be comparable to Test A.


comment:
Use the text from my last comment on the previous screen for this screen.


comment:
We can combine the comments here with the previous screen comments.. This section was getting too long.


comment:
Even though Test B is now reporting results in IU/mL results at the low end of the assay are higher than Test A and results at the upper end for Test B are  lower than Test A.  In the end, the results from these two tests cannot be compared even though both tests report in IU/mL.  This is another reason why even with calibration to the WHO standard, results from different tests may still not be comparable.


comment:
Ellen's comments are the exact reason we are showing this example...this is not simple to do and many labs with LDTs may not know the correct approach.

I think we can end this section on the previous screen. This one is not needed.


comment:
From Kotton 2013:
All commercial and laboratory developed tests should be recalibrated and show colinearity to the WHO International Standard and results should be reported as IU/mL.
Would be good to include this quote...then you see the same words we used throughout the example.

Agree not to use the word "convert"


comment:
OR maybe:

Current consensus guidelines for SOT recommend reporting results in IU/mL, the conversion process is not straightforward.


comment:
Couple of key points missing for me here:
1. The fact that different calibrators can actually contribute to the problem.  We talked about this in Module 2  - maybe good to re-emphasize here
2. It is not just the guidelines but also the proficiency testing/EQA for labs that are expecting IU/mL reporting (CAP, INSTAND). 
We should figure out how to work these two points in here.


comment:
Think we agreed to not call it a continuum?


comment:
Agree...we should also emphasize that this is one type of LDT....in terms of our positioning we are also calling the CE-IVD kits of probes/primers, LDTs.  The "homebrew" LDT was the extreme category of LDT


comment:
To construct a Homebrew LDT, a lab must..


comment:
Like Jessica's suggestion. Maybe we can work "burden for the laboratory" in to her statement as well.


comment:
Can we add some spacing between the bullets - just a small amount would help in reading them


comment:
Maybe an idea to Ellens' point is to bold key words?

Low Cost
Flexibility
Open 
For the 3rd bullet of advantages we should re-word:
Use existing laboratory system ( not sure if that is what is meant?)


comment:
For disadvantages can bold
technical knowledge
limited
risk
inefficiency
Ongoing QC


comment:
For Sophie's final bubble...Delete "I used"

It would be good to keep the same messaging here as we will use in module 4 for positioning.

Risk and burden on the lab
Time and resources for the lab


comment:
Agree with Ellen's re-wording for the description


comment:
BLP- is there a way to add the examples to the continuum as Ellen suggests?  Maybe we can include a third company? 
Let's discuss


comment:
I think the equipment comes later in the example of how it is built - we could mention it here. 

In Ellen's first comment...add..

...use in combination with other reagents, consumables and instruments.


comment:
To Jessica's comment...yes we have package inserts.


comment:
This is a bit simplified from the PPT example...it needs more definition.

Should have the first puzzle piece come in by itself and it should say "Lab chooses...."  then the green box with related questions.

Then next puzzle piece and say.."Lab chooses..." then the green box

etc..

We should also show in the end that the assay may not perform that well with data - we can show the graph from the PPT example - since we showed them graphs to kick off the module this ties it together.

Perhaps we should also state we are using an actual package insert for a CE-IVD reagent kit for the example. We can add this to the resource tab.


comment:
Reference for "studies have shown" is 
Hayden RT, et al. J Clin Microbiol. 2012;50:337-345


comment:
..the test's results may still not be comparable to other CMV tests used at other institutions.


comment:
perform ongoing QC and requires time and resources for the lab which adds to operational costs. (maybe?)

It would be good to include the costs somehow here... linking time and resources to money as this is something we will use in positioning in module 4.


comment:
Based on the comments for LDTs..I think we add some space between the bullet and bold the key words here as well. I would keep them side by side.

The idea of the green dot for advantages and red dot for disadvantages is good...can we match the header to the color of the dots too?
If we make this change would be for all 3 sections.


comment:
Like Ellen's idea of the images but think it would look too crowded.  We could maybe save this for module 4?


comment:
Need to have more advantage and disadvantages here and provide a bit more detail in the disadvantages.  

Advantages:
- Some analytical validation provided but limited to instruments and reagents tested
- Product insert to provide some guidance on reagents/instruments 

Disadvantages:
-High labor requirements; Operation inefficiency (semi-automated; manual interventions)
-Risk assumed by the lab
- Troubleshooting challenges with reagents from numerous sources
- Performance will vary depending on other reagents and instruments that laboratory chooses

We can discuss how to shorten


comment:
It is also about a lot of choices for these tests even though a core component or components are CE-marked. 
Time, resources, risk....key themes to keep repeating


comment:
Agree with Ellen and Jessica's comments.

Should add Qiagen to this list above Abbott. They have more market share and have both CE and FDA approved tests.
artus® CMV QS-RGQ (CE)
artus® CMV RGQ (US


comment:
It is more than the manufacturer assuming risk is that we do validation as well...there are studies required to achieve a CE-Mark or FDA approval for a full test.

Description:
A CE-IVD or FDA approved CMV test includes all components necessary to perform the test. The reagents, consumables and instruments have been validated together and data is provided in the package insert to demonstrate performance of all these components together.  For FDA approved tests, additional clinical studies are required to demonstrate clinical utility of the test with patient samples.
Because the manufacturer invests more time and effort into the development of test and provides all necessary components the complexity of running the test and the risk for the lab is much lower.


comment:
Should keep the same turns..

Reduce the risk, require less resources to run, more operationally efficient so less time spent by the lab staff to run and maintain the test...they have more free time....

Maybe we change this to a dollar sign vs. coffee cup...they have more time to spend on other revenue generating tasks.


comment:
Advantages:
-Clinical validation, peer reviewed publications

Disadvantages:
- Specific instrumentation required  (to keep consistent with the use of instrument in earlier examples)


comment:
Add a yellow note to roche that we will need IBL business case information for this screen as learners would see it for our Purple Fever Assay.


comment:
Remove " I used.."

FDA approved

Again..keep consistent, time, risk, etc..


comment:
Agree with Ellen..if we highlight the key words in bold under the advantages and disadvantages we should then have them recall these...maybe the top box is about the description:  Describe a homebrew LDT...
Then pick 2 advantages and 2 disadvantages...
Let's discuss the design but also what answers to focus on..it is critical here to pick the answers that will link to how we position in Module 4


comment:
BLP - we should discuss the design of the game (as per earlier comments under LDTs) and also the points to emphasize/correct answers


comment:
For homebrew LDTs..we introduce the "no regulatory body oversight" here...probably should include this in the LDT section as part of the description so not new information here.


comment:
Would should say..In Module 4 you will learn"...late implies in this module I think?


comment:
Not clients...some clinicians and laboratories prefer


comment:
Here it is not about the difference. There is a difference between plasma and whole blood. It is about if it matters...

Some clinicians and laboratories prefer to use whole blood as a sample type.  What are some key points that are important to know about plasma vs. whole blood?

Maybe something like this...


comment:
Overall comment to Ellen's point:
Maybe we can switch the dialogue..Sophie can say...

15 years ago labs used end point PCR and assays were much less sensitive. Today we have real-time PCR but this is only part of the story... then use Ellen's comment below for the Lab Director's comments. 

Add this sentence at the end: CMV viral loads measured in whole blood samples are approximately 1 log higher than those measured in plasma samples, due to cell-associated CMV DNA template.
However, plasma measurements may have better clinical specificity for detecting CMV reactivation.


comment:
Sophie can say..Labs can perform CMV viral load testing with whole blood or plasma but is one superior over the other?

Lab Director can say...Agree with Sophie's comment. It is important to note that some guidelines, like the International Consensus Guidelines
on the Management of CMV in SOT recommend either sample type but that one specimen
type should be used when serially monitoring patients.


comment:
Sophie's dialogue is good so we should also include this in the lab director's comments...Maybe take out the beginning and just refer to the guidelines and that other review publications also support the use of either whole blood or plasma.


comment:
Should change the question:

What sample types do some of the guidelines and peer reviewed publications recommend for CMV testing?


comment:
Should use all references here:
Kotton CN, et al. Transplantation. 2013;96:s1-28.
European Society for Blood and Marrow Transplantation: Ljungman P, et al, Hematol Oncol Clin North Am 2011;25(1)151-69
Emery V, et al. Br J Haematol. 2013;162:25-39


comment:
We reviewed some of the guidelines and peer reviewed publications, but what about clinical studies that support the use of plasma as a sample type?


comment:
Sophie should say... There are some studies that propose viral load thresholds for CMV assays with plasma. Can you share more details?

Then take here current dialogue and add to the Lab Director...


comment:
Would use the wording directly from the slides:

enhanced detection of residual viremia using a whole blood real-time PCR does not seem to offer significant clinical advantages nor allows for better prediction of recurrence of CMV viremia or disease.


comment:
Maybe we need to put some intro before the question in the red box to emphasize points..

So we have seen that studies and real-world clinical practice support both plasma and whole blood and that plasma may be more indicative of active infection. 
How can plasma be beneficial to a lab's workflow?


comment:
Sophie should say:

Plasma can have several advantages for the laboratory from sample stability to workflow

Lab Director:
Plasma is an easier sample type for PCR assays. 
(Then use Sophie's current dialogue)


comment:
Change question in red box:

Are more labs and clinicians moving to plasma as a preferred sample type for CMV testing?


comment:
Sophie dialogue,
Many labs have moved from whole blood testing to plasma in recent years due to the availability of CE-IVD and FDA approved tests that provide automated workflow and report results in IU/mL.


comment:
Lab Director

Take off the last sentence..we don't have EBV on the cobas 4800.  We also won't have a multiplex CMV/EBV assay


comment:
Maybe earlier in the clinical section we need to add:
More sensitive for pre-emptive monitoring of HSCT patients.

Then the lab director can bring this up again as well as
Clinical utility for treatment monitoring in SOT patients appears to be the same.

Summarize key points from this section:
1. Current guidelines and peer reviewed publications support the use of WB or plasma for CMV Testing both for HSCT and SOT
2. Clinically plasma may better predict disease and provide evidence of active infection (re-wording?)
3. Labs can benefit from workflow advantages with CMV plasma and link this with other transplant markers that also use plasma as sample type

Discuss further...


comment:
See my comments on previous slides..maybe these are the key take homes?

In the end we want to tell the participants it is OK to have discussions with the lab about plasma and that it is possible to convert from WB to plamsa.


comment:
Because this section is so important, can you point them to the resource section here and tell them they can download a slide deck that summarizes the key messages about plasma vs whole blood along with the key references/studies?
This was a really nice overview but they will need the slide deck for a deeper explanation and evidence.


comment:
Yes..this will remain optional.  Antigenemia is not widely used in some countries and this module is long. We want to give the participants the option to skip over this...

Perhaps we can also say that there is a slide deck they can download via a link in the resource tab if they would like to learn more offline as well?


comment:
Sub head should change for this part to
PCR vs antigenemia.

It doesn't make sense to have Plasma vs WB


comment:
Should the learners get a paint brush once they finish Plasma vs WB even if they don't choose the antigenemia? 
I thought the test result comparison was the last part of the module?


comment:
Also for the order:  PCR vs Antigenemia for the green box and the easel


comment:
Use faster turn around time vs just 'faster" for operational considerations


comment:
Change "Diagnosis in children" to "Better Sensitivity"
Then this can include diagnosis in children and HSCT patients, specifically with reduced neutrophil count


comment:
Can the statements that come out to the right for each category be bullet points so it is clear what the advantages are and how many?

Should also call out here that there is a more detailed slide deck from a link in the resource library that provides more information for antigenemia vs PCR


comment:
For Operational considerations should include that PCR is more automated and less subjective...antigenemia is labor intensive and open to interpretation


comment:
Instead of repeating what was said in the previous screens, maybe use this:

-Most widely used & preferred method for CMV diagnosis, preemptive strategies, and monitoring response to therapy
-Considered to be the standard of care
-Better precision, broader linear range, faster turnaround time, higher throughput, and less risk of contamination 
-Testing is less complex; commercial assays available


comment:
When I finished the antigenemia course I was brought to the palette but still only had one paint brush?


comment:
You may have had discussions with your customers in the lab...

Remove "client" thorughout


comment:
would say...have had difficulty comparing results between two or more different CMV tests, including comparing to Roche CMV Tests.  With all the knowledge you have gained you can now have a conversation with a lab director about the challenges in interpreting results from different CMV tests.


comment:
Green box intro should change..

We are currently transitioning our CMV test from one your competitor's to the cobas CMV Test. The results in the method correlation study show high degree of variability. Can you explain this?


comment:
Agree with Ellen's comments
The answer should be:
Viral load results do correlate across different assays because of a lack of standardization and commutability even with use of the WHO standard and results reported in IU/mL.

Perhaps we can add a feedback window that reminds them of the reasons behind the statement: 
That assay results are impacted by many factors including assay design (primers, probes, extraction, instruments used, target region, amplicon size), the use of different calibrators, and the fact that patient samples behave differently from standards.


comment:
Can we add reinforcing feedback to the incorrect answer?

For reporting results in IU/mL - we can remind them of the fact that calibrating to the WHO is difficult and doesn't guarantee that results will agree....(refresh from first part of this module) and that other factors impact assay performance (see feedback on correct answer - also applies here).


comment:
Sophie's feedback could be that as a result of the lack of standardisation and commutability of results even with the WHO standard, universal thresholds have not been established that can be applied with all assays....


comment:
Both answers should change based on Ellen's question change.

There have been studies that attempt to establish viral load thresholds however, because of the variability in CMV tests results, these thresholds will be specific to the assay used, the institution and the patient population in the study.


comment:
Change wrong answer to: 
Yes, there have been universally applied thresholds established for some clinical indications.

Struggle here because there are some guidelines - like the stopping treatment for two consecutive negative results..?


comment:
Sophie's feedback should include why - because of the variability in assay performance...


comment:
Lab Director question....

It is clear there is a high degree of complexity in managing CMV. How do clinicians use CMV viral load results to make clinical decisions?


comment:
Agree with Ellens' comments for the right answer. 
Must interpret results in the context of other clinical information...

However, clinicians assess other factors (patients tolerability to drug, toxicities & other comorbidities) when considering treatment decisions.


comment:
This not really a wrong answer...make it more obviously wrong...

Clinicians can refer to universal guidelines to help them in making treatment decisions based on CMV results.

?


comment:
Not sure about the first part of her summary...maybe this should be worked into the dialogue with the clinician...it is confusing that we say test results can't be compared and there are not universal guidelines but then we say guidelines recommend...

This is true, there are some guidelines but they are not followed by everyone and they are not for every patient population etc...

We could have her close with just the second part of the green box


comment:
Should add at the end, that this is something the scientific and clinical community continues to try an address through studies but we have not yet reached a point of true standardisation for CMV testing.


comment:
for many reasons:
- many different CMV assays used from homebrew LDTs to IVDs with results that do not correlate 
- still lack of standardisation across these tests even with the WHO standard due to many factors that impact assay performance (reagents, sample type, calibrators, amplicon size etc..)
- patient samples behave differently from standards which means a lack of commutability of results across institutions

As a result of these ongoing challenges, there are still no universally established treatment thresholds that clinicians can use for decision making.


comment:
Before we complete this module, we would like you to respond to some common customer questions to practice using the knowledge you have gained.


comment:
Agree with Ellen - can we put QC & Validation into one box together as the correct answer?

Also - from earlier comments..we should change 'System profile" to match change suggested...think it was "systems already in the lab or equipment already in the lab"


comment:
Should we clarify this is "homebrew LDT" or is this meant to be all types of LDTs?


comment:
Agree with Ellen - I think the Homebrew LDT is the lowest cost - at least in terms of straight reagents.

Also..calibration is a requirement for these tests..it would be good to emphasize this...

As mentioned in other feedback in the module we need to be consistent on what we say...risk, resources, time etc... if we re-word throughout that section of the module we can then re-word here.


comment:
Would not really say they are more complicated to troubleshoot - it just means the lab has to rely on the vendor...but this can be a good thing if you have service and support like Roche that is strong.

Like the option of closed.  We should work that in as well as "calibrated" as this is an advantage for the labs.

Take out commutability as a wrong answer.


comment:
For the WB vs Plasma we may need to re-work this based on the suggested changes in this section of the module.
Think we want to move away from clinically neutral - maybe it is better to say "equivalent"...there are studies that show CMV in plasma reflects active infection...

Let's discuss after we go through the WB vs Plasma section


comment:
Based on the feedback for this section of the module, we will have to change these statements.  We can come back to this after we make the other updates.


comment:
Your knowledge of the advantages and disadvantages for the different test types and samples types, the challenges in converting assays to IU/mL and difficulties in comparing results across institutions are key concepts to master.  (maybe something like this?).
These are important in the art and science of selling Roche's CMV Tests. 
Go ahead....


comment:
Last statement...

You are almost there! In the next and final module you will learn how to position...


comment:
Realize we have many questions at the end of a long module...however, there is nothing about converting to IU/mL in the challenge. Thoughts?


comment:
This is a long module...should we give the participants a heads up about this before they start and explain why it has so much?


comment:
Second question:

How do you convince a customer that Roche CMV tests are the best choice for their lab?


comment:
First question...

...advantages do Roche CMV tests have over..


comment:
Do you mean the "Homebrew LDT, LDT with CE-IVD reagents and CE-IVD/FDA tests?
We should show the list of competitors - like the table provided in module 4 PPT


comment:
Is this meant to be a reminder of what was learned in module 3?


comment:
CE-IVD and FDA approved tests throughout


comment:
Agree. Like incorporating the funnel but it will need to explained well and labeled well.  Maybe we can say it is a tool to help remember how we can win against different types of competitors for different reasons and in the end Roche CMV tests are the best choice for the lab...ie eliminate each competitor through the funnel criteria


comment:
Good point Ellen - let's filter out in the funnel so put the criteria that filters out each category


comment:
Not sure this works for me...We can maybe keep the funnel to the side...then we can go through the learning as to how you rule out based on IU/mL - ie not standardized to WHO?
Then for LDTs - we would show how to rule out Homebrew LDTs and then CE-IVD reagent built LDTs.

Really important to not over simplify here and use information in the PPT. Let's discuss.


comment:
Roche CMV Tests  = we have more than one test so need to be plural throughout


comment:
Like this - this is good to show how you use the conversation, positioning and objection handling to end with Roche CMV tests :)


comment:
Clarify if this is a homebrew LDT or CE-IVD reagent based LDT...should have an example of both


comment:
Like this structure and showing the optimal conversation at the end.

Did not look at the questions/answers content as you mentioned we can make these changes and edits using the branching conversations in spreadsheets for the alpha phase.


comment:
Maybe with the funnel we include the idea of the complexity of CMV landscape and testing...this is why we need an organized way to think about the competition and how to win in this space?  Thoughts?


comment:
CAP/CTM CMV was the first FDA approved/CE-IVD test...this is not cobas CMV... the two answers here apply to CAP/CTM CMV...
We can use these but we have to figure out how to link to the cobas CMV tests- maybe as second generation automated real-time CMV tests?


comment:
In terms of what points to emphasize here, would it be helpful to go through the PPT slides for Module 4 and pick them together?


comment:
Since the image at the end will be from the SPOT campaign we should include key statements from the campaign in Sophie's response


comment:
Hmm...overall I think we need to go a bit deeper with this module. The slide deck was built in a very specific way because more detailed information is needed here and specific positioning.  There needs to be more upfront in terms of teaching. There are specific slides that should be included - either as pop out tables/graphics or in the resource tab.
We also missed a whole section of content on how address broad menu....

One idea might be to show each of the key reasons why labs choose LDTs/CE-IVD reagents for LDTs and how we bust those.

I really didn't see how that would happen in this module.


comment:
should we say investigator site?  vs. site?  For the site location change:  the investigator site moves to a different location after it has been selected


comment:
for the process change I suggest just stopping after destruction and delete changes.


comment:
protocol change- I don't know that we need to specify significant suggest considering:  Protocol changes that require additional evaluation.


comment:
why it matters for location change: everything here points to CT material when the first reason it is important to assess a site when they move locations is to ensure the new location meets all of the trial and GCP/ICH requirements.I would combine the existing first 2 bullets; I don't know that we need to include the inspection ready comment on each on vs. just capturing it as a take away or elsewhere in the training


comment:
things to consider- the first bullet doesn't make sense to me- 1st bullet:  I don't like the use of extra guidance- maybe once I understand the bullet I may be able to provide a recommendation


comment:
I think finalize location change documentation could happen before or after the move since the CDC may go out and assess prior to the move


comment:
The CDC may go and visit the site and do evaluation prior to finalizing the move so I am not sure if this slide may cause confusion since a CDC could go and visit the new location prior to the move being final- need to consult with the SMEs on this slide


comment:
why it matters- overall the first reason is to ensure that any process change that requires an evaluation or re-evaluation meets the trial and ICH/GCP requirements


comment:
I am concerned that we are using process because when the learner sees process they may think anything that changes at a location vs. specific changes which need an evaluation or re-evaluation; things to consider the last bullet should we say the change acceptable?


comment:
always do- delete change at the end of the first bullet


comment:
The CDC only needs to complete the change form if the site decides to revise their process.  I think the example should include what the site wanted to do but check with the SMEs


comment:
therefore step 3 shouldn't be as written since the CDC will not be approving the site to destroy CT material- they would not document the change to destruction of CT Material since the site chose not to revise their process- without having an example of what the site's process was and what the CDC recommended I am not sure this is as valuable an example as it could be?


comment:
first bullet doesn't flow.  Something that includes the following or a version of:  A protocol change could result in loosing some sites or impacting trial timelines which we better understand through the re-evaluation process.


comment:
things to consider:  2nd bullet can we add site's qualification for the trial or potential success?


comment:
always do:  should we say when applicable complete....since not every change may result in completing the change form?


comment:
should we say what should you discuss with the site vs. tell?


comment:
I am not sure what we are trying to achieve with this exercise?  is it to get the CDC to understand what the next step is in the process?  In this scenario the CDC would inform the site of the new requirement and inquire if this change is something they can meet.  The site's response will determine the CDC's next steps so I am not sure that the way we have this exercise set up addresses the overall objective?


comment:
why it matters- I think the 3rd bullet could be revised a bit:  Documenting these types of changes ensures that our systems and documentation are current and contain accurate information ensuring we are inspection ready by regulatory authorities


comment:
Another thing to consider is Who needs to be aware of this change?


comment:
I am unclear as to why notifying the CRA is not important but we need to notify the financial team?  Why do we need to notify the financial team?


comment:
it looks as if you can advance without watching the videos just checking to see if that is how we want the video to be set up or do we want to ensure the learner watches the video to move forward in the video?


comment:
I think this course should include more context around the change when applicable.  CDCs also want to better understand what do I do if I learn of a change after it happens or what if I can't get to the location prior to the move what do I do?  Can I do an evaluation over the phone until I can see the location?  We should pull quality into this module sooner vs. later to help with some of these scenarios that cause confusion.


comment:
pop-up CDC - If a change needs to be re-evaluated is not only a judgment based decision. An evaluation of a change like PI change is required per Lilly procedures


comment:
Pop-up CRA - More details could be added like requesting new accounts if applicable; verification if the site provides the new contact information to subjects is applicable


comment:
pop-up why it matters: Following bullet could be added: Patient safety could be affected


comment:
for the first bullet I would say trial and regulatory or ICH/GCP requirments


comment:
let's just double check the ISEC against what is in the system


comment:
we should verify with product delivery which term to use- sites use IP terminology and Lilly uses CT Material; some of the questions are different in the ISEC therefore obtain a revised snapshot of ISEC questions for CT Material section


comment:
maybe revise the first bullet to be closer to the following reason:  CT material should only be accessible to the appropriate clinical research staff and securely stored to prevent accessibly by non-research staff


comment:
the 2nd question on the ISEC is not as it is in the training.  The question is :  2.	Is the site able to store CT-Materials according to the protocol or other written instructions (i.e. label, pharmacy manual).  Double check against what you get from Trialforce team


comment:
wherever we say ICH GCP shouldn't we be consistent and use either ICH or GCP or ICH/GCP as I am noticing we capture this differently and should be consistent; question #3;


comment:
we have revised the questions within the ISEC related to central pharmacy; once we finalize please get the final snapshot from Di


comment:
the comment associated with central pharmacy should read more like (verify with our PR&D folks:  Ensure that those the site has contracted with to store and distribute CT Material are doing so according to the label and if any deviations occur  there is a process in place to communicate deviations so Lilly can determine if the IMP is still fit for use.  Impact patient safety and trial results.


comment:
you can also include have the appropriate licenses/registrations etc. to the statement I have noted for central pharmacy


comment:
believe Lakisha provided some information specific to controlled substances


comment:
first question- should the last sentence say...the ISEC will serve as the documentation that the site has been authorized to destroy CT Material or something similar just to be a bit more specific


comment:
For the 2nd question we should include a similar statement about the ISEC being the documentation that the TPO has been authorized to destroy CT Material on behalf of the site


comment:
For our PR&D partners- is authorization to destroy only for IMP?  if yes then shouldn't the ISEC questions say IMP and not CT Material?  Also our comments associated with these questions should say IMP and not CT Material- correct?


comment:
should we also include in example 1 a note that the CDC will document the follow up item within Trialforce through until it is rectified prior to being declared enrollment ready


comment:
this is where we may want to also capture the overarching objective of all we ask in the CT material section: :  Ensure that CT Material is being managed according to the label & GCP requirements and if there are any deviations the site has a process in place to communicate these so Lilly can determine if the IMP is still fit for use.


comment:
the audio did not seem to work for me in this module


comment:
Do we want the Service Advisor's reactions to match the context of the conversation?


comment:
The course is "stuck" on this page.  Nothing happens when I select "submit" and I can't go forward on the screen since no "next" button. I can move on via the menu on the left.


comment:
I got the perception from the video that we just sent out a newly trained tech with no practical experience out to the field to resolve an issue. Intended?


comment:
"Audit Statuses" sounds a little funny. Consider reword to something like: historical inspection/audit results OR prior inspection/audit history OR inspection/audit status (singular)


comment:
This page had the top 2 radio buttons already selected.  I had not selected anything and screen asking me to submit these pre-populated answers.


comment:
The answers were already selected when I got to this screen. Is this a re-use of the same screen from the previous exercise using a new site (and now this is example for existing site)?


comment:
For clarity, suggest instead of 'they decide' 'the Level 2 Technical Support agent decides'


comment:
The answers were already selected when I got to this screen. Similar to above comments, is this a re-use of a previous slide in the other example which used a new site? (this example is for existing) I can't change any answers or do anything on this screen except hit submit.


comment:
At the beginning of the video some of the career pathing could use more time on the screen.  Also thought we could use clarification on the 'CFSE' vs 'Field Service Engineer' on the career path comparison.


comment:
1st question on live vs. phone SEC:  I don't know if this is correct to say HIGHLY recommended to conduct a live visit. If there is already feasibility data for a trial or the site is actively in other trials, then phone visit is appropriate. It seems like this sentence can be removed since whether to conduct a phone or live visit should be judgment based.  For some trials, we shouldn't need to send a person to a site to repeat information we already know.  Can you confirm with Clin ops leadership?


comment:
Easel title: Standardisation is misspelled.


comment:
2nd to last question: "compliance with our standard requirements" - not sure this is worded correctly. Are you trying to say  "compliance to requirements in the standards"? (But standards aren't on learning plans for the masses after the harmonization project in quality. Only on plans for those people creating procedures. As a suggestion, can you state this as:  "compliance to requirements"  That would cover both compliance and business requirements that are in the process maps and procedures.


comment:
After the final question, I selected the "x" but could not advance the page to the next page. The cursor then went back up to the questions that had already been viewed and closed.


comment:
The last 3 links all led me to the DNU site.  Looks like Sophie found this for Trialforce but it happened to me for all 3.


comment:
Please use the zoom feature on the image.


comment:
Elaborate language here that at Cummins there are many different account plan formats used today, but there are these common elements that should be in every account plan.


comment:
Add a yellow note to roche that we will need information for this screen as learners would see it for our Purple Fever Assay.


comment:
On the instructional text in the memo, remove "and underlined" as well as the line about distractor elements.


comment:
We need to add Platform since that is a required field.  It should be clicked and dragged to the Platform box.


comment:
When I click Save Changes and I'm incorrect, the last button I clicked on the screen disappears and there is a cobas green highlight around the image frame.  Let's add feedback that says "Try again."


comment:
Try again 2x then [feedback about real world consequences for choosing incorrectly and providing correct answer]


comment:
Can we add a highlight box around Purple Fever Assay after 5 seconds so they know where to click if they can't figure it out?


comment:
Can take out the "Pass the course assessment" section


comment:
Text edits "...recognize where they'll need account plans means looking..."; "The criteria can include the customer's total..."


comment:
Text edit "...Matrix is also a useful tool..."


comment:
Allow the user to select no more than two incorrect answers and then display the correct answer automatically.


comment:
After reading the information on the participant and clicking back.  I have to listen to the voice over again before selecting the next role.


comment:
Ah, I was using the back button instead of Xing out.


comment:
Also protocol revisions could require equipment or expertise the site does not have.


comment:
The text says "all there is to know".   Would change this to " some helpful information"


comment:
Did not see a listing of other functions in the video, so not sure how the student would know. (Did I miss that?)


comment:
Would not say that Business Performance Excellence is a process


comment:
1st answer - CT Material, medicinal product and IP don't have the same definition. Please confirm with PD SMEs/PO.


comment:
Controlled substances answer: 2nd sentence is really long - can you divide into 2 sentences.


comment:
(1) Customers would not use the term "Prime Power Generation Unit (2)  An alternator is not a realistic example of a component that would be replaced in the field. (3)  Suggest talking with someone with PGen experience (e.g., Dave Held) for a better example of a hard to diagnose issue.


comment:
Answer to 1st question - CT Material and IMP both used.  Please confirm correct terminology with PD SME/PO.


comment:
Last answer - check use of IMP with PD SMEs/PO


comment:
Correct answer says daily monitoring is acceptable but the scenario states it's not done daily - just M-F.  What about temperatures over the weekend?


comment:
the next button doesn't appear after completing all 3 check marks.


comment:
The iSEC does not match with the iSEC in Trailforce


comment:
Last pop-up: Confirm with SMEs, but I think "IMP" should be replaced with "CT Material".


comment:
Last pop-up: "When extra materials (plural) are used..."?


comment:
1st pop-up: Could we specify which documentation is needed by Lilly to confirm that CT material was destroyed. Mostly CT materials are destroyed by TPOs. Usually TPOs dont confirm the destruction of the CT materials to the site. Is it acceptable to document the destruction on a destruction log without any confirmation?


comment:
2nd scenario:
last sentence in reply ".. if it is going to participate in the study"
Rather say They then it.
"should they participate in the study"


comment:
1st box: write "and" rather than using "&"


comment:
VO: "... regardless of whether your office is open".
What does that mean? Propos eto remove this wording.


comment:
Last box: confirm with SMEs, but I believe IMP must be replaced with "CT Material" as not only the IMP needs approval for destruction.


comment:
Isn't the 1st answer option the correct one? I clicked it and got an incorrect feedback.


comment:
Can the incorrect feedback, when you only select the 1st answer option be something like "Almost correct, there is a second correct follow-up question"


comment:
I think I asked this at alpha, but couldn't attend the review meeting, so not sure what was decided:
I would remove the "patient-exam-bed". from this image as access to CT Material is restricted. I don't think patients are allowed to access?


comment:
Same question as previous scenario: Would patients be allowed in this room? Controlled access?


comment:
How will CRAs get the information if a site is authorized to destroy CT material or not? With the new process no documentation is available in ISF, or?


comment:
The explanation why answers 2 is incorrect is not adequate. Please reword the explanation


comment:
Is weekly preparation ok for reconstituted material? SMEs?


comment:
Why is "equipment" mentioned in the two reply options?


comment:
"We have a contract with the lab":
This is about the pharmacy, change lab to pharmacie?


comment:
#3 Lilly expectation: Say CT Material instead of investigational medical product?


comment:
Slide header: say "Is the site qualified?"


comment:
Use below url for the Site Selection Guidebook:
http://lillynetcollaboration.global.lilly.com/sites/DCOEHub6/onboarding/SiteSelection/default.aspx


comment:
After Sophie shows up, you can still click through the items. The text for immuno-suppressive drug monitoring overlaps Sophie's speech bubble


comment:
#3 - "CT Material is a Lilly owned product"   Is this needed?


comment:
It sounds like from the edits in the spreadsheet (rows 4 and 7) that "also known as real-time PCR" should be added. Agree?


comment:
Ignore my comment about PCR... row 21 says we can leave as is


comment:
When you go into each of the sub-menus (ie Developer Tasks),  you cannot select the Next button like it tells you.  You have to select the Back button to get back to the System Tasks Introduction screen.


comment:
Way too blurry.  We will need to find  way to make these images more clear.


comment:
Should "for transplant recipients" in the slide title on the previous screen remain here as well?


comment:
Should the question on this screen replace the question pop-up in the module menu?


comment:
When you answer the question of the refrigerator the 3 answer are incorrect. the same situation with the boxes of medication.


comment:
"preferred" should not be used. Change to "... CMV infection. Antigenemia can be used if PCR is not available."


comment:
Given how long this para is now, can we pull the second sentence content into two bullets on an easel next to him?


comment:
Same thing here about adding an easel: Leave first sentence, add easel with header: Challenges to converting to IU/mL: 
- Difficult
- Not sufficient to ensure commutability
- May require further calibrations, which may actually worsen commutability


comment:
Ditch the easel thing - text should actually be replaced per row 64 of my commented spreadsheet


comment:
Graph X axis label is cut off on both graphs


comment:
Feedback on "NOTES"
- Make sure to match testing method categories to module.  For exmaple, "Traditional Culture" should be "Culture using conventional media".  We made a few wording changes n a couple of these so make sure to refer back to the module after all the changes are made


comment:
Can we add a label to the dotted line - this is the line of unity (x=y).

Also, state these are just two examples of bias for a PCR assay.  (We need to add this into the text)


comment:
All of these comments are about notes.
- Under "Con" of automated ID / AST, change "Reduced TAT" to "Reduced Hands on Time"


comment:
Disk Diffusion and E-Test pros Faster than other AST methods (replace the old one).  Cons  Limited number of antibiotics tested per plate.  Take out "concentrations".


comment:
May need to reword the question - will check with Julie.


comment:
Add to resources link the corporate account plan template and reference to Salesforce.  Call out in language on this slide to check out the resources for a template.


comment:
The questions should align with the criteria / variables to consider when prioritizing a customer for an account plan.


comment:
Have the journal be the same format as the corporate template (tabbed version shown throughout).


comment:
Include initiatives on the account plan example since that can also drive key stakeholders to engage on the team.


comment:
Need a place to click "Print Certificate".  Maybe on the certificate?  Right now, clicking the certificate doesn't do anything.


comment:
Text edit - "...focus on these stages in the rest of this course." delete rest of that sentence.


comment:
Take out Common Sample Types from the third page in notes.  Replace with Select Competitors and Products


comment:
For Vitek 2 Say Biochemical / Susceptibility
Bio-rad is not an instrument.  Change to No


comment:
Add to my comment.."If the assays were co-linear then the points would be on the dotted line."


comment:
replace "BD & Cepheid" to 
BD MAX Cdiff and Cepheid Xpert C. difficile


comment:
For BLP...we may want to delete the last 4 screens - and just use the first two graphs and we can use the some of the text that has been written in my comments to create a summary text ...maybe the first graph screen is repeated a few times to get in all the text.


comment:
Maybe make more painful process...have to click many times to represent the number of choices that have to be made for LDTss


comment:
Suggest to make the questions in the green box easier to read - they are pretty dense...space or font size?

Maybe we can eliminate some of the questions.

Let's discuss


comment:
Change coffee to clock with the numbers as dollar signs on the face and the cobas logo on the face - add comment about saving time and money - resources can be used for other revenue generating activities


comment:
Summarize 5 key points here to support plasma at the end...ties up the story


comment:
Need to also point them to the resource section for the full plasma vs WB slide deck for more details...


comment:
change variability to discordance  (in the green box question rewrite from me)


comment:
..incorrect answer...it is difficult for the conversion but need to add this is not the only issue


comment:
We tried to make edits to this together but difficult to follow a dialogue with these feedback format. Can we have this in excel format so we can edit?


comment:
One overview point should be to ensure we are writing these statements to position advantages and disadvantages all relative to a CE-IVD/FDA approved test...


comment:
To address Beth's comment, label testing methods as "Common Testing Methods" and carry it through the module.  Take out "BD Max" from SDA and change spelling of Pheonix to Phoenix


comment:
To address Beth's comment, replace second sentence.  "If the GDH is positive, it then needs to be confirmed to determine whether a toxigenic strain of C.diff is present.  This is typically done by testing for Toxin A and/or B."


comment:
C.diff should be capital C and lower case d throughout the document unless it's part of a competitor name.


comment:
Redoing above comment
Please say "examples" of ________ competitors across all clipboards. Also, the clipboard here does not look like other clipboards in this module.


comment:
1st answer option: a question mark is missed


comment:
I suggest to add one more wrong answer option. For instance: What are the types of existing refrigerators?


comment:
1st popup: extra space between required and to


comment:
was the edit on line 13 of the spreadsheet supposed to be on this screen? If so, I don't see it


comment:
Text should be modified to say "...where you will learn all there is to know about working in the service function."   'The' is missing from the current sentence.


comment:
I know Nancy gave you exact wording for the correct text, but I'd clean it up a bit. Spell out hte numbers and change on to in in the first sentence


comment:
Text in Tuesday planner should not have a plural for 'functions'


comment:
Edit says to change to "are documented", you have "get documented". Was this something changed live?


comment:
Ignore - I see a later edit from ksb where she said get documented.


comment:
Throughout: TCR-B is supposed to be one of the short, fat vials according to Cheryl/Dewi's notes. TCR is one of the skinnier vials. This affects this screen and the See It in multiple places.


comment:
remove the word "glass" throughout. Not all of the vials are glass.


comment:
Should we include the SPI (investigational product section) ?


comment:
Erika you are much louder than the others...can you turn yourself down a little?


comment:
I suggest to include the red border for  the scroll bar in the iSEC pop up.


comment:
Global: the last digit of the clock is outside of the actual clock throughout.


comment:
first popup - I still see references to SC (edit in line 26). I'd do another find and replace for it


comment:
I feel like the second bullet came up to soon.


comment:
What was the final decision on the edit in line 34? I see both trial-specific and protocol-specific on screen. Just confirming this is correct.


comment:
Line 35 edit: region specific questions is still mentioned in the audio


comment:
update transcript - replace protocol with requirements (last word)


comment:
update transcripts - swap peppered for scattered


comment:
globally - make sure transcripts are updated


comment:
spell out study coordinator in transcript


comment:
Once I complete the conversation, it loops back to the beginning slide and you can inadvertently repeat the same conversation again.  It's hard to determine when I'm done and ready to click next.


comment:
Just confirming that this is the most recent guidebook link (I can't tell when I click). Thanks!


comment:
Never mind, I mistakenly clicked the "try again" button.


comment:
Purchasing, Sales, Marketing, and Logistics are examples of Service Functions? Check for accuracy.


comment:
Make sure the apostrophe is in Cummins' for 'Cummins issue had to do with limited capability...'


comment:
CFSE should be spelled out to Cummins Field Service Engineer


comment:
Provide links to Cummins Connect community? Add to resources page as well.


comment:
Maybe, we sould provide additional instructions for example 3. Where the CDC should document the additional fee requested by the site?


comment:
I really don't like the concept "most significant". Are the other 5 course less significant? 

Sorry, is just a consideration, at this moment I do not have a best suggestion


comment:
ryan - Their note was the the refrigerated one is the one that's "b" are you sure kathryn has it wrong?


comment:
audio is cutting off a tiny bit when it first starts. Can we fix?


comment:
not sure if it made it to the edit spreadsheet or not, but we need to add player buttons to this animation


comment:
when you get the correct feedback, the 35.00 in the stopwatch is falling out of the face of the watch


comment:
50 is falling out of the face of the watch too. Can you please check that the font didn't change or something on these?


comment:
I would clarify in the instructions:

There are four items in this room that you should investigate "realted to CT materials"


comment:
Why is the text on the bottles fuzzy? Can we fix the resolution of them?


comment:
related to the boxes:  Feedback establishes that boxes are clearly refrigerated, and maybe they are not "clearly refrif¿gerated"

In a site, refrigerated boxes can be also fresh samples ready to be shipped.


comment:
TrsnCelerate URL opens the -Site Qualification and Training (SQT)- page, is this OK?


comment:
Pop-up of ISEC: please change the terminology of IP to IMP [Investigational Medicinal Product], it is the new terminology that we are using now.


comment:
First pop-up: we use investigational product and it should be investigational medicinal product. Also CT Material includes IMP and AMP. Please see the definitions below

The new definition for:
CT Material is: An umbrella term that includes both investigational medicinal product (IMP) and auxiliary medicinal product (AMP).  (Does not include conmeds)
IMP: a medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial.
AMP: a medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product, such as medicinal products used for background treatment, challenge agents, rescue medication, or used to assess end-points in a clinical trial.  Auxiliary medicinal products should not include concomitant medications, that is medications unrelated to the clinical trial and not relevant for the design of the clinical trial.


comment:
Please clarify if we will collect temperature excursions for auxiliary medicinal product (AMP. CT Material includes IMP and AMP, we normally do not collect temperature excursions for AMPs


comment:
Where can we verify the definition of controlled substances? It is not clear the instruction in the parenthesis


comment:
First pop-up: Lilly assess how IMP is destroyed, historically destruction of  AMPs have not been coordinated by Lilly. I think this should IMP, please verify with Brian S. [CT Material process owner]. Also Please change Hub/depot for Lilly designated Hub/Depot, so it is not confused with a TPO hired by the site directly. 
For sites that are authorized, we can add a statement that CDCs can inform the CRA if the site is authorized for IMP destruction. Also there is no guidance for the CDC to know what the documentation should be on file to document site destruction.


comment:
Second pop-up: please modify the second sentence for...
Examples of evidence includes certificates of destruction,...
If we incorporate IMP and AMP in the sentences, it will be clearer for students when taking the training


comment:
Last box, can we include Lilly designated Hub instead of CT Material Hub. Please confirm this with the PR&D team.


comment:
It says "One of the most significant parts" so it does not exclude other parts. I do not think there is anything inappropriate.


comment:
Don't think CT material is only a Lilly-owned product.


comment:
It would be nice to have a continue botton or an indication about what to do after this screen


comment:
I think it would be nice to see that you are currently in module 1 and what it is about (transplant process??)


comment:
A brief summary of the topics treated on this section in this main screen would be helpful to have in order to not get lost and enable people to better follow the training. You must keep in mind that most people will do it in several sessions


comment:
When you reach the last color it would be nice to have another button of continue or any indication to know what to do


comment:
Last red box  Should be protocol specific section instead of trial specific section, or?


comment:
Updating the link to site selection Guidebook


comment:
In the 1st example question, should the "no" box be ticked?


comment:
1st example question:
Are that 2 different example questions?
If so, I would make that clearer. For example:
- Example 1:
- Example 2:


comment:
We generally do not open the work orders  for service providers.


comment:
We may want to check the mileage with service provider. We should mention that we could tell him about the base or extended warranty.


comment:
Trialforce - the f needs to be lowercase.


comment:
The alarm is ringing and it says TOMORROW is our first day? Shouldn't it say TODAY.
Unrealistic to say "ALL there is to know", maybe the most critical, useful, helpful...


comment:
apologies, I do see it indicates SUNDAY the day before


comment:
Don't like how the papers and inside the elevators the posters undulates, visual sea sickness


comment:
Can Gloria say, "Please" read the information.


comment:
Can Jose say "Good job" or "Well done" or "Great" instead of "good memory"


comment:
Consider "Congratulations" if "Well done" is used in previous slide.


comment:
I understand what "ponder" means but it is not a word used that often in conversation, can it be "consider" or "review"


comment:
I would say for diagnosis and monitoring more than screening and monitoring...
What about to include "resitance studies to antivirals"?


comment:
with regard to antigenemia disadvantages I would include that the assay performance diminishes
when the absolute neutrophil count is less than 1000/mm3 and as the blood specimen has limited
stability the assay should be processed within 6 to 8 hr of collection to avoid a decrease in test sensitivity


comment:
In the timeline of Antiviral prophylaxis there is not QNAT testing. If I am not wrong even if the laboratory monitoring is not at regular intervals to detect early viral replication like in Preemptive therapy there is also a testing of it with less frequency


comment:
I do not know if it is only with my computer but I could not see very well the summary of this second plaque. I can see the first one very well


comment:
VO: 1st sentence: 2 times "trial": three-part trial trial.
Is this how it's supposed to be? Would suggest to cut out one "trial"


comment:
In the Incorrect feedback, 1st sentence use "and" rather than "but"
"..., and the CDC thoroughly discussed..."


comment:
2nd Lilly expectation: is protocol requirements correct? Or should it be trial requirements?


comment:
In the Site Evaluation Summary: 1st sentence should it not be "trial protocol" (singular)?


comment:
Was noted but wanted to say it again - Transcript still needs to be updated.


comment:
Not sure if it's needed but Next button doesn't show when I revisit this page.


comment:
Wordsmithing here: The last sentence on the Contemporaneous popup - you could probably drop the 'of this.' and end with 'a good example.'


comment:
Original popup- Capitalize the O in second bullet


comment:
Accurate popup - Need a comma after systems in first sentence (I think)


comment:
On Legible popup - I would reword the last sentence: 'An example is a site's process to record documentation in pen.' 

Just get rid of 'of this.'


comment:
1. Setting the clock to 8am;
2. The text says "all there is to know". Would change this to "some helpful information" or similar; 
3. Change third sentence to "...working in the service function."


comment:
On contemporaneous popup, change last sentence to: 'An example is a site's process to record procedures in the EMR immediately.'


comment:
Original popup, second bullet. I'd capitalize the 'O' I know it's continuing the sentence above but it looks weird... :(


comment:
Comma after 'systems' in the first sentence


comment:
Tuesday planner: should be "service function" not plural.


comment:
What is the correct answer here? I clicked paper towel and it told me correct but on the next screen it is still saying post it was correct.


comment:
I also can't retake this activity  to test it again.


comment:
I don't think your home button is working from the menu.


comment:
Last paragraph, first sentence: Comma after 'signed/dated'


comment:
On your edit spreadsheet Lilly_SourceDoc_BetaEdits_20170413 line 28, I can't tell if this has been addressed or not.


comment:
keep last image on screen through to the end


comment:
bold "button" in click next instructions


comment:
First popup, first bullet: add a period.


comment:
Last popup: Extra space before auditors.


comment:
can we move the LA over so she isn't so close to the text?


comment:
1. Agree with IO's comments;
2. Keep Vision, Mission and Value, COS practices (add names under the icons); Add "functions use practices to reduce waste..."
3. Eliminate goal tree;
4. Right before exiting the building, replace "Service" with this sentence: "Service function works across all Cummins Business Units to develop common processes, tools and capabilities."


comment:
last question popup > first bullet > add period at end


comment:
if i click back from here, it automatically lets me go to module 3 from the main menu even if i havent clicked it.


comment:
can we shorten the correct answer text box so you don't have "it" all by itself on the second line?


comment:
1.Eliminate the Business Units information in the video;
2.Add Legendary Service content - see Daphne for file.


comment:
need to update the CC: "site coordinator" to "study coordinator" in last sentence


comment:
1. Develop an exercise around the Legendary Service information.
2. Agree with IO's comments;


comment:
big gap at end of CC before last sentence


comment:
is the lilly record retention schedule link right? i get "missing certificate" which seems less like a login or special link and more like its wrong?


comment:
1. Eliminate "Goal tree" option;
2. "Let us see if you remember..." -- "Let us apply what you have learned from the video".


comment:
1. "ponder" - "think"
2. Remove all red "C";
3. COS: "10 practices that help us continuously improve processes" 
4.Service Function Mission will be replaced with Legendary Service info.


comment:
3. Eliminate Service Function Mission content


comment:
1. Replace COS with Legendary Service information; "Excited to be someone our customers can be rely on".


comment:
Make the exercise about Legendary Service content.


comment:
Second thought..keep this exercise on COS.


comment:
Be consistent with "Service function" unless it is a title.


comment:
1. MRG and Steering Committee: spell out the word; remove "meeting frequency"; sentence for membership and objective;


comment:
Sentence the key processes and key roles; Eliminate the key tools. Explain what QuickServe is in a couple of sentences.


comment:
Add sentences on key processes;
Take out bullets from key roles.


comment:
Sentence on the key processes;
Take out bullet on key role;
Key role: Warranty - Central and Regional Roles


comment:
Same as previous; 
Remove Customer Support from key roles;


comment:
Same as previous; Use TVD suggestion.
Key role: service diagnostic engineer and managers.


comment:
"Solution" at beginning of 2nd bullet belongs at the end of the 1st bullet. We think this is contamination?


comment:
Perhaps indicate in parenthesis that there are 4 groups. I keep skipping over the little stack of collars and I know about them. They're easily missed..


comment:
Can you narrow the margins for the "Store at 2 degrees C... receipt)" on the box so it doesn't split the word and doesn't fall off the box.


comment:
Remove target capture from last paragraph so it's more general: "The reagents must be paired... "


comment:
Top message about getting to know the stuff needs to disappear and only show the "Wow...that's a lot of stuff" message.


comment:
Nice work Kendell! This turned out great :)


comment:
...multiple times for each assay, because this is part of the Panther's tracability process.


comment:
The instructions said to click on Make a Decision button, even though I already completed it.


comment:
I believe it should instead say click on Manage and Document Follow-Up Items


comment:
Sample slide deck link - this wouldn't open for me.  Tried twice.


comment:
3rd expectation - Why it matters.  Sounds a little funny to say sites are put into something.  Consider reword from "...ensures sites are not put into an enrollment commitment they are not comfortable with"  to "ensures sites are comfortable with an enrollment commitment" OR "ensures sites are not agreeing to an enrollment commitment they can't meet"


comment:
as I am working on wording qualifying questions would the following be a more qualifying question:  The site needs to have a trained rater with at least 1 year of experience in administering the Mini-Mental Exam (MMSE).  Can the site meet this requirement?


comment:
add:  If No, provide additional detail as to how the site will meet this requirement by  enrollment readiness.


comment:
I think the If No should be in the 2nd box if the answer to this is checked no since that is a child question to the original question being asked.


comment:
If No provide additional details as to how the site will meet this requirement by enrollment readiness


comment:
we plan to revise this question to just say PI and remove site personnel- Sophie check with me when we do the final review as to if Di is able to make this change otherwise we will need to keep as is and update after release


comment:
to make the 2nd one a qualifying question suggest:  The trial requires that the Principle Investigator or Sub-Investigator (shouldn't these be capitalized?) are able to interpret the 12-Lead ECG at the time of ECG examination and prior to submission to the central vendor or have a local qualified physician who can fulfill that role.  Is the site able to meet this requirement?


comment:
replace 1st question with:  :  In Arm 2 an evaluation of response is required by PET-CT Scan, including diagnostic CT scan of chest, abdomen, and pelvis (preferably with both oral and intravenous contrast). Can the site meet these requirements of the protocol?


comment:
Answer to question:  Yes.  Additional Comments:  The site has access to an onsite PET-CT scan, which they have used on prior trials, that can accommodate the requirements of the trial as outlined in the protocol.


comment:
To replace the Manipulation question how about the following though it could be worded slightly different by TA:  
IP Traceability- The site evaluator for the applicable country will need to evaluate the IP Traceability requirements for the country/compounds as defined within the ISEC:
If asked during a site inspection or regulatory review process does the site have a process to provide traceability of site sourced commercial material (manufacturer, lot #, expiry date)? 

Please document their process below (enter N/A if site does not have a process)
If the site has a process to provide traceability, how long is the data maintained?"

If less than 15 years, confirm the site will provide documentation of traceability in their study file at their site for future reference.

If the site does not have a process, would they be willing to implement a process to provide traceability, enter N/A if the site already has capability.

If the site is not willing, STOP, and contact COM/COPM to have further conversation with study team.  Document study team's decision prior to qualifying the investigator site.


comment:
Incomplete: do we have to use the same question?  I have another example:
The site will need to be able to conduct an ECHO with Doppler as outlined in the protocol.  Can the site meet this requirement which includes they will need to have available staff to be trained, tested and become certified prior to being declared enrollment ready? No
If no, provide additional detail as to how the site will meet the ECHO requirements of the trial prior to being declared enrollment ready? 
Site is not familiar with performing ECHO with Doppler and has limited research personnel.
This is incomplete because the CDC did not include how the site plans to meet this requirement prior to being declared enrollment ready.


comment:
bullet 3- are we really asking trial specific questions to determine if the trial is operationally feasible?  Isn't that what feasibility is when it is done?  Don't we ask these questions to ensure the site meets all the necessary requirements (not sure if we want to say trial and protocol requirements or leave it) to be considered for the trial and optimize or ensure (feel like ensure is an absolute and nothing is an absolute with this process) the best sites are selected for the trial.


comment:
I couldn't get it to download when I clicked on the sample slide deck


comment:
should we add that very experienced is subjective to highlight a subjective comment same as quite a few?  Also do you think we should be clearer by adding to the $ comment not to document within the ISEC or do we think it is not necessary?


comment:
we say subjective in the other modules should we remain consistent or add in () subjective?


comment:
Key Roles in Technical Training: Suggestion to mention Branch /Service Managers to be specific than just Managers.


comment:
The screen is not navigating back to the the home screen when you click Back"'


comment:
we need to add Selecting sites contents before this wrap-up slide.


comment:
1. Eliminate the semicolon before "feel free..";
2. Eliminate "Mexico";
3. Monica's outfit doesn't fit in Service Operations - need a Cummins branded uniform;


comment:
1. Take out the chuckle at the beginning. 
2. More energy and enthusiasm in the tone; less like reading a script.


comment:
4. Title line: add "Let's explore one area in the Service function."  

Jose: "Monica is a Cummins Service Advisor in the Service Operations sub-function..."


comment:
Make sure to update the answers with the training information in the module.


comment:
1. Jose: "Each sub-function has responsibility for unique processes that it uses...";


comment:
1. Title line: "learn more how the critical process of the service function help support our customers during a service event. Mike will be your tour guide".
2. Jose's watch and wedding ring - keep consistent throughout the course;
3. Change the paragraph to reflect QuickServe process;
4. Add sub-function names by each number;
5. Tie seven sub-functions to the service facility tour; each description should help how that sub-function helps the customer during a service event;


comment:
take out "the technician stayed to talk to the group"


comment:
I think the text boxes with the job titles should also be clickable, not just the people.


comment:
Should this say "As someone involved" versus involves?


comment:
Need to name this as "Qualify and Select" sites in TF, not just select


comment:
Highly recommend that Laura Ludwig review and approve this course as she is very much want to say that it is not the documenting site selection matters, it is documenting site qualification matters.  So the wording of choice should come from her and/or quality


comment:
last sentence again, before qualify and select a site.


comment:
when I click 2nd and 3rd pictures, nothing new display?


comment:
what is the significant of the red circle?


comment:
I have to click the x to close the first window in order to precede to the 2nd and red circle.  Not very intuitive.


comment:
PLEASE add the following points:

- PI's email is populated as it is an essential data for safety mailings process
- site personnel information at the TF trialsite contact roles have all the complete contact information as it is important the information is complete and correct at the time of site selection as other functions (e.g. contract, training, site activation group) are relying on these information to kick off their works.


comment:
sorry I didn't know what the red circle mean so my feedback over there are covered here.


comment:
really nice summary video done by Erin!!


comment:
For LM's comment - we are covering screening with serology so should leave that in.  We could add diagnosis...

For screening, diagnosis and monitoring..

Resistance studies to antivirals is a bit out of scope for the module.


comment:
For the question for QNAT vs real-time PCR vs PCR.
If we can define QNAT when we first introduce PCR as a test method in the module then we can go with PCR throughout.
QNAT = quantitative nucleic acid test which is how real-time PCR is referred to in many publications. We will refer to it as PCR for our training. 

Something like this.


comment:
last sentence in the feedback:

PCR is considered to be the standard of care, and available guidelines recommend PCR.

Note:  Don't want to give the impression that there are universal guidelines available that clinicians follow..there are some publications and the SOT guidelines but nothing officially accepted by all.


comment:
Type of Organ...the risk is not for contracting CMV.

...represent the highest risk for CMV disease.


comment:
Type of Immunosuppression.

Delete the end "Everolimus".

Sentence would end..as opposed to other immuno-suppressive drugs.


comment:
To LM's comments.  Under the Prophylaxis description can we add the statement: 

Laboratory monitoring (NAT) for CMV reactivation is
not routinely recommended for patients receiving
antiviral prophylaxis. However, some viral load testing may be conducted depending on the institution.


comment:
Use case...think the names are not correct in the description.  The patient is Antony so it should say this vs Mark?  Was Mark the old name?


comment:
For Paula under use case: 
Paula's clinician chose preemptive therapy because of Paula's CMV-seropositive status as CMV D-/R+ and to achieve reduced drug toxicity.  Paula had a history of experiencing side effects to medication.


comment:
The Roche account managers usually don't have access to clinicians to speak to them directly. 

change.."you should"...to "..,we will speak with the professionals..."


comment:
To LM's comment:
Can we make the last sentence into bullets?

Reporting results in IU/mL is now referenced in:
- 2013 International Guidelines for SOT
- Proficiency testing (CAP & INSTAND)


comment:
Challenges to converting to IU/mL..easel..probably should not introduce commutability here as we haven't defined it yet.  Change bullets to:

- Difficult to convert LDTs
- May not be sufficient to achieve result agreement
- May actually worsen result agreement depending on calibrator used


comment:
Remove "client" throughout...

Customer Conversation


comment:
..prohibits the development of universal viral load treatment...


comment:
Should we blind the tests on the graph here for variability in clinical vs constructed samples?

CAP/CTM becomes Test A
cobas becomes Test B

Ellen? Jessica?


comment:
Great module!!!  Lovely ending and summary!! :)


comment:
The titles over the paintings look really good!


comment:
To LM's comment. Both plaques were clear on my computer


comment:
Comment on the script for the introduction video from Module 1..noticed Sophie introduces herself as a sales rep... not sure if we caught this in the script review. 

Can you make sure she calls herself a Roche Account Manager?


comment:
For all the statements that refer to X% CMV disease and X% mortality rate need to add a footnote:

Rates are estimates based on a review of clinical trials and retrospective and prospective clinical studies.

Also, need to avoid using absolute numbers....say instead...as high as 50% etc..


comment:
Change from Graph 1 and Graph 2 to  

Fig 1 
Fig 2 

To match the publication


comment:
Add a footnote: 

This figure was developed by Roche Global MSA to illustrate the effect of amplicon size for CMV viral load results as a theoretical example.


comment:
Reminder as to what "D" and "R" mean e.g Donor and Recipient


comment:
on the correct feedback, I think the "...taken in account..." should be "...taken into account..."


comment:
why is there an asterisk after "ways:" in the top sentence?


comment:
I think we need to specify that this question is for transplant so we get to choice 3. From what I've been reading, Anginemia is used in conjunction with PCR for Congenital CMV diagnosis - choice #1.  (as an aside, when used in this situation, saliva and urine are informative, and blood is not. Mreover, if only one is available, some would prefer IgM+IgG to qNAT (choice 2), as it can pick up the infection in neonates earlier....


comment:
it would be nice to say why Harold is at high risk for cmv disease, and his serostatus - we mention the serostatus of both Paula and Antony...


comment:
Is it ok to throw Seracare under the bus?


comment:
Love the pain splotches! So much better than the flower


comment:
Perhaps at the end of the first paragraph, we should add "including".
so it would read, "... questions for clinicians, including:"


comment:
Do we want to say, "complicates CMV patient management." instead of "limits CMV patient management?


comment:
Just a suggestion to clarify -since we just defined commutability, maybe we can use it in the sentence? I.e., So for the different tests to be comparable across different institutions, the control results must be commutable to patient samples. Namely the assays must perform exactly the same on patient samples as on reference materials."


comment:
Totally agree with Joni that we should blind the test names to Test 1 and Test 2 in the legend


comment:
confusing definition of commutable in this syntax. The results from controls are note commutable to patients, but you don't say the results from 1 test are not commutable to another. You would say the lack of commutability of the controls means that even if the control data can be compared across institutions, the patient data cannot....


comment:
I find the "wrong answers" to be very flippant and blatantly wrong. I don't know if we want to tone it down?


comment:
the second blank is still wrong- it should be, "immunosuppressive drug therapy" is used to help prevent organ rejection.


comment:
2nd bullet + VO:
Lilly and other stakeholders? (could be Quintiles, inspectors...)


comment:
I will follow-up if follow-up items is the correct term. Is noticed different wording in the process map


comment:
For the 2nd sentence, maybe start with:
Similarly, they also have to be able to explain


comment:
We have used the job interview analogy different times. Should we add some introduction, like:
You have seen in other modules how site evaluation and qualification can be compared to a job interview, also in making the qualification and selection decision is very much like selecting the right candidate...
... or something to this extend


comment:
there seem to be some words missing in the 1st bullet?


comment:
1st sentence
... her findings after assessing the site... ?


comment:
Start of the scenario, should the study team start their push back with saying, "The PI of site 1 is a renowed endocrinologist, we would like him to work with him in this study..."?


comment:
Given that we've used the head and hearts in all the SEC modules, I wonder if we should use that here as well. Show the heads and hearts of her findings and thoughts... tie it all together


comment:
1st bullet "CDCs have the responsibility": already stated in start of the sentence, would delete this wording


comment:
1st sentence:
my responsibility to document my site assessment properly...


comment:
I clicked the 3 pop-ups and next button does not appear


comment:
After having clicked the red circle, the instruction doesn't change to saying "click the 3rd circle"


comment:
To confirm with SMEs, but could there not be a trial site with only a PI (no study coordinator, pharmacisist etc)? In the case of simple trials?


comment:
We need to reword this slide.
2nd bullet: Documenting Site Evaluation and Qualification is required per ICH GCP and Regulatory requirements.
3rd bullet: The Site Evaluation and Qualification documentation can be shown to auditors and/or inspectors if requested.
(confirm with SMEs)


comment:
Propose to re-word the analogy a bit to link it better:
proposal for last paragraph:
Just like a teacher collects information from homework and tests and records grades, you should document all relevant information collected from your site evaluation in Trialforce and document your decision about the site's qualification and final selection.


comment:
It looks like there are overlapping arrowheads on the cycle graphic.


comment:
I think the icons should be larger to stand out a little more.  It's difficult to tell what the shaking hands are.


comment:
It's difficult to read the white on the light blue buttons.  Change to dark gray or black.


comment:
On the positive feedback, the character has a typo - change "looked" to "look."


comment:
I didn't see anything change on the screen.  When a learner receives positive feedback from the rep, should new information appear on the strategic alignment tab?


comment:
I don't think we need a box for positive feedback -- this can be what the learner/miner character says.


comment:
Can we make the shovel stand out more?  The bottom color gets lost in the background. It wouldn't hurt for the shovel to animate in as the text appears so it calls it out a little more.


comment:
Should we call out that this is an opportunity for a monthly meeting?  Need to move the marker to the right.  Maybe between month 2 and 3?


comment:
This screen locked up on me and won't allow me to continue.


comment:
I can see another question underneath the reps question.


comment:
We need to have the sales rep provide feedback.  I didn't get any feedback after clicking submit - only the next button activated.


comment:
I'd like to have the flags appear after the learner reaches this screen so it's obvious what the new tool is.


comment:
Can we have the sifter come in after the learner reaches the page?


comment:
A number appears over the dinosaur on this screen.


comment:
Need to tweak the text here to make it relevant for sales managers.


comment:
add text at the end of the last sentence "to you and your sales reps."


comment:
We tell them about these meetings up front, but have not included them beyond this slide (with the exception of bi-weekly/weekly).  Look for opportunities to weave these in -- we don't have anything for wrap up/goal review that sets the stage for the following year and we have existing opportunities for monthly and quarterly. Need to be deliberate in calling these out.


comment:
Incorrect feedback needs to give the learner the answer since we're not trying again.  Maybe something like "I checked that, but didn't find anything new. I actually found some info about this on their website.  Check out what I found."  and the updated text can appear in the notebook page.


comment:
Have the new tool come in after the learner reaches this screen.


comment:
FOR ALPHA - Let's make sure that you get the screens in this section from me/ that we harmonize how we use the account plan book/tabs/etc so that everything is the same from course to course.


comment:
I'm not sure if there is a more optimal way to lay this out so that Digs' feedback doesn't have to be right over the questions. maybe the options can disappear on the feedback layer?


comment:
The instruction needs to be changed to video conference context.


comment:
Should the title be "A Year in the Life of a Sales Manager"? or are we just going to keep the colon?


comment:
"...account and FOR mapping their influence..."


comment:
The subtitle of this screen should perhaps change. Maybe "Account Plan Lifecycle" would work.


comment:
I like JC's comment. Also, I don't think we need the quotation marks around the pop-up text.


comment:
Change the first sentence of the instructional text: "Click the best source(s)for the information that the sales rep needs."


comment:
When I hover over the non-highlighted tabs in the book, my cursor changes to the pointing finger for clicking, but the tabs aren't clickable.


comment:
I experienced the same lock-up issue. Also, the positive feedback isn't very definitive. I'm not sure whether or not I've made the correct choices.


comment:
Re: JC's first comment: On the positive feedback layer, I can see the rep's original question underneath his new speech bubble.


comment:
I agree with JC. Also, speech bubble should read "...indicates that THE learner has earned..."


comment:
The first and third response options suppose that the sales rep is female, but he is male. Change "her" to "him".


comment:
On all of these interactions, can we make the selected state for the answer options more obvious?


comment:
The placement of the subtitle on this screen is *slightly* off from the placement of the subtitle on the previous screen.


comment:
Change all masculine pronouns in Digs' speech bubble to feminine.


comment:
Some of the questions that are multiple select tell the learner the number to choose and some do not. Would like to be consistent if possible.


comment:
Please add the zoom feature to the image.


comment:
We may want to rethink this question since some customers may not have a module listed. If the question stays as is, the 701, 702, 502 and all modules will need to be unbolded and change c to e for the 602 module.


comment:
If question stays the branding needs to be corrected in the feedback. cobas c 701, cobas c 702, cobas c 502 and ISE modules with cobas c bolded throughout.


comment:
Add Reaction to the beginning of the sentence. "Reaction cell rinse nozzle tips should be cleaned..."


comment:
Disregard previous edit and change question to "Reaction cell rinse nozzles should be cleaned with a lint-free cloth moistened with deionized water."


comment:
Update feedback to reflect new wording in question. For example, Correct feedback should be "That's right. The reaction cell rinse nozzles should always be cleaned with deionized water on a lint-free cloth."


comment:
Update branding on correct feedback. Should be "On both the cobas c 701 and cobas c 702 modules, a level..." with cobas and c both bolded.


comment:
Add modular analyzer series behind 8000 and before Operator's.


comment:
In the correct feedback, change on to in.


comment:
This section gets too much into managing customer interactions and relationships versus account planning key points.  Would recommend removing exercise and we supplement with case studies or in another way if needed in the future.


comment:
I think we want to focus primarily on the three rows of the if/then table. Would it be possible to show the "retrieve form" and "document inspection" steps as static boxes along a 3-box timeline? (1. Get inspection form; 2. Complete the inspection <THIS WOULD BE THE ONLY CLICKABLE ONE>; 3. Document the inspection)


comment:
I like your prompt to use a story. Very thoughtful.


comment:
AND the clipboard is clickable??! Super bonus points.


comment:
Circle over the broken barrier could be centered over that better... not sure if that matters.


comment:
There are no follow up Q's to scenario 3 - is it supposed to be a "No issues" scenario? If so, make that the correct answer.


comment:
Let's confirm with april whether this course will need the resources or glossary pages, if not we can take the out for her.


comment:
Update branding "...for the cobas c 701 and cobas c 702 modules and in a large bottle..." with cobas c bolded.


comment:
The options listed do not match the buttons highlighted on the screen. Change Manual Registration to Reagent Load Unload List.


comment:
Will need to update the branding for the Daily Checklist Basics topics. Can just have c 502 etc.


comment:
If this is written as th elearner will see it, the feedback needs to be more than "not quite."


comment:
again, this negative feedback is not enough to just say wrong. Either make them get it right (my preference) and the negative feedback is a hint, or tell them what they should have selected. Make the learner engage in the course!


comment:
Fix feedback - I'll just let you check this throughout


comment:
the way the course is currently set up i can easily get to this screen with incorrect answers. so "well done" is not an accurate statement. Do a logic check throughout the course with yuor scripting


comment:
that box clip art does not match the style of the other images on the screen. For the DP, I would not have all of these graphics already picked out.


comment:
Last part of the audio is a duplicate of the first part. Please check the audio does not match with the transcript.


comment:
1st pop-up: I would delete the example as this information is already mentioned in the first bullet point.


comment:
Do we need the example for each ALCOA principle? Mostly the examples are duplicates of the bullet points. This affects the next slide (ALCOA Paper Source Documentation), too


comment:
In the demo on how to display an Investigator site change form, we don't mention that the CDC will have automatically a new investigator site change form in the ISEC section if he/she needs to do a new assessment. For example I do a PI change, I re-qualify the site; one week later I need to do a Location change, a new "Investigator site change form" in create mode is automatically available in the ISEC section. I can click on create and select the Location change category. If I select "Not-Qualify", I won't be able to use an "Investigator site change" form anymore.


comment:
For the Word File example, I would add "dated". Printed, signed and dated notes (in the example and the feedback)


comment:
For the 2nd pop-up, had we agreed to add a reference to the Global Record Retention Schedule?


comment:
2nd pop-up: I would include the information if a feasibility is required an COPM approval of the feasibility questionnaire is required before evaluating a site


comment:
3rd pop-up: location should be entered at least for CT material and lab supplies with the responsible site personal.


comment:
please ignore my comment regarding 3rd pop-up


comment:
1st pop-up: Discuss with a Trialforce SME if it is mandatory to attach the confidentiality agreement in TF? I log a call that the signed confidentiality agreement was received without attaching the document. Is this acceptable as well?


comment:
upper paragraph seems to have a different font color in the text?


comment:
Purple box "... put them in the source"
Can we discuss if this is correct wording? If they have an EMR then that would be the source, mayve re-wrd to "... put them in a source-binder"?


comment:
Can you change the last bullet to EU Directive 2005/28/EC?

Thanks!


comment:
Is it feasible to implement a practice activity regarding entering the email address for Safety mailing? This topic should be included somewhere in this training.


comment:
second link guide me to Vault QualityDocs but not to the right document, could you please check


comment:
For quarterly popup, change "use these meetings to assess" to "Use the account plan to assess"


comment:
The feedback should appear from the sales rep character.  Don't need the feedback box.  The only thing we need from the feedback box is Click Next to continue.


comment:
On this activity, when a learner gets incorrect feedback, we need to tell them what the correct options were.  Maybe Digs does it?


comment:
I feel like they need to get a little more info from somewhere in order to figure out who else should be involved.  Maybe we have a popup of the Strategic Alignment page from the account plan that shows the Cummins team members.  I can mock this up for you if you like.


comment:
Change to "During your quarterly meeting with the team for the team performance review, you notice one of the account plans seems to have gaps in it, and you ask whether the plan has been shared with the customer or not. All of your reps are shocked that you would ask them to do this. How will you respond?"


comment:
Let's expand Digs' statement a little and say "Digs shares additional information about how the account plan can be used as part of a team performance review and indicates that the learner has earned another valuable tool for their sales team."


comment:
Let's tweak the final statement to "Digs congratulates you on your remarkable discovery and your success coaching your team on account planning."


comment:
I would take the opportunity to highlight JBDM steps (not just head and heart at the end).  Here, I think you could add at the start of the 2nd paragraph, "Monica begins by identifying the helpful frame for her decision, by taking a look..."

Then, I would add either here or on a separate screen, some information on her identifying what's important to this decision? (it sounds like it's risk but I'm not sure that's really it?  Maybe something like, based on the frame, she feels that the most important thing in making this decision is to minimize the risk that the site will not be able to meet the requirements of the trial (or something like that).


comment:
I would call out that in using sound reasoning to eliminate a site, Monica focuses on what she identified as the values and pays attention to her head and her heart (like Sophie mentions too).


comment:
Question for SMEs - is the value/important decision making aspect really low risk?  or is it something else?  Something like, "Ability to meet all or most of the trial requirements" or Credibility of site/Ability to successfully complete the clinical trial?


comment:
is 2 conferences over 4 months a red flag (and is that obvious to CDCs)?  It didn't seem excessive to me.  If it was 2 over 2 months, it would.


comment:
or would the values be enrollment potential, PI oversight and data integrity only?


comment:
first sentence is very long - would break into 2.  the first part of the sentence didn't make sense to me but after I read SV's comment to revise, it does.


comment:
the first icon didn't make sense to me - is there a better icon that would show the beginning/trial initiation (two people talking, a blueprint or document?


comment:
I would add specific instructions for navigation here, it was not clear what I should do (or make the circles at the bottom active to use for navigation instead of clicking the "x".)


comment:
I thought if it was required it would have an asterisk? was I supposed to know what was required from the previous video?


comment:
Minor suggestions for Low Risk Site #2, last point: to change upper-case N to lower-case in a word Need; also, site activation rep should be changed to site activation team


comment:
3rd bullet: How to manage -action items- identified...


comment:
Not sure that participation in conferences is the best example of limited PI's involvement. In my experience PI's simultaneous participation in many other studies might much more significantly affect enrollment due to limited PI involvment.


comment:
next to the 7 we should have a >/= sign to be complete


comment:
first one say PI is....I am fine with changing conference participation to the PI and Study Coordinator will have 14 active trials, 9 enrolling, at the time this trial will start enrolling.


comment:
2nd to last- comment- add established to relationship


comment:
add to the 2nd bullet- has participated in 5 diabetes trials within the last 2 years...


comment:
if we revise the scenario for 1 we need to update this box- add something like upon further discussion with the study coordinator I learned that she can't manage the trials they have now.  When the PI was approached about the potential of hiring additional staff he said not at this time.


comment:
should we have low risk before site?  maybe lower risk or just site?


comment:
site 3- bullet 3-maybe we add a bubble that says: remember if a site does not meet certain criteria required for participation in the trial the CDC must document this within the ISEC and as a Task within Trialforce,  including the sites plan to resolve the issue before being declared enrollment ready


comment:
regarding the MRI and documenting follow up- can we have a bubble or something that says something along the following:  If a site or PI does not meet certain criteria required for participation in the trial. The CDC must document this within the ISEC and Trialforce, including the sites plan to resolve the issue before being declared enrollment ready.  We will talk more about this later or something to let them know we will be explaining what you need to do. 
ays:


comment:
MRI bullet- revise to read: CDC will document this within the ISEC and Trialforce as a follow up item


comment:
I am sending some content on follow up items so you can revise this aspect of the training accordingly


comment:
first bullet prior to selecting a site because the ISEC can be modified while in the qualification stage so if something changes they can update the form should the site resolve the issue before selection but they can't update the form after selection at which point they need to capture the follow up item


comment:
2nd paragraph:  qualified to participate in the trial


comment:
At the top should we include prior to final selection the following steps need to be taken?


comment:
maybe rather than put we say participate or be considered- just not a fan of put


comment:
We need to highlight that before a site is selected the CDC needs to partner with the COM and COPM to ensure the allocation strategy is being met


comment:
first sentence....as Back-Up for consideration later in the trial.  I think we should highlight that the form can also just remain in the "qualified" status


comment:
Here you call it Sales Support Source - elsewhere I've seen a different name. I would just make it consistent across all screens.


comment:
disregard my comment of adding that the form can stay in "qualified" status as this is more appropriate for the next slide


comment:
add to the 2nd bullet ...complete the steps to qualify and select.....


comment:
not for right now, but I would group the six steps to match your 3 customers (before the sale, during, after) by using a different color for that organizational banner down the side. That would make it clear that steps 1-3 are pre sale, 4 is during, etc.


comment:
is the arrow a different color that's pointing to resources? I don't think it's the same Cummins red as everything else.


comment:
in the sample PDF, you probably want to put the title where it currently says "PDF Title Goes Here" in the black section at the top.


comment:
customer a - I am ready to buy... (am missing)


comment:
I would make the opening text here a little more personal. "Now is your chance to use the Sales Tool Source. Learn about three customers, and then decide which tool to use with them. Be sure to consider where they are in the sales process: pre-sale, during, or post-sale."


comment:
directions "to the filing cabinet" (the missing)


comment:
I would capitalize P in Process in title


comment:
just for the DP - when you trigger the Try Again feedback, can you also bring up a yellow Note to Cummins that gives them the correct answer? Since they don't have the full Sales Tools Source to review, they may need it.


comment:
I would anchor the feedback to the left, since you have all the draggable items on the right.


comment:
Correct feedback last sentence "Find out more..." (out missing)


comment:
"to the file cabinet..." (the missing) -For directions make the same updates as you did to customer A here and at customer C.


comment:
I got the try again feedback when I sorted per what's in the parenthetical statements.


comment:
before I forget we need to ensure we capture satellite changes which are documented in the Satellite Change Form or note that should a change occur at a satellite location you must complete the necessary steps and document in the satellite change form


comment:
actually, ignore my edit about the title. I would remove where they are in the sales process from the title as I think it might make it too easy. Can we include in the Incorrect feedback "This customer is in the middle of the sale." to help them know where they are?


comment:
same issue with getting Try Again feedback when I sorted correctly per parentheticals


comment:
I would add one more screen after this that shows the 3 customers labeled with their point of sale (pre, during, post) and the appropriate tools listed next to them. That way they get a little summary of what they learned in the exercise.


comment:
Resources disappeared - which makes it hard to bookmark the guide.


comment:
I would remove the note to Cummins here. I feel confident those are the right points. :)


comment:
start bullet 2 with "Remember, the..." so that it's parallel with Bullet 1


comment:
Finally - I would make the tip a real tip that stands out in some way. Maybe with a paperclip icon to represent bookmarking? or a star? It shouldn't just be a bullet.


comment:
The numbers 1,2,3 on the graphics are difficult to see.


comment:
Consider spelling out "Site Profile Information" form the first time it's mentioned, instead of using the acronym.


comment:
I do not know if Defend is the most appropiate one, it is to support your decision. I agree that we need to add other stakeholders as it is not only for Lilly.


comment:
Document the deceision in TF could be a correct answer, some COPMs ask the team for feedback and sugest to include the communications as an attanchment at TrialSite level


comment:
Could we open the next steps without close the first one?


comment:
For # 1... Will we be able to set sites as Back up without confirming with COPMs?


comment:
Should we include a link to the TF collab - training section?


comment:
This question needs more clarification on back-up site vs. one we are just waiting to select, because those are two distinct scenarios with different answers.  Alternatives: Q - "What if a site is qualified, but we do not plan to select them unless they are needed at a later time?" A - "List the site in the system as a back-up."  Q - "What if a site is qualified, but we are not ready to select them yet due to COPM guidance, trial timelines, etc.?" A - "Wait to click the select button until you are ready to select the site."


comment:
Slide said I completed all practice activities after I only completed 3 out of 4.


comment:
It is not clear qualification vs selection


comment:
First pop-up: please clarify is LOCs are always uploaded to TF. I checked the TMF Index and there are references to TF and eTMF.


comment:
First pop-up: last bullet point: please clarify what site interactions are added to TF. Is it a field that needs to be completed? or is it emails that need to be uploaded?


comment:
Minor comment: Consider removing the "s" since system is spelled out after the acronym - From: Electronic Medical Record (EMRs) system  to" Electronic Medical Record (EMR) system


comment:
I thought the napkin example was going to removed per the beta comments which say this will be covered via the new examples.  Do you want to remove from this chart?


comment:
I like the change to the text for the 4th pop-up. This is much clearer than the beta version. THANK YOU!


comment:
pop-up Always Do: change the email address for Safety Mailings in Trialforce; Request to update IMPACT


comment:
pop-up Always do - following information could be added: complete the investigator change form and update SPI if applicable


comment:
link to Trialforce collab site could be added


comment:
1st box: I would als add the word MAJOR, as it is in the VO:
Recognize the important considerations for the five major change categories.


comment:
VO, 1st paragraph:
"... once the trial has started" or "... once the site has been activated"?


comment:
VO, 2nd paragraph:
"... qualified to participate throughout the entire lifecycle of the trial."


comment:
VO, 2nd paragraph:
"When a change occurs during the trial, either at the site or at Lilly, we evaluate the site to ensure they remain qualified to participate."


comment:
VO: 3rd paragraph, to review during the meeting as I don't know what is intended with that sentence.


comment:
VO: 4th paragraph: "You need to reinforce with your CRAs that as changes may impact patient safety, any new site-information needs to be communicated to you promptly.


comment:
VO;
Bureau of Motor Vehicles isn't global. Replace with something more generic. "... update your driver's licence and car registration at the applicable authority"?


comment:
CRA pop-up:
1st bullet: I don't think requesting accounts relates to communicating to the right people. Split this bullet in 2?


comment:
Can we review Site Activation box with the SMEs. I think, and also from the process map, they do much more then these bullets. Distributing docuemnts, update the Clinical trial Agreement if applicable, etc.


comment:
Use the full name of the form: Investigator Site Change Form


comment:
1st bullet in purple box:
Contact the site as soon as possible to learn...
It may or may not be over the phone?


comment:
SAM Representative in Always Do instead of Site Activation Site Manager


comment:
I feel like all 3 people should be the same size here and in order a, b, c


comment:
These screen feels a little jumbled. How about "Take It" and "Leave it" on the headings, and make it a table. I'll actually just mock something up for this screen to help and email it to you.


comment:
Tool 2 icon needs to be centered vertically on button


comment:
Same as Kristen - got try again even when i sorted based on what should be correct


comment:
Same issue again for me too with try again feedback when correct


comment:
Also same thing as previous slide on Tool 2 icon


comment:
I think the scenario instruction needs rewording: "... and the site informs you the PI is leaving and sub-investigator will take the PI role (?)


comment:
Should "study coordinator" be capitalized since it's a title?


comment:
Should "principle investigator" be capitalized since it's a title?


comment:
Should EMR be updated here as well as it was in line 6 of the spreadsheet? If so, you may want to do a global search for this term.


comment:
In the transcript, should "study coordinator" be capitalized?


comment:
Same comment about "study coordinator". This may just need to be a global search if it is determined it should be capitalized. :)


comment:
Transcript doesn't quite match with the audio (it only says ISEC and SPI and does not spell out their definitions like it shows in the transcript currently). May want to update this.


comment:
"Refer to the Guidebook" instead of See the Guidebook?


comment:
2nd bullet Why it Matters:
-... If CT Material shipments


comment:
last bullet:... we are ready for inspections by Regulatory Authorities


comment:
Under things to consider:
2nd bullet: ... If so, use your judgement to determine if enrollment needs to be paused while the new site is evaluated.


comment:
Things to consider
3rd bullet:
Plan for the move: does this refer to the transfer of the CT Material? Should we say plan for the CT Material transfer?


comment:
Always do:
1st bullet:
Given that this scenario is on a site move, I don't think we should refer to the example of switching from paper to electronic filing. I would delete the sentence of minor changes, unless SMEs have examples of minor changes related to a site move?


comment:
Could there ever be a phone evaluation in this scenario?


comment:
Why it Matters:
1st bullet: can we add some examples of process changes that would require re-qualification?


comment:
Things to consider:
1st bullet: rephrase: ... For example, you may need to update the SPI in addition to the Investigator Site Change Form.


comment:
Always Do:
2nd bullet: SMEs, should we refer to developing a mitigation plan and developing a follow-up item in Trialforce?


comment:
In the scenario, I would change last sentence to:
After assessing the site's CT Material destruction process and documentation, you determine it is not acceptable to Lilly.


comment:
Saying "when applicable" under "Always Do" seems contradictory. Maybe say: In cases where the site needs to be re-qualified, complete the Trial Evaluation portion of the Invesigator Site Change Form.


comment:
The resource/notes/etc. buttons all have a red X to close, but I was sure they had the "return" button in the previous RCRA course because that's why all the popups have that now. Can you confirm if their template has changed?


comment:
I don't know that is is about overcoming difficulties.


comment:
1st answer option: re-word:
Inform the site that if it doesn't have the required equipment, THEY will not be able to participate in the trial any longer.


comment:
2nd bullet, add:
".. and Manage Site Information process maps"


comment:
For all the Things to Consider boxes, should we add the head and heart symbols for reference to judgement-based decision making?


comment:
Transcript (and VO) - 2nd paragraph, change first part of sentence to, Lilly, as the sponsor, is responsible for...


comment:
Information change - question for SMEs, wouldn't some personnel changes require qualification, e.g., PI change? if so, I would clarify personnel as Non key Site Personnel for this example


comment:
Wasn't sure if I was supposed to click on the first box?  it already had a white checkmark, so wasn't sure


comment:
"Always Do" seems awkward as a title.  Maybe replace with "Actions you should always take?"  I know it's wordier but seems less strange.


comment:
Since it's a global audience, not sure if "Things" to Consider would resonate, maybe Questions to Consider or Key Considerations?


comment:
I only clicked one response by accident and nothing happened, should there be a feedback response that you must select a response for both questions?


comment:
clarification of my comment, not "non-key" site personnel, (the example used with the Study Coordinator I think is considered a "key site" person, maybe just "some" personnel changes, with an "e.g., Study Coordinator", may be enough


comment:
In the instructional text at the bottom of Sophie's speech bubble, only "Click Play" should be bolded in the first line.


comment:
In the pop-up for the orange spot, "FDA approved" should be hyphenated.


comment:
Based on the revised text in Sophie's speech bubble, the title of the easel should read "Key Performance Characteristics Redefined After Calibration." Not sure if this is what the client wants though.


comment:
Revise the text on the tablet as follows: "Tests that are built from scratch by the laboratory are called "homebrew" LDTs. These LDTs have no regulatory body oversight. As you will learn, LDTs can also be built using commercially available components. To construct a homebrew LDT, a lab must:" The bullet points can remain the same.


comment:
Should just leave up Roche Account Manager or Sophie up vs. changing it to "Guide"


comment:
Site activation in responsible to performance the submission and obtained the approval if we have a Change of PI or Site.


comment:
Global change: in other courses the continue button is placed directly under the speech bubble


comment:
Third bullet under advantages should read: "Can be designed around existing laboratory system"


comment:
Move the continue button under speech bubble


comment:
Also in third bullet under advantages, bold "existing laboratory system"


comment:
In the Constant Bias popup, change "normalize" to "normalise"


comment:
We need to add some text to Sophie's speech bubble: "For this example, we used an actual package insert for a CE-IVD reagent kit. That insert is available under the Resources tab."


comment:
Obtain ERB and MOH approval until to authorized site change.


comment:
We need to bold all instances of cobas. It appears in the bullet points and in the references pop-up.


comment:
Revise the parenthetical text at the end of the first bullet to read as follows: "CE-IVD/FDA-approved"


comment:
In Sophie's speech bubble, change first sentence to: This hand tool icon represents LDTs...


comment:
In the green instructional text, "FDA approved" should be hyphenated.


comment:
Change the instruction text (i.e., Click the table...) to green


comment:
Change instructions text (i.e., Choose a material...) to green


comment:
The "i" in the more info/references icon should not be italicized


comment:
When the dragger for Roche cobas tests is dropped in its correct location, the cobas text reverts back to standard (i.e., non-bolded) text. Also, the registered trademark logo reverts back to being non-superscripted. Both of these formatting errors need to be corrected.


comment:
On the easel, all instances of cobas should be bolded.


comment:
Change slide title to "CE-IVD/FDA-Approved Tests" instead of "CE-IVD and FDA approved Tests"


comment:
Change slide title to "Connect the Dots: CE-IVD/FDA-Approved Tests" instead of "Connect the Dots: CE-IVD and FDA approved Tests"


comment:
Let's change "customers" to "clinicians and laboratories".


comment:
Remove the spaces before and after the slashes in sophie's speech bubble


comment:
Add a period to the end of the instruction sentence


comment:
2.And take out "so the technician entered the fault codes...";


comment:
Bold the words "click" and "Resources" in the final sentence of Sophie's text.


comment:
In sophie's speech bubble, change to "...availability of CE-IVD/FDA-approved tests..."


comment:
For consistency, we should remove the commas and periods that appear at the end of the bullet points for Technical Advantages and Clinical Utility.


comment:
In incorrect responses, use "try another option".


comment:
Bold "Click" and "Resources tab" in sophie's speech bubble


comment:
Add "PCR" to the end of the first line of Sophie's text. Add "is the" to the beginning of the first bullet point. Change "&" in first bullet point to "and". Add "is" to the beginning of the second bullet point. Add "has" to be beginning of the third bullet point. Change "turnaround" in third bullet point to "turn around". Remove "Testing" from beginning of the final bullet point. Replace ";" in fourth bullet point with "and". Add "are" between "assays" and "available" in final bullet point.


comment:
Remove spaces before and after slash in "HSV 1/2"


comment:
1. Agree with JSA;
2. Option 3 change to: Cummins technical experts need to come to the site to help troubleshoot. 
3. Change the right answer response to "Good thinking! At this point, it was time to dispatch a Level 3 technical expert. The technical expert used an engineering tool to understand the issue and complete the repair. It was a great outcomes to a complex problem. By escalating the issue to the right level of expertise, Cummins was able to get the customer back on the road as quickly as possible."


comment:
Remove "A comprehensive resource designed to.."


comment:
Bold the cobas and r ball in the lab director's speech bubble


comment:
Change last sentence to "in my onboarding session today."


comment:
In the bottom option... remove extra space between "Test" and period. Also bold cobas and r ball


comment:
Shouldn't we jump back to the module menu and have learners click the masterpiece spot on the palette?


comment:
On theses challenges in the feedback pop-up, make the "Click Continue." text green


comment:
1. Change "cohort" to "session";
2. Change the last sentence to: "Just like this restaurant, we must have a reliable product that our customers can depend on."


comment:
1. Change first sentence to: "However, just having a great product is not enough. The Cummins Support Network must deliver Legendary Service to meet customer expectations. Legendary Service includes:";


comment:
Remove "Your knowledge of" from the beginning of Sophie's speech.


comment:
We need to update the challenge questions on the Module 3 pop-up plaque.


comment:
The image for mod 3 needs to fit the frame... there's extra white space to the left


comment:
1. Change "Regional Response Teams" to "Original Equipment Manufacturer Dealers"(this is a correct answer).
2. Remove "OEMs".
3. "Global Remanufacturing Centers" is an incorrect answer.


comment:
Add the trigger to show the pop-ups for mod 1 and 2 when the plaques are clicked


comment:
In the mod 3 popup, move the scrolling box down a bit. the title gets covered up a bit with the text


comment:
I would switch Site Not Select to the left side and add CDC should update site, PI, information directly to trialforce besides ISEC update.


comment:
Should we add after site is selected????  IF this is before site is selected, the only action is the second box.


comment:
Is DNU site called out here for any reasons??


comment:
Why does it auto transfer to another screen when it goes from John's audio to Abby's?


comment:
Move performance pieces (what the manager can learn by looking at the account plan) to the beginning after the account plan segment review or end, if feels out of place thrown in with the customer sharing section.


comment:
These types of questions should be asked throughout the year in 1-1's and quarterly reviews and this gives the impression it is just an annual reflection / check-in.  Maybe this goes better with the points on times of year to review account plans to elaborate further.


comment:
Could also move the glossary to a page in the resources.  Right now when I click Resources, nothing happens.  We at least need a placeholder for information.


comment:
We are not "revisiting" different phases, rather we are learning about the order and purpose of the phases of the business review process.


comment:
What happened to having the learner figure out what question(s) are answered based on the slide?  The slide provides critical information to the proposal, what question(s) does it help answer?  Need to have the learner make the connection.


comment:
Need to bullet the instructions; it's difficult to read.


comment:
Need to bold the key elements in your instructional text.


comment:
Ummm I only plotted one point and it was sort of incorrect, but I got correct feedback and the continue button.  I never plotted RMD EMEA.  Was I supposed to?  Is this what learners will actually do on the job?


comment:
This is the first time I've seen anything about using content across slides to tell a story / using data to tell the story in a consistent manner.  May need to include that information up front as a why and a how.


comment:
I accidentally hit TAB to move to the different fields, and when I do, I get yellow highlight boxes on different items on the screen.  TAB from the first box goes to highlight th title bar, TAB from the 2nd box highlights the MENU button...


comment:
I don't understand how the chart on the right is providing these values.  Can you put the values on the chart?


comment:
Maybe we add a highlight box on the chart to show the three items we're looking for.  On the chart on the right, they are all listed as whole numbers so I don't know where the decimal-specific ones are coming from.


comment:
Transcript should read: ...so I have to ask myself, "Are charge codes triggered?" (add quotes)


comment:
Can we extend the music to not end at 3:15?


comment:
Sounds like it just ends for a second or two, then comes back but much quieter than it was before


comment:
0:31 - audio says "store forecasts it will SPEND" and transcript says "SELL" - assuming it should be sell. Re-record is just a NICE TO HAVE though.


comment:
transcript, 2nd last paragraph - add a comma after decrease


comment:
End - should the 3rd thing also be a green check? looks the same on paper and computer screen.


comment:
2nd sentence - should be "The market will..."


comment:
Greenhouse or green house? We have it as 1 word on button and in paragraph, but with 491 it is 2 words


comment:
Text in popup is cutoff... starts with "consumed, the EIM is charge for..."


comment:
Javier should be bold in directional text


comment:
Why do we not have summary notes here? I see that we have a note to them, but can we not write these now??


comment:
1. Capitalize "Service" not "function" in the entire course;
2. Remove "and wants"; 
3. Change "Those skills" to "The skills below";
4. Take out "Unique" in the last line;
5. Second skill - "Learn how customers use..";
6. Third skill - change "channel" to "service network", check for consistency of use of "network".


comment:
Feels weird how we keep auto advancing to different screens. This all seems like 1 screen


comment:
Transcript, last sentence - the c in charge looks like it has a strikethrough on it


comment:
Icons - the blue bkgd is a little harsh with the other colors. Perhaps lighten it to more like 75%ish


comment:
First sentence doesn't really make sense. Maybe it should be "Offset settlements are calculated by looking at what was dispatched and transferred between EIM Entities. Then, any differences in the LMP are settled up with EIM Entity Scheduling Coordinators." ??


comment:
Again feels weird that we are autoadvanlcing between screens


comment:
first paragraph - change period after charge to a comma, bring which in turn up after it so it is all 1 sentence.


comment:
Why do we call it a situation sometimes, and a scenario others?


comment:
QRG/resources tab should also be available on this screen since we reference it


comment:
Once we click Rhonda and audio begins, can we change her pose to looking at us?


comment:
Scenario details button - can we make this more of an icon button? Like a small square or circle with a notebook? And move it to the top right corner?


comment:
Scenario details button doesn't work. Also same changes to it as mentioned on previous


comment:
Sentence two, start with a capital letter


comment:
Please stick in Sarah's updated animation, assuming it's available tomorrow


comment:
Animation script, 6th paragraph, 1st sentence:
add -ed to end of forecast

"...EIM Entities' records for energy forecast(ed) and energy delivered. "


comment:
Animation script, 8th paragraph: 
Add a comma after "during"

"....triggered based on what happens before, during(,) and..."


comment:
THis screen needs some love: 1. We never reference the list on the easel, 2. Sophie's text feels like a catch-all/very wordy. Can we "tell the story" better, and maybe use bullet points or something to make the important info more extractable??


comment:
Animation script, 14th paragraph:
Add "to" between "and" and "understand"

"...validation data, and (to) understand...."


comment:
Text change, 2nd sentence:

"These charges may also be triggered...."


comment:
1. Add a brief intro of the video;
2. TVD/RK - will provide new pics with Cummins tools and engines - make sure PPE shown;
3. JSA - stay on the career paths screens longer;
4. Change "Soft skills" to "leadership skills";
5. Change "track" to "path";
6. Change "Create diagnostic, processes, and tools" to "individual contributor path";
7. Remove "than mine" in "He had a completely different path than mine";
8. Add another bubble explaining both need a combination of leadership and technical skills but the below are the primary skill sets;
9. Change the first technician path to "Engine in-shop technician" - "Power Generation field Technician" - "Supervisor" - "Level 3 technical expert". 
10. Change bubble to "He began as an in-shop technician performing repairs on truck engines and then through training and work experience became a Power Generation field technician."
11. The next bubble is "A few years later, he was promoted to supervisor." 
12. The next bubble "Now he is a Level 3 technical expert." Change picture to two people collaborating in front of a Cummins product;
13. Change the second technician path to "Engine in-shop technician" - "Diagnostic in-shop technician" - "Customer on-site technician" - "Technical trainer".
14. Capitalize "Service" in "service function"
15. Change to "Enjoy the journey".


comment:
1. Different background picture; 
2. Add "talk to your manager to begin your journey".
3. we don't plan to add additional resources to this page.


comment:
Need to mention the game here - scoreboard doesn't make sense until the next slide.


comment:
1. First bubble: "...I know it is not "all about me", but I wish I had some direction about where I can go from my current role.";
2. Second bubble, last sentence: "we have input into our career journey."


comment:
Move directional text over by the intro text where it usually is


comment:
1. Second bubble: "...based on my strengths, interests, and business need." and take out the last sentence.


comment:
Text on buttons on q1 of 2 is left aligned, here it is centered. Check the others too and make consistent


comment:
Audio stops when i click transcript button


comment:
1. Daily debrief part needs to go to the first screen of the scenario with the scoreboard;
2. take out "Product performance sounds interesting...";
3. Change all the options to: "Problem solving", "Customer support", "Communication", "Product knowledge".


comment:
remove periods from buttons 1 and 2 since there's already a period after the blank


comment:
Correct feedback - make it so e- and Tags is not breaking over 2 lines


comment:
Correct feedback - Q2, period after first sentence looks giant


comment:
Is this a recap of challenges? If so, can we bullet point under an umbrella sentence?


comment:
In menu, I see scenarios 1, 2, 4, and 5 debriefs, but no 3. Also wondering if we should put submenus in for each scenario with the associated pages nested under each one so this menu isn't quite so long to look at/make it easier to navigate using menu


comment:
First box - I'd bold/green "does not lose money" instead of just 2nd instance of not


comment:
audio stops when transcript button is clicked


comment:
1. "Cummins is actively differentiating...";
2. Make sure newspaper summary matches the daily titles;
3. Change "cohort" to "talent";


comment:
correct feedback, q2 - add comma after meters


comment:
Change the background pic to new DBU HQ building - will provide the pic.


comment:
Sometimes charge code numbers stand alone (i.e. first dragger on this screen and associated feedback), and sometimes they have CC (i.e. 2nd dragger on this screen and associated feedback). Which is right? Make consistent.


comment:
Edit first sentence "I think of tests built from scratch by the laboratory as "homebrew" LDTs: a completely custom solution that has no regulatory body oversight."


comment:
I thought that the advantages and disadvantages were going to populate either side of the image. To do that, it would make sense to have the corresponding side of the outline populate.... let's discuss.


comment:
Please align the bottom of the table with the bottom of the bulleted list


comment:
Text in first two green boxes should be "Choose primers/probes/master mix for the lab." and "Choose QC materials for the lab."


comment:
When green bulleted list boxes appear, please add a heading to each one: "When making this selection, a lab must consider:"


comment:
Need to add the particular test example this is based off of from the ppt. JAMES can you provide? It's Altona something...


comment:
Introduce the specific kit on this slide (re: the example you're about to see...") ADD PI IMAGE TO RESOURCES


comment:
JAMES - confirm a.)that this is the right graph, and b.) refine text to make some connection to this image


comment:
HTP: Scoot up the bottom dollar sign - right now the point at the bottom overlaps it


comment:
Please bold the question text in the red boxes.


comment:
Recommend changing Key Players to Key Roles Impacted by a Site Change.


comment:
For the CDC pop up, suggest changes require rather than changes requires


comment:
Edit the "If nothing else" sentence: Do a hard return, and start the sentence "REMEMBER: It is okay to have discussions with labs about using plasma. Converting from whole blood..."


comment:
Script, 3rd paragraph, last sentence:
missing a "the" 

"If THE number of parts..."


comment:
script, 4th paragraph, 1st sentence
add a comma

"...to serve the load(,) the ISO runs..."


comment:
In operational considerations, bullets don't start with verbs, while previous popups have started with verbs. ALSO: first bullet for antigenemia - labor should be "labour"


comment:
Recommend changing Study Group to Study Team on the Study Team pop up.


comment:
Replace discordant in option 2 with "different"


comment:
For the CRA pop up, more information is required to understand the statement "verifying if the site provides the new contact information to subjects".  It is difficult with the current wording to understand who at Lilly would be involved in this step.


comment:
script, 7th paragraph, 1st sentence
missing a comma

"...EIM balancing authority is paid, or charged(,) for load deviation."


comment:
Script, last paragraph
Missing hyphen
"Over and under(-)scheduling charges..."


comment:
Edit to sophie's fdbk : "practise" should be spelled wiht an s


comment:
I also wasn't clear if I was supposed to click on each individual box to get more information or click on the CDCs picture


comment:
1st sentence, delete "through the" 
"At T+37.5, resources may be schedule for the..."


comment:
First answer should actually be "neutral," shouldn't it? Please change the "equivalent" distractor to "expensive."


comment:
Recommend changing "big gaps before visiting the site in person" to "additional issues and gaps at the site to determine the urgency of visiting the site in person."


comment:
In first sentence delete the word "of" after each comma.


comment:
fourth wall plaque overlaps the stanchion


comment:
Note on Christa's feedback - Greenhouse is one word


comment:
Meter and e-tag pop up, 67750 (Congestion Offset)  should be 67740


comment:
7087 should be Daily Flexible Ramp Down Uncertainty Award Allocation. Missing the word "Uncertainty"


comment:
In the charge code list, 4575. Align "charge" under "Scheduling", just like the charge code above it.


comment:
NEXT arrow doesn't appear after the video is closed, can't advance past this screen.


comment:
Ignore comment about the NEXT arrow not showing after Forecast fee. It appeared after I clicked all of the green boxes.


comment:
charge code 4575 - the transcript says "Settlements, Metering, and Client Relations", but the on-screen text says "Scheduling Coordinator ID Charge". Change the script and narration to "Scheduling Coordinator ID Charge."


comment:
The Resources document is not attached or the link was lost.  When I try to download the PDF, I get error 404.


comment:
I don't see where we have hit on the satellite change form here or in the satellite module- we need to mention something in 1 of the modules as to how to handle all changes- primary or satellite locations after selection; maybe at the end of the 1st sentence we say ...Site Change Form for either the primary or satellite location depending on what has changed; depending on what module we add this to we should add something in the objectives to highlight the possibility of changes at the primary and/or satellite location.


comment:
More of a reminder as to if we add a reminder about accessing the satellite location change form in a similar way just off of the satellite location page


comment:
This question seems to be for a previous scenario (over and under scheduling) and not the current scenario. Check the question against the script to verify.


comment:
Add the following sentence after Sophie's current sentence: "For this activity, we will use the Altona RealStar CMV "kit" as our example."


comment:
To confirm, this *is* the correct graph from the content deck. Replace all the text currently in Sophie's speech bubble with the following: "As you can see from this graph, even after all these decisions and all this work, our test built with the Altona RealStar CMV "kit" shows low concordance with the results of an Abbott CE-IVD CMV test. In other words, the results from an LDT built with CE-marked reagents will likely not be comparable to the results of CMV tests used at other institutions. And the lab will still have to perform ongoing QC, which requires time and resources, adding to operational costs." NOTE: We may need to reposition the tablet so that the speech bubble does not hide the graph.


comment:
After adding the sentence I just suggested (i.e., "For this activity,..."), add this sentence: "You can find the package insert for this kit under the Resources tab.


comment:
Change Form Summary is capitalized differently on bullet 3 than on bullet 4


comment:
Bullets 3 and 4 seem to be duplicates.  Keep 3, eliminate 4.


comment:
Always Do: should first check point say "PI Change Form" instead of "Investigator Site Change Form?"


comment:
Answer #1 re-word suggestion: "Inform the site that if they don't have the required equipment, they will no longer be able to participate in the trial."


comment:
Information change: I would recommend to add first the definition and then the example.


comment:
Please confirm that we will use the term site selected vs site qualified to be aligned with the process and other modules


comment:
CRA pop-up:please clarify the second bullet, the CDC also handles some of the timing ... it really depends on the type of change


comment:
Site activation pop-up: There are cases where the site personnel changes (e.g. pharmacist)  are managed directly with the CRA or site personnel.


comment:
Please confirm with product delivery if their team is now called CT Material team. There may be also a need to request support from Product Delivery when there is a transfer of refrigerated material from previous location to new location... so Product Delivary can also be consulted when there are site changes


comment:
there is no guidance on when the CDC should visit the site to assess the change or when the change can be assessed virtually


comment:
Always Do pop up: there is nothing related to update Impact and any other system updates such as IWRS, SAFRNS, etc.
Communication to the study team is another task that needs to happen


comment:
Things to consider: if there are changes that impact new equipment... isn't the updated form coordinated by the COPM? I do not know if a statement to verify or confirm key protocol changes with the COPM should be included.. please confirm with the SMEs


comment:
I agree with Sophie, changing source documents is not related to a location change.


comment:
Always Do: communicate to CRA any process change that the CRA needs to be aware for monitoring tasks


comment:
Rhonda is the settlements analyst and would not submit base schedules.  Change the text in the top text box to:  "Rhonda's BA submitted base schedules..."


comment:
Change text in FMM textbox to:
"The BA's participating resources were dispatched by the market, but the market clearing price doesn't cover their operational costs."


comment:
GLOBAL EDIT for feedback on these types of screens: We need to add hints to the feedback for Try Again, otherwise its just a frustrating guessing game.


comment:
GLOBAL - Same as other feedback comment. We need to add some kind of hints to the Try Again feedback language


comment:
Try Again feedback for Scenario 4. 

"The charge codes selected either aren't triggered, or aren't the only ones triggered.  Keep mind that Administrative charge codes apply whenever a resource is dispatched to the market. Review the scenario details and try again."


comment:
Edit the Try Again feedback to 

"The applications selected either are not used to validate this charge code, or aren't the only ones used. Keep in mind that BAAOP, BSAP, and ADS are used to input data into the real-market data.


comment:
Two edits for this slide:
Edit #1: Drop Forecast fee. 

Edit 2: Change Try Again feedback text to 

"The charge codes selected are either not applied or not the only ones applied. Keep in mind that resources were dispatched, which triggers instructed imbalance energy charges, as well as flexible ramp charges.


comment:
There is no question on this screen. Review the script - if the question is not in the script let me know.


comment:
Correction to edit above. Can't just have c 502, e 602 etc.


comment:
The last sentence should change to: This course will help describe the steps and tasks I must take as a CDC  before I can qualify and select a site.


comment:
Header in upper left is missing when you click 1


comment:
Can we tie in the image in number 1 better? I'm not sure what it is, or why it is shown. Also Trialforce is spelled wrong in the complete bullet.


comment:
Stop 2 - same question on the image. I realize you're showing me the contact roles, but not sure why you're just showing this section. Also - can we add states to these numbers? And when you're on step 2 it says to click the red circle instead of step 3.


comment:
Step 3 should say to click step 4. It says click the final stop now.


comment:
Feedback will need to be updated to reflect the new wording of the question.


comment:
Can you let Matt know that this course is going out and see if we can get it ASAP?


comment:
With the background someone might find it hard to see 4 separate images. Can we add boxes?


comment:
I believe the back button may not be working on this screen.


comment:
If question stays need to update the Incorrect feedback to "The sample probes on the immunoassay modules are not cleaned with alcohol."


comment:
Popup 2, 3rd bullet: You may want to add "form" after "Site Profile Information" per the edit on line 30.


comment:
Not sure if it's necessary at this stage, but should the transcripts be updated?


comment:
Should this question stay in the Overview or be moved to the module specific questions? Will check with Julie.


comment:
Looks like there may be some extra space between the first and second answer options. May want to check that they are all equal distances apart from one another.


comment:
Similar to the first question, it looks like the first and second answers aren't quite the same distance apart. May want to verify they are all equally apart. Could just be a nice to have at this point. :)


comment:
Should we change to "Select the three materials needed to perform the Green wash rack maintenance."? Then change "Select the three materials." Will check with Julie.


comment:
Third Bullet: Suggest capitalizing Collaboration and Site.


comment:
First Bullet: Suggest capitalizing Process Map.


comment:
Second Bullet: Should "Guide book" be "Guidebook"?


comment:
Check the visited states on this screen.


comment:
Maybe the learners should be reminded of the formulas before the activity?  After the fact seems too late.


comment:
I am missing HOW the data tells a story and why these slides are critical to the key question and the story.


comment:
Need to add another one of these interactions since we say we want three from RMS.


comment:
Need text that links why talking to the regions is important and what question it answers.


comment:
Can we add a certificate of completion like Jackie has in the SPMT course?  Learners click it to print a certificate. This might help eliminate their initial feeling that this needs to be annual training.


comment:
When I click the menu button, the other buttons on the screen don't all load at the same time.  They sort of filter in with Introduction being last to fully appear on screen.


comment:
Why is the regions label blue instead of green?  Is there a reason we're making them different?


comment:
For Proposal, can you put some text in about what happens when preparing for this phase and why it's important?  This is the only one you need to do.


comment:
May need to change question due to SCISE. Will check with Julie.


comment:
Refer to EcoTergent as ECO-D (EcoTergent)


comment:
Need to update for cobas e 801 and new lots no longer have to have the label applied. Question will need to be reworded. Will check with Julie.


comment:
Ensure it is "ECO-D reagent pack" in question and feedback.


comment:
Need to reword question. Will check with Julie.


comment:
Need to update branding in the title for all modules in the Daily Checklist Basics


comment:
Add "That's right." to the beginning of the correct feedback.


comment:
Check with Julie. The ISE has 2 checks. 10% for slope and 2.5% for comp conc. Need to verify. Maybe just make more general feedback.


comment:
Should we indicate the number that are correct. Will check with Julie.


comment:
Should we indicate the number of correct selections? Will check with Julie.


comment:
Need to check with Julie on this question. Content is not clearly discussed in training guide.


comment:
In the fist paragraph shouldn't it be "that" instead of who (two instances).


comment:
Should it be "Where are two places you can look for troubleshooting tips in the software?"?


comment:
This question seems better suited to be in Troubleshooting section. Will check with Julie.


comment:
Change the sentence at the bottom to "Click the Main Menu button to review any of the Learning Checkpoints."


comment:
Add "the" before Study Team in the last sentence.


comment:
I know this is late, but could we have some sort of image here? Like maybe show the follow up section in TF so it's not just another red box of text on screeN?


comment:
Change last bullet from "in what time frame" to "in a specific time frame?"


comment:
Resources popup doesn't match the to learn more links.


comment:
I think the last word of the easel title should be "Calibration" not "Recalibration".


comment:
The number 3 at the end of the second bullet point should be superscripted.


comment:
Delete the second sentence on the tablet. I.e., "These LDTs have no regulatory body oversight."


comment:
The words "tests" at the end of Sophie's first sentence should be singular ("test").


comment:
The $ at the 3 o'clock position is slightly overlapped by the dot at the 3 o'clock position.


comment:
Each of the bullet point statements should end with a period.


comment:
In the pop-up for Module 3, under the third question of Challenge 1, remove the extra space between "approved" and "tests" at the beginning of the first sentence. Also, change "FDA approved" there to "FDA-approved".  Make this same change in the third sentence of this same challenge question.


comment:
Incorporate all question edits from Bench Tech questions.


comment:
Legal Language - remove training from the title. Also it appears the bottom of the title letters are cut off.


comment:
Font of "Roche Diagnostics Key Operator Training" appears different than the "Roche Diagnostics Bench Technologist Training" header in the onsite training learning checkpoints.


comment:
The "To update the reagent..." option (third option when I took the course) radio button looks different than the other 3.


comment:
Should we add the e 801? Discuss with Julie.


comment:
Change to "... is connected to a pre-analytics system, routine samples come from the pre-analytics system. Calibrator and controls are loaded at the Rack Loader areas."


comment:
update the feedback - change MPA to pre-analytics system.


comment:
Update branding on Day 2 module options. Can't have just c 502 etc.


comment:
e 602 module is not checking off even though I completed all questions.


comment:
In the Key Operator version (Day 2 c 702 question 4), Buffering Mode and Direct Mode were bolded in the answers. Would like the same formatting in the Bench Tech version.


comment:
Is there any way to make the green greener? It is very close to a yellow color.


comment:
Change correct feedback to "That's right. Knowing the status colors will help you when loading reagent cassettes."


comment:
Since e 602 will not check off, Day 2 will not check off completed.


comment:
Image is not very clear. Do you need another screen shot?


comment:
This question does not apply to e 801 only configurations.  I would like to change question to: Which maintenance item is initiated prior to cleaning the components on your c 701, c 702 and e 602 modules?


comment:
Change 4th bullet (wrong answer) to: To generate calibration and QC load lists.


comment:
change question to:  Samples are loaded on the two right trays and unloaded on the two left trays. True


comment:
correct feed back should be : That's right, the right two trays are for loading samples and the left two trays are for unloading samples.


comment:
Disregard my change to the true false question about the rack loader unloader.  didn't realize there would be a similar question later.


comment:
Change the correct answer to:  Verify the correct cobas 8000 analyzer series label is applied and positioned correctly on the vial.


comment:
COPM call-out:
1st sentence, 2 times "strategy". Replace 1 with "approach"?


comment:
Course got stuck here.
Couldn't move to next screen by clicking next button


comment:
Should the Note to Lilly stay? It seems the video's have been updated.


comment:
Need to check programming. When I click next, it takes me to main menu, but asks to click "Introduction to Trialforce " button


comment:
The question seems off here as the site didn't send any information back yet, or at least the learner hasn't seen anything come back. The only thing seen is teh e-mail Mark sent to the site. Should it be:
Based on the e-mail Mark has sent to the site, what other information does he need?


comment:
Nancy, should we replace "action item" with "follow-up item"?


comment:
Trialforce collab site link, links to DNU site. Change to: http://lillynetcollaboration.global.lilly.com/sites/trialforce/SitePages/Home.aspx


comment:
Same comment for last bullet, though that one may probably be deleted?


comment:
not sure the first answer what is ETMS???   Do you mean eTMF


comment:
2nd answer should say:  Document PI qualification details in ISEC.  Why do we elaborate document discussion and final decision in ISEC???


comment:
Course name should be changed to align with the other 2 RLC courses.


comment:
Remove verbiage around WWID in the text.


comment:
Underline part c of the first box since there is a hover state on it.


comment:
Third box: Add a after If at the beginning of the sentence.


comment:
I think we should say CT Material vs. Materials throughout. I believe CT Material is plural, but maybe this is something you have already discussed?


comment:
I feel like we need a smidge more setup for the learner here.  We can link it to what we just completed - You know why the proposal phase is important and what we're trying to accomplish (make sure this is in the Proposal info on the previous slide) - Here is the ultimate question we're trying to answer for our business reviewers (Is this project attractive?)  Which are the best questions we can ask to help our reviewers determine if this project is attractive?  If our learners can think through this, each of the slides will make more sense.


comment:
I would add a note that feedback text will be updated to include why these are the right questions.


comment:
Should this slide have a subtitle?  If it's the template timeline setup, add the subtitle for that section.


comment:
Can you add an outline to the clickable elements that we rollover on the computer screen just prior to this one (when we're making our selection)?


comment:
I feel like the instructions are reversed here.  We need to click the waterfall, then click the folders to figure out what information to enter.


comment:
Maybe the instructions are "Click the waterfall to access the datasheet. Then, click each folder to access your data and enter the information on the sheet."


comment:
Second sentence should be changed to include mention of existing addenda: 
It begins when a change is identified that may impact the protocol or existing addenda or require a new addendum.


comment:
Can we disable the ability for selecting the next button until all safety, efficacy and/or scientific integrity boxes have been reviewed?


comment:
We should keep in the certificate of completions for all courses at this time.


comment:
Course name should be confirmed that it aligns with the other RLC course names.


comment:
Need to confirm as we discussed having this apply for all regions (not just NA).


comment:
Sales process steps need to align with and utilize the Richardson verbiage.


comment:
The link to the second reference is incomplete and doesn't work. The full URL from Joni's notes is: http://www.cobas.com/home/newsroom/
news/immunosuppressive_drug.html However, this URL doesn't work either. Should we include the accessed date in the reference? Joni indicates in the screenshot doc that she accessed the URL in March 2017.


comment:
In the footnote, should U.S. IVD read US-IVD? That's how I've seen it elsewhere.


comment:
The URL for reference #5 isn't clickable. It's HTML tagging seems to be connected with the number 6 at the beginning of the next reference in the pop-up list. However, the URL for reference #5 doesn't work even when you cut and paste it into a browser. The page is "not found".


comment:
Correct typos in reference #8 URL. URL should be as follows: https://doi.org/10.1111/j.1399-3062.2010.00532.x


comment:
not sure why we separate this as debrief and the next as wrap up.  It will be good just do a summary.


comment:
The references pop-up appears underneath the Continue button. Also, Joni wants us to revisit the language we're using when we speak of disease incidence and mortality rate. Compare parenthetical language we used on Risk Factors slide (Serologic Status layer).


comment:
the top title "evaluating a site" is different from the purple text "documenting site selection in trialforce"

The two boxes are also different.  VERY confusing.


comment:
The references pop-up is also partly obscured by the R-/D+ file folder.


comment:
Based on what Joni has indicated in the screenshots doc, we need to revisit the language of disease incidence and mortality rate throughout the section, on basically every layer.


comment:
Contraction in Sophie's last sentence: "Let's" should be "Let us".


comment:
The pop-up layer covers over the Information marker. The marker should be available even when the pop-up has appeared.


comment:
Note contraction in Incorrect feedback layer: "that's not it" should be "that is not it".


comment:
The URLs for references #10 and 11 are not clickable. The URL for #10 is non-functional when you copy and paste it into a browser. The page is unavailable. Joni includes accessed dates with these references in the screenshots doc. We should probably do the same.


comment:
The more components added to the process...


comment:
in first bullet point

...will need to choose the correct level.


comment:
The Hayden doi doesn't work, but it seems to be correctly typed out. The article itself is available here: http://jcm.asm.org/content/55/2/423

The doi is also listed on that page, but again, it doesn't seem to work. The Preiksaitis doi is also incorrect. See feedback on previous slide.


comment:
in the Detection Instrument

Choose and amplification and detection system


comment:
the asterisk next to the cobas CMV test doesn't have a footnote


comment:
Same comments as previously regarding the doi's for Hayden 2017 and Preiksaitis 2016.


comment:
Strangely enough, the doi for the Hayden 2017 reference is working here just fine. The URL itself does appear to be formatted differently than before.


comment:
Although Joni said on the screenshots doc that we do NOT need to reformat the reference on this page, we do in fact need to reformat it. The reference appears here as reference #1, but it should now be reference #13. Cf. the references document intended for the Resources tab.


comment:
Sophie's statement is a little hard to read...Maybe:

Few published reports support the superiority of one sample type over the other, demonstrating whole blood and plasma are clinically equivalent.


comment:
Same comments as before regarding inoperability of the Hayden 2017 and Preiksaitis 2016 doi's.


comment:
I finished module red but it's jumping back to red...shouldn't i move forward to green?


comment:
I finished the green module and it's telling me to click on the blue spot but it's highlighting the red spot


comment:
Preiksaitis doi does not work on any of the layers on this slide.


comment:
As before, both doi's in the reference pop-up route to missing/unavailable pages.


comment:
The Kotton doi is also routing to an unavailable page, but the doi appears to be correct: http://doi.org/10.1097/TP.0b013e31829df29d


comment:
I think we need to emphasize that the pop-up box is the final reminder that CDC need to verify the information they entered in TF are correct and up to date (using the pop-up acknowledged language).  Right now it didn't say anything right now.  After site selected, it is pretty much a done deal,  ISEC becomes ready only;  a serials downstream processes kick in.


comment:
Please change primary contact record to primary investigator contact record as only PI need a safety mailing email address


comment:
The last sentence and the second half of the last sentence seem to be saying the same thing. Also, did specificity get discussed in the prior sections?


comment:
Cannot "check" 2nd customer to get past this screen


comment:
The link to the second reference is still non-functional.


comment:
The link for reference 8 in the pop-up box is not functioning.


comment:
The URL for the Kotton reference (#1) is still not working on this slide. It works on every other slide.


comment:
1st ISEC question needs to change. I will provide the new wording in a seperate Word document to review in the meeting this Friday.


comment:
Should the red text "Example from a trial-specific ISEC" be removed? Given that this is an SPI?


comment:
Nancy, is this still ok to be used in the training?


comment:
Need to make sure the images have the latest branding on as this is changing at the moment and we should be as future proof as possible. Also worth discussing if we can amend the background at all to provide contrast with the with white units without breaking brand guidelines


comment:
Cannot have the Cummins 'C' and the screen titles together, this violates brand guideline - this is the same for all screens with the same format header


comment:
In the correct feedback I would propose some rewording as the requirement is to review in a reasonable timeframe, for example within 30 days.
That's right! This process is acceptable because it fulfills the requirement that safety mailings are reviewed within a reasonable timeframe, for example within 30 days of receipt.


comment:
1. Does North America need an Exclamation mark
2. Will we list the features and benefits for ALL products, that's a strong statement and probably not future proof
3. Not sure what we mean with the last point, ie the different markets beyond genset.


comment:
Sorry, I don't like using Block Capitols as it is known to be hard to read.


comment:
Site Selection Guidebook url needs to change. Waiting on recomendation from John


comment:
Like the overall feel of the slide and the layout and image types.
I think point 2 should be 'extreme weather events and/or natural disasters'
Point 4 should probably be the secondary driver is minimizing the inconvenience, discomfort and risk from a power outage


comment:
Last module is now called Trial Specifics


comment:
Last module of the 6 is now called Trial Specifics


comment:
This comment relates to all three customer types that are greyed out at the moment. The title of the customer type is different when you click to review ie it is a Doctors office in the main screen and then Light Commercial professional in the breakout screen. If this is deliberate then we should tie them together better


comment:
I deliberately 'forgot' which was the customer so clicked him instead of the Cummins guy and just got the first answer with no issues and no error.
We need to identify the Cummins man and make sure they review the clicks in the right order


comment:
Complete 2 to check 3 and complete 3 to check 2


comment:
This point needs to be checked by SME - refer to TB for this one


comment:
Last module in the series is now Trial Specifics


comment:
Process Map link should change to the UI: http://lillynetcollaboration.global.lilly.com/sites/CDCI/os/SitePages/Home.aspx


comment:
The last question does not match the SPI screenshot. Nancy, is this critical? The intent is the same, but some words were missing I believe


comment:
ISEC example, comments section, say "ready for enrollment" instead of site initiation


comment:
Propose to remove the hyperlink to the Site Selection Guidebook or replace with http://lillynetcollaboration.global.lilly.com/sites/DCOEHub6/onboarding/SiteSelection/default.aspx


comment:
Same comment as with the second module, the gensets need to be the latest logo / colour and the background could do with changing so they stand out instead of white on white


comment:
Cannot have the Cummins 'C' and the screen titles together this is against the brand standards


comment:
Avoid block capitols as per the grey banner title


comment:
Is it possible to recapture the image on the right so the website address in blue doesn't wrap over onto two lines


comment:
I like the look and feel of this screen but agree with EK that we need to map to the 'Richardson' selling process


comment:
There is a typo in the main text box, 'pre-sale' not 'pres-sale'


comment:
Overall I like the look of this slide, will be more obvious with all the correct text, I had to keep clicking on text boxes and people to get the next button to appear


comment:
We cannot make reference to the STAR program, perhaps the RLC classroom training would be a better reference


comment:
Process map bullet links to guidebook. Update the url to http://lillynetcollaboration.global.lilly.com/sites/CDCI/os/SitePages/Home.aspx
AND change the bullet text to: Identify, Evaluate and Select Sites Process Map


comment:
Trialforce collab site link is wrong. Use link sent by e-mail to Sharon


comment:
Remove the DNU site from the resources popup.


comment:
Since this course is done early - can we wait until the QRG is added to send? Will this be done soon?


comment:
The text "in the first module" is confusing to me. Do you mean in this course? Maybe we should just say "Earlier in this course, you learned"....


comment:
Next topic should be Support Decision instead of Make a Decision


comment:
Upon clicking target, should the text start with "That's correct" or other words to acknowledge this is the correct category and then continue into the explanation.


comment:
Move the statement to click the professor up higher so screen resolution issues don't cut off the instructions.


comment:
Change the header text to say "on the investigator site change form" to match what we say/show in the video intro.


comment:
Once complete, let's add the QRG to the resource pages.


comment:
This video includes the process map - I know Sophie doesn't want those. Can we remove that?


comment:
Change "Before you prepare for your site visit:" to "Preparing for your site visit:"


comment:
I think the words in purple are all caps in all the other courses


comment:
VO does not reflect the edit in line 3 of the spreadsheet


comment:
line 3 of spreadsheet - update transcript so the last sentence of the second paragraph ends at the word participate


comment:
line 4 of spreadsheet - update transcript


comment:
check transcript to make sure all edits to this screen are incorporated


comment:
Had the same problem, couldn't move past this screen.


comment:
The end of the first paragraph in the brown pop-up box for the last question says, "...not familiar with the site, trial, or site processes."  Is it supposed to be site or trial processes? or is the site and its processes two different things?  if it is the later, I suggest making the "site" that is modifying processes be possessive.  Maybe use, "site, trial, or the site's processes."  I'm not sure of the best solution.


comment:
Processmap button url needs to change: http://lillynetcollaboration.global.lilly.com/sites/CDCI/os/SitePages/Home.aspx


comment:
double check that text on screen matches line 47 in the spreadsheet


comment:
Why It Matters - I'd remove the capitalization of regulatory authorities to match other courses


comment:
We changed the VO text, but the screen text needs to be modified as well.
Change "Central Pharmacy usage" to "External vendor usage " and "Controlled Substances" to "Controlled drugs"


comment:
I think you should remove the word "of" in the first answer.  "To make the site aware that they are still..."


comment:
1st pop-up: change "... that the investigational product(s)", to "... that the CT Materials"


comment:
2nd pop-up: replace investigational product(s) with CT Material(s)?


comment:
Assuming this can't be fixed at this time, but the iPad picture is covering the end of the 2nd line of text.


comment:
I don't think we should use the shortened "fridge" terminology. I think it should be spelled out each time.


comment:
no pop-up appears when I click the 3rd question


comment:
Site process text is different here than on previous screen


comment:
Trialforce resource can be deleted here. Also that link isn't correct


comment:
This may not even need to exist because the last scenario is being deleted. if there are no other deviations between the paths, go ahead and delete.


comment:
Please ensure there are white males somewhere in this module.


comment:
2nd bullet - can we change medical product to compound?


comment:
Inv slide - change to - In the morning, if the inversion continues, air doesn't move and emissions become trapped close to the ground.


comment:
fumigation - last part change to - Of all the weather-related conditions, fumigation CAN result in the highest ground-level concentrations of SO2.


comment:
In the example for legible, should we adde that the nurse also initials and dates her correction?


comment:
same comment as a previous training, should "site processes" be possessive?


comment:
Contemporaneous, again the example doesn't seem to correspond. We're talking about paper, not EMR. Could it be immediately records it on the paper source and initals and dates her entry?


comment:
Conclusion slide does not advance. I recommend not including a certificate at this point, as we may need them to complete classroom, attend launch event, or complete Powerhours


comment:
Back button does not work at this point. What if a learner wants to go back and review


comment:
not major- but preparing helps the CDC start to determine if the site has some of the necessary qualities to be successful in the trial & be a good fit-preparing doesn't in and of itself determine if the site is right for the trial


comment:
I think you need to add the word "an" in front of exemption.


comment:
Perhaps instead of using "LIST" we use "Understand"


comment:
looks like there are 2 instances where the word "an" is missing in front of the word exemption.


comment:
I recommend we consistently use Section 1 of 1 or Chapter 1 of 1. Learner would benefit in understanding where they are within a course.


comment:
The URL for reference #3 in the HSCT pop-up is not working.


comment:
The same goes for the URL for reference #2 in the SOT pop-up.


comment:
I would retitle the Section Learn and use your tools. Or Understand and Use


comment:
"Use and Download" should be "Download and Use"


comment:
I also agree with EK that we need to provide 6 step sales process at this point


comment:
The spacing between the bullet points is inconsistent. We need to add a space between bullets 3 and 4.


comment:
I agree with IK, difficult to understand where to click to get to next screen. Please provide direction for user.


comment:
I would provide both comments the customer provided so the user can toggle through the conversation to remember what stage of the sale they are choosing the correct tool.


comment:
I would change to 'download or bookmark in your browser' unless we are going to provide users the ability to bookmark from course.


comment:
I'm not sure about this one, but in the nephrologist's speech bubble (paint spot 2), should "program" be "programme"? Not sure if the Brits use the latter spelling when referring to computer programs as opposed to, say, printed programs.


comment:
Technically speaking, some of the verb tenses are wrong in the sentence beginning "To know Bill's risk for infection..." (paint spot 3). "includes" should be "included" and, in the following sentence, "are negative" should be "were negative".


comment:
Not proofing errors in patient's speech text (paint spot 3). Text should read as follows: "When I got the call, I had only 4 hours to get to the transplant hospital, which was 240 km away."


comment:
"Note proofing errors", not "Not proofing errors" :-)


comment:
Remove comma after "deceased donor" in surgeon's first sentence (paint spot 4).


comment:
We should change bullet #3 to "Be able to create customer centric(specific) insights from F & B of products


comment:
Do we really need the parenthetical--i.e, "(polyomavirus)"--when we say, "which is in the polyomavirus family"?


comment:
Note missing word in Sophie's third sentence. Sentence should begin: "Depending on whether the donor and recipient have..."


comment:
Is there a way to add a pop-up that appears when users try to advance when the button is not RED. something to the effect of: "please click on each customer"  
Just a nice to have, not imperative


comment:
In Sophie's first full sentence, "Starry Night" should be italicized. (And that's right, I used the `merican spelling of italicized.)


comment:
I would change to "Have a conversation to understand customer needs and prepare to position the Cummins solution"


comment:
Same comment as I provide in tool section. I would not provide certificate at this point.


comment:
I would change to 'Summary' instead of conclusion. Next slide says conclusion as well


comment:
Change "Next" to "Close" or allow to advance without printing cert.


comment:
When referencing the CDC we say CDC yet in the COM notation we say site evaluators- for consistency are we ok interchanging or do we want to stick with CDC?  Remember that Quintiles will be reviewing this training should they select sites on our behalf


comment:
#4 should it be representative of or for Lilly?


comment:
The 2nd sentence in the answer doesn't makes sense.  Maybe remove the word "is"?


comment:
can we verify that BLP has all the links they need as I recall they mentioned they couldn't access Citeline or one of them and would like to verify they have what they need


comment:
with the focus on verifying the PIs licensure I think we should add licensure websites or something that highlights this is a resource that is expected to be accessed- could include in first bullet


comment:
which anaser(s) are correct because I clicked on all and got incorrect so not sure what combination of choices is correct?- the 1st and 4th are the ones that come across to me as correct and none of my incorrect answers told me what was right it just moved to the next screen therefore how is the learner supposed to know what the right answer is supposed to be?


comment:
since this addresses the PI licensure we should add that as a correct answer option replacing one of the others- replace with something similar to:  verification of licensure in good standing within country or state of practice


comment:
I would prefer we don't use the TransCelerate SPF in the training since we don't know how long that will remain active within TransCelerate and if it gets retired we will need to revise our training- suggest either removing that or ending the sentence at he would like to receive the site profile information


comment:
So I spoke with Jeff Ramsey who told me the following about the SPF.  I will have you determine what is the best course of action as to whether to include or not:  In the july release of SIP this year there will be a new version of the transc spf form.  it will also be maintained by cognizant moving forward to keep in sync with the online screens


comment:
Apply changes from the seller's training to this section of the text during and after the animation including sound removal.


comment:
The courses 	- Site Qualifications
	- ERB
CT Material
have the ISEC button here that leads to a screenshot of what the section looks like. Should we add that here too?


comment:
2nd bullet should we say look for and ask about?


comment:
Same comment as on previous screen for ISEC


comment:
Will we be comparing Di's screen shots to the slides to ensure our snapshots of ISEC and SPI are correct?


comment:
There is an additional ISEC question added to the equipment question which is tied to the 1st question that asks about the site's equipment


comment:
need to replace snapshot of SPI with updated version


comment:
as per my last slide comment need to add the additional question to this slide & a statement associated with it- because we aren't keeping word versions Di and Denise are the only ones who can provide the questions & answer options- therefore I will need to wait until they give that to us so I know what to provide you for the statement associated with it


comment:
we need to verify with Di/Denise if the example shown here reflects how it is in the system


comment:
I am not as familiar with the equipment site and wonder if this site is a viable resource that will be kept up since the PO has changed?  I'll see what I can learn


comment:
is "...records retention period." intended to be possessive?  If yes, add an apostrophe, if not, I suggest removing the "s"


comment:
same comment as other courses, I think site processes should be possessive.


comment:
Need to obtain the new snapshot from Di:  the 1st ISEC question will be as follows:  For this trial, the following qualifications are required for the PI :
(i.e. Specialty, 	Experience, Licensure)


Does the PI meet these qualifications?  (Yes/No)

If the answer is No "the following appears and the CDC has to provide additional documentation to submit the ISEC:  
Provide additional detail and mitigation to resolve prior to being declared enrollment ready. 
We can keep the statement associated however I believe since we have the if "no" option we should add something after last sentence:  If the PI does not meet the qualifications as specified additional documentation needs to be provided about how this will be mitigated


comment:
the following question has been added (get from Di).  this would be after the first question on this slide or in addition to because they both are associated with the same statement in the tan box:Does the PI confirm the site has qualified staff to conduct the research?  (Yes/No)
If the answer is No "the following appears and the CDC has to provide additional documentation to submit the ISEC:  
Provide additional detail and mitigation to resolve prior to being declared enrollment ready.


comment:
currently "addition" is singular, I would make plural to match "deletions or alterations"


comment:
I assume date and time are two different things, so need a comma between them


comment:
There is a new question to this section which Di can also provide; it would be first on this slide:  Does the Principle Investigator have an active license, in good standing, in the country or state of practice as required by local laws/regulations? (Yes/No)

If No, provide additional detail or mitigation.
The tan box that goes with the other 2 questions is applicable for this as well; I think we should add a () after licensure or add to the existing one ...tis includes verifying the PI's license is in good standing and any specific ....


comment:
we may want to make an additional slide for the SAE/AE and safety mailing questions and 1 for the PI qualifications


comment:
where is the first question in the ISEC that applies to PI qualifications?  1.	Has the principal investigator (PI) been disqualified by any regulatory authority?
Refer to local regulatory body or other local sources able to assist with this question.


comment:
So we would just need to revise this to only include the PI information and the answer would be yes and delete the rest because I think we already have an example of what to do if a PI doesn't meet the qualifications- the rest of the question would be asked as a study specific question now and not applicable for this question; the comment associated with it could be- the PI meets the qualifications and in the event this was not the case the CDC would provide additional detail as to what wasn't met and how this would be mitigated or what discussions occurred with the study team resulting in the approval to move forward with using the PI- otherwise we can just leave it simple


comment:
for the first- can we add review PI licensure status


comment:
I suggest we revise to reflect the overarching objective of why we ask all of these questions a bit better- I did send this after my call with product delivery when we discussed the new questions that will replace the central pharmacy questions I didn't pick up that it wasn't fully incorporated:  When assessing a sites CT Material storage, management & processes the CDCs overarching objective is to determine that  CT Material is being managed according to the label and if there are any deviations there are processes in place to identify and communicate these to Lilly so that we can determine if CT Material it still fit for use.  Not knowing about these deviations impact patient safety and trial results.  - maybe we add to the bullet:  ensure the site has the abilities and processes to store and manage CT Material according to the label 
Verify the site has processes to identify & communicate any deviations within the required period of time so Lilly can determine that the CT Material is fit for use


comment:
need to verify destruction questions are reflected properly as there were some minor changes


comment:
maybe we add to the last bullet comment box- Should a temperature excursion occur Lilly needs to determine if the CT Material is fit for use prior to the site dispensing to a study participant


comment:
You will get the final questions from Di but so we know what comments to put with the questions:
1st question:  Does the site outsource the storage and distribution of CT Material to an outside vendor? (yes/no) 
The tan box associated with this will be:  The external vendor receives initial CT-Material shipments and holds CT-Materials until requested by the site.  When using an external vendor the site remains responsible to perform the necessary steps to randomize and assign CT Material for all applicable study participant visits and will notify the external vendor of what CT-Material to distribute to the site. Note, this excludes vendors Lilly contracts with to store and distribute to the site.  
If yes the following question appears: 
Does the site have a contract with the external vendor?  (Yes/No)
The tan box associated with this will say:  
For the external vendor to be used the site will need to have a contract in place.  If a contract is not in place the CDC should probe further to verify the site is truly using an external vendor to store & distribute CT Material.  If the above is answered "yes" the following questions will be answered:
Has the site confirmed that the external vendor has the necessary license(s) to store and distribute CT Material per local requirements?  (Yes/No)  
 
If the answer is No the following needs to be documented:  Provide additional detail and mitigation to resolve otherwise the external vendor cannot be used.  
The tan box associated with the next 2 questions: If the storage and distribution of CT-Materials is outsourced by a site, an evaluation must be done to determine if the appropriate controls exist to ensure good distribution practices.
The 2nd question:  Has the site ( satellite location) confirmed that the external vendor has documented processes which describe the details for CT Material receipt, storage, temperature monitoring, and shipping of drug, from the external vendor to the site?  
 
If the answer is No the following needs to be documented:  Provide additional detail and mitigation to resolve otherwise the external vendor cannot be used.


comment:
controlled substances is controlled drugs as we discussed the other day


comment:
I don't believe the legible example is correct.  The definition of legible is:  readable at the input and output stage in a form meaningful to an independent reviewer . It embeds also traceable and permanent.  How about the following:  An electronic system that has secure, time-stamped audit trails that independently record operator actions and attribute actions to the logged-on individual or the paper equivalent to an audit trail using single-line cross-outs to record changes with name, date and reason recorded


comment:
not sure the original example resonates with me but if it is correct that is good-


comment:
I put a example of legible on the comments prior


comment:
1st pop-up. We use COPM in the other courses. We can replace Trial Planner with COPM if everyone agrees.


comment:
how is this for contemporaneous:  procedures requiring that activities be recorded in paper records with the date of the activity (and time as well, if it is a time-sensitive activity);


comment:
The other courses do not have that 1st audio saying that this course has both audio and on screen text. Is this ok for everyone?


comment:
The How pop-up, last bullet say
Handle all trial related site evaluation, qualification and selection documentation?


comment:
Is the Answers pdf supposed to be hyperlinked to an actual document?


comment:
need to revise to reflect the following:  For this trial, the following qualifications are required for the PI :
(i.e. Specialty, 	Experience, Licensure)


Does the PI meet these qualifications?  (Yes/No)


comment:
I am not sure what we are getting at with this slide; I don't think this is correct because you can't reopen the document after a site has been selected at that point you would complete a change form or have an admin reverse the status of the site so I think it should read:  circumstances may change after a site has been qualified-


comment:
change question to: A red TraceDoc warning/error within the the Information window can indicate which of the following issues?

Correct answer is still the third choice.


comment:
Remove this question.  Functionality in the software has changed.


comment:
Change portion of question to: Which maintenance is initiated prior to cleaning the components (except for e 801 only system)?
Make this change in Day 1 in Key Op for the same question.


comment:
1st bullet - suggest removing "documentation in the system is proof of their work" since 2nd bullet talks about the requirement


comment:
2nd paragraph - "participate in the trial in Trialforce" seems out of order in the sentence.  Do you mean to say instead "Only sites that are documented as qualified in Trialforce can be selected or chosen to participate in the trial"?


comment:
Suggest changing "document items" to "document information"


comment:
1st sentence: Instead of "You should start documenting site evaluation when the initial..." Currently sentence has site selection as the 1st step but isn't that at the end after evaluation/qualification?


comment:
Suggest changing "entering" to "enter" to be more active voice


comment:
3rd bullet - grammar/flow not clear.  Is it accurate to state "At a minimum, complete required questions in the.."  OR "Complete required questions..."


comment:
Suggest changing "documenting" to "document" - more active voice


comment:
Suggest changing "Before Clicking Select" to "Actions before clicking Select in TrialForce"


comment:
3rd, 4th and 5th bullet - a little long/detailed. Consider more concise wording.


comment:
1st two sentences state "must". Are these requirements with controls or are these best practices (replace must with should)?


comment:
3rd bullet.  Is "must" a requirement with a control? If not, change to "should". 2. "Shipping" isn't a function.  Recommend rewording this sentence since labs, CT Material, ECGs, ancillary supplies, etc. all need a correct address.  Suggest removing "(like shipping)" from the sentence and end it with "as other functions rely on this information."


comment:
4th bullet - doesn't read clearly.  1st two examples are roles/people and then switches to supplies.  Suggest reword.


comment:
1. Nice demo. 2.  The "Quick Reference Guide" link in upper right in purple circle didn't work.  Went to BLP and not the actual guide.


comment:
Suggest rewording "Get to Select" to something else. Is there a better description/more professional way to state?


comment:
2nd example under heart - I've seen other examples that describe the heart decisions differently. (will site be responsive, etc.) This example could be head/thinking since a site is deemed appropriate if meets specific criteria.


comment:
Ignore question on heart.  It's ok after reading pop-up.


comment:
Upper left - what is meant by "Change Considerations"?  That doesn't seem to fit the content of this slide.


comment:
Suggest changing 1st sentence to make more concise. Example: You've been asked to select 5 sites and 3 back-up sites.


comment:
In upper left: Instead of "introduction" should this say "main menu"?


comment:
1st sentence seems as if it is missing a verb.  Suggest: .."or determine which fields need.."  OR "..or identify which fields need..."


comment:
Correct answer pop-up: Suggest changing from "Treatment is a required entry" to "The number of Planned Patients is a required entry". Please confirm with SMEs - to me, the meaning of this field is meant to be about the # of patients.


comment:
Is "defend" the right word or is this "describe"?


comment:
But an operational or mechanical failure during startup can cause high concentrations of SO2 which certain weather conditions could bring to the ground. Inversions...


comment:
I feel like we need some sort of end screen here.  I was waiting for it to continue since the picture was still on the screen.  :o)


comment:
This video seems a little fast.  Might want to slow the pace down so we can see more of the process.  It's difficult to keep up and see what he's doing.


comment:
I thought this was the one where we showed the side view "for the purposes of this video."  Can you double check?


comment:
Need to slow down the pace a bit.  It's difficult to follow with back to back narration.  Add a little space between if possible.


comment:
Pacing was better on this one, but could also slow down just a touch.


comment:
I think we should slow this video down just a touch.  The spacing when he replaces the cable is great, but could slow down right before and right after.


comment:
At 1:02, I think we cut too quickly to the screenshot.


comment:
At 1:07-1:08 there's a wonky spot where the screenshot hasn't disappeared before the VO and video are displaying.


comment:
For all videos, after setup and before introducing the Rexis notification, add a couple of seconds to transition.


comment:
This video is a little fast.  Need to slow down between narrations.


comment:
Let's make it voiceover.  "After using the ABC checklist to ask the customer the right questions, you're still not sure what the root cause of the problem is.  You'll need to head to the lab to help you identify the solution."


comment:
If we are looking at the process on the next screen, change the text at the bottom here to reflect that.  Maybe something along the lines of "Looks like you'll need to dig a little deeper to figure this out."


comment:
On the water bath popup change "as well as assess" to "and assess"


comment:
I'd like to see the feedback for checking the most common culprits appear after I've closed the last popup window.


comment:
Can we change the pointer to a finger when you hover over a clickable area?  I kept waiting for it to change.


comment:
When the pop ups pop up, if you happen to click anywhere on the popup, it closes.  Should just close by clicking the x.


comment:
Edit top section text: "...eliminates tests that do not report in IU/mL."


comment:
Edit middle section: "eliminates tests that are not CE-IVDs."


comment:
Edit bottom section: "...eliminates competitor CE-IVD tests based on factors such as workflow, clinical studies and data, and FDA approval."


comment:
Edit bottom section: "The third filtering section separates CE-IVD tests..."


comment:
CUTE! Reset to initial state so I can watch the Roche logo go thru the funnel repeatedly. ;)


comment:
Change "considering" to "using" in Sophie's text bubble.


comment:
Nope.  I don't think that's fair at all.  I wonder if we have two lab screens?  One for the lab we're working in and one for a "typical" lab where we talk about all of these issues.  If we leave it to the FESs at this point, they will just select everything because everything is a potential issue causing the bad readings.  Part of it is going to have to be in the setup of the question "Based on what you know about CO2 readings and potential causes you've identified in the ABC checklist, what in this lab could be impacting the report?"  Let's talk.


comment:
Image is not large enough even when zoomed to read the text well. Please change the instruction to click to DOWNLOAD the reference guide.


comment:
If all tests on both modules are bad (I'm thinking we need to be way more specific with our scenario), there's nothing we've said that would lead me to the water line as the first point to check.  Maybe we need to go back to the troubleshooting process?


comment:
Check the animation.  It seems like I clicked on one page and the Top 10 went to full screen, then we went to another screen or layer and it re-opened.


comment:
Can the text in the boxes that appear left-align?  The top one is too far to the right.


comment:
Bold "convince a customer" and "best choice" in the first pop-up. The second pop-up needs revision: "What are the reasons that labs typically use LDTs?" Let's bold "reasons" and "use LDTs".


comment:
A couple edits for flow:
1. This screen tells users to download the funnel - Perhaps this makes more sense to move to the end of the intro?
2. A new start-of-section screen shows JUST the zoomed-in section of the relevant part of the funnel, and sophie introduces it like, "Take a moment to review this section of your reference guide. As you can see, a primary reason labs still report in copies/mL is because of familiarity, but with research recommending reporting in IU/mL, this is the most basic level to overcome."
Let's discuss for clarity.


comment:
When I click the environmental box, it opens and closes immediately since the entire text box is clickable.


comment:
Edit sophie: "During that conversation, I helped clear up confusion the customer had about how calibrators can lead to variability. She seemed happy to learn..."


comment:
If we want to keep this as the lab (which I think we can do), let's add text to each popup that indicates whether in THIS lab it is an issue.  For example, when clicking the window, let's say "If an instrument is placed too close to a window, the sunlight can impact test results.  In this lab, the placement is fine."


comment:
Change subheading under course title to LDTs


comment:
In Sophie's speech bubble beginning "Many customers have decided to adopt...", change "CMV Test" to "CMV test". Also, in the last sentence of the same speech bubble, change "reports" to "report".


comment:
Instructions: "Listed below are reasons that labs use "homebrew" LDTs and LDTs created with..."


comment:
In the Flexibility pop-up, "CMV tests" should be "CMV Tests". Also, change first line to "LDTs can offer sample type flexibility, but they are more complex..."


comment:
In the Low Cost pop-up, "CMV tests" should be "CMV Tests", and we need to add "been" between "would have" and "spent". Also, change the first line to "LDTs may not have high up-front costs, but they are a resource burden..."


comment:
In green spot on canvas, change "Threshold Establish" to "Thresholds Established".


comment:
Be sure that "cobas(r) CMV Tests" is always plural and that "Tests" is always capitalized when referring to these tests by their full name.


comment:
In the "Threshold Establish" pop-up, add a comma between "test" and "so" in the first sentence. Also, change first sentence to begin: "Any thresholds established with an LDT only apply to the lab that..."


comment:
Change first sentence of "Broader Menu" pop-up to begin:"LDTs can be used to test for various markers, but they compound..."


comment:
In the last sentence of Sophie's speech bubble, move "once more" from the end of the sentence and place it between "to review" and "the counters".


comment:
Love the way the paintbrush points to the selected objection.


comment:
In the correct response option (beginning "Most labs feel that their clinicians are satisfied..."), add a comma in the first line between "thresholds" and "but".


comment:
In the response beginning "Reporting in IU/ML is step..." add "a" between "is" and "step". Also, in the second line of this response, add "reported" between "when" and "in".


comment:
"Our lab uses CE-IVD "kits" to build our LDT. This helps reduce the complexity of building the test, provides us..."


comment:
In the first response option (beginning "Flexibility, broad menu, and cost savings..."), add a comma between "consumables" and "as" in the second-to-last line. Also, in the same line, add "the" between the second "as" and "time".


comment:
After two bad choices on the part of the learner, the clinician's facial expression doesn't reflect the tone of his speech bubble here. Speech bubble begins "I am quite sure that we would not be interested."


comment:
When updating the speech bubbles and response options in these branching scenarios, don't forget to update the text on the Optimal Conversation easels that appear at the end of each convo.


comment:
Edit sophie: "Great work! The most common reasons that labs choose LDTs are: <BULLETED LIST> -low cost, -flexibility, -thresholds they have established, and -the possibility of providing a broader testing menu.
Use the responses you have practiced to help reshape customer needs toward CE-IVD/FDA-approved tests for CMV.


comment:
Let's change Sophie's second sentence to begin as follows: "However, in the rest of this module you will learn..."


comment:
Edit to James's edit: Q.2, "How can you respond to the reasons that labs typically use LDTs? Bold respond and LDTs


comment:
Let's make Sophie's text into two sentences as follows: "You have had a chance to familiarise yourself with the messages that help you position the cobas(R) CMV Tests against our top competitors. Now let me show you..." Remember, "cobas(R) CMV Tests" (capitalized "Tests").


comment:
In the lab director's speech bubble beginning "We decided that we could gain...", delete the word "test" at the end of his second sentence.


comment:
First section... should be "Tests" in the question I think


comment:
Why is she grumpy with me after I chose the right answer?! Sheesh, back off, lady.


comment:
OH. I can't do the sliders, I'm sorry. Let me take a look at these, and will edit them down somehow.


comment:
The lab director needs to mention the Abbott assay here, before Sophie mentions it on the next layer. At the end of his speech bubble here, add a sentence that reads "We selected an Abbott RealTime CMV test."


comment:
... and learn how to discuss the difference between copies/mL and IU/mL with customers.


comment:
In regards to my previous comment, change "We selected" to "We are considering".


comment:
Last line, delete "and clinicians" (duplicate)


comment:
Add instructions to click the image on easel


comment:
Screen auto-advanced after I had only placed two answers


comment:
Same - after I place the second answer, the screen auto-advanced


comment:
Looks like the last two answers are reversed in where they think they should go. Tell 'em who's boss.


comment:
Auto-advance issue applies to all three FItB screens


comment:
Correct answers aren't programmed properly - double check against the original statement


comment:
In the screenshot... remove red line under "Standardisation"


comment:
I agree! Grumpy lab director! Also, change "M" to "million" in the second response option.


comment:
In the lab director's speech bubble, change her last sentence to read "How do cobas(R) CMV Tests compare?"


comment:
In the lab director's speech bubble, change "test" to "Tests".


comment:
GW! Now...weather. Weather changes happen around us all of the time, but odd looking stack discharge during startup can be a clue that you need to take a closer look.


comment:
In the lab director's speech bubble, remove the extra space between "PLX" and "for".


comment:
In the footnote, remove the extra space between "CMV" and "or", then add a space between "1" and "&".


comment:
In the feedback box, change "to find" to "to finding".


comment:
On second layer, "Let's" should be "Let us".


comment:
Change question to: "What advantages do the Roche cobas(r) CMV Tests have over their competitors?"


comment:
I experienced the same auto-advance problem that LF noted.


comment:
The drop targets for "FDA approved" and "superior workflow" need to be switched.


comment:
Change question to "How is Roche shaping the CMV testing landscape?"


comment:
As LF noted, the drop targets for "most complete solutions" and "less common markers" need to be switched.


comment:
In Sophie's speech bubble: change "helps" to "help" in the third sentence. Remove extra space between "Our" and "drive" in fourth sentence. Also in fourth sentence, change "optimized" to "optimised".


comment:
Be sure to update challenge question text in the plaque pop-up after making changes elsewhere in the course.


comment:
Fix the states in these activity... I think they should be red when they are incorrect and green when correct


comment:
Is the grid with the orange border a tally sheet or a calendar?  What is its purpose?


comment:
add the words "or less" after the word "more" in the sentence that starts with "Sometimes, shipments arrive...."


comment:
In the paragraph where we start talking about EIM, add the phrase "energy dispatched" after "energy forecasted".


comment:
In the next paragraph add a period after the word "needs"  The next sentence should say "The energy dispatched or consumed will be paid or charged accordingly."


comment:
Change "Over and Under Scheduling" to Over-scheduling and under-scheduling"


comment:
Change the Uninstructed bullet to say "Uninstructed imbalance energy, which is the difference between the meter or e-Tag data and the final ADS dispatch or hourly load base schedule, and"


comment:
Change "metered demand plus transmission losses" to "the sum of metered demand and transmission losses."


comment:
Remove the words "represented by a CC followed by a set of numbers."


comment:
Disregard the edit above and change the entire paragraph that begins with "These payments..." to "On a settlement statement these payments and charges are categorized using charge codes.  A charge code represents the final settlement amount for a scheduling coordinator based on energy dispatched, energy consumed and penalties as defined by the tariff. Learning the different charge codes is key to validating your settlements."


comment:
Change the next paragraph to say "To validate a settlement statement you'll need to understand how each charge code is calculated, and where to access your validation data in order to compare it to the settlement statement."


comment:
Lets just say "our mosaic meteorologist can tell you more" and not give him a name


comment:
In the paragraph that begins "Many scheduling coordinators", move the first sentence to the end of the paragraph.  Change the next sentence (which will now be the first sentence) to say "The ISO provides validation information in several applications including..."


comment:
Change "LMP pricing" to Locational marginal pricing" and on the display add "(LMP)"


comment:
In the paragraph that begins "The first step..." change the second sentence to say "Compare your source data to the ISO's published data and verify that your shadow settlement calculations correspond with the ISO's settlements calculations."


comment:
In the next paragraph change the word "error" and "discrepancy".


comment:
AFTER STARTUP APPROVAL, BUT BEFORE THE PLANT STARTS


comment:
MAY relay current visitor information to those who need it.


comment:
Replace the existing "You can find..." sentence with "You can find additional settlements information on the ISO website's  Settlements page located under the Market and Operations tab."


comment:
Apparently the guard's role varies pretty strongly at each site. for this slide, we should just list which tools a guard MAY need at your site because everything is site specific. Take away the question element because there's no way to make it work by site.


comment:
The slope in the table is distracting.  The monitor will slide off.


comment:
BEFORE STARTUP
REQUESTS STARTUP AND GETS APPROVAL
AFTER STARTUP APPROVAL BUT BEFORE THE PLANT STARTS
uses the site pre start...


comment:
The visual on the left of CIDI screen is blurry and bleeds off the page.


comment:
At the end the message "Click the right arrow to continue" is unnecessary. on this screen.


comment:
Please increase the font size on the timeline.


comment:
after startup approval but before the plant starts


comment:
strike that... there should be two 

after appv but before start is travelling downwind then during startup is the other three


comment:
Suggest changing the title of the timeline to "Charge code timeline" and then take the words "charge codes" off of each heading.


comment:
Change "Before Market" to "Pre-market validation"


comment:
The two edits above should be global edits.


comment:
T+40 - "Settlements impacted by test performed prior to the real-time market optimization"


comment:
The box with the ! and the CC needs to be changed.  Remove the CC and replace it with a warning sign with the word "fail"


comment:
The script on the second paragraph is correct, but let's talk about how the words should  be emphasized.


comment:
Suggest explaining over and underscheduling does before the auto parts analogy.


comment:
In paragraph 3 - Make the following change starting with sentence 2 "The auto parts store has a long-term contract to regularly deliver parts to a specific customer based on historical customer purchases.  This is like the ISO forecast."


comment:
In the same paragraph add the words "each day"  after "certain number of parts."  Change the next sentence to say "The customer understands that if final order is not within 5% of their tentative order there will be penalty charges."


comment:
"If the tentative order is not within 1% of the store's forecast, the customer may be assessed a penalty if the final order is plus or minus 5% of their tentative order."


comment:
The GM only uses the information from the sulfuric supv to grant or deny approval. Please take out radio/phone option and have supv option be the only required answer.


comment:
Let's talk about the edits above at our meeting.


comment:
Let's talk about the clock graphic - it stops at the wrong places.


comment:
before
gathers info from ops
keep both apprvs
determines if inversion is risk

after approval but before startup
notifies guard or sulfuric to run code blue
ensures sulfuric operations have completed all required tasks
ensures downwind field observer is in place for startup

during startup
keeps in touch with sulfuric operations and downwind field observers to ensure safe startup conditions

post
determines when all-clear can be called


comment:
We'd like to mention somewhere what the other tests do, or suggest that they want the Base Schedule Foundational concepts CBT.


comment:
On the graphic can you add a line showing the load forecast?


comment:
Deciding whether or not to start up the sulfuric plant affects a lot of plant personnel. (period, delete rest of sentence)Take out from after all to conclusion. Leave Many questions to the end of that sentence.


comment:
In the sentence that begins "Lets' look at two examples" after the sentence about the 90 MW schedule and the 100 MW metered demand say "10 MW represents a 10% differential which is clearly more than the 5% threshold for under-scheduling..."


comment:
The lady in the purple is smaller than the others and she should not be smiling.


comment:
First sentence change "applied" to "calculated" and delete the rest of the sentence.


comment:
Change "resources may scheduled for the fifteen minute market..." to "resources may receive awards from the fifteen minute market..."


comment:
Change "dispatched for" to "dispatched by"


comment:
Let's talk at what happens after you have review the this section once and then go back to look at it again.


comment:
Change the first sentence to say "The market will calculate forecasted movement as the difference between the  binding and advisory energy schedules."


comment:
Remove the word serious.  Also make the same change for the same question in the Key Operator check points.


comment:
Change the first sentence to say "If energy is dispatched from an EIM BAA outside of the state of California to serve California load, the market will award greenhouse gas obligations to resources from that EIM BAA based upon their greenhouse gas bid."


comment:
I think it might be better to move this to be 701 and 702 module specific questions.  I also believe I changed one of the incorrect answers in the Key Op version- see that edit.


comment:
Note that at the bottom of the Greenhouse gas, the play button indicates that this is for FRP not GHG.


comment:
Change "generation and load" to "supply and demand"


comment:
See my edit to this same question in the Key Op version.


comment:
Change this to read "After the meter or e-Tag data is submitted, flexible ramping product costs will be allocated."


comment:
The Bid cost recovery video is linked to FRP allocation improperly.  We may want another box on the timeline specifically for BCR.


comment:
Not sure why the graphic with the closed sign.


comment:
Charge code numbers - let's discuss how they spoken - e.g. "6-6-2-0-0" should be "sixty six two hundred"


comment:
remove Delete samples with Pending Results.


comment:
The forecast fee is charge code 701, not 7071


comment:
Find and replace the word Westgard with the word QC throughout all versions of the check points


comment:
Change the bullet that says "operations and maintenance" to "market services and operations"


comment:
This analogy was for the greenhouse gas, not the forecast fee.


comment:
Let's talk about the forecast fee analogy - it combines concepts of both the forecast fee and the greenhouse gas


comment:
change question to: A red Tracedoc warning/error within the Information window can indicate which of the following issues?


comment:
I think this question is in another section.  Do we need to duplicate?  Will discuss with Lori


comment:
Typo - PI is principal investigator not principle investigator


comment:
2nd sentence - remove "that" so sentence reads: ...meet the trial requirements and will be the most successful.


comment:
1st box and answer - is progressive the right word? answer says aggressive.


comment:
2nd box = the answer doesn't seem to fit with the thoughts.  Thought is covering capabilities and experience with titration and the answer is talking about capacity concerns/potential enrollment.


comment:
4th answer seems a little strong to say "red flag" but please confirm with SMEs if they want worded that way.  If previous ePro wasn't a Lilly trial (states this site is new to Lilly) seems like connectivity issue is a f/up item, not a red flag tied to data integrity.


comment:
Answer to 2nd box contradicts either info that the protocol allows primary care.  Also, this isn't a COPM decision - the type of PI for the study depends on what is stated in the protocol.


comment:
1st box - is 342 a realistic example? Use smaller number?


comment:
1st example - is 232 too large of a number to use? realistic?


comment:
1st box answer - narrowing down 232 patients doesn't seem like a concern.  Sites aren't allowed to enroll huge patients anyway. Suggest instead of "concerns me" could state "could be a concern is this impacts the  expected # of patients".


comment:
4th answer - suggest reword of last sentence - "they managed" seems like a minimum expectation to me. Maybe something like: They had some trouble the first time they used ePro haven't had issues since then.


comment:
Site 1 answer - consider shortening. could eliminate the sentence about "no way to validate enrollment..."


comment:
Lower risk site 2 - 1st bullet: I don't think this is worded correctly. It's not really that "teaming up" is approved, the approval is that a primary care physician can serve as the PI.


comment:
Lower risk site 2 - last bullet - consider being more specific than "things progress" and not sure why site activation team is called out. There are also budgets, contracts, etc. I suggest changing to something like : New to Lilly, need to partner with the site to support and answer questions OR  New to Lilly, need to partner with the site to ensure they meet requirements to start enrolling patients OR describe what is needed from site activation besides "things"


comment:
Lower risk site 3 - 4th bullet - this doesn't provide great confidence the way it's written. Suggest something like: Had minor issues with ePRO that are now resolved.


comment:
Agree with comment - have already completed the Make a decision section.


comment:
I think a couple of the words used sound negative.  Examples - 1. instead of "study team will push back" could say "study team may ask for rationale to understand the decision" 2. From "Monica had to discuss her decision" to "Monica explained the rationale behind her decision"


comment:
Consider a different way to explain why site wasn't recommended. Example - CDC said site was "extremely qualified" but then didn't select the site for the trial. Also avoid using the words "red flag" in any rationale for not selecting a site.  I would keep rationale to site 1 only without comparing to another site. I would also avoid stating a site is "lower risk"


comment:
Suggest using "explain" vs. "defend" - defend sounds negative and not confident in decision rights of the CDC. (clin ops has decision rights for site selection and if study team or CRP puts pressure on CDC, then escalate to supervision)


comment:
Instead of comparing to site 2 as "lower risk" can this be stated as "better fit" or some other description.  Describing sites as low risk/high risk sounds subjective and is skipping the factual elements of site qualification.


comment:
Replace "got" with "heard" or "received"


comment:
next topic needs to be updated  - this point in the course, we are ready for manage and document follow-up items.


comment:
Should this say prior to enrollment instead of prior to enrollment readiness?  Enrollment readiness means different things to different functions.  Do you mean prior to study drug shipment? Prior to screening patients? Prior to enrolling patients?


comment:
The info about Site 1 and attending conferences seems out of place - this has never been mentioned before in previous slides.  Seems like enough reasons have been provided to explain why site 1 may not successfully enroll patients into this trial. The competing trials, study coordinator workload, etc.


comment:
This is the wrong link for BWL. Link should take users to the CDOS user interface collaboration site as in other courses. This link is the IBM link and not the way to enter BWL maps.


comment:
I clicked through the colored dots, and it took me to the gallery walk.... if i didn't know any better, i would think there was no content in the module... Perhaps we shouldn't let this happen :)


comment:
The asterisk should go after "diagnostic tests" in the heading of the list, (and not on amplicon size).


comment:
Grey out the "continue button" until they have clicked on both graphs (to assure they really open and look at them).


comment:
Cosmetic - the two highlight colors used in the table are difficult to differentiate on a laptop. would be great if you could use 2 more distinct shades...


comment:
In the QC materials section:
Swap the bullet points (2nd one 1st, 1st one 2nd), and rephrase so they are both questions. Make the sub-bullets full bullets. Also, does "lot to lot variability" refer to the controls? If so, I would make this a separate bullet point.
CHANGE TO:
(1) What QC will need to be performed?
(2) How frequently is QC required?
(3) What level of High positive and Low positive controls will be used for Quantitative Assays?
(4) What is impact of lot-to-lot variability of the controls on QC process?"


comment:
in Extraction Method section: Make the bullets into questions (to match the other puzzle pieces). Add the first bullet to the header. CHANGE TO:
"As studies have shown that the DNA extraction method chosen will affect PCR performance(ref1): 
(1) Which of the many available methods are compatible with the CE-Marked reagents?
(2) Which will give the most accurate and reproducible results?"


comment:
under "Detection Instrument" section, make questions to match the other sections. CHANGE TO:
The Package insert of the CE reagents specifies that choice of Detection instrument will influence results, so a lab must consider:
(1) Which instrument is compatible with the CE-Marked reagents?
(2) Which instrument has appropriate analytical sensitivity for the test?
(3) Which instrument gives the most accurate and reproducible results?


comment:
I LOVE THIS! The section came out really well!


comment:
Make the parenthetical text consistent for all example assays:
1. (CE-IVD and US-FDA); 
2. (CE-IVD).... (US-FDA); 
3. (CE-IVD).


comment:
In the paragraph that begins "Over and under scheduling charges do not apply..." add an "s" on to the end of "coordinator"


comment:
In the paragraph that begins "Let's look at two examples..." change "a" to "an" before "EIM"


comment:
Change the paragraph that starts "When the market runs at T+7.5..." to "When the market runs at T-7.5, your resource may be instructed up or down from its base or FMM schedule.  These instructions are considered to be RTD instructed imbalance energy and will settle in charge code 64700."


comment:
CHANGE Sofie's text to:
15 years ago, the first CMV test were based on low sensitivity end-point PCR. Using whole blood gave the laboratory a better chance to detect infection because it included both viral DNA released into the plasma, as well as CMV DNA integrated into the host's chromosomes. But the highly sensitive real-time PCR assays of today can detect and quantify viral DNA from the plasma, without relying upon integrated DNA.


comment:
Somewhere there needs to be an explanation of what we mean by the "T-XX" terminology means.


comment:
The Babady reference should go to the Doctor's final sentence that plasma might be more clinically useful


comment:
About the reference-  are there 2 references smushed into 1 line? See previous slide for format...


comment:
Or maybe that's 3 references? Joni can probably fix this best.


comment:
Syntax issue in last sentence of lab director's response: CHANGE TO: "...My lab can perform assays using WHICHEVER sample type a clinician prefers, but..."


comment:
For each explanation box on this page please make sure the distance between the header and the first paragraph is consistent throughout.


comment:
change "occurred" to "was supplied or consumed"


comment:
Lab Directors's Perspective: CHANGE TO,
"Plasma offers GREATER specificity for ACTIVELY replicating CMV..."


comment:
The "Click the X to continue" box does not appear at the end.


comment:
Make sure the resources have what we need. I only found a single image of the altona PI (no actual PI), and one table showing sample types....


comment:
The "better sensitivity" section has redundancies with the clinical advantages" section. Delete first 2 bullet points (they aren't about sensitivity).


comment:
Change "ideal market scenario" to a simplified market scenario".


comment:
Sorry in my previous comment I meant to say "simplified market situation."


comment:
Syntax issues: (1) cobas CMV test (singluar, not plural); (2) test-of-choice


comment:
2nd sentence is too long and winding - moving the last 4 words might help. CHANGE TO:
By positioning the Roche cobas(R) CMV test as the test-of-choice for labs, we can help OPTIMIZE CMV MANAGEMENT FOR patients like Masahiko by moving clinical practice towards standardization and increasing commutability of results across institutions.


comment:
Third funnel doesn't mention US-FDA tests....


comment:
Let's change the first paragraph to say "In our foundational scenario, a resource that was bid into the market receives an economic dispatch because the load forecast has changed."
Then let's talk about how we should proceed.  The way that it is currently laid out the relevant information about the scenario is buried.  Perhaps we can just display all of the icons and definitions, but skip the verbal explanation.  Highlight the one that is relevant, which is the second one.


comment:
For Joni - we made a pretty big effort to distinguish CE-IVD reagents from CE-IVD tests. It might be good to put examples (logos) of these reagents into the LDT section of the competitive funnel graphic, much like we have done for competitor CE-IVD assays, to signal to the affiliates that they should emphasize the distinction with their potential customers....


comment:
The "So I have to ask myself" doesn't sound right.  (Makes me think of Dirty Harry :) )
Also, please change the last sentence to In this circumstance, because the base schedule was within 1% of the ISO load forecast, no charge codes were triggered.


comment:
In the first sentence change the words "market run" to real-time market optimization".


comment:
Change the second sentence to read "The fifteen minute market runs at  T-37.5 and scheduling coordinators will receive their awards at T-22.5 for the first FMM interval of the hour."


comment:
Change the third sentence to say "The real-time dispatch, or RTD runs at 7.5 minutes prior to each interval and resources may be dispatched two minutes later."


comment:
Can you start with all the charge codes on the screen and then check the ones that apply?


comment:
Only the bottom half of the table is appropriate here... We can probably take the background color off to make it easier to read since we just need the bottom.

The top part of the table are for the CE-IVD/FDA approved tests which is for the next section


comment:
Should the most common Transplant Molecular Targets go into the resource tab for Module 2?

We should also refer to it somewhere?  Let's discuss


comment:
The Top half of the table from the previous section introduction should be here as a pop out - background color can be removed. This will show a summary of the CE-IVD and FDA approved tests.


comment:
References are being updated with the screen shot document.


comment:
Can we make all of Sophie's comments into questions? 
This way we don't need to reference them and all the references can be with the Lab director's response.


comment:
For Technical advantages...delete the first bullet.  We have been saying all along that PCR results are not comparable.  

Replace this bullet with:
- allow CMV detection in HSCT patients with with neutropenia


comment:
Agree with Ellen on the first two bullets under Better Sensitivity
- lower sample volumes and better turn around time can move to Operational Considerations


comment:
Can delete lower sample volume actually - this already under Technical advantages


comment:
Perhaps neutropenia for HSCT comment I made should actually go under clinical utility

Let's spend a few minutes talking about this section on the call and ensure we have the bullets in the right places.


comment:
Subhead here says Plasma vs Whole Blood. Need to change to Plasma vs Antigenemia


comment:
Agree with Ellen.  The participants needs to complete the module before they can enter the gallery walk


comment:
We sometimes use "standardized" to the WHO vs "calibrated".

Let's discuss which word we want here.. then we can delete the other distractor so not confusing.


comment:
Let's discuss this fill in the blank...not sure specificity is correct.


comment:
Need to update this...it is stating the problem in reverse.  This was changed in the branching discussions.

Let's discuss


comment:
Can you move Sophie to the left and her dialogue box so the painting is not as covered?


comment:
I am just starting the module and it is saying...re-visit any of the spots.

Think overall the module menu has glitches


comment:
The subhead in this section is Test Types?

It should be "Converting to IU/mL"

Check with Ellen on the call in case there is a better subhead


comment:
Agree with Ellen - need to make sure they open the graphs


comment:
For the text in white...should it be just Conversion Discussion?

It is not a challenge or a review.


comment:
Take out " I think..."  Start with "Test built from scratch..."


comment:
If they click on the resource tab to get the package insert..how do they get back to this spot again to keep going? 
I had to start the module over.


comment:
Agree with all of the Ellen's changes for wording. ;)


comment:
The asterisks refers to the text within the "i" red circle. Since this is not a reference but a footnote can we move the statement with the "i" to a footnote with an asterisk?


comment:
For the last statement change to:

Saving time, and resources for other revenue generating activities and reducing the risk for the lab are key reasons....


comment:
Not sure about the correct responses for Description and for Advantages...

Need to make some changes


comment:
For disadvantage - let's change to 
Operational Inefficiency


comment:
For advantages change to:

Some analytical validation provided


comment:
For description correct answer change to:

All components validated together


comment:
Check this change with Ellen on the call


comment:
For the US-IVD section at the top remove the (CE-IVD) in the brackets

For examples for US-IVD we need a footnote or asterisks because the cobas CMV Test is not yet FDA approved.....

*cobas CMV is currently pending FDA approval

For CE-IVD section - delete US-IVD in the brackets


comment:
Agree with Ellen's re-wording for Sophie's statement.

For the second statement from Ellen - refer to the Word doc with screen shots that I sent  - all references have been updated.


comment:
Agree with Ellen's comment but we don't need to put the words in all CAPS


comment:
Resources tab will be updated at the end with Mega course


comment:
Requires significant calibration?

Let's discuss


comment:
We will need to review this wording with James during our conference call. - Flexible ramping


comment:
Although the narration starts off talking about offsets, it is not mentioned anywhere on the screen which may be confusing for the learner.  The screen looks like we will be talking about the elements of the LMP including greenhouse gas.


comment:
On all of these screens there is a lot of white space.  Perhaps the fonts could be larger.


comment:
The funnel reminds me of plastic drinking cups...maybe make it wider and more pointed at the bottom?

Ask Jessica for colors within the cobas brand that might work?


comment:
I sent a note to James to review the wording for the offsets. We can revisit during our conference call.


comment:
Instead of saying "eliminates" say "removes test as the best choice if they don't report in IU/mL already"

For the CE-IVD funnel - the statement is not correct because within this section are the CE-IVD reagents used to build LDTs...should say can remove tests that are homebrew LDTs or LDTs built with CE-IVD reagents


comment:
Change the final funnel statement to:

The third filtering section removes competitor CE-IVD or FDA approved tests based on key factors such as clinical validation and workflow efficiency.


comment:
Agree with Ellen the writing on the last funnel section should be CE-IVD/FDA approved


comment:
Like the way each filter layer is described and how they are revealed when you click on the funnel. Very nice :)


comment:
By using these three filters of the funnel to remove the competition, you can position Roche CMV tests as the obvious choice for your customers.


comment:
Agree with Ellen. This is a great idea to put the logos of the key CE-IVD reagent companies in the LDT section. 
It might also be nice to have the table from module 3 here again to show them the top competitors in one place.  Maybe page 2 of the PDF download?

Let's discuss with BLP


comment:
To BLP - Really like the idea of downloading this as a PDF. Will provide additional feedback via the PDF and upload to basecamp


comment:
"You will be helping a settlements analyst", not a "scheduling coordinator".  Please correct this on the screen and in the narration.


comment:
In the narration - instead of "what charge codes will be triggered" say "which charge codes will be triggered".


comment:
It is not the research community..it is the clinical community - use consistent language from module 3. 

Current consensus guidelines for management of CMV in SOT patients recommends reporting in IU/mL and proficiency testing organizations provide samples in IU/mL.


comment:
Instead of "...or download" change it to "..and download"


comment:
The question in blue is not clear to me..

Converting to IU/mL is not straightforward. Why go through all effort to convert an LDT to IU/mL?

Is this what the goal for this question is?


comment:
"This is Rhonda, a settlements analyst for an EIM Entity Scheduling Coordinator.  Instead of "Each day.." say "In each scenario she will share the assumptions and market conditions with you".


comment:
Should clarify here that this section is for LDTs, both homebrew and LDTs built with CE-IVD reagents.


comment:
Will provide comments for the orange and blue bubbles in the PDF


comment:
After the first time I went through this module, after I clicked on Rhonda the right arrow did not appear to go to the next screen.


comment:
Remove the word "by" after the word "Rhonda".


comment:
For low cost there are two key points for the Roche response:
1. Time, effort, labor etc..which is covered in the current response
2. Hidden costs - other reagents required to run the LDT, like extraction reagents, calibrators, consumable, instrument service costs 
Should be clear because people tell us that LDTs cost 10-15 CHF but if you add the other hidden costs it is closer to 20 CHF then on top of this you add labor (the point you currently make in the response) and of course the risk.


comment:
Change the wording for the over-scheduling and under-scheduling to say "These costs occur if the base schedule fails the balancing sufficiency test.


comment:
For thresholds established - need to take out the comment about not comparable. It is the results that are not comparable and therefore the thresholds from those results. 

Reword:
Any thresholds established with an LDT only apply to the lab that developed the test and conducted the studies because CMV results are not comparable across institutions.  The cobas CMV .....
Comparison of the results to the lab's LDT can allow them to re-establish thresholds...ASK ELLEN how to finish this statement.


comment:
Rhonda does not check settlements every hour. But instead she checks her settlement statement and is reviewing hour ending eleven for Monday.  This would occur at least three days after Monday.  Let's discuss a more appropriate way to frame this scenario.


comment:
In the last sentence, matches should be match.
The white text boxes all need to be the same length.


comment:
For Broader menu change to:

Using LDTs provides the lab with the opportunity to offer tests for other transplant analytes as part of their test menu. Roche is committed to expanding CE-IVD test offering with CE-IVD/FDA approved tests for EBV and BK*, the most commonly tested analytes after CMV.  In addition, cobas 6800 Omni channel menu expansion will include other key transplant analytes.  For cobas 4800, the UDF capability with cobas z480, the MagNA Pure instrument and 3rd party reagents provides menu expansion opportunities beyond CMV. 

It would be good to somehow work in that CMV is the highest test volume for transplant so even moving this assay to a CE-IVD or FDA approved test can help streamline workflow in the lab...in other words there is opportunity to sell CMV even without the broader menu.

Add footnote:
*cobas 6800/8800 EBV and BK tests are currently on the stretch agenda


comment:
We need to provide an updated graphic for this...will send via Basecamp


comment:
In Question 1 change "they" to "their base schedules"


comment:
Now that you are familiar with how to handle key objections relating to LDTs, you can practice with some potential customer who are currently using LDTs.


comment:
In the second question the second answer should be "Because the meter data value is not more than 5% or less than 5% of their load base schedule amount."  This should also be reflected in the answer.


comment:
That was really good!  I think once we tweak the text some on the conversation - maybe we can continue to try to shorten the responses we will be in a great spot!!


comment:
If you one answer correct, and the other one incorrect, the answer says "Sorry that's incorrect" implying that the entire answer was wrong.  How can we fix this?


comment:
Last question change to:

What advantages do Roche cobas CMV tests have over other CE-IVD or FDA approved tests?


comment:
I'd like to amend my first comment two rows above - The answer provided in the results box is ok and does not have to be fixed.  The multiple choice answer that the learner selects IS incorrect.


comment:
We have already covered the CE-IVD reagents list - the bottom of the table. We should keep these section only to CE-IVD/FDA approved tests. 

I would suggest using the bottom of the table for the intro to the previous section and the top of the table for the intro to this section.
(there was a suggestion to split the tables like this for Module 3 - could re-use those again here)


comment:
Wording here from Sophie would then change to just talk about competitors that offer CE-IVD or FDA approved tests.....


comment:
We are considering the Abbott RealTime CMV Test  
(there is only 1)


comment:
The true or false statement should not have a question mark at the end.


comment:
Now it is your turn to speak with potential customers who are currently using or considering competitor's assays that are CE-IVD/FDA approved.


comment:
The subhead on these screens should be CE-IVD/FDA approved tests


comment:
Somewhere we need to explain that the orange notebook box contains the scenario.  This is not obvious.


comment:
Change "You chose: False.  Why is that?"  to You chose false as your answer to the previous statement that an EIM entity is always charged for over or under scheduling when they are within 1% of the ISO forecast. Why is that?


comment:
....against our top competitors offering CE-IVD or FDA approved tests like Abbott, Qiagen and Siemens.


comment:
You have learned about the complexity of transplantation and how much... 

...to deliver standardised results...


comment:
For the second bullet..it is the CAP/CTM CMV that is referenced in the guidelines via reference to a multicenter study

cobas CMV Tests are not all FDA approved...cobas 6800 CMV is pending approval and cobas 4800 CMV won't be FDA approved

Maybe this bullet can be, Roche has already invested in second generation real-time tests with cobas 6800 and cobas 4800 CMV?  

Discuss with the group


comment:
If you want to review the scenario, it completely covers the screen you are working on.  Heidi has some ideas about how you could use the white space to show the scenario, or if the learners can print out a sheet with all the scenarios they could have it in front of them while they look at the screen.


comment:
For the first bullet...

Roche is committed to the transplant testing area with EBV and BK on the stretch agenda and other markers in development for cobas Omni channel

Let's discuss with the group


comment:
Not sure what is correct here...let's discuss these


comment:
We are determined to keep the scientific and clinical community moving in the direction of harmonized test results and improved patient care


comment:
Need to modify the last part of the statement.

At the moment the cobas CMV tests are not FDA approved and only the cobas 6800 CMV test will be.


comment:
Like this statement but we need to modify the end since we don't have EBV and BK...

Let's discuss


comment:
Need a better resolution image here

Jessica do you have a high res?


comment:
Sorry another change to the "correct" answer.  The correct answer should say "Because EIM Entities are only charged these penalties when the meter data value is not within 5% of their load base schedule amount."


comment:
Roche's SPOT CMV campaign is focused on patients...need to modify the first part of the statement...let's discuss


comment:
These answers do not answer the question "Why is that?".  Either remove that question or we will need to fix the answers.


comment:
Another suggestion for fixing this problem.  If the answer options are left as they are (removing the yes or no before each), the question should read something along these lines: If Rhondas base scheduled amount is under-scheduled, is a charge code is triggered?


comment:
The fact that this exercise is only dealing with the scenario that we just reviewed needs to be clarified.  
The natural tendency (at our office at least) is to try and match the box on the left with one of the items on the right and the idea that we are only dealing with one very specific scenario is lost.


comment:
The first time I did this I picked the correct first answer to the first question and then the incorrect answer to the second question.  The second time around I select the correct answer to both questions.  Even though I got the green box that said "That's right" it still said that Question 2 was "incorrect."


comment:
These are Heidi's comments:
For this exercise, I believe that each charge code that pops up should be listed at the same time along the left side of the screen. (CRH - Heidi - I'm not visualizing what this means, let's discuss) 
Also, there should be some kind of icon next to the Charge code does not apply in this scenario. It could be a circle with a big red X in it, or the words could be bolded and in a different color, just something to make it stand out. 
The instructions should read as follows Drag the charge code to the appropriate scenario detail. Note that not all charges will apply.

Also, Heidi mocked up an example that can be provided.


comment:
The first sentence talks about market conditions over the day, however we stated that these examples only cover one hour.


comment:
There should be a legend that explains that a green check means the answer is correct and a red x means the answer is incorrect.


comment:
The charge code names for 6045 and 6046 are incomplete.


comment:
The "That's right!" for 6046 should say "...and occurs when payments are collected in CC 6045."


comment:
This is not really defined well enough to answer, so we should either call this out better a few slides before in the scenario, or this needs to be changed. I think it is good that they know where to look, so maybe it could just be clarified when the scenario is being set up explaining where Rhonda is looking for information to true up her data.


comment:
I have concerns that the learner is probably just guessing at this point.  We mentioned the grid management charges in the last module, but that may be a lot to ask.  If we use this learning technique throughout every scenario it may get frustrating.


comment:
Should we mention something here about the grid management charges to reinforce this concept?


comment:
First sentence of the narration should read Now that youve gone through a basic example yourself to help Rhonda with her charge codes, it is time to look at another scenario with her and help her validate her settlements statements.
Second sentence should read You will be working through another scenario that relates to a typical market situation with a few different market conditions added in.


comment:
Same comment regarding timing that I stated in Scenario 1


comment:
Note, this slide also needs to have the white text boxes made the same length, and matches should be match in the last paragraph.


comment:
I believe that we stated earlier that Rhonda is a settlements analyst for an EIM Entity Scheduling Coordinator.  This means that she will not have a participating resource.  You will need to have a different settlement analyst for this scenario from a participating resource scheduling coordinator.


comment:
Refer to comments on Scenario #1 related to the yellow notebook and displaying the scenario


comment:
Confirming with James whether these answers are correct.


comment:
Instead of "Based on Rhonda's situation..." display "Based on Rhonda's information in this situation..."


comment:
In question 1 I chose "True" (which is incorrect) and the green box stated "Correct! the answer if a false statement"


comment:
I'm not sure how the first and third answers differ...and they are both incorrect.  The SC will only get this charge code if they are instructed to move their resource up or down in the five minute dispatch.


comment:
If I choose the incorrect answer to the first question, I should not receive a "That's right!" green box.


comment:
The title "RTD vs. FMM forecasts" does not seem like the correct title, unless I'm not understanding the intent of the question.


comment:
This question seems more appropriate for the RTD vs FMM title (maybe?)


comment:
I think that these questions are not recognizing when I change my answers from the last time I went through the scenario.  The results boxes (showing my answers to questions one and two) do not reflect the answers I've chosen.


comment:
Honestly, now that I've done this several times, I don't know the problem with the logic, except that it is not correct.


comment:
I would change the word "awarded" to "instructed" in this question.  Let's confirm with James at our meeting.


comment:
The way this question is worded sounds odd to me.  Let's discuss.


comment:
It seems like when there are multiple right answers and a learner chooses only one and it's right, they should not get a response that says "Sorry, that's incorrect."  It should say something more encouraging, to indicate that they are right but there are more right answers.


comment:
Feedback under Thats right! is incorrect. It is a copy/paste from another answer regarding CC 6046


comment:
The first point is not necessarily correct.  A participating resource could have a base schedule and then get a RTD instruction without any instruction in the FMM.  We need to figure out how to revise this statement.


comment:
Change the introduction to say "Rhonda receives a settlement statement after the trade date and needs to check and see if the amount energy that was dispatched equalled the amount of energy that was supplied."


comment:
Change the second to last sentence to say "Some resource's meter data and some interties' e-Tags were not equal to their dispatch instructions."


comment:
Question 2 response replace "pays or charges" with "settles"


comment:
In some of these two part questions the learner knows which part of the question they got right or wrong.  Other two part questions do not.


comment:
Add the word "For" at the beginning of the problem statement.


comment:
It seems like both of the answers related to the base schedule are correct.  Check with James.


comment:
It is not clear that Bid cost recovery does not apply. The scenario states in the FMM line that all the resources were dispatched economically, but it does not state that in the RTD line, so the could be dispatched and be eligible for BCR.


comment:
Remove the word "fee" after "Bid cost recovery"


comment:
The correct charge code is 64750 not 64700.


comment:
The first bullet should include wording that this is over a trade day,  The way it is now could imply that they are eligible for BCR in every interval.


comment:
You need to make the same distinction for the second bullet also.


comment:
"The ISO"  o "The market operator" dispatches the energy, not her BA.  Please correct the script and the screen.


comment:
The question doesn't seem to match the answers.


comment:
Javier did not introduce this scenario.  Shouldn't this happen to maintain consistency?


comment:
In all of these scenario description screens it would be nice if we could highlight where the change is.


comment:
The "That's right" screen did not reflect the answers that I selected.


comment:
64700 is RTD Instructed Imbalance Energy, not FMM Instructed Imbalance Energy so this box is in the wrong place.


comment:
Let's get the course up to speed and then we can figure out the key points.


comment:
I would suggest having one for pre-market, one for market, post market and administrative charge codes.


comment:
In addition to downloading from this page, we should put this into the resources section.


comment:
I stared at this page for a long time. Is the blue our response to the red? If so, think there are much better ways to address this objection - we already gave it in the green above (but instead of research, I would say GUIDELINES recommending reporting in IU/mL...)


comment:
the comment "large menu requires unique and rigorous calibration and maintenance for every single test"is not consistent with the branding/messaging of the cobas 6800/8800 systems. We should not be bashing broad test menus. We should probably give a more, "me too" answer.
"The 6800/8800 systems allow for menu expansion, and unlike LDTS, they do not require rigorous validation and unique calibration and maintenance of every single test." (or something like that...)


comment:
agree with JZ, though i remember seeing this table intact in module 3 (because I had a hard time distinguishing the two shades of gold/peach on that slide.


comment:
agree with Joni.  THis needs to be checked thoughout the module.


comment:
In correct feedback the "I" form and "the CDC" form are mixed.


comment:
Per alpha feedback we were going to add head and heart content and her sound reasoning. Do you have what you need to add this?


comment:
We had taken out the content of attending conferences. This 2nd bullet needs to be updated with the concerns on site 1: 14 active trials and 9 enrolling at the time this trial starts


comment:
Does site evaluation and qualification need to be capitalized?


comment:
2nd step 3rd bullet:
Is it really a requirement to have COPM approval? Feasibility is blue steps in the process map in BWL.


comment:
Propose to modify course title to Documenting Site Qualification and Selection in Trialforce (look for VO impact)


comment:
2nd Stop - 2nd bullet. The introductory clause reads weird. Suggest either remove the "a" or add a noun: "If feasibility is required,..." or "If a feasibility assessment is required,..." (don't know if assessment is the most accurate word).


comment:
Is there any way to put a star on the 2000ppm box to say that Riverview's interlocks happen at 1000ppm rather than 2000?


comment:
plant wide box - Change "if the stack of so2" to "If so2 at the stack"


comment:
plant wide box - end sentence with "operators take corrective actions", remove the four bullets.


comment:
Ops Man box - end paragraph at suspending certain activities.


comment:
1st inversion box - Since it's only 10:15, there exists a possibility of an inversion, even though the stacks appear normal.


comment:
after discussing it with the area manager, you agree that you'll wait for another 45 minutes to make sure that the risk of inversion has passed. after 45 minutes has passed, as the production supv, you need to reevaluate the situation.


comment:
it's now 11am and, seeing that the stacks are still dispersing normally (and it's not shift change), you approve startup since you are the production supervisor.


comment:
Is there a way to make this clearer/easier? after the discussion with the area manager, can the NO line up to the top highlight so they know to start over? Also, when you click on the >30 box it's technically correct even though you already know. Can the comment that comes up say "Yes, we know that the plant has been down for more than 30 min since we started this process at 1015! The "was the plant tripped with high so2 lower box is also correct even though the information was previously presented. It should also say something like "yes, we know the plant was tripped on high so2!"


comment:
3rd Stop - 2nd Bullet: "All necessary forms" is an incomplete thought, needs something more here.


comment:
3rd Stop - 3rd bullet: too many caveats, suggest re-wording.


comment:
(the prod supv don't start work at 9)It's 9am on a Sunday morning. You're a production supervisor working at your desk. The plant has been down, but is ready to start back up. Let's remove the "plant really needs sulfuric to run" piece.


comment:
the gm/area manager should also ask about wind speed, wind direction, weather conditions around the stack.


comment:
for YES lets say, "because of the risk of inversion due to time and lack of wind to help disperse the plume, we will err...


comment:
for NO, "...you ensured that everyone in the plant was safe in case there was a bad startup during a time when inversions are likely. No wind would've kept stack emissions close to the ground.


comment:
change "high winds" to "no wind" and make it a green check mark. apparently that is a reason to not startup as well... :)


comment:
take out "even the slightest" and leave it as "if there is a risk of inversion...


comment:
3rd Stop - last bullet: this is confusing, please update


comment:
speaking of before...it looks like it's past 11am and the risk of inversion has passed. the wind has also picked up and is dispersing the stacks well. Lets see if you know...


comment:
all downwind work on the list must be suspended. upwind work may continue at the discretion of affected area management with safework permit approval.


comment:
You or your sulfuric operators need to talk to other area...


comment:
or the verbiage can be more vague. instead of saying you or your operators, it could just say that the other areas need to be notified. that would leave the option to the site on who does the notification. the supv just needs to ensure that it's done...


comment:
Suggest changing the end of the first sentence to: "...on the site selections made by the CDC."


comment:
Are we changing the name of the "Investigator Site Change Form" with the July release? If we do, this will need to be updated throughout this (and all) training course(s).


comment:
Site Activation text: use of the word "we" sounded odd to me. It isn't wrong, but I don't think we have used this nomenclature in any of the training modules.


comment:
Site 1 - it seemed strange to read the feedback on Site 1 in the first person.  If you are going to do that, I would add after..."Select the best answer and see Monica's response" OR put the feedback in the 3rd person.


comment:
I would switch the pictures for product delivery and the study team.  It seems odd to have the study team picture be only 3 people.


comment:
I'm not a big fan of "s/he", is there an alternative way to write the sentence to eliminate the need to say "s/he"?


comment:
I would remove the 2nd part of the second sentence after "requirements."  Then I would add after the bulleted list (to tie is more obviously to JBDM).   "Next, Monica identifies whats important to her (her value in making the decision), which is sites ability to successfully enroll and complete the trial."


comment:
Agree with Karin's comment about eliminating the sentence in Site 1 answer. I would also eliminate "The risks outweigh the benefits".  then add a final sentence that states, "Based on the identified value for this decision of selecting a site with the ability to successfully completing the trial, she should eliminate this site, as she has concerns about their ability to do so.


comment:
Instead of lower risk (in Karin's comments), similar to what was stated as a value, should Monica say, "I made the decision to qualify sites 2 and 3, because I had more compelling evidence that these 2 sites could successfully complete the trial." or something that links this back to the data gathered to help determine which trial best met what was important (successfully completing the trial).


comment:
I briefly saw a screen that showed "values and sound reasoning" to make the decision, but when I moved forward and then tried to go back, I can't find it now.   I was trying to find it to evaluate if my previously comment would fit better on that screen.


comment:
2nd bullet suggestion: Give reasons why Site 2 would be a better choice, with the information we had to evaluate their ability to meet the trial requirements. (wordy but something like that?)


comment:
navigation appears to be off - the screen instructions should point the learner to click on Manage and Document Follow up Items


comment:
I think it should be eTMF in first distractor


comment:
Use image associated with account plan in opening versus dinosaur.


comment:
Found this page confusing - the question and answers don't match.  Is this page just for functionality?


comment:
I personally don't like having to reset the question by hitting the 'try again' button.


comment:
Minor point.  On the landing screen when you type in your name, the tab button should take you to the WWID box  it doesnt  or at least didnt when I tried it.


comment:
can you put the greater than/equal too sign vs. >/=?  My computer wasn't giving me the symbol when I tried to do it


comment:
First box recommend revising: PI is aggressive in his treatment approach to achieve....


comment:
This section should be after a section on how to prioritize accounts based on the information sent.  Then this section turns more into coaching team on thinking through the criteria to identify where accounts plans are needed or to help make the case for why an account plan is important for a customer.


comment:
because the site had epro issues the data integrity was compromised as some was not able to be used and there were data entry inconsistencies compared to the other sites and the complexity of the trial this site has a higher risk


comment:
I thought we changed this up both the purple and brown box for the 2nd bullet?


comment:
Currently does not allow person to proceed until they get the right answer no matter how many wrong answers.  Should max out attempts at two before giving the correct answer.


comment:
brown box associated with last purple statement- use some of what I put in my earlier comment to revise this:  rather than red flag can say is a concern and along with missing data can say:....that resulted in missing data limiting what could be used and because of the difficulties some patients stopped their participation in the trial.


comment:
Engaging the right people is about resourcing (not prioritizing) the account properly to achieve what is desired by and for the customer.  If it is a priority account, we need to make sure the resources are allocated / participating / supporting this account.


comment:
can use 212- with a data base of thousands both could be realistic; not following ksb other comment entirely: so it is clearer:  for purple box add to last sentence:  will also be able to refer patients for the trial; brown box:  The study team did say they would consider primary care physicians and this PI also has an Endocrinologist as a Sub-I who he partners with on diabetes trials.  I will review this with the COPM to see if we need to discuss with the study team.


comment:
Revise the first bullet:  Prefer the Principle Investigator (PI) is a licensed Endocrinologist though the study team may consider a primary care physician depending on prior experience, enrollment potential and site capabilities.


comment:
by revising the initial slide and the specifics in 2nd statement I think this may be better


comment:
3rd brown box:  ....concerns about the HBA1C criteria is a positive sign for possible enrollment.


comment:
in response to ksb:  because we revised the last one let's change this one up:  since there wasn't mention in the purple about HBA1C concern let's revise the purple box:  Site performed a database search of Type II Diabetes patients on metformin only which resulted in a potential of 188 patients.  The PI did mention that this search wasn't based on all inclusion/exclusion criteria and therefore the potential patient number would be lower.  The associated brown box revise:  Because the site's database couldn't search for all the inclusion/exclusion criteria I will need to ask more probing questions to understand the site's enrollment potential.  (see how everyone likes that)


comment:
change language to - "what are other ways you can use the account plan during account reviews or employee 1-1's"


comment:
2nd purple box- may read better if we say:  five insulin titration trials within the last 2 years (it's implied that they are diabetes); brown box:  The trial prefers licensed Endocrinologist with insulin titration experience; it is encouraging to see this PI meets those requirements (or something similar)


comment:
3rd brown box:  It is concerning that they haven't worked with an MRI center in the past.  I will need to get a better understanding as to how the site plans to meet this requirement and partner with the facility for success.


comment:
4th purple box:  Has used ePro on three trials in the past two years with minimal difficulty on their first trial which they were able to trouble shoot and none since then brown box: I am glad to hear they haven't had any recent issues with using ePro and were able to work through the challenges they faced on their first trial


comment:
add to the first purple box that the site has access to the patient population but was not able to perform a database search to get more definitive patient numbers; PI also stated he is aggressive with his treatment to ....


comment:
2nd purple revise:  PI is a licensed Endocrinologist thought leader with 9 years of academic and industry research experience; he is currently enrolling 9 diabetes trials, 4 which are recruiting Type II DM patients requiring insulin; brown box can then read: The PI's experience is a benefit in managing the trial's patients.  I'm concerned about is enrollment capabilities because he wasn't able to give me an idea of patient access and he has 4 trials competing for the same population.


comment:
Titles for CC 6045 & 6046 
CC 6045 Over and Under Scheduling EIM Settlement

CC 6046 Over and Under Scheduling EIM Allocation


comment:
add to the 4th purple box: The site staff is hesitant to use ePro again.


comment:
Is ePRO a common term?, should we use electronic diaries?


comment:
need to revise based on prior comments:  Site 1:  The PI has access to patients but was not able to give more definitive patient numbers, is aggressive in his treatment and will be  enrolling in competing studies.  PI is an Endocrinologist with access to an MRI.  The site has ePro experience but it is limited and they are concerned about using ePro.  Site 2 revise patient number; add to 2nd sentence, physician with experience working on insulin titiration trials. He also has an Endo who partners with him on his diabetes trials. Site 3:  revise patient number; 2nd sentence: PI is a licensed Endo...


comment:
Site 3: Is "document in the iSEC and Trialforce" redundant?


comment:
More tan 1 additional option was available


comment:
the box that pops up for Site 1:  Let's start with the added information that was learned:  The CDC learned the PI has 14 active trials with nine that will be enrolling at the time this trial starts, 4 which the CDC knew would be competing for the same patient population.  Upon further discussion with the study coordinator (is this capitalized?) the CDC learned that she is the only one on staff to manage the workload and there is no ability to hire additional staff.  This site comes with more risk than the others as it relates to enrollment potential, workload capacity and ePro experience.  Since the site is new to Lilly the CDC has no historical information to help lessen any concern.  The risks outweigh the benefits as compared to the other sites.


comment:
Site 2:  Reviewed the PI and site's capabilities with the COPM and Clinical Research Physician (CRP) who had no concerns moving forward with considering this PI for the trial.  Data indicates the potential for good enrollment. the rest can remain as is


comment:
Exec summary - would stress that most of the account plan is likely confidential and not to be shared/reviewed with the customer.  Competitor analysis - competition may be weak but could also be stronger than CMI.


comment:
When I clicked on the button for where to find more info needed, I wasn't sure it was actually selected - hard to see it was selected and/or if I needed to choose more than one.


comment:
In the feedback to the correct answer, I suggest to clarify how to document in Trialforce includin a task.


comment:
May 8 discussion - this is the latest comment:
We need to not have words or phrasing that implies elimination or blocking of competitor - it needs to be that based on our product features and benefits labs will want to use our product


comment:
Site 2:  Discussed the PI and site's capabilities with the COPM and Clinical Research Physician (CRP)who agreed to move forward with considering the PI for the trial especially knowing he has an Endocrinologist partnering with him as the Sub-Investigator; Data indicates potential enrollment capabilities that could meet and exceed enrollment commitment; ....need to partner with both the site and site activation to help remove barriers in achieving enrollment readiness (see what the others think)


comment:
May 8 - updated comments:
We need to have the funnel as a screen where the tests that have the required features remain in the funnel.

For example, if the test reports in IU/mL at the top of the funnel, it remains in the next layer because it meets guideline requirements.

Does that make sense?


comment:
Focus more on the positive then the negative...rather then removing competition it is selecting the features and benefits that the lab needs most


comment:
May 8 comments:  Change the blue bubble to:

Current consensus guidelines for management of CMV in SOT patients recommend reporting in IU/mL and proficiency testing organizations provide samples in IU/mL.


comment:
site 3:  Tangible enrollment data and  additional discussions revealed they see 14 new patients a month adding to their enrollment potential; Site hasn't used the local MRI center for research and needs to follow up on how this will be arranged(need help with wording).  The CDC will (not sure if using I is consistant with how the wording is on other slides?) document this in the ISEC and Trialforce as a follow up task. ePro experience with limited issues on the first trial.  Site is known to Lilly with no quality issues, short enrollment ready cycle times and has met or exceeded prior enrollment commitments.


comment:
I suggest to include "complete the shipping locations" and recommend to use the "Trial site task list"


comment:
a few things for the "correct" verbiage: ....the site has access to an MRI to use during the trial.  The CDC will document any updates associated with the follow up item which was entered into Trialforce as a task until it is resolved.  If the site is not able to find an MRI center to use for the trial the site will no longer be able to participate in the trial (check with the group to see if the last sentence is necessary to state)


comment:
I closed the windows accidentaly and when I acces again to the course, I did nor have the option to resume where I left


comment:
based on other revisions need to revise this:  Monica had to review the PI and site's capabilities with the COPM and CRP since he was a primary care physician.  Everyone agreed that the PI could be considered for the trial.  I think the next sentence should state: How should Monica document this discussion?  Agree don't know what ETMS is?


comment:
Suggest rewording because it isn't really up to the COPM to make the decision- he/she just has to help facilitate the discussion- revise to: Since alignment was reached to move forward with the PI the CDC will document the discussion and outcome in the ISEC


comment:
should first bullet say within the ISEC and TF?


comment:
ksb- no it is prior to enrollment readiness because the site can't be declared enrollment ready if follow up items are not resolved- agree with DW we can combine & can combine as 1 or 2 bullets


comment:
do we need to revise the VO as a result of our revisions?


comment:
Also, do we want the wrap up to be more about what to take into consideration when making this decision vs. specifics to Site #1 or we not what needs to be taken into consideration and pull from site #1 as an example of those considerations?


comment:
VO should we say tasks required in TF to qualify & select a site?


comment:
#2 3rd bullet- At the minimum complete the required Site Profile Questions (SPI)at the SITE (not sure why this is capitalized?) level in Trialforce


comment:
should our verb usage be enter, complete, document.....


comment:
shouldn't it say before qualifying for #3?  Also should we include documenting follow up items for step #4?


comment:
For this question, since there is only 1 correct answer, it should not say "Select all that apply." Change it to read "Select the answer that applies."


comment:
Is required to upload the LOC in Trial Force. 
We upload this document in eTMF


comment:
1st stop.  For me the PI´s email is not the activity that we evaluation during the first interactions. For me the order is LOC, Feasibility and after that we perform the activities related to site evaluation


comment:
Last purple box -pop-up: the CDC can investigate further if previous issues with connectivity were due to site's connection, device problems, etc. ad determine if any change is in-place to mitigate this


comment:
Site activation text - 2nd bullet on ensuring access to systems sounds like CRA bullet.  Which role is updating access to systems?


comment:
Site activation text - last bullet sentence sounds incomplete for the type of submission.  Do you mean "Performs the ethics submission and obtains approval?"


comment:
Financial group - I'm not clear what this is.  Do you mean the budget group within site activation?  What financial documents do you mean?  Financial disclosure, budget (attached to the contract?


comment:
Second brown pop-up: To address KSB's comment, maybe the box should clarify the requirement for the type of PI the trial requires vs the study team preference. Some protocols are descriptive on the type of PI license/qualification needed. It seems for this case that the study team prefers to have Endocrinologist instead of being a trial requirement


comment:
Navigation didn't work for me. After I clinked the PI change icon, the next button didn't bring me back to the Explore the changes page with the 5 types of changes icons. I had to select the back button vs. next.


comment:
consider adding lab supplies or other trial required supplies to this example.  It's not just CT Material that can be lost with an address change.   CLO seems to be sensitive to being included in site logistics.


comment:
We've been using "study participant" instead of "patient"


comment:
Key considerations: 3rd bullet, consider expanding beyond CT Material. Can also be ancillary supplies, lab kits, other trial supplies that are shipped, etc.


comment:
Navigation - didn't work for other icons that were selected.  Could not return to this page with the 5 icons after reading about the change.


comment:
I agree with the suggestions made by Nancy. Last bullet point for Site 3 does not provide clear information on what process the site knows, so the additional info Nancy is suggesting addresses this.


comment:
Protocol change - 1st sentence a little long. Suggest reword to something like: If the protocol changes, you need to understand the potential impact and confirm the site understands the impact of the protocol change and remains qualified.


comment:
Protocol changes - 2nd paragraph - not clear. Consider a different protocol amendment example or change description.


comment:
Site change - why it matters - 2nd bullet: I don't think "processes" is the correct word.  Do you mean "Trial-related financial and/or regulatory information may not be current"?


comment:
Key considerations: Study Participant is typically used in the CDOS instead of patient.


comment:
Second bullet point.. She was able to:
Provide rational to select site 2


comment:
Ignore navigation comments. I don't know how to remove/delete.  I reviewed again and needed to complete the "you try it" exercise in order to navigate back with the next button.  Sorry!


comment:
Information change - you try it: Not sure what is meant by financial team.


comment:
For the correct answer: I would recommend to include something related to timelines of the follow-up, we do not want the CDC to check this until a week before the site will be declared enrollment ready as it may be late in the enrollment ready process. In this course it has not introduce how to manage follow-items/tasks in TF.


comment:
Protocol change: Please ask SMEs if clarification is needed around getting ERB approval before implemented changes from a protocol amendment.  After reading the examples, it almost reads as if the CDC needs to give the site approval to proceed when actually the site needs to submit the protocol amendment and get ERB approval before operating under new amendment.


comment:
Please clarify if the LOC is needed in TF or in the eTMF. It says now if necessary.. or clarify in which situations is necessary.
Please clarify if the email address is crucial at this early stage or find another example of PI information that needs to be populated in an early stage...


comment:
Second stop - Third bullet point: SPI (At site level in TF)... is there a SPI form at other level in TF? I d not know if the parenthesis provides additional information


comment:
Third stop 
second bullet - The sentence seems incomplete or maybe all sentences can start with a verb
Last bullet - The sentence is not clear, suggestion start with the action and then the forms that need to be finalized


comment:
Site 1 answer: Shorten in general.  Eliminate sentences "The PI has not used..." and "There is no way to validate..., " they seem to be redundant and state the same conclusion as the prior sentence about number of potential study participants.


comment:
On main slide, consider replacing "Which site should Monica NOT qualify" with "Which site should Monica eliminate"


comment:
The explanation for the incorrect answers bullets 2 and 3, doesn't seem to make sense to me.


comment:
for the objectives, please write it like humans are going to read it. :) Change "objectives" to "You'll learn: and then summaries the bullets to "how to recognize when there are issues with how the samples were collected or prepared. You'll also learn when the problem might be in the lab environment. or something like that


comment:
I "think" I clicked everything here - 5 total things? but i'm stuck on this screen and can't get to the next thing


comment:
If I were this lab manager, I think I'd be more ticked that I'm having to have someone come out again. She's getting yelled at by someone as to why she can't get to test results.


comment:
Please pick more relevant images for the three xamples than open boxes. HaTrang should make some icons or something


comment:
update images on these questions with whatever gets picked on the previous page


comment:
This top 10 list feels like it should be a nice PDF with formatting and graphics.


comment:
Refer to my note above.  Please remove all of the verbiage except the sentence that I stated above.


comment:
Paragraph 2, second sentence "If the resources were ramping, then a portion of the energy dispatched in the FMM would be settled in charge code 64700.


comment:
Last paragraph "Since the FMM forecast is greater than the base forecast, the ISO will procure uncertainty capacity from resources to cover potential net load deviations.


comment:
see style guide for color specifications


comment:
maybe just say:

By using these three filters in the funnel you will position Roche as the obvious answer for your customers.


comment:
Please change may sentence above to say "...the ISO will procure flexible ramp up uncertainty capacity and flexible ramp down uncertainty capacity from resources to cover potential net load deviations.  Flexible ramp up uncertainty capacity will be paid in charge code 7071 Flexible Ramp Up Uncertainty Capacity and flexible ramp down will be paid in charge code 7081 Flexible Ramp Down Uncertainty Capacity."


comment:
Also please add CC 7081 Daily Flexible Ramp Down Capacity Settlement on the screen (and check it).


comment:
just a design question - can you remove the white background from the logos?


comment:
do we have a new version of this from Kieran?  at least update the colours to match the styleguide and colours throughout the presentation/training module


comment:
In the Offset paragraph change "in each component..." to "based upon each component..."


comment:
do we need to have a footnote for what CAP/CTM stands for or spell it out here...


comment:
Make the naming convention for these scenarios consistent.  Sometimes we refer to them as "Scenario XX" and sometimes we don't.  The numbering gets confusing unless you state it every time.


comment:
It's confusing whether this applies to this scenario, or just generally.  Need to be more specific.


comment:
Change the correct answer to be "Because the EIM Entity's portfolio passed the balancing sufficiency test."


comment:
Please make sure you let the learner know the applications that apply in the set up of the scenario.


comment:
Since there is only one answer change this to say "Select the charge code that applies"


comment:
Please add to the end of my last comment "..to this resource?"


comment:
Change "Supply was awarded..." to "Their supply was awarded..."


comment:
Change the question to "Which applications are used to validate the settlement of CC 64700?"

Correct answers are ADS, CMRI, OASIS


comment:
64750 - The box for 64750 should be associated with the e-tag and meter data option, not the RTD option


comment:
On the last bullet, add MRI-S as an application used to validate this charge code.


comment:
Where's Javier?  This is not consistent?


comment:
In this scenario it can't be Rhonda because she is a EIM Entity SC.


comment:
Please be consistent with capitalization.


comment:
On Question 2 of 2 the statement doesn't match the Question 1 of 2.


comment:
Remove "ADS" from the last sentence of the incorrect answer box.


comment:
Remove Forecast fee the That's right box.


comment:
Change the first sentence to say "When reviewing her settlements, Rhonda notices that some of her resources were dispatched to serve load in the ISO balancing authority..."


comment:
The scenario does not mention anything about the fact that the energy was dispatched to CA.


comment:
Remove "due to California state regulations."


comment:
We never mention why UFE occurs before this.  We should add it into the scenario.


comment:
Question "What application should she use to validate UFE?"


comment:
Let's the review the logic of this exercise.


comment:
Can we add "Manage Site Information" to Process Map in the button?


comment:
The financial piece is done by site activation in many countries. Maybe remove that button and add the bullet to site activation with a comment that this may be done by other function as per local practice?


comment:
We're not longer "approving" sites to participate in trials. Replace with "selected"


comment:
when clicking "what should I do", I would propose to change 1st bullet in purple box.
Propose:
Contact the site as soon as possible to learn about the new storage location and conditions. To help determine the urgency of visiting the site in person, try to uncover if there are any gaps or issues with the new location. Use judgment...


comment:
Should a bullet be added around notifying appropriate parties (e.g. the CRA, Product Delivery)?


comment:
Say Site Selection Guidebook instead of Guidebook


comment:
Slide header to read Site Location change?


comment:
Always Do:
Does the CRA only need to be informed of critical changes?


comment:
we revised the 2nd bullet during our last discussion and wonder if we need to also revise the VO?  ....changes can also impact Lilly's ability to supply the site effectively with anything they need to continue seamlessly in the trial


comment:
should we include something that touches on type of evaluation - live vs. phone in the first bullet?  I mention because we have been receiving several emails asking us if a visit should be live vs. phone and the CDC needs to use their judgment based on the situation.  Just putting it out there for consideration.


comment:
under CRA is notes requests accounts- doesn't site activation also do this if applicable- just want to make sure that if more than 1 role performs this it is reflected


comment:
for bullet 2 for location change- could we add ....if supplies or CT Material shipments ....especially if it results in these being lost.  Also, if Lilly is ....


comment:
we don't mention that the protocol changes are driven by the COPM and think we should include that somehow as it has been asked often


comment:
Need to be consistent with numbers. Anything 10 or less should be written out in words. (2nd box should be two and not 2).


comment:
check spacing in Site 1 popup - last sentence.


comment:
I think this PF is wrong. This is the debrief slide for module 2 make a decision, and it says Defend the decision section 1 page 1? Might want to confirm.


comment:
2nd sentence doesn't make sense. Should investigator be "sites"?


comment:
This slide has a different heading - change considerations, but is under the manage and document module. Should it be updated?


comment:
Suggest adding notifying the Clinical Contracts and Grants Office (CCGO) referred to as "Financial Group" in this training of the PI change since site PI changes require normally require contract/Letter of Agreement changes that can delay the new PI assuming the PI role at the site. This is important in instances where there are ongoing patients in the trial when the PI change occurs.


comment:
Can you put the QRG in the resources popup too?


comment:
Bullet 3 should be submits updates to required systems


comment:
Bullet 4 - either submits change to EC or ensures the change is submitted depending on local practices.


comment:
When there are PI changes, there are activities that are done by the CRA. Suggest to add communicate to the CRA of when the new PI is qualified, so the CRA can follow up on training, updates to key study logs, etc.


comment:
Suggest to add notify the CRA when the site change is approved, the CRA also has to verify that the PI notifies patients of the new location


comment:
The -NEXT- option is enabled prior to click all the icons


comment:
As well as CRA, Site activation should include request new accounts if applicable if changes were made between site selection and SIV.


comment:
I am not sure if -complete in-person location evaluation- should be done during the move


comment:
"This course includes a information on navigationg in ValGenesis..." change to "This course includes information on navigating ValGenesis..."


comment:
Site Information - period between icon and to


comment:
Display Name and Site Information are complete sentences. It might flow better to have all icons show complete sentences for consistency.


comment:
Is My Tasks supposed to have a green border on the initial visit?


comment:
Change "Entity Management in Inventory Manager" to "Entity Management in the Inventory Manager"


comment:
Reports - Change first sentence to "The reports icon displays all reports a user can access."


comment:
This might be nitpicky - but visually when the popups slide out the icon just bloops in while the popup wipes in smoothly. Is there a way to add the icon to the popup so it wipes in with the popup itself?


comment:
There is a glitch on the color dots - once the popup coms out if you roll your mouse to the right it glitches and just rapidly repeats the animation.


comment:
No next button available to proceed. I am assuming it is because this module is not finished.


comment:
Probably need an exit course button on here.


comment:
Please reorder Meter and e-Tags and Flexible ramping allocation tabs. Have Flexible ramping allocation first, Meter and e-Tags second and Bid cost recovery third. This will help with the overall flow of the animations.


comment:
Last sentence "Clink the second stop to continue". Should this be "step" instead of "stop"?  This is also on next couple of screens.


comment:
4th bullet under Trial Site Complete section: ECG (Shipping) doesn't make sense in the sentence. Remove "shipping".  Also, sentence starts with "other roles" and none of the examples after sub-investigators are roles or contacts as currently written.  You could change to state something like: Other roles or personnel serving as key contacts such as... OR add "personnel" after each example: laboratory personnel, eCOA personnel, etc.


comment:
Minor feedback: Instead of building button in upper right, can it stay on the page?


comment:
Title of slide: What If - Landing Page.   Is the "Landing Page" supposed to be showing in the final version?  Looks like a note left over from course creating.


comment:
Is "storage protocols" the correct terminology?  Should it say "storage requirements"? OR "storage instructions"? OR "storage procedures"? If CDCs are used to hearing it this way, it's fine. I just haven't heard this described in this way before.


comment:
Is "controlled drugs" the correct terminology? Should it be "controlled substances"?  That's the typical description in a pharmacy.


comment:
Pop-up answer to a,b,c: 1st paragraph, 1st sentence - suggest changing to: A site needs to have a contract in place prior to using an external vendor.


comment:
Pop-up answer to a,b,c: 2nd paragraph - 1. No hyphen in CT Materials  2. Should "CT Materials" be singular (CT Material)?


comment:
Pop-up answer to a,b,c, 1st paragraph:  need a comma: If a contract is not in place, the CDC...


comment:
Pop-up answer to a,b,c 3rd paragraph - suggest changing to: If the answer is No to any of these questions, the external vendor can't be used unless additional detail and mitigation to resolve is documented.


comment:
2nd grouping of questions and answers: Is "controlled drugs" the correct terminology? I thought regulations describe as "controlled substances"


comment:
ISEC button links to questions that aren't related to this page (outside vendor and controlled drugs)


comment:
Completed this section and there is no "Next" button to advance the course.  I had to go to menu to advance the course.


comment:
ignore comment re: no next button.  I missed a section.


comment:
Pop-up to 1st question -1.  needs a comma. "When using an external vendor, the site..." 2.  Suggest rewording last sentence- not clear as currently written. Do you mean "The ISEC question does not apply to the external vendors that Lilly contracts with to store and distribute CT Material to sites"?


comment:
pop-up to 1st section: 1 remove the word "themselves" 2. Change to "... the process and documentation needs to be reviewed"


comment:
pop-up to 1st question: Change "Should the site be authorized" to: "If the site is authorized..."


comment:
ISEC link doesn't link to correct section of the ISEC. (unrelated questions)


comment:
1. ISEC question b doesn't make sense - not a question.  2. Pop-up answer to 2nd section - 1st sentence is too long and repetitive. Could change to: "..how they will work with the TPO including evidence that the materials (any drug supplied by Lilly)are destroyed" 3. Change sentence starting with "Evidence" to "Examples of evidence include: certificates of destruction..."


comment:
3rd question: "Does the site have a process in place.." no check mark appears when this section is selected, no pop-up rationale pops-up.  Only pop-up when the underlined words "CT Material" is selected.


comment:
ISEC link - links to unrelated questions.


comment:
Example 1 - good answer text refers to "See the resource tab for an example of this." Where is this on this page? I don't see the resource tab.


comment:
Example 3 - comment text - last sentence is too long. Please shorten to more concise statement since this is being used as a good example.


comment:
Suggest using "incorrect" instead of "wrong"


comment:
Example 2 - answer text - 2nd sentence is too long.  Suggest ending sentence after "omission". Don't need to state "should they participate in the study"


comment:
Debrief page - remove ISEC button -doesn't belong on debrief/summary page.


comment:
same comment as before on use of the terminology "storage protocols"


comment:
The final country allocation (FCA) is not mentioned in these screens. I would suggest to add the FCA. It is an important step in the site qualification and selection process.


comment:
Under trial site completed; please add that shipping locations need to be entered: 4th bullet is not clear


comment:
Is it possible to include the information that uploading of LoC in TF is not applicable for all countries (under required items in TF)?


comment:
Should we say Letter of Confidentiality instead of Confidentiality Agreement?


comment:
Safety mailing address is added under the PI contact details and not under the primary contact records


comment:
bullet points and the recording don't match. Please check


comment:
Change the host spot location of the syringe check to be under the c 501.  Move Rectangular box to be on the c 501 doors (middle of the doors is fine. Co2 is not run on the e module.


comment:
Feedback on line 7 states that it is odd to have the study team picture be only 3 people, but it is still 3 people. Was that intentional?


comment:
Need click next directions.Also next never appeared.


comment:
Change bullet point for Reagents need to be at room temperature to Some reagents need to be at room temperature before use.


comment:
Make the dry ice box a little bigger (samples might fit in this box so it is usually medium size. Then overlay some fumes coming off like you would see with dry ice. Translucent looking .


comment:
When clicking on the thermometer or barometer the text does not explain what it is. It jumps to All of these environmental issues can impact analyzer results.


comment:
Under Why it Matters - capitalize Regulatory Authorities


comment:
To eliminate the he/she, can we just say "they meet".


comment:
Capitalize Regulatory Authorities under Why it Matters


comment:
The text still says "not delays" instead of no delays here - I think it's on the Next button layer.


comment:
Correct feedback - change locations to "location"


comment:
Ignore my regulatory authorities comment throughout. Keep these as is. SORRY!


comment:
Why it matters - change patient to study participant in the last bullet


comment:
Could you please add that the prior oral diabetes trials are Lilly trials? In the debrief (make a decision) it is mentioned that site 3 is known by Lilly.


comment:
3rd stop/2nd bullet.  will the training audience know all the possible forms represented in the 2nd bullet and if so, do they know when they are necessary and when they are not necessary?


comment:
3rd Stop/3rd bullet.  Why is "feasibility form, if necessary" not already covered by the 2nd bullet?


comment:
4th stop/4th bullet.  Unblinded should be lowercase, Sub should be lowercase, Laboratory should be lowercase, Shipping should be lowercase


comment:
The only addition we should add or highlight  is that before a CDC selects a site they need to verify with the COPM that the correct number of sites & patients is being selected as per the strategy.  There needs to be constant communication between the CDC, COM & COPM throughout the qualification & selection of a site.


comment:
For the first purple box-it just isn't flowing for me- the purple box talks about not being able to provide more reliable numbers however the tan box doesn't really speak to that it addresses something different which could also be an enrollment challenge- maybe we should add another sentence to the purple box like: The PI stated that the A1C criteria could be challenging because of his standard of care treatment.  And add to the sentence in the tan box- ...enrollment abilities and I have no way of quantifying this because they are not able to perform a database search.


comment:
2nd tan box if we add the 1 sentence to the tan box above I suggest removing the he wasn't able to give me an idea of patient access; also I would revise to say Again I'm concerned about enrollment capabilities because he has four....


comment:
2nd sentence: Suggest replacing "should" with "could"


comment:
site 3 3rd bullet- suggest- but the PI said he would reach out to the facility over the next couple of weeks to confirm their ability to partner with them on the trial.  Since this won't be resolved prior to selection the CDC will document....


comment:
Slide layer for feedback: A couple of the options state "your statement sounded a little demanding".  "Demanding" is better than saying "harsh"  but could consider replacing "demanding" with "abrupt" or another word.


comment:
Can we highlight in the guide that the CDC has to use the topic Site Selection Follow Up as that is the topic that must always be used with follow up items identified during site evaluation- not sure if there is a way to also stress this on the demo?


comment:
In the feedback text, consider changing "should" to "could" in order to coach CDC on another approach to use.


comment:
Please change "excursions" to "temperature excursions"


comment:
I may be over thinking this but I suggest removing "one month later" from the first sentence.  It wasn't clear to me if the example was trying to provide the timing in order to show the site was enrolling patients and it didn't seem realistic that the protocol amendment would be a surprise to the CDCs or that a site would have submitted an amended protocol and received ERB approval within a month.


comment:
"Notify the contracts and budgets group" is considered an incorrect answer but it seems like any appropriate function should be notified.  Some sites don't have a separate dept. to manage the contract/budget so it the study coordinator is the contact, then budget and contract group should have updated contact info for budget and contracts amendments.  Suggest thinking of a different incorrect answer to replace the "notify contracts and budget office).  Could add an incorrect Trialforce step?


comment:
Is a re-evaluation of the local lab really required?  Labs have strict regulations and the access to the labs are sometimes limited to site personal. In this case a re-evaluation would be not possible.


comment:
please specify the ERB approval; approval after the site location change or the initial site approval; I guess the approval after the location change is meant here, or?


comment:
Key consideration: Following point could be included: Does the protocol change require an amendment of the site contract?


comment:
Why are Investigator Databank and TransCelerate BioPharm listed here? These webpages are related to site qualification and selection, or?


comment:
Can you add "Identify, Evaluate & Select Sites" before Process map?


comment:
I believe the Protocol Change needs to change to "trial change" to match the updated procedure. Confirm with Nancy and John


comment:
add the word "new"
"... ensure that the NEW PI's qualifications..."


comment:
Per recent discussions, should this slide header be "trial change". And then have the 1st sentence start with:
For example certain protocol changes, ...


comment:
In Simon's feedback should it be "accounts require"?


comment:
If I hover just to the right of the journal, I get the pointer again.


comment:
Nit picky - there is only one girl in the group on the previous page, but I see two women noted in the plan.


comment:
I think the instruction here should be to click the flags to learn more about each of these?


comment:
How big a deal would it be to change this background to the tent for this screen and the next?


comment:
Let's have Simon say something about this screen. "Take a look at the information you've been able to update based on those items." or something to that effect - then click next to continue.


comment:
When I hover over the information at the bottom of the journal, I get the pointer so that it appears the text is clickable.


comment:
When I click a shovel to go to a section, it works beautifully.  But, when I click Back from that section, it takes a few seconds for the shovels and instructions to re-load on the screen.  Any way to set it so that is already re-loaded?


comment:
WE need to verify the commnets regarding Time Zone and how the server time vs PC time is captured


comment:
why it matters 2nd bullet:  revise end of sentence to read:  and could result in temperature excursions which could make material unfit for use


comment:
To Ksb's comment: yes, controlled drugs is correct


comment:
Can we look at the incorrect feedback for this question again? I selected "What is your process for CT Material receipt", but the incorrect feedback then stated that it would be appropriate to ask about their CT Material receipt processes, which was the answer I selected. 
I got the incorrect feedback as two answers need to be selected...


comment:
I thought we had already gathered all the info we needed.  Why do some of these still say "Info goes here"?


comment:
I'm not sure how much of the Planner module we will actually use.  We should check with Jason to see if we still need this complete definition.


comment:
We will need to update the deviations definition.  We don't use the deviations module anymore.  Deviations are now just a regular template.


comment:
Ask Jason if we are still going to use Periodic Review in ValGenesis.


comment:
I'm not sure that documents "can be converted to PDF" is the right verbiage.  I think ValGenesis automatically converts them to PDF and makes them available as Word and PDF documents.


comment:
The animation has the user select Close twice instead of selecting Close and then Execute.


comment:
This module is mixed up with the next simulation.


comment:
After we click "Document ready for routing", it should offer us the option to select "For review, peer review, or approval"


comment:
The user needs to select mapping in order to get to the mapping screen.


comment:
No Next button is offered after the three modules are completed.


comment:
It may help if we could add examples how a TPO should document and confirm the destruction of CT Material. My colleagues and I have never seen such a documentation. For me it is not clear how a TPO can track which materials were destroyed? They pick up big containers with plenty different materials.


comment:
CT material boxes - The correct answer " What is your process for CT Material receipt" is marked as incorrect. Please check. The answer " Did these boxes just come in?" is for me not really incorrect. It is not the best question but the CDC have realized that the CT marital is not stored proper.


comment:
Instead of "requires change management" heading of 2nd column  can this be changed to "requires impact analysis and implementation plan?" I think this is confusing bc we have in the last column that the change needs approved, but the 2nd column header makes it sound like there is not a formal change request that will need approved for a level 1.


comment:
I couldn't get the study manager to open, is this role supposed to have description?


comment:
For the feedback that pops up once the appropriate functions have been selected, the last sentence should have the "ed" taken off of implemented. It should read ".... and implement mitigations for risks".


comment:
For the CPM response what does it mean "make a submission for an assessment review"? Maybe need to provide some clarification to this as I am not familiar with what this means so others may not as well.


comment:
The second paragraph, first sentence has an extra word I think: "This change requires additional extra safety exams at per"-this should be changed to "the" maybe?


comment:
Correction to the feedback, this sentence should be changed to remove "at" and change it to "....exams per the country level requirement"


comment:
There is not an implementation plan required here and no approval is required even if it was completed. I would suggest changing this to "Edwin needs approval of the change record, but he is not sure whom to seek this approval from".


comment:
Need to add "for" in the last sentence "..the need for more..."


comment:
I don't like the statement that the next step is to develop a follow-up plan bc that is not required or mentioned anywhere in the process maps/procedure (that I am aware of or have seen. Can this be changed to "Her next step is to provide oversight to verify that the functions are completing...."


comment:
Since we asked this same question in the previous case study, can we change this question to, "Once all the tasks have been completed in the implementation plan, what is the next step for the study manager to do" 
1) Communicate to the team that all tasks have been implemented and completed.
2) Communicate and document that all tasks have been implemented and completed.
3) Nothing, all the tasks have been completed.

The correct answer is #2


comment:
Add to the last row an additional sentence: Study manager should document implementation and completion of all the tasks once this has been confirmed.


comment:
The "s" on decisions should be removed. It should state "Using judgment-based decision making..."


comment:
First sentence should state...that may impact the protocol"


comment:
CDC - prefer pop up vs scrolling.  Also, last sentence doesn't make sense.  What is meant by site personnel - study coordinator? How would the PI site personnel add a satellite location and why would site activation know this at any given point in time.


comment:
CDC - should CDC notify CRA directly? Seems like CRA pop-up asks CRA to notify CDC but CDC passively communicates to CRA via Trialforce.


comment:
Trial team's supply management:  1. Remove the comma  2. Suggest end sentence after "supplies" (e.g.; ...to ensure this location receives the appropriate study supplies.")


comment:
Can we remove the 'Next' button until all boxes have been clicked?


comment:
I don't recall this being addressed earlier in the module.  How would the user know that answer?


comment:
Should we spell the acronym CBSO group? On the second feedback


comment:
Again, I don't recall this being taught.


comment:
We can't go back in this screen. Is that in purpose?


comment:
Previous sign is still clickable. It should be grey now and we should only be able to click on the new orange sign


comment:
Same feedback for the next icon. We can still click on the 2 previous icons


comment:
Remove "iOS simulator" header from all screenshots - applies throughout course.


comment:
Update background images in video to be of the clothing racks as we had in the prior version of the course. 
(:05 - :18 and :19 - :24)


comment:
Lower case as follows: "Medical research advisory boards related to a clinical trial"


comment:
Update poster in the background to show the salon menu/price list. Also crop the photo in closer so the travel size product rack in not in view. We want it to appear as was shown in the previous version of the course video.


comment:
Insert ", if applicable" after Ensures confidentiality agreements are obtained with the appropriate signatures.


comment:
First sentence should guide you to click on the second box: 'develop & Manage timeline'


comment:
Update yellow accent color to be #8EC8BE Pistachio on the branching screens (when clicking on each button, and when the check mark appears upon completion).


comment:
Might be a good idea to change "The Budget Approver has authority to spend under the FRAP policy and will review and will approve the work to be performed and any invoices."  Recommend the change since all activities may not require that an invoice be submitted.


comment:
Animation seems off. The finger should tap on My services. Right now it looks like it taps on the Stylist button. Refer to previous course for animation timing.


comment:
Add ", if required" in the last bullet point.  Not all requests require documentation be submitted.


comment:
Cannot move forward with the module after selecting the correct answers.


comment:
Copy at the bottom is overlapping the device. Once the "iOS simulator" header is removed, please shift screen shot up to fit.


comment:
This is out of order. This smartstyle.com screen should come before the previous screen showing the ticket source.


comment:
The last question/answer is confusing. I think we should specify the answer covers the last 2 blanks (to know the 2 roles are for the 2 blanks). Also, I think it's confusing the terms study manager and CPM because I understand that study manager is a generic term that would also cover the CPM role. I would like the SMEs input here and for several scenarios as well


comment:
Same feedback. the wording should change to reflect the title of the following section


comment:
Highlight color for the second response should be teal.


comment:
The letter "r" is appearing in the thought bubble when I click on the first response. Please remove.


comment:
Update copy in the second response, 3rd sentence. 

Just search for SmartStyle Hair Salons and then tap to install.


comment:
Complete the final challenge button should be in teal.


comment:
I suggest making this slide higher level and not mention countries.  "In some countries, Institutional Notification (IN) which is a part of the Anti-Corruption Due Diligence (ACDD) is required. The CBSO may facilitate the completion of this task when it is required.  Depending on the country where the consultant resides, other supporting documentation may also be required (i.e., consent, banking information, tax documents, supplier acknowledgement form, etc.).  Click here for more information about ACDD."


comment:
Response buttons should be in teal throughout the Final Challenge section.


comment:
I recommend adding the word "may" in this sentence.  "The CBSO Representative follows an escalation process and may contact Global Contact Meeting Services-Medical Research for assistance."


comment:
Please move "Financial Responsibility Authorization Procedure (FRAP)" to previous slide where I mentioned it.


comment:
in the last row under, significance of requirement response, remove "both" in the sentence.


comment:
please ignore my comment. Now I realized that I have to tick more than one answer.


comment:
regarding refrigerator: Third option - Could you please reword this sentence. E.g Could you please explain who have a key for this fridge?


comment:
this is 5000 times better and the visual much more closely relates to the actual content


comment:
strageic alignmnet is blank and looks like an oversight. Write something like: No information yet. or something


comment:
if resources tab is going to be blank, get rid of it.


comment:
the guy at the top of the screen either needs to be full body or you need to anchor his bottom edge to something (you could put his face in a circle or draw a line under him). You can't just have him floating in space


comment:
this page needs a graphic designer. you can't have all of these heads floating on the screen.


comment:
This month thing shows up here with no explanation and no context. You guys have to transition to it and is it based on months or should it be based on the milestones you showed on the circle graphic and use those icons?


comment:
the learner is never set up as to how you are using this case study in the course and what the black and red text mean. they need some context


comment:
how should a learner use this information in the book to form their team?


comment:
should the "owners" be the functional areas they just moved so they can see how those people are contributing to the plan?


comment:
need to have the customer analysis tab highlighted.


comment:
recommend moving the talk bubble to the top of the screen so that its read first.


comment:
You guys have an opportunity here to update the graphics on this page and make it more than flat gray earth. Tie the graphics to the story you are telling.


comment:
T-40: is the text that is not bold a continuation of the above phrase in bold to make a sentence? Or should T in the be capitalized at start of regular text?


comment:
T-37.5: add hyphen - fifteen-minute market


comment:
disregard my comment about t in the here - i was scrolled down on box and didn't realize it! :)


comment:
Per line 18 of edit spreadsheet, we need to add some space between the bold header and the body text on this popup


comment:
Here is an example of where we would either fix now or document as a future fix the "Closeout Sites" process.  Changing Closeout to Close Out


comment:
Directional text, 1st sentence: "Rollover each module to find out what you'll learn in this course." Current sentence is clunky.


comment:
Instructional text, 2nd sentence: remove the word "part" (Drag the slider to see the market time points in the next (part) segment."


comment:
T-40 popup title: pluralize "test" - "Settlements impact by tests performed prior to..."


comment:
T-37.5: CC 64700 text - it looks like the left parenthesis is not aligned with the rest of the text, move to the right one space


comment:
T-37.5 popup title - should say "Settlements that occur based on the RTD" not FMM (that was the title of the T-37.5 popup


comment:
CC 64700 text: Should be "RTD Instructed Imbalance Energy", missing the word imbalance


comment:
CC 7076 and CC 7088 text: The CC name text is not aligned with the rest of the CC name text


comment:
Bid Cost Recovery button - Make the text on the button sentence case to match all of the other buttons (Bid cost recovery)


comment:
Grid management charges popup - 1st sentence, capitalize "entities" since we capitalize it everywhere else.


comment:
Grid management charges popup, CC 4564 text - capitalize "transaction" to be consistent with the naming of other fees and charges


comment:
Forecast fee popup, CC 701 text: capitalize "fee" to be consistent with all other popup text


comment:
Instructional text, 1st sentence: change to "Financial settlements are associated with events that occur before, during, and after market optimization." to be consistent with the 2nd key point at the end.


comment:
2nd key point: remove the word "the" before "market optimization"


comment:
Instructional text, 1st sentence: add a comma after "during"


comment:
The appearance of "Losses = 0 MW" doesn't sync up with the audio. At the very end, the text should be "...foundational scenario is a simplified market situation" (missing the word "a")


comment:
Question text onscreen: Make "Over-scheduling" lowercase


comment:
CC text (all): make "Settlement" lowercase at the end to be consistent across the course


comment:
Transcript doesn't appear when you click the icon


comment:
No blue arrow appears next to CC 7081 when it's mentioned that that charge code will be paid out


comment:
Transcript, 2nd to last paragraph: make "Flexible" lowercase


comment:
"Controlled drugs (see definition)..."  question: where is this definition?  Is there something to click in this course that provides the definition (if so, sorry I missed it).  If not, are you telling them to go out in Lilly world somewhere to find a definition?  If so, I recommend change the text to, "Controlled drugs (see the Lilly glossary definition)..."


comment:
The timing of the blue check marks is super delayed compared to when they are mentioned in the audio


comment:
Transcript 2nd paragraph: change "fifteen-minute market" to "FMM" to match the audio.


comment:
Instructional text: since we added Anthony in, change to: "...you'll be helping two scheduling coordinators as they go through a week of validating settlements."


comment:
View charge code information text: "...download the quick reference guide (QRG) from the Resources tab..." make Quick lowercase and identify the acronym used.


comment:
View charge code information text, 2nd sentence: "The QRG contains charge code information that will help you complete the scenarios." just tightened up the language.


comment:
Before the ending directional text comes onscreen, the original directional text pops up briefly.


comment:
Curious why "Hub/Depot" is uppercase letters.


comment:
Anthony is a "Settlement analyst for a Participating Resource Scheduling Coordinator (PRSC)" and Rhonda is a "Settlement analyst for an EIM Entity Scheduling Coordinator". Need to update their role titles to reflect this.


comment:
Since we added Anthony in, this needs to apply to both of them. I would remove Rhonda entirely since we can't fit both onscreen, and then center the icons. Change directional text to "Throughout the day, Rhonda and Anthony review any incoming settlements statements, and try to determine if everything is trued-up."


comment:
Bullets onscreen don't line up with the audio. Adjust based on the timing of when things are mentioned.


comment:
Question text: capitalize "entity" to be consistent throughout the course.


comment:
Make my comment global, and I won't add it to any other screens ;)


comment:
The T/F statement doesn't match between question 1 and question 2. Change to "...she should see a charge for an over-scheduling or under-scheduling penalty."


comment:
My comment about adding a space applies if you choose false as well.


comment:
Question 2, answer option 3 text: Make "Over-scheduling" lowercase to be consistent throughout the course.


comment:
Let's make "Over-scheduling and Under-scheduling" the global way we identify this charge code, from the timeline to the scenarios. That's how it is in the animation, and I've seen it a few different ways so far.


comment:
QRG - row 1, add hyphens: Over- and under-scheduling


comment:
Rhonda's green text lines 2 and 3 is larger than the Anthony's blue text lines 2 and 3


comment:
For me, Anthony's blue text is overlapping the directional text


comment:
Missing a period at the end of the View scenario information sentence


comment:
Transcript, 1st sentence: change "it is" to "it's" to match the audio.


comment:
RTD icon text says Rhonda instead of Anthony.


comment:
Consistency - make all of these charge codes capitalized based on how we've used them throughout the course


comment:
Consistency - CC 701 should be Forecast Service Fee


comment:
Key point #2 text - "This charge codes leads to a settlement when supply is awarded in the RTD." (add -ed to award)


comment:
Onscreen blue text - change to "Final dispatch instructions" to match the transcript/audio (remove -ed)


comment:
4th popout text - is something missing from the end of the sentence? The text ends without a complete thought. Is it supposed to be "participating resource."?


comment:
when i click/submit 6046, it changes to a green check but i get incorrect feedback


comment:
Question 2 of 2, answer option #2: change to "Her resources's meter data..."


comment:
Question 2 feedback: change to "...the difference between the resource's dispatch instructions and its meter read."


comment:
Question #1 feedback: I think the last sentence is unnecessary since that info is included in the Question #2 feedback already.


comment:
Feedback popup: Can you move it down a little bit so it doesn't overlap the question text?


comment:
The script shown below the "Validation basics and timeline: Settlements overview" is not the script that the narrator is reading. The written script applies to over-scheduling and under-scheduling.


comment:
Please change "what charges are triggered" to "what charge codes are triggered" in the opening paragraph.


comment:
At :17 of the animation, on the graph, add a small 1% on the left hand side of the dotted lines like you have at 2:02 of the animation. With the > 1% sitting on top of the line, it could lead to some confusion. May consider placing it on the forecasted load line, or and up/down arrow noting it can go either way just for clarity.


comment:
CC 64750 incorrect feedback text: "resource's FMM forecast" add an apostrophe before the s


comment:
CC 64750 feedback text: "This charge code settlement is triggered when the resource's FMM forecast is greater than its base forecast" change by to when


comment:
CC incorrect feedback: "...when the resource's..." I saw this on a few feedback boxes, make sure the sentences are grammatically correct using this as a template


comment:
CC 64600 feedback: are we missing an edit here - the feedback says "Uninstructed imbalance energy does apply here..." but the CC is for "Instructed Imbalance Energy" not uninstructed


comment:
Says Rhonda on the text popup - check this out globally


comment:
consistency - capitalize the 2 offset answer options like they are across the course


comment:
Question #2 answer options seem to be missing something: I think each one needs to start with "These charge codes apply when..."


comment:
Incorrect feedback: why do we reference BAAOP and BSAP if they aren't correct answer options?


comment:
2nd key point text: "Resources that are dispatched by the market operator, and do not receive enough revenue to cover operational expenses, receive charge codes 66200 and 66780." add 2 commas


comment:
Break up the transcript into paragraphs that align with the key points that come out. Otherwise, it's just a block of text.


comment:
Transcript/audio - last sentence - says BPMS but should be BPMs. Chuck's audio needs to be corrected


comment:
Adjust question text box to be more of a left column/width of button choices so it doesn't overlap with feedback


comment:
There is a white "1" on drop zone of row 2


comment:
missing dragger for 64700 per line 142 of spreadsheet


comment:
Incorporate edits from lines 126 and 127 here - both boxes should include wording that this is over a trade day. Current wording could imply that they are eligible for BCR in every interval.


comment:
Per edit line 107 - Change the introduction to say "Rhonda receives a settlement statement after the trade date and needs to check and see if the amount energy that was dispatched equalled the amount of energy that was supplied."


comment:
Per line 106 - Change the second to last sentence to say "Some resource's meter data and some interties' e-Tags were not equal to their dispatch instructions."


comment:
Per line 111 - change distractor "the base schedule and e-Tags" to "the FMM and base schedule"


comment:
Transcript, sentence 3 - add a comma after "capacity tests"


comment:
There is a white 1 in the drop zone on the 2nd line


comment:
The text for the first funnel section (Copies/mL) is confusing. Having read JZ's and EEP's comments, I would rephrase as follows: "The first filtering section removes tests that do not report in IU/mL already and retains tests that do report in IU/mL as the best choice." If that rephrasing is not acceptable, at least remove the "of" between "best" and "choice" in the second line of the current text. Then add "the" between "as" and "best" at the same point.


comment:
"FDA approved" should be hyphenated. Update pop-up for third question/section.


comment:
Edit sophie's text: Insert hard return after sentence 1. Edit sent2: "Use this competitive "funnel" to help filter out options and position the cobas(r) CMV tests."


comment:
Most basic "level" to overcome? I would suggest "objection" or "reason".


comment:
Typo in Thresholds Established pop-up. First sentence should read: "Any thresholds established with an LDT only apply..."


comment:
For 3rd funnel, I think we need to combine rows 10-11: "The third filtering section removes LDTs built with CE-IVD reagents and competitor CE-IVD/FDA approved tests based on factors such as clinical validation and workflow efficiency."


comment:
Typos in Broader Menu pop-up: "Using LDTs allows..."; "Roche is committed to expanding CE-IVD test offerings..."; and "FDA approved" should be hyphenated.


comment:
In pop-up slide, I would suggest changing "Cost Effective" to "Cost Effectiveness" and "other revenue-generating activity" to "other revenue-generating activities".


comment:
We need to insert the references for this final good response (GGG, cell 6F in the spreadsheet).


comment:
The references for the GGG response also need to be added to the Optimal Conversation easel.


comment:
We need to add the reference to the good response here (BGG, cell 10F in the spreadsheet).


comment:
We need to add the reference for the good response here (BBG, cell 12F in the spreadsheet).


comment:
We need to add the references for the good response here (GBG, cell F8 in the spreadsheet).


comment:
In the Low Cost pop-up, I am quite certain that "consumable" should be "consumables".


comment:
The zoom seems unnecessary(?) If we kept the same screen layout as previous screen, is the image big enough to read? Then sophie could just say, "Here are some details about the top competitors shown in your funnel quick reference guide. These competitors..."


comment:
Edit Low cost popup: "...can add up quickly. Components include extraction reagents, calibrators, consumables, and instrument service costs. There are also hidden labour costs,"


comment:
The wrong answer on this page contains the 'Merican spelling of "standardiZed"...


comment:
Speaking of labour, please plan to Britishize this sometime between now and GM.


comment:
Re: my previous comment--the *correct* answer contains the "misspelling".


comment:
The incorrect answer on this page contains the 'Merican spelling of "labor"...


comment:
In Thresholds popup, add comma to sent2 between "consistently produced, ready-to-use"


comment:
In Broader Menu popup, I might suggest moving last sentence to become second sentence. It seems like the most compelling, with the other sentences as support stmts - do you agree? Maybe: "Using LDTs...menu. However, because CMV is the highest test volume..in the lab. In addition, Roche is committed..."


comment:
Broader Menu comment #2: In addition to editing as I indicated, please bullet point each of the expansion efforts below the current sentence 2, so there's one bullet for 6800, and one for 4800.


comment:
Beware sacrificing readability in exchange for spelling out contractions. In "But if the results are different," option, delete the "not" in "Would it not be easier.."


comment:
Same comment applies to this table as LDT table; ideally, we could lay this out so as not to require the extra click.


comment:
I'm unclear on whether FDA-approved should always be hyphenated? If so, please do a global search for this, as it seems inconsistent.


comment:
Is cobas supposed to be in all caps at the end of Sophie's speech bubble? Shouldn't it be bolded?


comment:
In the incorrect answer bubble, change the beginning of sentence two as follows: "The Roche cobas(r) CMV Test for use on the cobas(r) 6800 System is..."


comment:
I don't feel that either option is a good response to "the Qiagen test has... clinical validation data." The "correct" option is just a laundry list of attributes. Please add a note to Roche that we want to refine this to better address the clinical validation concern.


comment:
Re: LF's comment - if FDA approved precedes a noun ("FDA-approved test"), then yes, it should be hyphenated. One could make the case that, if FDA approved doesn't precede a noun ("the Qiagen test is FDA approved"), then leaving FDA approved unhyphenated in these cases is fine. In general, I have been calling out all instances where FDA approved precedes a noun but has not been hyphenated. In this section, however, FDA approved follows nouns and is not hyphenated and I have been allowing those instances to stand.


comment:
Please cut down the "Consolidating the HIV, HBV, and HCV assays..." answer by deleting everything after "viral load monitoring."


comment:
Edit down "Yes, we offer a test...": "Yes, the cobas CMV...IU/mL.

ALSO, beef up "Yes, we have the cobas...": "Yes, we offer a CMV test--the cobas CMV for use on the cobas 4800 System, which outperforms the Siemens kPCR test. The results are clinically validated, and workflow will be more efficient than with Siemens. Honestly, their system just is not as flexible as the cobas 4800."


comment:
Final feedback for GGG mentions the z480 UDF, which we never mention in the edited version, unless I'm missing something? If that's accurate, delete the second half of sentence 1 in the fdbk.


comment:
Add to sophie's ultimate incorrect fdbk: "That is not quite right. Take a moment to review the correct answer: all but one of these statements about Roche's cobas CMV tests are true."


comment:
The incorrect answer on this screen needs a little TLC. I assume that cobas should always be bolded and not in all caps. Also, Roche cobas(r) CMV Test should always be preceded by a definite article ("the"). I would argue that "the" should also precede the long test name in sentence two (COBAS(R) AmpliPrep...).


comment:
The note at the bottom of the page should end "...6800/8800 Systems is pending FDA approval."


comment:
Ensure that (r) is superscripted throughout. See "Qiagen artus" in incorrect answer.


comment:
Again, COBAS should probably be cobas throughout, but bolded.


comment:
"Roche is engaging with the scientific community (e.g. through advisory boards), and supports..."


comment:
CDC #2 - different male picture pops up when answer box is selected.


comment:
ISEC button in upper right goes to Satellite ISEC.  Suggest change button to state Satellite ISEC


comment:
A noun is missing from the first sentence and sounds a little vague. 1. Remove "and" prior to "therefore"  Suggest:  therefore the CDC may only need to complete some of the questions within the satellite ISEC.  Suggest removing 2nd sentence.


comment:
ISEC button -same comment as above.  why not label the link as the Satellite ISEC?


comment:
1. "only" is used twice in last sentence - remove 2nd "only"  2. 2nd sentence not clear. Do you mean "This location was initially evaluated to only screen study participants?


comment:
Suggest re-wording the sentence referring to a single site reference number for the satellite locations.  It reads like each satellite location will have a site reference number. Suggest something like "All satellite locations will utilize the same site reference number as the primary site"...


comment:
Suggest rewording the sentence re: the CDC talking to the SAM about satellite additions.  That is not realistic.  That could happen any time after selection, and what would trigger the CDC to do that at any given time??  Suggest removing that.


comment:
Under Site Activation, should read:  "Site Activation needs to BE aware...."


comment:
Use of the words "outsource" and "vendor" implies a 3rd party, which likely isn't the case.  Are we referring to a central pharmacy here?  Can we use the words "central pharmacy"?  Would this apply to any sites besides a network??  If not, this is not a necessary example, as networks will not be completing satellite ISECS.


comment:
Purple box:
... or after the evaluation and selection of the primary site.


comment:
Red pop-up:
... and enters necessary information in the Satellite Location ISEC in Trialforce?


comment:
VO: propose added wording "and not perform any trial activities"
If the PI will only recruit study participants at the other offices and not perform any trial activities, then no, those would not be satellite locations.


comment:
in section "How to create a Satellite Site":
second 14 - pop-up: need CDC alignment on that pop-up wording. christine provided some alternatate wording per e-mail.


comment:
section "How to create a Satellite Site": should that be "Satellite Location"?


comment:
Should we say "main ISEC" or Primary site ISEC instead of normal ISEC?


comment:
The note on the bottom of these screens needs to be tweaked: "are" should be "is".


comment:
In the correct answer, "Qiagen artus" needs a (r) icon.


comment:
Also in the correct answer, "ready to use" should be hyphenated.


comment:
Need a space after footnote #2. Should viral load be hyphenated?
THis is so long... as the end of mega-course, it may be better to divide into two screens.


comment:
"artus" should always be accompanied by "(r)", "Roche cobas(r) CMV Test" should always be preceded by "the".


comment:
I still love the marriage of theme and structure to these courses. Job very well-done!


comment:
Will we be getting the references for these screens before GM? The correct answer here (cell 6E in the spreadsheet) needs a reference.


comment:
If we retain the second half of sentence one, we need a space between "z" and "UDF".


comment:
Check subject-verb agreement in these answers: "cobas(r) CMV Test that IS calibrated," etc.


comment:
Delete Sophie's "We have a lot of ground to cover" sentence.


comment:
We've gotta put this course through the britishizer as well. Change organizations in bullet 1 to organisations


comment:
Label package insert: Altona RealStar(r) CMV Package Insert


comment:
In detection instrument popup, sentence 1, is Detection instrument capitalized for a reason? If not, use lower case d.


comment:
I am probably crazy... but is there something different about the text/font on this screen? It just looks different to me. If not, we'll pretend this never happened. :)


comment:
This is not what the comment meant. Keep categories as Description, Advantages, Disadvantages, and Examples. Edits refer to changes in the dragger.


comment:
In Technical Advantages popup, there's no "subject" of the sentences. I would add a non-bullet under the heading that says, "PCR tests - "


comment:
First line of text on tablet needs to be updated: "Tests built from scratch by the laboratory can be thought of as "homebrew" LDTs..."


comment:
In QC pop-up, first bullet point needs to be edited and revised as follows: "What QC will need to be performed?"


comment:
RE: my other comment. Client comments about first bullet of QC Materials pop-up are inconsistent and confusing (see rows 19 and 20 in spreadsheet). Not sure where to apply row 20 edit, which says to add "...will need to choose the correct level" to the first bullet point. Do they want "What QC will be needed to choose the correct level?"??


comment:
At the very end of the second bullet point line, add "d" to "approve".


comment:
The asterisk at the end of the first bullet point line has no reference. It needs a footnote (see spreadsheet rows 29 and 30).


comment:
Remove comma after "Saving time" at beginning of last sentence. Add space between "reasonsfor" in last sentence. Also, I'm not totally sure that we need a comma after "lab". If we do add one there, then we also need one between "activities" and "and" in order set that whole clause apart.


comment:
Remove extra space between "standard" and "by" in the second line.


comment:
Remove extra period from end of sentence.


comment:
Bullet 3 should we say temperature deviations- I think we discussed last time.  After seeing it I think we should be more specific- what do others think?


comment:
The first question brown box should read:  This excludes vendors that directly contract with Lilly to store and distribute to the site.


comment:
3rd incomplete answer- we should add that the answer also contains subjective language and not objective facts to support why their "set up" is good


comment:
Typically in these boxes on the main page, this is where they are in the process map, not the sections of the course. Talk to Matt for guidance in this. Michelle needs to do the same.


comment:
Be sure to update the resources page before alpha goes out by either replacing links with what Sophie and Paula send us or by deleting these old ones.


comment:
Given that there will be no audio in these courses, the CC button needs to be removed from this screen and the menu. This is a global template change.


comment:
First paragraph--I think there's an extra space after "opportunity".


comment:
"trial studies" needs to be replaced with "trials". Refer back to the style guide I posted on basecamp for terminology checks.


comment:
check this whole page/course for appropriate use of trials and studies. In general, trials is the main noun you use unless it's referring to a person. For example, a study manager works on a trial and ensures study participant safety during the trial.


comment:
It seems like the second paragraph should say, "The scope of the process INCLUDES amending..." (replace "is" with "includes"). It sounds funny to me with "is". Also, I'm not sure that the third paragraph is really part of the process definition? I think I might take that out of the red area and include it as regular text underneath. Totally your call--just a suggestion. :-)


comment:
for the 2nd and 3rd paragraphs in the red box, I'd like these to be more graphical and they may need to be on a separate page. That's the key of this whole course - fitting it within the process and I don't want it to get lost in a definition box.


comment:
To match the rest of these courses, I'd expect to see a menu screen in the course where they can see the flow of things. This should have been in the storyline template from matt


comment:
First paragraph: add the word "are" after "there". (...there ARE no clear, correct answers.)


comment:
change study to trial in the first paragraph.


comment:
in instructional text, remove the word "for"


comment:
fix the bolding of your instructional text (only bold action and button name). Do it throughout the course as you make final edits.


comment:
I think that the style convention for directions is that the word "Select" should be bold and the thing being selected (most critical action) should be bold. All other stuff should be in regular font.


comment:
in first paragragh - change to - ...which action to take first....


comment:
add a spance before your bulleted list at the bottom


comment:
Maybe reword the second sentence to: "The assessment plan considers how the change impacts:"


comment:
can you have christa take a look at the layout of the this screen? I think there's an opporutnity for us to make these boxes bigger and get some more white space. One easy thing might be to not have your character on the screen


comment:
delete the phrase "lsoing approval opportunity" (that doesn't sound like Lilly. Add a transitional statemnet to this page leading into the next one.


comment:
when I come back to this screen, it needs to reset so that I can see the intro text and click buttons again


comment:
I agree with Jenn's idea about the layout. I would suggest: 
1) remove the learning agent and have the text on the left (perhaps make the width of the text box shorter).
2) move the icons up and over to the right side of the screen. 
3) move the pop up text under the icons. Expand the width of the pop up so that the left edge aligns with the left edge of the first icon and the right edge aligns with the right edge of the second icon.


comment:
In the implementation pop up, there seems to be an extra space between "should" and "take" in the first sentence of paragraph 3.


comment:
Please use the head/heart icons from the other course. Also, you need to tie your text to that idea by using "head" "heart" language. See the "Does the site meet the ERB requirements" page in this course for an example of how we've handled it in the other set of courses: http://bottomlineperformance.com/clients/Lilly/siteSelection/EvaluatingSite_ERB/FinalGM/story.html


comment:
level 2 and 3 boxes seem to be mostly the same?


comment:
please make it more graphically clear which boxes can be clicked


comment:
heads up - a lot of study vs. trial misuse on this page.


comment:
Isn't this the screen where we needed to add the directive?  Underneath the existing text, add a new sentence that says "Click the analyzer to look for the issue."


comment:
I think you may have updated the wrong text.  Here instead of "Click the analyzer to get started", update the instructions on this screen to say "Mouse over the analyzer and click the highlighted areas to gather information."


comment:
I don't understand the 3rd example (lab specimens).
Would that not require a "normal" change form?


comment:
I suggest to begin this screen more general for example: Some questions are unique to the satellite iSEC. Below is an example. It is important...


comment:
I would remove the last words "for screening trial activities. It is a repetition.


comment:
last pop-up could be more specific...satellite iSEC should be completed separately for each satellite location


comment:
This is a nice to have for DP, but let them just click box to box without having to "x" out each box.


comment:
I still don't get why the checks and stars indicate required and not required. I think different icons would be clearer - but that can be for alpha


comment:
Ideally for DP, you would have scripted ONE of these pop-ups to confirm that the information fits and they can see what you're going to say.


comment:
can we show where this fits into the screen? ie, where will they find this on the one pager?


comment:
Let's update two of these bullets these to be more active:
Recognize customer needs and develop a value proposition to meet these needs.

Position Cummins products to customers.


comment:
revision date looks like it's automatically updated by the system and isn't something they actually type in. If so, don't make them click that to see it.


comment:
Earlier we called them Powergen products, here we say Genset. Are these interchangeable?


comment:
because you didn't put the "boxes" in the sales fields on the form, it took me a second to realize that's where i was supposed to drag it.


comment:
i clicked all four risk bubbles and nothing happened to allow me to move foward


comment:
within the same talk bubble, either stay descriptive or write as the learner will see it. Don't switch


comment:
I'm not sure I get the logo used for Agriculture. Is that a gas pump?


comment:
same thing when i see this again in the "try it". Since my feedback on both the see it and try it is showing up here - are you reusing that screen here?


comment:
2nd paragraph doesn't make a whole lot of sense. I think I know where you're going....I'm going to let you edit that yourself for clarity and active voice.


comment:
I feel like you could simplify this screen. Maybe you could just say: "As you've learned, change introduces risk to a trial. It could compromise patient safety or data integrity. The trial change management process provides internal and external requirements that help manage the impact of change so the trial stays on track. Let's take a look at the process in more detail."


comment:
ok - we need to brainstorm this activity. By putting the titles on these chairs, it looks like the goal is just to drag everyone over. Once I did the activity, I get why it was the way it was, but it's going to be confusing. (i can also hear nick in my ear about what he doesn't want to do related to the logic of this.) One idea would be to flip it and have everyone in chairs to start and tell them to drag the people away from the table that shouldn't be there. If you guys don't like that idea, I'm ok with other options....but it's confusing the way it is.


comment:
please add note to Lilly on this page that we need help identifying why these people need the information


comment:
If you add the suggested transition to the previous screen, I would make the text at the top of this screen say something like: The change management process has four steps. Key decisions correspond to each step.


comment:
remove the (correct) from option 1. Also, please mix up the answer options so that A isn't always right in this scenario


comment:
Make the first sentence active: "The Identify phase requires classifying the criticality of the change. During this phase, the change owner gathers input..."


comment:
Based on what you've got written for this sceanrio, I think you we can put in a couple of best practices and finish this screen


comment:
Agree with Jenn on making the clickable boxes more visually clear. Maybe just make the borders of the column thicker so it's more obvious? Or ask Christa :-).


comment:
For consistency, I would either add "about the change" to the end of the first bullet OR delete "on the change" from the second bullet.


comment:
checking against the design, we need to tie these case studies to the 4 part change management process. My suggestion would be to tie in the icons and use headers/language etc to show where learners are in the process as they work their way through the questions/story


comment:
I was relieved to see Jenn's comment. I don't get this activity.


comment:
Just a minor thing: I think the convention for screen headings is title case, so "belongs" should be capitalized.


comment:
Ok, I'm getting it. I think what confused me was the directions. I feel like if you just simplified the content, it would be a lot better. Suggestion: 
"It's important for the right people* to attend the STEAM. Based on the details of the scenario, who belongs at the table? Invite the 6 people who should provide input by dragging them to their respective seats."

I would put the note that's currently in the first paragraph under the people with an asterisk and in small, italicized text. If you make these changes, I think it helps make it clearer what you're trying to accomplish without having to reprogram. BUT check with Jenn :-).


comment:
Just another style call out--only the words "Click" and "Next" should be bold in the directions. Check globally for this convention.


comment:
I would update the directions as suggested previously on the placeholder case studies, too.


comment:
The "Correct" slide out box needs a bit of formatting. I would reduce the space between paragraphs so that the direction text isn't butting against the bottom of the box, and make the word Correct at the top bold and maybe a bit larger. Also need to make sure the correct bolding is applied to the "Click Next" directions. Applies to all slide outs in this type of activity.


comment:
Maybe add (up to you): "You've completed the Facilitate Change section. Here are some key points to remember..."

Also, maybe say "Click Next to learn about the Change Management Mindset."


comment:
Should it say "trial" instead of "study"?


comment:
Should the email come after this screen instead of before?


comment:
Edwin's legs are extending beyond the bottom of the background into the footer.


comment:
Edwin's legs are extending into the footer. Needs to be repositioned or cropped more.


comment:
Edwin's legs are extending into the footer.


comment:
The leg thing again. Check all of the screens with Edwin on it.


comment:
At :51, on the screen it says "final order" and "forecasted order". The script at this time states "The customer understands that if the final order is not within 5% of their tentative order there will be a penalty charge." Could we change what is on the screen to say "final order & forecasted order not within 5% = penalty charge"?


comment:
At 2:43 and 2:58, the 1% and 5% lines are so close together that the numbers overlap. Can they be spread out a bit?


comment:
At 1:27 and 1:59, the FMM and RTD icons show up under the white X that closes the animation. Not sure if we can move it for this round, or if we need to save for future edits.


comment:
On the Flexible ramping information box on the right hand side of the screen, there is a substantial space gap between the header and the language below. We had requested to have the spacing of these boxes be consistent. This is the only one that seems to have been missed.


comment:
Still incorrect at 2:01. Should be "UNCERTAINTY" not "UNCERTIANTY"


comment:
At 1:24 of the animation, the alignment of the order #s, "placed" boxes, and dotted lines are at an angle. Should be straight across.


comment:
Still incorrect at 2:23. Should be "UNCERTAINTY" not "UNCERTIANTY". The note I entered before about the other misspelling actually begins at 1:54. It is for the all caps words for both the up and down direction.


comment:
At 3:22, a random clock appears on screen for a few seconds, and does not seem to tie into the script. It appears during the language added from row 17. If it is meaning to depict that 5- and 15-minute markets, the timing needs to be adjusted. Would be better not to have it otherwise.


comment:
Previous edit request that we had discussed: "Change the type of generator that is located outside of California to either wind or solar." At 2:43 this was done (good!); at 3:07 and 3:25, this was NOT done. Please make consistent.


comment:
At 4:37 of this animation, the red and green $ imply that they are associated with 69850 only. Could we either have them flowing to/from both charge codes at the top of the page, or just have the existing ones shifted to go in between both of the charge code boxes?


comment:
At 1:36 or 1:37, the narrator says "revamping" instead of "ramping". We need to fix this.


comment:
Under the Flexible ramping allocation box popup, change "the EIM..." to "the SCs are charged..."


comment:
At 3:17 the narrator says "bidder adder price" instead of "bid adder price". Need to fix.


comment:
Says "bidder adder" again at 3:33 instead of "bid adder". Need to fix.


comment:
At 3:41, the 491 on the screen does not have the CC in front of it like others.


comment:
At 2:21 add CC in front of 701 for consistency.


comment:
Same comment about adding the CC at 2:26


comment:
This is NOT an ideal market situation, which we stated in earlier edit requests. It was removed in the script but the narrator still refers to it. Needs to be fixed.


comment:
CA should be taken out of the script. Should just be ISO.


comment:
In the final paragraph, should be "EIM entity and SC..."


comment:
Need to include 64700 as one of the options for drag and drop. Should drop to the "RTD is less than FMM forecast..." box


comment:
This scenario should be Anthony since it is participating. Rhonda is non-participating so this scenario would not apply to her.


comment:
The animation that is attached to Flexible ramping allocation is the animation that SHOULD be attached to the UFE and Offsets box. The animation for Flexible ramping allocation is currently attached to the Grid management charges box, so that needs to be moved here.


comment:
At the end of the last sentence of the script, it should say "...should validate that it wass allocated to them correctly." It looks like we missed that in prior edits, so if we cannot edit the narration, can we please add it to the written script and we will note this for future edits.


comment:
The title of CC 64700 is Real Time Instructed Imbalance Energy EIM Settlement". Needs to be fixed on screen.


comment:
In front of CC 4515, 4564 and 4575, "GMC" should be inserted in front of each title to be accurate with the title we have posted on our website.


comment:
Under the "Check your responses" header, change ..."you see..." to "...you will see..."


comment:
I believe that Rhonda is a "non-participating" SC; we need to confirm with James Monday; if that is the case, we will just add non-participating onto the screen and leave the narration as it is.


comment:
CC 64600 title is FMM Instructed Imbalance Energy EIM Settlement


comment:
CC 491 title is Greenhouse Gas Emission Cost Revenue


comment:
CC 66200 title is RTM Bid Cost Recovery EIM Settlement


comment:
Title for CC 67450 is Real Time Uninstructed Imbalance Energy EIM Settlement


comment:
Title for CC 64700 is Real Time Instructed Imbalance Energy EIM Settlement


comment:
Title for CC 64740 is Real-Time Unaccounted for EIM Energy Settlement


comment:
Title for CC 67740 is Real Time Congestion Offset EIM


comment:
Title for CC 64770 is Real Time Imbalance Energy Offset EIM


comment:
Title for CC 64600 is FMM Instructed Imbalance Energy EIM Settlement


comment:
To be consistent with the change made to the summary, MRI-S should be one of the applications used in this scenario for research (ties with row 119 on spreadsheet)


comment:
CC 64770 Real Time Imbalance Energy Offset EIM


comment:
CG CC 69850 Real Time Marginal Losses Offset EIM


comment:
Add ADS to tools used for research to be consistent with later question


comment:
Needs to refer to CMRI and OASIS as research tools to be consistent with other scenarios.


comment:
CC 64700 Real Time Instructed Imbalance Energy EIM Settlement


comment:
CC 64750 Real Time Uninstructed Imbalance Energy EIM Settlement


comment:
CC 64740 Real-Time Unaccounted for EIM Energy Settlement


comment:
In paragraph 3, sentence 2, it should say "settlement" after both "Capacity".


comment:
CC 64600 FMM Instructed Imbalance Energy EIM Settlement should be added as a drag & drop option. Confirm with James that it should be dropped in "RTD is equal to the FMM forecast" box.


comment:
Change the first box to read "Charge code 64700 is triggered on a participating resource in either the FMM or RTD when the instruction is higher or lower than the FMM instruction or base schedule." This was requested before (see row 106 on spreadsheet) but missed.


comment:
I like that both types of LDTS (the full home brews and those with CE-IVD reagents) are in this part of the funnel. You need to change this in the introduction, where the CE-IVD reagent LDTs are still lumped with the LDTs with the CE-IVD assays in the last part of the funnel...


comment:
The transition, "in addition" in the first option for the branching conversation should be changed to, "HOWEVER"


comment:
Joni - Can we meet briefly to come up with the 2 responses to the customer considering the artus system and asking about clinical validation...? The easy answer is the Roche assay is (will soon be?) FDA approved), and the workflow is better. But there is a lot of other information in that answer that seems to me unnecessary...?


comment:
the registration marks should all be superscripted.


comment:
Joni - I am not happy with either of the options against Siemens question 2 wrt what he'd like to see:We don't mention that we can also consolidate HIV, HBV, HCV and CMV on the cobas systems. Only 4800 is mentioned in the first response. ?


comment:
Same as John's courses, we haven't been using these boxes as the module titles, but rather the steps of the process map


comment:
in Dennis's status report, he has the course number as 9176506 - is this not right?


comment:
As with John's course - we don't need reference to CC if there is no audio (applies to this screen and the menu)


comment:
that teal on the red is a little much for the senses. I'd recommend leaving it white


comment:
i'm not super clear what "function" means on this screen?


comment:
per the email from this morning, i have a feeling your talk bubble may change


comment:
I'd like to see the menu pages impelmented in this course as in the template you guys got from Matt since that's what Sophie is used to seeing.


comment:
The design for this course says: Serving as PDO
Learners meet an IMPACT PDO character (sometimes, this is the Study Manager) that tells the learner about their role in clinical trial systems.


I'm fine if you tell me, we got into content and there wasn't much to tell there. Just want to be sure we can justify the decision to not emphasize this role andn what it does for systems.


comment:
Kind of like with John's course, I don't see any reference to the process maps here - I know we're not including them, but is there an opportunity to visually provide some context of what triggers these systems and where it falls in relationship to other trial activities?


comment:
Need some kind of feedback response for this question if the person chooses the correct answer. ...looks fine. Now I'd like to check the lab for other possible causes.


comment:
Response could be. That is a good idea. There could be other factors in the lab that are impacting the sample results. Let's see what might happen if you did not check on pre-analytical or environmental factors. Click on...


comment:
A damaged test tube label could cause the sample to be rejected leading to missing results.


comment:
This training comes as part of post training activities so 2 more of the icons would be checked off.


comment:
Check this page there is a second check mark showing up when you click the tube area multiple times.


comment:
The extra check mark comes up with tube number 2.


comment:
It's the day of your service call and you have arrived at the Lab.  (remove reference to Lab Corp)


comment:
is it possible to remove the white background on the logos?


comment:
is it possible to remove the white background from the logos?


comment:
should the third filter only include CEIVD approved and then we should move LDTS built with CEIVD reagents to LDTs second filtering section?


comment:
superscript the (R) in COBAS(R) and TaqMan(R) - check throughout also please


comment:
when i finished the LDT section it jumped me back to the beginning of the LDT section instead of to the start of the IVD section


comment:
actually when I finished the IVD section it jumped me back to the beginning of the IVD section not onwards


comment:
It is not user friendly. It is like a puzzle, need to simplify the way to move on to next pages. I spend a few min to look for the right button to trigger the next page. We are all very busy, do not have time to explore all around the picture looking for the clicks.. I failed to find the button to complete this page.. giving up now.


comment:
Sorry I don't like this image, it is not representative of the genset range only the smallest end of the range and therefore only white units, the majority of the range is green


comment:
Do we need the blue text 'click start to continue' when it is clearly just above the 'start' button


comment:
I didn't think this was to be a North America only module, I though this was global, in which case we need to remove the reference to NA


comment:
I understood this was Know the Basics - Diesel Gensets, as we have another module 'Know the Basics - Gas Gensets'


comment:
with the changes in the business names I think this test needs to be ' He just joined the Power Systems sales team as a sales rep focussed on selling Gensets'


comment:
We have the next button live as well as the red outlined 'George' it will not be clear as to what should be clicked, I think only one route should be live at a time, eg Click George until the Next button becomes live as we have done in other modules. This needs to be consistent throughout the module


comment:
This is the first point where we have tied Genset and Generator Set together as the same, this should have been done the first time if possible, I have already gone through a number of screens mentioning on or the other to get to this point.


comment:
So now we have formally tied the two terms Genset and Generator set together. We need to decide how and when we can best do this. Something for discussion in the review meeting please.


comment:
Possibility to tie the second stage (heat to mechanical) back to the Engine basics course and then tie the third stage (mechanical to Electrical) to the Alternator basics module


comment:
Would prefer to have at least one that should not be included as there are a couple of these screens and they each need all boxes checked - no real test here.


comment:
Having clicked submit and got it correct, it shows me a hint that all should be selected.....what is the point?


comment:
It would be great if Georges report is still partially visible underneath the 'Correct' window with the beginning of Georges report completed. This report has the items added following the upcoming screen with the additional checkpoint items


comment:
Submit button is still visible after submitting, so I have a Continue button and a Submit button on show with the same design and weight but only the Continue works


comment:
Why do we have a continue button instead of the Red 'Next' button as in previous screens?


comment:
I like this but we either need a meaningful image for the Start screen or we start in the 60s-70's. Is there perhaps a very early 'in the beginning' type image / text to include with the start position?


comment:
Should probably have brought the controller in at the beginning when we discussed Fuel to heat to mechanical to heat.....all managed by the genset controller.


comment:
When we discuss the product range we should identify if certain products are sold into certain regions if this is to be a global course per my earlier comments. For example the PowerConnect series is NA focussed


comment:
Georges' Boss stays outlined in red even though she has no more text to reveal after the first click


comment:
I believe in other screens / modules, when a correct answer was clicked the 'That's Right' box was outlined in Green and the incorrect one were outlined in Red, we have all responses outlined in red in this example


comment:
Once the continue button appears, the back and next buttons in Red, no longer function


comment:
If I don't complete the Section A, , C etc exercise I can still advance or go back using the Back / Next buttons


comment:
You can only get to this screen using the Menu drop down and I found it by accident


comment:
Again the boss stays outlined in red after she has no more words to reveal


comment:
Again, you can only get here by using the menu drop down to get here directly or from the previous screen


comment:
This will need some work to pick up the major points and also the alternator outline is not correct.


comment:
Should think about including the following:-
Air filters, Fuel filters. oil filters, Circuit breaker, Anti-Vibration mounts, turbo's. Again there are options then to refer learners to specific other modules covering items in more detail.


comment:
We just need to be consistent with all the other courses we produce.


comment:
I did not hear any sound until digging. Is that right?


comment:
I feel like this text might be missing something to connect the digging experience with account planning. I suggest adding "...results. My findings from my experience are similar to those for account planning. I want to pass..."


comment:
One catch I just noticed is the name of the course. We are moving away from calling any course "basic"- it has negative connotations with sales people. Sorry I didn't make the comment before. You might consider calling it Account Plan Elements or something else and remove the word basic.


comment:
One thing I noticed on this slide is I had to scroll to get to the last tab, as I couldn't see it before scrolling. This might be a browser setting, but a warning it could cause confusion.


comment:
The month graphic appears "grainy" to me. We might need an adjusted graphic of higher quality.


comment:
Is there a reason some of the font is in red vs. black?


comment:
Might be me, but don't understand the % behind each competitor name. Is it market share?


comment:
The guy standing on the rock looks like he is holding a knife at first glance. I believe it is because his tool blends in with the background.


comment:
Need space on exec summary tab between N-ER-GEE and the summary of proposed product/project solutions.


comment:
The professor does not have eyes but the rest of the characters do. Might want to update him to be consistent.


comment:
Text change, 2nd paragraph, 1st sentence.  "This results..."


comment:
3rd bullet, top. Should IMPACT be bolded?


comment:
Check the size of the gray background for sTMF, (the one with bullets)


comment:
Check the settings on this slide, when I return to this screen, the Storyline player Prev and Next buttons appear.


comment:
Should we specify that it's trial-leve change management? Maybe change the first sentence to 'you will learn about the trial-level Change Management process'


comment:
Second sentence should be reworded to something like 'This process is used for amending a protocol or adding new...'


comment:
Replace 'complete' by 'implemented' in last sentence


comment:
Would 'early phase' be confusing? We use this terminology vs. late phase for specific types of studies. SHould we say 'I'm in the early stage of my trial'


comment:
Please ignore previous comment and leave'complete' instead of 'implemented', sorry


comment:
We may want to steer away from the 'process' box approach on the splash screen. In the  map, I think Manage Trial Change is a red box ... but here it is white.  This runs counter to what we are trying to instill.
Also, Lesli's color-scheme is teal and yellow, not red.
Because of meaning of red in the process map (something that is required) we need to be careful how we use red in all of the courses


comment:
In the last few days, it has been determined that we will not have a separate resources document in Word.  We may or may not need 'resources' in these courses.


comment:
I'm confused by the buttons here.  I see Change Management mindset in the menu, but it is also a button here.
Since these buttons do not appear active, does that indicate a content gap?


comment:
Per previous note, I recommend using a color other than red as an accent color.  Would prefer a shade of yellow as that is SDMT color scheme is teal / yellow.


comment:
This screen looks like the cycle should be clickable or have hover text ... the text at the top sounds like pop up / hover text.  I suggest making the graphic interactive and revising the text on screen to strengthen the tie between the text and the two graphics.


comment:
Ruth's role is not identified.  It is ok to name the characters, but it is critical for the focus to be on the roles.


comment:
I like that the story is interactive, but it may need stronger introduction.  "Put yourself in the shoes of the study manager.  What would you do when faced with this situation."

I see that Ruth is identified as study manager here, but the thread is lost because we then just call her Ruth.  Need to focus on role.
Suggested:  'Click to see the study manager's story.'


comment:
It seems a little odd to me that subsequent character has a name, but this character does not. 
As noted later, the names are 'nice to have'.  We need to be sure to focus on the role as that is what we need people to remember.


comment:
Please adjust table format for more balance/readability ... 3rd column has lots of white space but 4th column is jammed.
Icons could be smaller.
Recommend adjusting the click statement - Click the 3 highlighted boxes.
Can the highlighted be more pronounced?  
Use of red for X is ok in this case.


comment:
character not identified by role or name.

Suggestion:  Label each character?
*   Ruth, Study Manager
*   Study Manager


comment:
I think the study manager probably needs to be at the table to begin with


comment:
did character coloring change?  seems darker on this screen


comment:
disregard comment about back button ... I have to click all 6 to get next to appear


comment:
I now understand the buttons.  Please revise lead in so that learners will understand that the buttons represent sections of the course and will become clickable at the appropriate time.


comment:
like the format of the case studies.  On the last screen, I wasn't sure how to navigate for a second because there was no next button and the teal diamond seemed part of the background for a moment.  Suggest that the teal arrows have a yellow border instead of white.


comment:
This applies to all courses.  Need a paragraph something to this effect:  Process maps, quality documents (procedures, required tools), and supporting materials are available to support the performance of your work


comment:
To be explicit - I was pressed for time and reviewed from a design perspective only (not content perspective).

Level of interactivity is good throughout.  However, I don't think I saw any traditional knowledge checks.  There may be a few pieces of content where a knowledge check is appropriate.  Please ask SMEs ... these should be just the very most important pieces of specific content.


comment:
Change the last sentence of the second paragraph to " This likely means the protocol needs to change so I need to perform and assessment."


comment:
Remove "plan" after assessment on the second option


comment:
Change "have all impacts been taken into consideration"


comment:
Would discuss the clinical validation and agree with other comment


comment:
Can we remove plan after assessment and put in the assessment pop up box after "The assessment considers how the change impacts" add that the list is not all inclusive in parenthesis


comment:
The end of the first sentence sounds a bit awkward to me


comment:
Can the 2nd sentence be changed to the following: The change owner should evaluate their specific change or impact of not implementing the change appropriately to determine its criticality level.


comment:
the site manager needs to attend the meeting to provide input on how the change will impact their function. Training would not need to attend the initial discussion meeting bc their impact would be discussed during the implementation of the change not the decision to make or impact of the change. The patient does not need to be included in the decision of the impact but should be notified once the change is implemented.


