# Feedback

comment:
"I am responsible for site selection in my assigned territory" (they are not just involved, they own it for their area).


comment:
The relationship building part is missing from the "my most important roles". In order to not make that a run-on sentence, suggest the following as an additional final sentence: "Also, it is a critical aspect of my job to maintain relationships with the site, so that a good partnership can be had across all involved in the trial." (or something like that)


comment:
Update these based on prior slide comments and coming changes.


comment:
I would rephrase the last sentence to "Ensure information is in the system in a "real-time" fashion" with the explanation that the site evaluator should document in Trialforce when it is actually being collected, whenever possible. We don't want to encourage them to do things outside the system - best situation is they document directly in the system (i.e. do the SEC inside the system, not on paper or other notes that get transcribed).


comment:
Update bottom right icon text to "Investigator Site Change Form if there's..." and remove "addendum" - that word means nothing. Just stick with PI Change, Location Change, etc.


comment:
Potentially re-label the upper right icon to "Confidentiality Agreements" instead of LOCs - some people call them LOCs, some call them CDAs, etc.


comment:
I don't know that the "site stays within the budget" statement is really relevant here. Are you trying to reference the cost of drug development overall? I would probably alter that last part to "and we can bring medicine to patients faster." or something else a little more generic. Wouldn't reference budget here.


comment:
Are you going to hyperlink the other two bullets?


comment:
Menu button stopped working on this screen.


comment:
I don't know how to fix it really, but I don't love that the Trialforce topic is heavily rooted in "The Outcomes", as Trialforce isn't something to be done at the end, which I feel this implies. Not sure if this would be better labeled as "Documentation & Outcomes"?


comment:
Should it be understand vs. Identify how Country Budgets are calculated?


comment:
Suggested re-wording: The exception approver reviews, negotiates exception requests as needed and either approves or rejects the exception request.


comment:
There really isn't a site activation window.  It should say something like their activation is delayed which results in a delay to beginning to enroll study participants into the trial.  They may have less time to enroll if the trial is enrolling quickly.


comment:
Make sure it's not viewed as a kick-back


comment:
The name of the BWL process map is: Develop, Finalize & Execute Clinical Trial Agreement


comment:
You only refer to site-level budget here, but the process map also shows site-level contract.  I think the language on the slide needs to say site-level budget and contract.


comment:
It says in the yellow box, if the site requests additional approval...it's not additional approval, it is the site requests additional items to be paid for on the budget or an increase in the amount paid for of an item included....


comment:
I am not sure how much value add it is to have the content in the boxes if you click on the activities. Some of the content is self-explanatory from viewing the activities and the swim lanes.


comment:
This seems add to have this statement about where the step is in the higher-level map....you are already really far into the training.  I think you would want to say this in the beginning to set the stage of where they are in the process.


comment:
I wouldn't say good sites can participate in trials.  It's ensuring we are paying fairly for services rendered.


comment:
There is a section for how Lilly determines pricing....this doesn't really show this in the next slide?  It goes to the process which isn't really showing the country budget process.  It's showing the site-level budget process.


comment:
This doesn't tell us how budget and numbers are determined.  Also, I am not sure of the point of this slide since it's duplicative with the slide showing the entire process that was already done a few slides ahead.


comment:
Define acronyms (CRF, SAE).  Also, trial vs. study


comment:
In some of the questions, we give the answer when you select the wrong choice.  in this one, we say go back to the section and review again.  I think we need to be consistent.  Also, can we limit the number of times they can answer?


comment:
Sound was a little low in this section.  Also, pictures didn't show up until almost after she was done speaking...not sure if it's just because this is a development space?


comment:
Did we define CPP before? I know we used the term cost per patient ,but did we say cost per patient equals CPP?


comment:
These aren't potential sites at this point.  They are selected sites.


comment:
We typically have three number sites....like 101, 102.  I would say Site 100 or something similar...


comment:
same comment as other screen...site 201,...


comment:
Suggested re-wording for the answer: ..when the site provides adequate justification for the request.


comment:
For the first response, I would say that based upon the trial design,it does not appear that the Nurse needs to be present during the infusion.


comment:
suggested re-wording: ...can delay getting the site activated, so the site is unable to enroll study participants into the trial as recruitment for the trial has been closed.


comment:
Do you want to reference the Finalize and Manage Investigator Budgets/Contracts and Administer Payments process or the lower level process which only discusses site-level budgets, contracts and exceptions?


comment:
After reviewing this course, I think it's bigger than only Negotiating Exceptions. I think there is a lot of great content in here about budget costs, can we update the title of the training, so it covers this content too?


comment:
Instead of using Identify, I would use understand...


comment:
I think this needs to be re-worded.  It's confusing


comment:
I think we need to scope this a little to say this is the vendor budget and contract process when non-HCPs are participant in clinical trials..this is for the investigator portion of the clinical trial budget.  I think we need a scope slide.


comment:
I don't think they are requesting the budget from the study manager.  It's from the site.


comment:
I don't understand the comment in the red activity: all pieces must be signed and approved before a vendor budget or contact is finalized.  It should be that the contract with the vendor is executed before work begins.


comment:
Should we use Procurement representative vs. team?  Also, they are signing the contract vs. approving.


comment:
Again, should we use representative vs. GCBC team?


comment:
I think we can use study manager vs. study manager/CP/CPM right?  I think the term study manager is widely known.


comment:
Regarding the response for question 1...use GCBC representative and they are approving contract language vs. budget.


comment:
....begin work immediately; however, ...


comment:
Derrick, scenario 2 feedback. I gave correct responses to all questions and the final score shows 7 out of 6 points.  Something is off with the calculations on this one.


comment:
Coach bubble - word spelled incorrectly - "reprioritize"


comment:
scenario shows that I already did one attempt here with a score of 5 out of 6 - this is the first time I'm doing it. Maybe it pulled from Derrick's Scenario B?


comment:
Schedule a follow-up. I selected the correct answer on my 1st try (same day as incident) but feedback was "Almost.." which would be the response if I made 1-2 errors before selecting the correct response.


comment:
Text edit to feedback.  "...help being proactive.." not "practice"


comment:
Still get "Almost..." feedback when answering correctly on the 1st try.


comment:
I chose the best options and still got "You can do better." feedback.


comment:
Row 60 of internal edits spreadsheet - not complete, still says "tuck" instead of "stuck"


comment:
Last feedback box - "confidant" should be "confident"


comment:
eval and selection - replace RFP with "Request for Proposal" - do a global find and replace on that term


comment:
on resources popup - update Models to Manual too.


comment:
make the first bullet the last bullet on this screen.


comment:
cert general popup - Is Observe needs "r" at end to be Is Observer


comment:
We need to change onscreen directions to say Click Patient (not Patient ID). Sorry I didn't catch that before!!!


comment:
continue button appears when the new section about making it a default config shows up.


comment:
add a sentence to the final text box with OST. "For more informaiton, see the Certification Next Steps course."


comment:
Can you re-order the left navigation so the screens match the revised order of this section?


comment:
Please add Claustridium difficile to the list of examples for the Stool Sample


comment:
I like the flow for the content. I expect that by using Anna again as the one going through this experience, that this will be even more engaging.
Definitely like the trackers.


comment:
update title - needs to be Implant Overview - do a global search and replace, just in case I miss it. But I'll try to call it out.


comment:
title - this applies to the course title at the top of the screen everywhere you see this edit.


comment:
I don't think you have the most recent version of this screen. The pictures on popup 3 are still flipped.


comment:
end the second sentence (just before the bullets) after the first PAH team on line 4. You'll delete "including the PAH clinical team, the implanting team and the post-operative care team."


comment:
is this the new icon for system implant? The pump still looks too little in this version - get a new one from Matt.


comment:
pump icon fine here and on other screens in top left. Only too small on main screen.


comment:
last paragraph, split last sentence in 2. "At no point should the line be flushed. In addition, the pump delivering Remodulin&"


comment:
Same comment as before - and it is determined that the site is still qualified to conduct the trial.


comment:
Adjust the scale of the syringe and Remodulin vial images (same as previous slide).


comment:
need to update this image. They wanted us to put circles on the left and right sides of the abdomen rather than the pump.


comment:
in opening text after "best location" please add "(right or left side)"


comment:
need to add "(treprostinil) Injection" after Remodulin in second paragraph.


comment:
overdose popup - need Injection after "(treprostinil)"


comment:
Underdose poup - same edit re: adding Injection


comment:
main text - change "external delivery system" to "external line"


comment:
Adjust big yellow note to say "Karren, which article should we reference from the options you sent?"


comment:
add "Injection" after (treprostinil) in line 3


comment:
do a global find for (treprostinil) and make sure Injection is after all of them, just in case I missed any.


comment:
bullet 4, shift "or" down to last line so Overdose isn't an orphan.


comment:
Globally - check that the MENU button is working. I tried clicking on it on several screens after completing the course (and skipping around via the left nav) and I couldn't get it to work.


comment:
horizontally center the title and the start button onscreen


comment:
in transcript, italicize Select the Right Patient.


comment:
remove (R) (treprostinil) Injection in the grey text.


comment:
remodulin tab, remove (R) in line one after Remodulin


comment:
diagnostic measure - can you make sure comma is after BNP - looks like it's actually connected to SpO2.


comment:
treatment history - remove the 1 and reference popup.


comment:
main screen - change directions to read "Click each item to learn more. Rollover bolded acronyms to see the definitions. Then, click > to continue."


comment:
update direction text to say "To understand how the pump calculates flow rate and refill intervals, click and review the equations. Then, click > to continue."


comment:
can you animate the red boxes on, timed to the audio like you did on the opening screen?


comment:
Delete all references on this screen. Replace with the text "Information on selecting the right patient is available in the Technical Manual."


comment:
Update the References popup in the top navigation with the same text.


comment:
Italicize "Select the Right Patient" in the grey text.


comment:
remove the right anchored text box and instead place it under the screen title; it should match the conclusion screen for the programming course


comment:
italicize select the right patient in the transcript too


comment:
The SynchroMed pump is not the first and only approved implantable pump. You could specify that its the only pump approved for delivery of Remodulin.


comment:
Is this a mode? Therapy Stop actually sets the rate to minimum rate.


comment:
We usually add a disclaimer that the volume of the alarm they are hearing may not be representative of what an alarm sounds like on an implanted pump.


comment:
I recommend that you remove the alarm durations (i.e., three second) because Neuro is in the process of changing the alarm durations.  You can say that the critical alarm is a dual-tone alarm.


comment:
Consider whether to instruct the learner to review the drug labeling for all symptoms of overdose and underdose


comment:
can we make key supported functions popup cover the first OST box better? not covering on left.


comment:
she didn't make an edit here - should have Certification on far right (after Instruments and Materials)


comment:
CC was not updated appropriately at the Pending tab click. Please add "You must enter the minimum information required in the Pending stage as it is always required, however your observers will usually be directly assigned to the Certified stage from another certification."


comment:
reverse the order here. Should be Configuration, Materials, then certification.


comment:
The slides are out of order at the very start of this practice. It has me pick Instruments, then add, then certification.


comment:
Just a note - I realize you don't have the professional audio yet but the Audio timing seems off. When the Roche person is speaking the customer is gesturing and vice versa.


comment:
I need to see this corrected before commenting further. The gestures seem off.


comment:
Some observations already commented, just for consistency.
- The illustration is a man and voice a woman
- Illustration is pointed the wrong direction
- Maybe improve the volume


comment:
I suggest a stronger introduction to new concepts as trial planner, site evaluator and site manager, they are new or changed from former procedure


comment:
The diagram has an extra picture in the lower left corner


comment:
I suggest additional definition on new concept qualify a site


comment:
I suppose this training also applies to new arrivals. Does this approach work for a new CDL?


comment:
I suggest a replay button; I missed the audio and need to complete the test again in order to listen to the message


comment:
Sincerely, I failed the SPI- question. I thinks it is not clear


comment:
Propose to re-word: to confirm with the SMEs
In this course we refer to commercial Clinical Research Units (CRUs) as "vendors". 
Vendors employ physicians who are non-Health Care Professionals and other important site personnel during trials. If the budgeting and contracts process goes well, vendor relationships will be strong.


comment:
Propose to have a red box earlier in the process map, i.e. around "Determine Budgeting Organisation and Is an HCP Involved". In the pop-up say "The scope of this course is the path to follow when non-HCPs are involved in a trial". (to confirm with SMEs)


comment:
..."Who will help employ PIs during a trial"... is wrong wording I think. Replace by: "a CRU who has been selected tu run a trial for Lilly"?


comment:
Wording "As a reminder, this vendor will be assisting with hiring PIs throughout the trial" is not correct I think.
"As a reminder, this vendor has been selected to participate in trail ABCD" (confirm with SMEs)


comment:
wording "they tend to hire excellent PIs" - confirm with SMEs


comment:
Not sure if this scenario is correct - confirm with SMEs


comment:
Confirm scenario with SMEs - reword to "Since we need to screen patients immediately..."
Accordingly, the 3 choices need to be verified. I don't think vendors hire PIs.


comment:
Review incorrect-feedback with SMEs
- Vendors feel safe?
- Other trials negatively impacted?


comment:
Protocol change around PIs? review with SMEs
Replace with a change in the protocol around the patient schedule?


comment:
Again, revise scenario about new PIs being hired.
Study Participants are being recruited, maybe that's what it should be changed to?


comment:
Add some more wording around how the contract signatures were obtained and who signed?


comment:
or continue in the trial - whichever wording Larry and Teri like


comment:
Wondering if it's possible to un-highlight the previous tab once you move onto the next?  Up to the team, but I don't think I like having all of the tabs outlined and highlighted.


comment:
Agree with Sophie's last comment. We should revise #1 to something like, "The site has indicated their price includes 1 hour of PI time and 3 hours of SC time for every unscheduled visit."


comment:
We shoud use the words, qualify and select in these sentences too so it matches the map.  Larry and Teri - how should we incorporate the words.  We must have the appropriate documentaiton to ensure that approved and selected sites are qualified to conduct the trial through a thorough evaluation?  Larry and Teri - thoughts?


comment:
This is about site selection - is this relevant for this course?


comment:
Title "A New Procedure", but scenario is about enlarging the site? And how would that cause additional costs for Lilly?
Revise with SMEs


comment:
I believe the "Incorrect" feedback is not correct for this scenario.
It should be "think about all potential issues if work begins before all signatures are obtained on the contract"


comment:
Add content on types of agreements and who should sign?


comment:
Should the last step in the roadmap be "Agreement (or contract) executed"?


comment:
Add in pop-ip box "Develop Site-level Budget" "The Negotiator receives the Country Target Budget from the Global Budget Representative".


comment:
Propose to delete the 1st sentence of this screen. Or wouldn't refer to that step if the higher-level process, but rather to the sub-process "Develop, Finalize & Release Country Target Budgets"


comment:
The Voice Over said on the previous screen that we were going to look at 3 sites participating in an oncology clinical trial, but this scenario covers a neuroscience trial?


comment:
Other courses have refered to the process diagrams in Blueworks Live here. Suggest to do the same


comment:
This slide seems to fit better after the country budget piece, when exceptions are covered


comment:
This slide seems to go in detail in the exceptions piece, rather then bringing an intriduction and impact.
Focus this on the potiental delays and attempts to skew decision making and bring definition oof exceptions to the respective content part in the course?


comment:
Pro popup - update first bullet so line wrap isn't bizarre


comment:
plus - update bullet 1 line wrap here too (there's way too much space after devices in second line)


comment:
line 2 of instruments popup - change to cobas IT 1000 application and add a period to the end of the sentence


comment:
patient results - bold cobas appropriately


comment:
user management - bold cobas appropriately


comment:
QC - bold cobas appropriately (appears 3 times on this screen). Also, add a comma after rejected in line 1


comment:
Make the first bullet the last one on this screen, since we moved the order around


comment:
main text - change meter to instrument (Please do a global check that we don't use meter anywhere else in onscreen text)


comment:
can you remove the section with the reminder tab? Just have them click "OK" on the certified tab and go to the last slide of the captivate


comment:
Leo - It appears a whole screen with a captivate got deleted somehow. There should be a third certification demo before this screen - the file name was cop_Show. Let me know if you don't have a file, I have the scripted edits.


comment:
the "- Customize the Screen..." thing in the bulleted list needs to be it's own bullet. She ran them together.


comment:
when you finish a demo and come back, right now you get a big grey box for the demo you completed. Can we just grey out the instrument? Feel free to call me about this one.


comment:
popup directions upon return to this screen - add a period in place of the :


comment:
the Entry and Cert required slide (slide 2, I think) needs CC that matches the onscreen text. (Sorry, Roche snuck that in there and I didn't send her an updated script for that slide)


comment:
for slide 1, copy the OST into the CC. she didn't update it to match what we'll have the narrator record.


comment:
patient ID min length screen - the OST either has an extra line of text or the box is cutting off the text.


comment:
the whole section with the barcodes is missing CC. use the OST as the narration too.


comment:
the last screen seems to jump back, as it goes from barcode back to QC settings (Roche added the Barcode section, which is what caused that). Can you remove the last slide without screwing up the triggers?


comment:
cc on send operator password slide needs a space after "note:"


comment:
Continue button gets triggered too early, on the "Congrats you have finished the server setup" screen. (Roche added a whole section, so you need to move the trigger to the end of the new section. Sorry!)


comment:
update the transcript to say instruments instead of meters. (I'm not going to re-record the audio, but let's make the ost right so Mike records it right.)


comment:
remove the "1" on the Materials practice button.


comment:
don't make them click reminder here. Have them click OK on Certified tab and bring up congrats message and trigger continue.


comment:
they don't have to click the Operator list - we don't need to show those options here in the practice.


comment:
don't trigger continue button until the end of the practice - new section from Roche


comment:
Right now, there's a transition text box telling you that you're going to create the default config that fades off too fast to read. can we make it all one text box, ending with the directions on what to click (from the next slide?)


comment:
congrats message - change to "Congratulations, you have completed Server Setup and created a default configuration."


comment:
the continue button should be triggered after they finish 7 practices. (They don't have to do both the ID setup for the Plus and the Pro)


comment:
actually - funny story - the continue button doesn't show up at all. Please fix with the trigger I mentioned previously.


comment:
On main title slide, update spelling of "Siemens"


comment:
Will need new cobas IT 1000 screens to not include: cobas b 121, Opti CCA, OMNI 1-9, OMNILINK, REflotron, OMNI C

Also applies to the course screens.


comment:
Need new screen shots to remove products not cleared for use with CIT1k in US  (b 121, Opti CCA, OMNI 1-9, OMNILINK, OMNI C, Triage, Reflotron)


comment:
I'd like to modify William's (Customer Insights Representative) background information. Perhaps an education background in marketing or human centered design, with more professional experience.


comment:
Please clarify which characters we will be using in module 2?


comment:
What does the meter bar below "TRY IT" mean?


comment:
1. Stool collection cup does not look right. @ Beth and Mike - please double check.

2. Add loose stool in stool sample type for detecting C.difficile.
3. Add CT/NG as example of infections found in urine samples.


comment:
Add Mycobacterium Tuberculosis as example of infections found in sputum.


comment:
I'm missing the meter bar (See it, Try it) down below. Will it be added to the page?


comment:
Is this page suppose to be the last page of this module? I see no further navigation beyond this page.


comment:
1. Should we have a nasal swab?
2. I think it is confusing to have to drag the sample over to the collection site if you don't know beforehand what the container is. Also, if you do click it open, then it is laborious to have to click X to close when you want to move to another sample type. If you click on another sample type, can you automatically close the current one?


comment:
It seems like the definitions of these phases are different from the Roche definitions. The lab defines pre-analytics as whatever happens before accessioning into the lab? But Roche defines pre-analytic as what happens before the sample is loaded into the instrument. How should we resolve?


comment:
Can we make each number under each phase "appear" one at a time automatically, with maybe 1 second intervals


comment:
It is time consuming to  move the sample over and it is finicky about exactly where it lands. This section seems like it takes too long for how simple it will be for them. Specimen collection is one of the most familiar concepts for them


comment:
I think you should see all of the choices before having to place them in the correct order


comment:
The answer obscured my answers so i couldn't see what I had right or wrong.


comment:
Time of collection is also important for some specimens. Or time from collection to processing in the lab.


comment:
I really like the idea here but the execution is a little confusing (agree with Jean's comments).  Definitely do away with the "x" closing out the window once matched.  Nasal swab should definitely be included.  Would it suffice to just show the correct collection container and info when you roll the mouse over the collection area?


comment:
We didn't cover all of these specimen types previously. And is it really important that they can identify a specimen type by visual only?


comment:
Are we calling these specimens or samples?


comment:
Transport should probably show what is typical for in-hospital vs. across hospitals


comment:
I know we're not reviewing content, but it's already here:  

Isn't "clerical staff processes the test request" the same thing as accessioning?


comment:
It wasn't obvious to me when I did this at first that I got the answer wrong.  Now I see that "clerical staff processes the test request" is in the "pre-lab" part of the process.  Can we make it more obvious when they get something wrong, like maybe put the wrong steps in red?  Or is this another opportunity to make the steps not "sticky" until they get it right?


comment:
Please reduce the number of "X"s they have to push to continue, maybe by putting the information about the bench below the picture instead of after getting the question right?


comment:
There's really a lot of emphasis on the pre-analytic phases and only 2 screens on analysis.  Do we have interactions planned for the analytic phase?  There's probably the most content to cover here, including  culture, classification, gram staining, and identification methods.


comment:
this is not the most up to date version of this screen. replace with current template.


comment:
"continues participation in" is not correct grammatically. I know that's how the SME wrote it, but we need to make it sound right. Fix.


comment:
This vo was not recorded as per the lines in 11 and 12 in spreadsheet. what's accurate?


comment:
assess screening box - the 2nd paragraph makes no sense and isn't written clearly. read it, make sure you understand the point you're trying to make and edit/rewrite


comment:
It's line 26 in the spreadsheet - but she wants a pop-up on the first decision point - has there been a change.


comment:
close out sites - gray box isn't lined up around the red box. missing period at the end of the sentence in the box.


comment:
assess the change box. missing a space before last sentence.


comment:
PIs leave all the tim box. Missing periods and bad comma use in the first sentence. Change the first sentence to: By not reaching out to the site to discuss the timing of the change, the site may not be ready for first patient visit, PI oversight could be jeopardized, and most importantly study participant safety is at risk. (make this last phrase your red text)


comment:
first sentence - we don't typically say "with the trial on pause". Change to "With the trial paused," My expectation is that even though we might "Accept" an edit from a SME, you are still editing it for clarity and grammatical accuracy.


comment:
per the language guide, SEC should be ISEC


comment:
per line 58, i think you need to remove the word "Site" from the purple box


comment:
For line 70, the note that i had made on my spreadsheet is that you would pull the PI change as it's own button on this screen. Here's the full note I had typed when I was sharing my screen: Add PI change to the list of changes discussed in the course. (Pull content/what to do from the change form) Include checking with local requirements for process changes in the correct feedback.


comment:
Enrollment Manager - Why - in call out box, should read "Completing these required tasks..."


comment:
spelling error - in 2nd option should be commitments


comment:
The stated question gives the response away (couple of required tasks.  Change to:  "Select the answer that indicates a required task or tasks, ..."


comment:
It may be challeng users know how they could complete


comment:
Check this slide as it is linking to your original close captioned file, so close captioned appears here.


comment:
scrollable popup is a little blurry... maybe make a little smaller


comment:
shorten body text box so woman doesnt overlap it... move text in red box up to centered


comment:
Onscreen audio transcript callout box: align text to the left.


comment:
Intro text, 2nd sentence: Change "As you recall,..." to "As a reminder,..."


comment:
Let's mix up the icons so they aren't in the same layout as the drag spot layout.


comment:
Adjust for a new N-1 value and Adjust the dispatch boxes: Add periods to the end of both sentences.


comment:
I'm not sure we were having audio for these screens? can someone confirm?


comment:
add "Click the Next button to continue" instructions


comment:
Intro text: Change to "In this course, we're going to focus on infeasibilities. We'll learn more about market factors that change resource availability and generation, and how to identify infeasibility indications."


comment:
have the body text have a "done" state that changes instructions to "Click the Next button to continue" when you show the next button


comment:
Transcript: Remove bolding from words in the transcript.


comment:
for each popup layer, add an invisible hotspot behind everything so that when they click it, it hides the layer first. that way they can't scroll and get things all wonky on the page with the popup still showing


comment:
Transcript, 4th sentence: "master file" needs to be "Master File"


comment:
for popups on the left side, keep the X in the top right


comment:
hide Next button until all red boxes are clicked


comment:
make sure red bubbles have brown visited state


comment:
text for button for "After all review changes..." under WHAT changes on it's visited/selected state


comment:
may not be needed, but add a "done" state with click next instructions replacing "click each box...."


comment:
not critical, but can the continue button be in the mold of the purple SUBMIT buttons previously?


comment:
move answers over to left so character's hand isn't overlapping


comment:
replay button came up before the end, however i would check to see if we are using the default player here rather than those buttons (so you can see how much time is left). i think we did that in another course.


comment:
she needs to be cut off at the waist and bigger like all the other courses


comment:
Yellow placeholder box: Change text to "This roadmap will be presented in the alpha version of the course, using VO and images. We would like to use it to introduce the troubleshooting process that learners follow in BAAOP. We will need SME input to determine the steps of the troubleshooting process and how to describe them."


comment:
move the body text up or have the popups cover all of the instructions paragraph. it looks weird cutting off the middle of a line


comment:
There is old feedback in here from the ISO - where is this feedback pulling from?


comment:
I can't choose answer options on this screen, so can only get "Incorrect" feedback.


comment:
Transcript callout box: Align text to the left.


comment:
Please update first bullet point to be:
Learn to complete the Configuration screen in the Instruments module.


comment:
Please update first text box to read:
The following configuration screens must be completed prior to deploying a meter for use with glucose testing.


comment:
Audio, 1st and 3rd paragraphs: Pronounce as "aim" rather than "a-i-m" per DP edits.


comment:
The steps need to include:
- Activate the default configuration if it is deactivated
- Deactivate the default configuration after copying to create new configuration


comment:
4th onscreen bullet: The timing is off. It should come onscreen when the 4th sentence is spoken (beings with "UAAs can add or remove...").


comment:
Transcript: last paragraph, 4th sentence: Transcript says "UAAs" but the audio says "User access administrators". Select one for consistency (recommend changing audio to match transcript).


comment:
The demo says to choose Aztec for barcode; however all barcode options are shown as active. Need to update captivate.


comment:
Please view and check audio; it seems like some of the audio is missing when text is displayed.


comment:
Entity: Training box: The DP comment says that a highlight box will appear around the "Authorized Entity" box when the learner rolls over the "Entity: Training" box. However, that highlight box (orange) appears when the learner rolls over the "Authorized Entity" box itself. I would change the trigger for the orange box - and the orange box itself is not aligned with the "Authorized Entity" box.


comment:
There is a difference between the audio and text for Password. Audio says 123, and text states 1234.


comment:
Transcript/audio: Last sentence: what is the difference between "Endorsed to" and "Endorsed by"? Should this be "Finally, I'll show you how to process users who are employed by your organization, and request access for users endorsed by your organization."?


comment:
For Commercial Education team: is there plan for customers that ask about barcode masking?

We need to have a path forward.


comment:
Intro text: Change "User Access Administrator" to "UAA" since you've previously defined it.


comment:
Same feedback here. A whole section of text is displayed without matching narration.


comment:
We just read the non-audio text box for barcode mask. Do we want this information on the user section of the training course as well?


comment:
Not 100% sure, but thought the patient ID was a number?  Perhaps need to verify with someone in Neuro


comment:
Change the scenario to say "...include a GHG bid adder and wants to view some historical data before submitting his offer."


comment:
Should we explain here that this is part of the Develop, Finalize and Deliver Training process within the high-level Activate Sites process?


comment:
change first sentence in audio and transcript to - "Welcome to the Develop Effective Protocol-Specific Training course"


comment:
Change all references to title of course to "Develop Effective Protocol-Specific Training"


comment:
Agree with Tera--I would spell out Protocol-Specific training content here and then put the abbreviation in after this screen by first denoting as Protocol-Specific (PS) Training


comment:
With Tera's requested revision, I would make this box more active, e.g., starting with, "The Training Owner is responsible for developing and updating the plan for training, which includes: Discussing...." (make into bullets), then end with the last statement in her feedback.


comment:
I had a hard time getting the transcript to come up and stay up on the screen.


comment:
Make box text more active like others before


comment:
Can we move the Daily Shutdown subtopic (& objectives) into Daily Maintenance since it is part of Daily Maintenance? If, so, then we can add "As Needed Maintenance" as a topic. There are three things (cleaning trays, cleaning reagent hats, & removing coverslip cassettes). This content was added into the Operator Manual.


comment:
Results Ranges text box displayed and hidden too quickly for user to read the text box.


comment:
Transcript, 1st paragraph, 4th sentence: "...and then I click the Create New User button." (missing the word click)


comment:
2nd paragraph, 2nd sentence: lowercase A in "account type" to be consistent with the other required information types.


comment:
5th and 6th paragraphs: Add a space between these. (before "To start, click the edit icon."


comment:
10th paragraph, 4th sentence: Change "down-down menu" to "drop-down menu"


comment:
13th paragraph: Need a space between the 1st and 2nd sentences. (...Request History Tab. Here you'll see...")


comment:
Intro text: update sentence: "When a user changes roles, the UAA can modify which applications the users can access using AIM." (add comma and correct misspelling)


comment:
Please update OTE text to be:

All Accu-CHEK Inform II meters assigned to this configuration can now be used to enter manual pregnancy results.
Use this procedure to enable additional tests under the OTE menu.


comment:
Onscreen callout box 18/20: "acces" should be "access" and "can not" should be "cannot".


comment:
1st paragraph, 1st sentence: It looks like there is an extra space at the beginning of the sentence.


comment:
Please be aware that the text states EAP, audio says EPA. Please correct and update.


comment:
4th paragraph: 2nd and 3rd sentences: looks like an extra space in between "...portion of CIDI." and "So, I'll select..."


comment:
7th paragraph, 2nd sentence: "And that completes the task." Not spoken in the audio and doesn't appear to be required. Remove.


comment:
Intro text: Still has placeholder text onscreen.


comment:
We propose asking the customer if they are a IT team member or POCC prior to the start of the EAP configuration section. The IT section will go in depth related to EAP setup, while the POCC view a high level overview.


comment:
User2 versus Training User2 versus Training User 2: Make sure these are globally the same, and say/show in the transcript "Training User2" to match the onscreen text.


comment:
12th paragraph, 1st sentence: Extra space at the beginning of the sentence. "Remember, I won't see..."


comment:
For the EAP section, please mention that in this EAP example, the customer will need to create an individual EAP configuration (username and password) for each instrument.


comment:
"sub tab" and "sub-tab" are used interchangeably throughout. Update all to "sub-tab" for consistency.


comment:
This captivate feels very long and it has a lot of redundant information, as provided in the first captivate (things like viewing the status of the request, e.g.). I feel like this can be cut out, and maybe just referenced as a sentence in the audio.


comment:
"appliactions" should be "applications" - do a search, I saw this more than once.


comment:
Nick's VO still says "a-i-m" instead of "aim"


comment:
Transcript - "CONTROL" should be "Ctrl" to be consistent throughout the course.


comment:
3rd paragraph, 1st sentence: Add a space between "...then click RENEW." and "To renew multiple..."


comment:
Add a space between the last 2 paragraphs.


comment:
Please update first text box to be:
After a new lot is added using a code key reader with the ACCU-CHEK Inform II it will be uploaded to IT 1000 the next time the meter communicates.

This new lot must be reviewed and assigned to the locations where the test strips will be used.


comment:
Last paragraph: remove the word "on" after "clicking"


comment:
Discussion point:
Show customers how to filter for un-reviewed test strips lots, rather than navigating directly to lot.


comment:
3rd paragraph, 1st sentence: Remove "people's"


comment:
Please use text from test strip review in QC Material textbox.


comment:
Transcript, 3rd paragraph, 2nd sentence: "When a user no longer needs access to any ISO applications,..." (add the word "any")


comment:
Same discussion point on filtering to QC materials to review.


comment:
Notebook text: remove period from 3rd sentence to be consistent throughout.


comment:
Feedback box at 10/22: Click Training User2 - remove the word "the"


comment:
Feedback box at 18/22: Click Training - remove the word "the"


comment:
"Click here to continue" hotspot doesn't work at the end, I can't advance this way.


comment:
Feedback box at 2/15: Change "Nre" to "New"


comment:
Feedback box at 8/15: Tells me to select CIDI (EXTERNAL IMS READ-WRITE) instead of CIDI (EXTERNAL SDS READ-WRITE)


comment:
Feedback box at 1/22: Remove the word "the"


comment:
We need to add the following note to the beginning of the Certification section stating:

Please contact ACCU-CHEK Customer Care if the certificate type needed is not visible.


comment:
Feedback box at 9/22: Access is misspelled


comment:
1st onscreen point: "User's" should be "Users"


comment:
Question text 1/10: "User certificates are valid until user access is revoked." (missing the word "valid")


comment:
Question text 6/10: Redundant "True or False?" at the end. (It's already listed above the statement).


comment:
Question text 9/10: "can not" should be "cannot"


comment:
2nd bullet point on the notepad was onscreen as the other 2 floated up.


comment:
Typically for the scenarios, we give the learner the chance to click the hotspot/dropdown/data entry field up to 3 times to get it right before giving them a "0" score. I had no idea if I did it correctly or not based on how the scenarios advanced.


comment:
Discussion point with team:
Do we need to provide additional background for creating an observer certificate?


comment:
For the intro, please update the text to read:

You can record the results of other tests using the Accu-Chek Inform II. An operator must be certified for each test they are allowed to record. In this example, we will show you how to configure a certificate that allows for the recording of pregnancy results.


comment:
Please update step to read:
Select ACI II with the Description Wireless


comment:
If we plan to change the earlier demo to show filtering by "reviewed" status, this task will need to be modified as well


comment:
Materials menu is already open when this demo starts.  Should it be collapsed?


comment:
The opening description is confusing. It makes it sound like the user will be certified once for a year and not be re-certified.  Restate to show that the user is certified with a non-expiring certificate that will not need to be renewed yearly.


comment:
Please update step to:

'Select Critical Range Message'

I think the words are swapped in the existing step


comment:
For EAP settings, as with the demonstration, this only needs to be done by IT resources, POCCs will not use this unless they are responsible for EAP configurations.  In addition, we need to mention that the name of the config will likely need to match the instrument it will be assigned to as many customers have unique user IDs for each device


comment:
as an alternative to scrolling down to get to the menu settings, the user could expand the instrument menu on the left to get to the sub sections


comment:
Please check how fast the text boxes are displayed; it seems fast


comment:
Matt - we agreed to do audio on this screen at alpha, so that's fine.


comment:
rachel - can we add some headers to your two lists that come on screen so that learners can know what they mean as they build?


comment:
need to change the module title on this screen - it's the old one when it was in the 2nd module


comment:
I'm not sure that we need a click for every single item on the process map? do you need them for each of the decision points? I will let it be your call - but there are a lot of buttons to click on this screen.


comment:
Your audio slides seem to pick up the audio 1/2 way through if I come back to the screen for a 2nd time. Please go through and do a check for that.


comment:
I'm a little confused about how the audio here relates to what I am seeing. The boxes are too small to read....what is the process map showing that supports what the audio is saying?


comment:
What do you think about the red lines showing up when I click the magnifying glass? If they don't stay on screen, i can't tell what that clinpharm "path" really was.


comment:
same deal here of keeping red lines on the big map.


comment:
I would like for them to see more than just "incorrect" with paragraph text. If they get it wrong twice, could they see the things in the right order or something?


comment:
in the VO, it sounds like she says clinpharm and lilly and IRB approved template. it should just be clinpharm lilly, right? clinpharm is lilly?


comment:
for the red unbracked text pop-up, it is text that is bracketed. could we make the visual match the description?


comment:
Change screen title to "Make the connection: Key points"


comment:
I'd like us to replace this with a previously used timeline interaction so they understand the look and feel of it. Go to course #10, "See it in action: When do I submit? - RDT startup timeline" screen. Lift this and replace all content with placeholder text. Put an onscreen yellow box that says "CAISO: If we need a timeline interaction, we will need content for alpha."


comment:
Add a yellow callout box onscreen that says "CAISO: This will be a series of BAAOP landing pages with individual sections described using rollovers. We will need to know which screens to show and descriptions provided for each section."


comment:
I realize these are placeholder rollover hotspots, but please make sure they are aligned to other boxes onscreen. The boxes now hang over different lines and look clunky.


comment:
Add a callout box onscreen here that says: "CAISO: Operating outside of standard market timelines appears to be something the user cannot do, based on source content reviewed. What should we show the learner here, and do we need to have them practice anything in the You try it module?"


comment:
Add yellow callout box onscreen that says  "CAISO: These are draft key points based on source content reviewed. These may change based on the interactions developed in this module."


comment:
I would scrap the audio here and replace everything with placeholder text. Remove the transcript text. Change onscreen notebook text to 3 bullets: "Situation text goes here", "Situation text goes here", etc. We don't have enough content to build anything here so let's keep it simple.


comment:
#4 - Not sure that the first sentence here is really saying anything? Could we delete it?


comment:
In red box - per the language whiteboard, we don't really use subjects, but rather study participants.


comment:
tHe instructions say to click next but there is no next button


comment:
i would love it if you bolded some of the words on this screen to help them know what to focus on.


comment:
in other courses, red boxes aren't clickable until after vo has ran. Matt - what's the rule?


comment:
in intro sentence - need to add the word "the"


comment:
I think your feedback tool is covering mutliple pages in the course. That's going to make finding edits challenging


comment:
the text in red boxes isn't consistently lined up with the top.


comment:
Are we capitalizing study participants? I don't think we are in other courses....


comment:
once you fix stretching, try to make it larger if you can


comment:
I think you should leave your headers on the tables once you click the magnifying glass


comment:
I think the edit in the spreadsheet was to give them the right answer after 2 chances? I would check this in all of your activities in this course.


comment:
I would focus the red box on study participant safety, not delays. we've gotten that feedback consistently that what they should ultimately care about is the patient.


comment:
It's beta - do we have links for these items yet?


comment:
Fast Facts: For consistency sake, update bullet point statements (either remove "the" in first bullet point statement "...is stored in pump reservoir and delivered by catheter directly..." or update to: 
- Remodulin (treprostinil) Injection is stored in the pump reservoir and delivered by the catheter directly into the superior vena cava.
- Programmer sets the pump flow rate (patients daily dose) and allows for drug titration based on clinical assessment.
- Only Remodulin 10 mg/mL is used with the implantable system.


comment:
Typos ins Lewis's text box. Please revise.  Ex. Community should be committee. Executive leadership should be executive leadership.


comment:
Request for Proposal not Request for Proposals.


comment:
I just realized my comment will impact the implant in Practice course too, so we may want to leave as is.  Let's discuss.


comment:
There is no directive after all numbers are clicked.  Once complete, the directive should change to "Click > to continue."
**This will affect the Implant In Practice course also.**


comment:
Becca's response - please tighten language slightly - reads slightly awkwardly.


comment:
Correct the orphan in the 3rd bullet point. (An 8 French introducer is required for implant.)


comment:
Just an observation...but in the Implant in Practice course, the bullet points and images are in reverse order in #3 Sutureless Connector. Since we're talking about the catheter in this section, we may want to talk about the catheter body connection first and then the connection to the pump (therefore, reverse the order and have it be consistent with Implant In Practice).


comment:
After all numbered elements are clicked, there should be a directive to "Click > to continue."
**This will also affect the Implant in Practice course.**


comment:
This will need player options. Matt will send globally.


comment:
When I first came here, I was able to click both menu options instead of just the process.


comment:
I lied about both being clickable. It is just the text that needs to be updated to tell me to click the Gateways module.


comment:
The gateway image disappears for the 2nd gate after about 10 seconds.


comment:
The third gate says to slide the button. I think it should say to click the next button to continue.


comment:
Since this is Beta - you should have you Review the Resources links finalized.


comment:
Text is telling me to click the 4th gate, but there is no 4th gate.


comment:
Remove the word "most" before important.


comment:
The link for the guide book is on the Writeboard for template changes. You'll want to request the 2nd link.


comment:
Also make sure to update the links here, and in the resources layer.


comment:
The text for this screen isn't correct, and neither is the transcript.


comment:
the study manager does not enter the site level enrolment in the interval systems


comment:
the enrolment manager does not enter trial level information


comment:
Based on the spreadsheet, I think the 2nd sentence should be updated to "This involves careful planning and understanding of roles and responsibilities for members of the PAH clinical team, the implanting team, and the post operative care team."


comment:
It is unclear to me about the enrolment manager completing trial level projections into the internal system - I had understood that this was a country level role?


comment:
As you will see from my later comments, it is difficult to equate these titles with current roles - either we need to be clear that multiple roles play a part in each role below of be clearer as to which are site, country and trial level roles.


comment:
Can we replace this image with the woman version? Also, is there a way with both these images to have the entire abdomen flesh colored? The red halo around the pump makes it look like inflammation (flash backs of SC site pain which ISR does not have)


comment:
1st sentence: add a comma "...implant patient education, such as:...".
The bullet point statements are inconsistent. I think we should update to:
- Setting appropriate expectations.
- Describing risks and benefits of the implant procedure and implanted system.
- Discussing limitations for daily living.
- Responding to alarm notifications.
- Recognizing the signs and symptoms of a drug underdose or overdose.
- Reviewing the procedure steps, including the need to place an external line prior to surgery and the potential need to stay overnight in the hospital.
- Understanding the importance of following their refill schedule.


comment:
Another observation... I thought we had a discussion about clicking on timelines.  Seems to me someone stated that we don't click on the individual steps in other courses, instead we had them click > to continue.  Is this an inconsistency? Or this instance different from the others?  Let's discuss.


comment:
Upper right corner timeline is different than the Implant In Practice formatting. I actually like having the entire icon red vs. placing a red/maroon circle around the icon. It's easier to see. I think we should be consistent and use the format you are showing in this course.


comment:
After looking at the content worksheet again, we can label 3 timepoints on the interaction I called out in my previous comment as 1) STUC - 4.5 hours out, 2) RTPD - 37.5 minutes out, and 3) RTD - 7.5 minutes out. Leave description text blank with placeholder text only. Change yellow callout box to "CAISO: To populate the descriptions for this timeline, let's discuss what information is most relevant to the BAAOP user."


comment:
Need to replace this with an image provided in content worksheet. Ping me for the image. Add a yellow callout box that says: "CAISO: This section aligns with the troubleshooting roadmap learners saw earlier. Does this need to be a Captivate or screenshots/VO?"


comment:
Ensure correct trademarks for cobas(r) Liat(r)


comment:
we are showing the 10mg/mL vial here and talking about unapproved drug indications. Should we be specific in the first paragraph... is approved for use with 10mg/mL concentration of Remodulin?


comment:
Replace blue box with image from source content. Ping me for image. Add yellow callout box onscreen that says: "CAISO: Placeholder for now. Need to determine if this is a Captivate sequence or screenshots/VO."


comment:
Correct feedback box: Capitalize "Correct" as the first word in the sentence, and add a period at the end of the sentence.


comment:
I am changing my feedback here - it appears that the answers, once selected, have a blue highlight around them. That's not consistent with the way we've done it in other interactions. When the learners selects an answer option, have the selected answer boxes turn into the teal color seen when you hover over the answer option.


comment:
Incorrect and correct feedback box text: Make sure these are all sentence case (Capital letters to start, and periods at the end.)


comment:
This feedback was supplied with the Accu-Chek Inform II module - customers are currently instructed by service to disable the default configuration after creating the first copy.  Disabling the configuration prevents it from being modified and being copied.  The creation of a new configuration should show the user activating the configuration, creating a copy, then deactivating it again to ensure we are following the same process as service provides the customer


comment:
We may want to change the image on the N'Vision programmer to a screenshot that's more relevant, such as the Infusion screen.


comment:
The look of these summary slides are different than other courses. Use a finished course example, like course #7 BAAOP basics, part 2 You try it: Summary to replicate the look of the boxes, font and colors.


comment:
The Show what you know intro says that there will be 10 T/F, MC, drag/drop questions. However, the question sets says X out of 8 questions. Let's make sure that 2 more are added, even if they are only placeholder questions.


comment:
Question 1 of 8: Add a space between the directional text in blue and the answer options, otherwise they look scrunched.


comment:
Question 8 of 8: "BAAOP provides reliability-based insight..." (add a hyphen between reliability and based)


comment:
When selecting the patient ID, there are two issues.  First, the user selects Patient, not patient ID (the caption is incorrect).  Second, the user does not confirm that Patient ID 1 is in the mapping field.  They need to confirm that the correct ID is selected that will be used on the device (some sites may use visit ID or a different patient ID passed to IT 1000).


comment:
When I clicked the "Prepare for Surgery" icon, the icon turned blue and the System Implant icon turned red before the course proceeded to the next screen. This needs to be corrected.


comment:
Need to replace this placeholder image with something BAAOP-related, not AIM-related. Ping me for a replacement. 

Even though this is a placeholder, we still need directional text at the top and an arrow icon on the image to indicate it's a Captivate simulation.


comment:
My previous comments applies when each of the 4 step icons in the timeline are clicked.


comment:
Repeat of previous comment, now global: The look of these summary slides are different than other courses. Use a finished course example, like course #7 BAAOP basics, part 2 You try it: Summary to replicate the look of the boxes, font and colors.


comment:
This demo shows material being added and assigned, but not reviewed.  The demo needs to show the material as reviewed as well so that it is approved for use in IT 1000.


comment:
correct the orphans in the Overdose and Underdose pop-up windows.


comment:
It still appears that the certificate name is overlaid and may not be the real certificate name.  Can we confirm that this is the correct name now that the training server has been updated.


comment:
This screen is out of order in the menu, it shows up as last, but comes right after the BAAOP basics screen. I think the big picture screens need to move down in the menu to the end of the module.


comment:
Second bullet needs to be changed a bit. Perhaps...Patients who have presence of known or suspected infections.


comment:
also bullet 4 needs to be tweaked similar to bullet 2.


comment:
Pneumothorax pop-up window:
Break the 2nd sentence into 2 sentences.
"Pneumothorax symptoms, including...and shortness of breath."
"The symptoms typically occur during the procedure, but may present as late as..."


comment:
We may want to add "Patient Emergency Card" to the last bullet point.  I am currently working with the team to develop this card.


comment:
On Remodulin tab- initial cap Prescribing Information


comment:
there are three docs standing on the right side of the screen, under all the menu/popups


comment:
remove ' in Siemens in the transcript and in bullet 1


comment:
"cobas® Liat Analyzer" is the proper terminology per the Roche Naming and Trademarking of DX Products Guidelines.

The R-ball is missing in many places other than the first page, but "system" is incorrect usage everywhere.


comment:
on hemodynamics can you ensure that the pop up description for 6MWD does not get cut off.


comment:
bold "cobas IT" in the middle of the paragraph.


comment:
"cobas IT 1000 application" (no R-ball) is the proper terminology per the Roche Naming and Trademarking of DX Products Guidelines.  The text is correct in many places in running usage, but the text at the top is consistently off.


comment:
directions got duplicated. Delete the version that doesn't have the bold text


comment:
user management - change IT 1000 to "the cobas IT 1000 application" (need to bold cobas and IT)


comment:
make the first bullet the third one please.


comment:
on this screen, we need to move the Certification to the far right. So it goes Configuration, Materials, then certification.


comment:
the congratulations screen repeated itself. The audio said congrats twice.


comment:
"Accu-Chek Inform II system" is the proper terminology per the Roche Naming and Trademarking of DX Products Guidelines.  The "system" is needed for proper trademark usage.


comment:
this one did the same thing- I got the congrats message twice in teh audio


comment:
in transcript, the spacing gets weird. can you double check?


comment:
in on place in transcript "cobas IT" needs to be bolded


comment:
move this screen to be right after "Certification: What You Will Learn" - they changed the order in another course and I want to match it.


comment:
Ok, I just double-checked. There is a totally updated version of this animation in ACInform II. I'll send you a link. The only think you'll have to do is update the transcript to add "To use OTS with the Signature Elite, you must have the POC Mobile module for the cobas IT 1000 application."


comment:
same re-order request here - move the Certification column to the far right


comment:
Comorbidites pop-up: add a comma "Comorbidities should be considered to determine factors, such as: ..."
Diagnostic Measures pop-up: 6MWD rollover text is getting cut off
Hemodynamics pop-up RAP rollover text is getting cut off


comment:
Question...should we only have one directive at a time on a screen? Or are there instances where multiple directives at once make sense?  I think we need to discuss this as a global element and make all courses consistent.


comment:
3rd bullet point/2nd sentence: change to "...ensure they are acceptable candidates for the implantable system." to be consistent with previous screen.


comment:
Under travel: ensure that their travel can...feel repetitive to say patient twice 

Under proximity to refill center: can we just say for the system or just end first sentence after refills. Also, do they need to "confirm" or discuss if there is a caregiver. Makes it seem like they need to have someone drive them home, didn't see that in the manual is this somewhere else? One of the benefits of the system is more independence.


comment:
extra spaces between aragraphcs in the CC


comment:
the purple in the red boxes is not the right purple. should be lighter


comment:
move the text a little bit further away from the character


comment:
cannot click the "click here" once the red highlights come on


comment:
let me know if you need the "Site Manager" row header for this


comment:
update instructions for click the next button


comment:
move the woman over so she doesnt overlap. or extend red bars to be behind her


comment:
The directional at the end is a bit strange. Perhaps say click on the buttons below to review the equations. Then click > to continue.


comment:
make the text in the red bar go to 2 lines and be shorter width-wise. put the review the guide button in the red bar on the far right. add insturctions to click it?


comment:
lowercase "Continue" in the instructions


comment:
maybe for the ones where the purple outlines are on top, we reduce transparency of the image behind it. specifically for the flyer. it's hard to see.


comment:
move the imagery down so not overlapping with the instruction text


comment:
possible to show next once all 3 have been visited, rather than only on the third one?


comment:
possible to keep the selections when we cycle back to see what we chose?


comment:
the box in the popup is lilly red in the other courses


comment:
remove "the" before Remodulin under anticoagulation management

on adipose tissue: should probably just say easily accessible during the refill procedure.


comment:
should the abbreviations that have pop ups be bolded or underlined to show they have a rollover state? Some indicator?


comment:
Change 2nd bullet to "Select and Manage Sites procedure in Quality Docs".
Applies to "resources" tab under menu option as well.


comment:
Please also hyperlink the Select and Manage Sites Guidebook in the "Resource tab" in the menu button (upper right corner)


comment:
Change 3rd bullet to "Select and Manage Sites Guidebook"


comment:
In the "Partcipants" call-out box remove the note after Site Evaluator as this role is for all trials, not only HP trials


comment:
In the "Notify Appropriate Parties of Required Actions" box replace Study Manager by Site manager as that box is in the Site Manager swimlane


comment:
May need to change to Voice over here as he only mentions the 1st 2 activities, not the agreements, training etc..


comment:
Under "Assess the change" Remove "We saved time and money by assessing the change". Replace by "we ensured continued study participant safety"?


comment:
Remove "ISEC" - say "meets the requirements"


comment:
Under the red button:
This might put the company at risk of being out of compliance." Remove the study participant from that sentence. Do we need to add study participant safety at risk thouhgh? Confirm with SMEs?


comment:
Under Protocol Change:
"... as identified by the COPM or Study Manager"
(as this is for Clinical Pharmacology as well)


comment:
Under "Complete Site Evaluation of Changes" 
The text needs to be replaced - propose:
The site is re-evaluated to ensure they are still qualified to conduct the trial. The re-evaulation is documented by either updating the Site Profile Information (SPI), or by using the Investigator Site Change form or the Human Pharmacology Investigator and/or Site Change Form, depending on the trial type and change.


comment:
Please update third bullet to be:

Practice application tasks such as certification and configuration

This change also applies to the Liat and Inform II course.


comment:
Please update first bullet point to be:

Receiving patient and QC . . .


comment:
Please update User Management bullet to read:

Manage and add users from this area. The operator list may already be available if the site is performing glucose testing. The cobas IT 1000 application can support up to 700 users for this device.


comment:
Later in the demo, the course details clicking on buttons, consider using clicking on the User folder. Applies to all folders clicked


comment:
Please update opening textbox verbiage to be similar to Inform II course. Comment is related to patient information tracking correctly.


comment:
Move up instructions to click Simon for proceeding in case it is cut off from screen view due to resolution.


comment:
Should we include audio for the last text box displayed regarding default configuration?


comment:
Discussion point for team: Should we display the text when the voice is playing or delay as it currently works in the course?


comment:
Please remove my previous feedback and leave this one: not clear the succession of events to be performed in this page. The "Please scroll down" options should appear after the speakings ends. Otherwise the learner is induced to scroll down without seeing the red boxes.


comment:
Discussion point for team: Sometimes the text box displayed does not include all audio. Should we update to match?


comment:
Hi Jen, Could we make one change on this screen. Make the IPad bigger and then circle the c 501 hardware tab in red when he talks about the cell blank issue. (Similiar to the screen when he talks about the hardware questions tab.  I think it looks great! Tell Ha Trang thanks!!!


comment:
Acronyms should be bold and information (directive) should be given to roll over the  acronyms...(similar to the Medical History screen in this course).


comment:
Correct the orphan in the first sentence of the Refill Interval and Pump Longevity pop-up box.
When "Continue" is clicked in the pop-up window the learner should be advanced to the next screen (shouldn't have to click on >).


comment:
When "Continue" is clicked in the pop-up window the learner should be advanced to the next screen (shouldn't have to click on >).


comment:
Acronyms should be bold and information (directive) should be given to roll over the acronyms...(similar to the Medical History screen in this course).


comment:
"for the benefit of all stakeholders"  vs the good of all stakeholder


comment:
Add a rollover for TAPSE (Tricuspid annular plane systolic excursion)


comment:
Make Becca an analyst in the financial department


comment:
REmove caps on Executive in the second line of Lewis.


comment:
Capitalize Competitive Transmission Process for Lewis. Please make consistent across all areas.


comment:
Please make Sue a Transmission Planning Engineer.


comment:
SUe - I don't disclose or discuss information with MISO stakeholders.


comment:
Please remove CTA staff and replace with Competitive Transmission Administration staff.


comment:
Qualifications tab is missing a period after applications.


comment:
Please add a paragraph to the effect that if not directly involved in the process you should not inquire about the process.


comment:
change management should not be involved to something like /......Individuals not involved in the process should not ask questions about the process.


comment:
Icons are clickable on this page and bring you back to the sections. Do we want that interaction here? I thought we were removing the interaction.


comment:
I know there was a comment about the clarity of the suture loops picture. It isn't anything special so maybe we can use the image already on the screen to recreate the image in the pop-up and just add circles around the suture loops?


comment:
I'm not sure that I agree with Carolyn. It seems that the standard is if there is something on the screen for the learner to do, the instructions are to do that task (i.e. click each numbered element), the forward arrow only appears after that task has been completed. For screens where there is no task to complete (they are just reading info on screen), those screens have a click next to continue button.


comment:
Scratch previous comment. Just reviewed Pump alarms screen again and on this screen after they click both alarms there is a new directive to Click > to continue. I guess it doesn not to be changed.


comment:
Up for discussion, but maybe they should click on words instead of the alarm icon? Click on the alarm icon to hear the tones? Do we need to make them different colors?


comment:
There seems to be a big difference in the clarity of the image of each physician - the implanting physician looks very fuzzy.


comment:
Since 20% is programmable, perhaps we delete the last sentence of the 2nd paragraph?


comment:
Workstream overview needs a PF number. The transcript for Workstream overview has a box around it that is missing lines at the top.


comment:
Let's bold the word "complete" instead of specific for the 4th bullet.


comment:
Can we spread these out more so that there isn't so much white space at the bottom?


comment:
Matt - can we visually do anything to this page to make it look better?


comment:
The end of this animation had the guys on screen and then everything disappeared.


comment:
lower case the "R" in required, and also bold tab.


comment:
I think this is the original EET comment that Sophie had. what does EET mean?


comment:
Capitalize "than" in the More Than a Checklist button.


comment:
extra space after then and before click.


comment:
I think your incorrect feedback needs work. I know what you're trying to say but I clicked on General Information and the feedback says CPSDS doesn't have information for the Assessment debarment tab, which made me think I clicked on that.


comment:
Check with team on notification template comment.


comment:
Feels like the red bars should start coming in sooner when she starts talking about what the course covers. There is a delay.


comment:
Can we give any notes on the download in case they need to maximize it? It opens fine for me :)


comment:
Something goofy is happening. The first tab switches from System Implantation to Disease overview


comment:
Are you planning on linking the HP-SEC here?


comment:
I just want to confirm that your link goes just to the BWL home page, not the actual map (as this link may change).


comment:
This page, and your resources master don't include the same information. Is there a reason they are different?


comment:
This last page text isn't correct per the template.


comment:
The last bullet in Weight, Height and BMI seems very wordy. Will a PAH physician even understand what this means? That detail seems better for implanting physician?


comment:
Should the rollovers also be capitalized? i.e. BNP Brain Natriuretic Peptide


comment:
could you move the Qualify Site popup down so not covering the flowchart box


comment:
update the the directions to click the next button


comment:
id show the entire spreadsheet the whole time... if you want to spice it up, put it on a computer monitor, but thats about all i've got. then have the zoom out just like you have it. have the 2 dudes slide out within similar size scale as whatever you do for computer


comment:
move "The" in second sentence to same line as rest


comment:
hide draft email button after it shows it. update directions to click next


comment:
if we are capitalizing "Than" then I would capitalize "Evaluating" for mod3


comment:
Delete the last sentence in the second paragraph. bold cobas and include the trademark in what is now the last sentence of that paragraph


comment:
Don't forget to fix the blueprint in the popups in this section as well once the correction Joni asked for is made.


comment:
In blueprint summary superscript the last (R)


comment:
This may be addressed in the blueprint fix, but just to be sure, in this blueprint the cobas z 480 analyzer is oriented differently than in the blueprints on the other screens. Which way should it be for all?


comment:
I got stuck here after I dragged both plates


comment:
Add the yellow not on scan scan pour place that we don't have the image to put here.


comment:
When are we planning on adding this system comparison?


comment:
Page subhead looks weird. Should the whole thing still be italicized or at least the word System?


comment:
Capitalize the word System in the green text box.


comment:
The photos in the popups are all still purple when they should be grey now to fit the new blueprint. Also, there is a purple background behind the blueprint which looks odd.


comment:
Wait, I'm confused. Is our blueprint purple or grey?


comment:
add a comma after CT/NG in the second sentence and delete the comma before that in the last sentence


comment:
The good work feedback has the wrong slide title. It says loading reagent cassettes and it should say Amplification Plates


comment:
The correct feedback should say "Great job! You loaded enough amplification plates for 960 tests!"


comment:
Ignore the two comments about wrong slide title and correct feedback being wrong. I skipped ahead!


comment:
The slide acted weird. I got the grey ones first (LDT) although it told me to load CT/NG first. Double check all of it.


comment:
I still had HPV sitting out there and a mostly empty rack when I got the feedback to click continue to see what happens next.


comment:
Why did we add the processing racks separately when we've been grouping?


comment:
The nice job feedback stacked up on top of the original screen direction


comment:
on last answer choice remove comma after module and add a 1 before HIV-1


comment:
Arrow to progress to next slide does not appear on this slide after the narration is complete.


comment:
Can we be consistent with what we are calling this system?  In the introduction we use Clinitek Status Connect.  Earlier in this video we just used Status Connect and now we are using Siemens Status Connect.  If the name has to vary throughout the training course, should we use the full name at the beginning to tie it all together - Siemens Clinitek Status Connect?


comment:
I feel the title should be 'Country Budget Development and Budget Exception Management' or something similar


comment:
Title should be changed to 'What's the Impact of Protracted Budget Negotiations' or something similar as Impact of what?


comment:
I feel this whole slide needs to be re-worded and I will propose something via e-mail as it not clear currently.


comment:
It is not clear that you need to click the red boxes in order of the algorithm


comment:
The comment re close out site due to "site not requalifying"...may want to consider adding a comment if this change occurred after the site has enrolled patients, the site may need to be close to enrollment and further discussions need to be had with the study team.


comment:
Clarification to the "site not requalifying"...I am referring to added protocol procedures that effect a site participation after enrollment.


comment:
FROM THE THREE STEP PROCESS IT DOES NOT ALLOW YOU TO SELECT A SWIMMER IT GOES DIRECTLY INTO THE 'DEREK' INTERACTION


comment:
WHAT DOES HIGH SCORE MEAN / ARE THE SCENARIO ATTEMPTS NECESSARY


comment:
CHANGE SHADOW TO CO-TRAVELING WITH JANICE


comment:
KEEP LABORATIAN'S EXPRESS THE SAME UNTIL AFTER JANICE'S BUTT IN IS FINISHED


comment:
CHANGE TO...'OK. I'LL LET THEM KNOW WHAT I DID TO REPAIR THE INSTRUMENT.


comment:
I think we should consult Heather as we may want to include that all lab supplies are included in the cost of the labs.


comment:
CHANGE NEED TO PROVIDE...YOU NEED TO PROVIDE MINIMAL  DETAILS TO MAKE THEM HAPPY AND LET THEM KNOW ITS WORKING AGAIN.


comment:
IS DERRICK PERPETUALLY MAD...HE LOOKS THAT WAY. HE DOES NOT APPEAR RECEPTIVE TO THE CUSTOMER


comment:
IS IT THE AFTERNOON OR EARLIER IN THE WEEK? CONFLICTING TEXT BOXES.


comment:
DERRICK IS STILL IN THE CAR...DRIVING OR PARKED


comment:
CONTINUE DOES NOT GO TO SCENARIO GOES TO THE CONVERSATION JANICE GOES THROUGH THE SCENARIO OVER


comment:
THE BUBBLE TEXT IS MISSING SECOND TIME AROUND AFTER FAIL (#3)


comment:
FEEDBACK CAN COACH SWANSON GIVE US A VISUAL...THUMBS UP OR THUMBS DOWN


comment:
INSTEAD OF 'HOW SHOULD YOU START THE DISCUSSION' CHANGE TO 'WHAT WOULD YOU SAY NEXT'


comment:
ARE WE USING A  BLUETOOTH CELL ON THE COACH OR IS HE TELEPATHIC


comment:
ALL RESPONSES ARE IN THE CORRECT ORDER, IS THERE ANY WAY TO RANDOMIZE


comment:
Would prefer a screenshot here of the programmer NOT in DEMO mode


comment:
Why does the "HP SEC" button not take the user to QualityDocs?


comment:
The link to HP SEC is not working.
This is the correct link:  https://lilly-qualitydocs.veevavault.com/ui/#doc_info/3132/


comment:
Should we use the complete process button instead of the magnifying glass to be consistent?


comment:
Last screen says to click update pump to complete settings once you have scrolled through the summary.  Update pump is not highlighted to know to click on it.


comment:
Take out the "to" in the study manager should to consult


comment:
In last sentence of determine need for R & R strategy, I would change will be to should be.


comment:
I think the voice narration is ok, no need to change at this point....BUT I would remove the text across the bottom that says, "Veeva Vault System" and just start with "QualityDocs"


comment:
1st sentence, 2nd paragraph reads oddly: say "He confirms that the new investigator has Phase 1 experience and met Good Clinical Practice (GCP) training requirements.?


comment:
Instead of saying the study manager documents the decision - I would say the study manager SHOULD - this is not a red step but a blue one


comment:
1st sentence:
... appropriate information to recommend and approva a site.


comment:
Finalize trial branding text - should say, if is decided that.....  this shows the decision point above


comment:
under Review sponsor-generated Translated R  R content - would start text with - if it determined that a translated version will be reviewed....


comment:
For the text of the approval step, should we can out that the master content is stored in the TMF as we did in other parts of the training.


comment:
The whole sub-process of modify country is not shown or described.  I think that the sub-process should be shown and walked through like in previous part of the training or at least some more text in the box explaining the whole lower level process.


comment:
The title doesn't match the voice over.  Should both milestones be in the title?


comment:
Course title to be changed to Manage Site Information Overview per BPO request. Can VO be changed as well?


comment:
Horisontal red-highlighted box is not clear because "Trial-Level ICFs" were not defined earlier in the course... They should either be defined, or Milestones need to be modified as: 
- eConsent Components Established
- TCED and Trial-level Addendum ICFs/Assents Created 
- TCED and Trial-level Addendum ICFs/Assents Quality Reviewed
- TCED and Trial-level Addendum ICFs/Assents Approved


comment:
I believe the voice over stated that if eConsent is not being used, the user can go to the next step in the process.  If eConsent is being used, they would still go to the next step...they would complete both paths.


comment:
Regarding the red activity, create trial-level Addendum ICF....make the description match the activity it should be Create Trial-Level Addendum Informed Consent Form


comment:
Ensure consistency within the descriptions: do you want to use trial-level informed consent documents or TCED or TCED, trial-level assent and/or trial-level addendum informed consent form?  It is different in each of the activities with a description.


comment:
regarding approval activity, I would just say all versions vs. initial and revised versions...


comment:
what's the point of this slide?  Does the content differ in the next slides depending upon which role you select?


comment:
Decision on what documents are needed can't be reached...do you mean can't be located?


comment:
Second bullet on left side of screen.  I would say instructions for countries or instructions for affiliates vs. country affiliates.


comment:
I would change Alzheimer's to Psoriasis or Oncology trial as tissue samples are rarely collected for Alzheimer's


comment:
I would change the role of the person writing the email to an Affiliate like "I am an Affiliate based in Germany."


comment:
Last answer, please change to regulatory authorities or ERBs


comment:
where it shows that the response is correct, you don't need to define ICF again.


comment:
is there a way to show the source and TCED side by side?


comment:
in response, you capitalized study schedule...I would make lowercase.  Check capitalization for consistency across training


comment:
The correct answer needs to be rephrased for clarity, for example: "The source document includes blood vloumes in teaspoons and mL, but the TCED includes incorrect units of measure for the selected data set."


comment:
I would clarify the MUGA risk langauge adding a sentence about the use of a radioactive tracer like "During the MUGA test, a small amount of radioactive tracer is injected into a vein to image the heart. The radiation exposure from this test is considered small and is not likely to adversely affect you or your disease. However, ..."


comment:
Signature Elite is branded as Hemochron (R) 
Not Siemens


comment:
Replace Siemens with proper company name; confirm with Marketing


comment:
Throughout the captivate screens, the following product names must be removed.

cobas b 121
OMNI 1-9
OMNILINK
OMNI C
OPTI CCA
Reflotron
BAY800


comment:
I chose XS Plus for ID setup.  In this piece it discussed the ability to use the barcode scanner to read the patient ID.  This device does not have a barcode.  All references to XS Plus and barcode need to be removed with ID setup and QC setup.


comment:
For CoaguChek XS Plus and XS Pro, STAT testing is not allowed.  This must always be disabled.


comment:
Barcode device setup option should only be available for Coag XS Pro, and not for Coag XS Plus


comment:
Marketing should confirm the name of the support group...I believe it is CoaguChek Technical Services (and not Customer Care)


comment:
State the full product name for the Device Setup buttons.  CoaguChek XS Plus instead of Plus.  CoaguChek XS Pro instead of Pro


comment:
Must remove the Stat Test configuration.  This cannot be enabled for both the CoaguChek XS Plus and XS Pro devices.


comment:
Barcode screen should only apply to Coag XS Pro.  This should be a separate component.


comment:
In the first sentence instead of saying their external pump needs to be replace we should say their central venous catheter needs to be replaced with a ...


comment:
Other training has the user hitting "enter" after typing into a field.  This one does not.  If the user continues to hit "enter" in this module an error occurs and does not always allow the user to go back and enter the information in the correct field.  I suggest to let the user hit "enter" after each typed field for consistency


comment:
The following products must be removed from the configuration and user exercise screens:

cobas b 101
i-Stat CDS
cobas b 121
cobas h 232
ABX Micros CRP
OMNI 1-9
OMNI C
Bio Triage
Hemochron Signature +
BAY800


comment:
the course title is not right in the VO. The script must have been off.


comment:
in the process map, the small box should pop up and expand when you are talking about it so that it is readable.


comment:
you and matt won't be super happy, but in your process maps (on screen) and in the PDfs, your text is getting cut off. He needs to repull and make sure he's resized the text to all show on screen.


comment:
Under 'Current Infections' can we change the wording to say 'Implantation of the system in the presence of known or suspected infections, bacteremia, or sepsis requiring antibiotics places the patient at an increased risk'


comment:
Lilly is super inconsistent whether to add a dash between trial-specific or country-specific for that matter. I think you're gramatically correct so let's leave it. but i won't be suprised if we have to defend that decision at beta. Fingers crossed! :)


comment:
Is it a problem to go with higher patient weights here as that will more closely mirror the patients that are being seen (maybe 65kg-90kg)?


comment:
even this - the box text isn't all showing up.


comment:
Add hyphen between site-generated in screen title to be consistent


comment:
Your VO audio is not right based on what you changed in the course. The focus of this course is not the whole process, but just that little part. This needs to get updated.


comment:
be sure and update headers on pop-ups to match full titles of boxes once matt sends you new images


comment:
you've got to have more detailed descriptions of what these boxes are. Go to the "docs" section in blueworks to see what you can put there. Just rewriting the title isn't going to be enough.


comment:
in first sentence, i know the sme wrote trial-level, but to be consistent with the course, change to trial-specific


comment:
In the other modules the moderator mentions all the red boxed items.  Should that happen here?  Not a biggie just a comment


comment:
in first sentence, uncapitalize all of that stuff. Also have an extra period


comment:
We need to put the actual link in the review the guide button.


comment:
in box - it's not trial particiapnts, it's study particapants (in both places)


comment:
this VO and on screen text is not the same as i've seen in other betas. please confirm you are using the most up to date template page.


comment:
PF feeback tool isn't working on next two screens. Please test.


comment:
for set-up screen - course title is wrong in the footer


comment:
for video screen - next button should be visable the whole time


comment:
instructional text is not in the right font


comment:
in participants pop-up, change last sentence to: Visit Blueworks Live for specific job titles that may perform each of these roles.


comment:
on line 9 of the spreadsheet, we said: On process map screen, add note to roles box that the site evaluator is ultimately responsible for the site selection decision.

This didn't get done, I don't think?


comment:
Site manager should have been changed to site evaluator


comment:
Should the second bullet point state, "the patient will be transitioned from the temporary external line to the implanted pump"  so no confusion with the line.


comment:
The second bullet might be confusing that the programmer is what transitions the patient from the temporary line to the implanted pump.  A manual stop/disconnect of the temporary line is required, is it clear in the bullet?


comment:
Please remove "It is important to note..."Sentence.  We are launching the driver for the CLINITEK Status next month.


comment:
Please note as with all of the presentations these are options and the user can modify to meet their hospital and regulatory needs.


comment:
Earlier in the training we stated that the total the # of operators the instrument could receive is 700.  In configuration we tell the users to set it to 630.  Please add a comment as to why.   "The max no of operators are set below the actual maximum to ensure we do cause communication failure with the instrument."


comment:
For QC Level Name Mapping,  Be sure to state that the Name Mapping has to match what is entered in the instrument for the 3 QC levels.


comment:
Are the settings we are providing in the elearning required for the device, recommendations, or just selections we are using for this demo?  I'm not sure that is clear.


comment:
The text explains other options but there isn't time to read the additional text and it is not called out in the script.


comment:
Here again, there is additional text in the box regarding security but there isn't time to read this and it is not called out in the script.


comment:
Entering information for the test is only valid if the customer has a Learning Management System connected.  This needs to made clear.


comment:
Why did one of the selection topics show up in red while the rest stayed as black font when they were being discussed?


comment:
OTS is not supported for this instrument.  this must be removed for the video.


comment:
Can we align the text with the verbiage?  We use the term "meter" in the verbiage but "instrument" in the text.


comment:
OTS can stay as long as we add a comment that it is only supported with POC Mobile


comment:
Main menu isn't set up correctly to change colors once a screen has been clicked.


comment:
Participants pop-up - should be "Medicines"


comment:
In 8000 the cobas logo is on the right and the Roche is on the left.


comment:
These screens need to be set up so that if you get it wrong twice, you get the right answer.


comment:
Change Analytical Unit to Analytical unit in the box.


comment:
i dont know how or why i know this but i left this page up for a while, did something else, came back, and the top 2 red bars disappeared. just check your timeline


comment:
Change Reagent Syringes to Reagent syringes in the Behind the Front Doors pop up window.


comment:
you can remove the purple glow here. only needed on first instance.


comment:
In the Sample Area pop up window move the info box for Sample Cleaner 1 for S2 CTS Probe up so that it does not interfere with the text below the image.


comment:
so nitpicky....but can you move the popup for the CBSO to the right a little bit more? it's really close to the person


comment:
In the Reaction Disk Area change Reaction Cell Cover to Reaction cell cover.


comment:
your submit button is doing that rounded thing again. make sure it's consistent on the hover


comment:
In the Reaction Disk Area pop up window, change Reaction Cell Cover and ultrasonic mixers to Reaction cell cover and ultrasonic mixers.


comment:
"click each red highlighted box" ... add "red"


comment:
add a hard return between paragraphs in the "obtain approvals and acknowledgments" popup


comment:
i think we need play/pause/replay buttons here


comment:
Add a period after each bullet. Some bullets have a period and some do not. Need to make consistent.


comment:
move click next instructions to be below your checkmarks


comment:
the hovers for buttons 2 and 3 are off. reuse button 1


comment:
Phone number is incorrect for Support.

1-800-526-2272


comment:
make your glow on selected a little more obvious. id go with purple


comment:
again check font on buttons in feedback popups


comment:
bold "button" in your click the next button


comment:
Check the bullets. The top one is a different size.


comment:
Wrong Support Phone Number.  Accu-Chek doesn't support this driver.  They must call 1-800-526-2272


comment:
I noticed that my browser tab says this is the cobas 8000


comment:
I wonder if we should say Clinical Pharmacology trials throughout the training vs. CLIn Pharm?


comment:
you already defined ICF on previous slides so you probably don't need to do that here again.


comment:
I had created a transition slide here; don't need to add a slide at this point, but we at least need transition text (in speech bubble): "I hope to learn about each phase soon but for now, let's check out the equipment used for each phase. 
The pre-analytical phase begins when a specimen is sent to the lab. Do any of these items look familiar?"


comment:
Additional comment - YES, let's create transition screen with the intro text from my slide 31, plus a speech bubble with the text in my other comment. Thanks!


comment:
suggested re-wording: to confirm that he or she wants to participate in the clinical trial vs. wants to be a part of


comment:
Suggested re-wording: Includes different information depending on the geography of the site, ethics review board, and ....


comment:
There is a word missing on the second sentence of the "Understand Changes & Determine Required actions Pop up "Based on the type of ? he or she....."


comment:
Need to bold key terms in the rollovers - they are bolded in the ppt slides, but a little hard to see.


comment:
at the trial, country, and/or site level vs. or....


comment:
Click each person to learn why you might need an addendum ICF or assent


comment:
trial-level, country-level and site-level vs. trial level, country level and site level....need to be consistent throughout training


comment:
Procedures that aren't required at the trial-level will need to be included in an addendum ICF...

countries or sites require certain procedures to be included in a separate ICF or addendum ICF...


comment:
The name of the process is Finalize and Manage Informed Consent Content


comment:
In the assess impact of changes and determine consenting needs, please spell out informed consent vs. IC.


comment:
Suggested re-wording: These individuals are responsible for the activities within the Finalize and Manage....


comment:
In the 2 major milestones, ICF Decisions Made vs. Informed Consent Decisions Made and Informed Consent Content Finalized vs. ICFs Finalized....regardless, I am not sure you need this box because they are self explanatory.


comment:
Suggested re-wording: Trial-Level consent documents are developed, reviewed, approved and distributed.


comment:
Same as previous screen, extend targets to include both label and image.


comment:
BOLD "Hover over an item" in instructional text.


comment:
Suggested re-wording: When a trial will be held at multiple sites within a country, master informed consent documents are usually created.


comment:
I don't think it works to have speech bubble disappear when you roll over an item, because most of the time I never end up seeing it. Please add "Okay" button or something to her speech bubble to dismiss it.


comment:
Master informed consent documents are created, reviewed, approved.  Ensure consistency with language on this activity along with the trial level and site level activities.


comment:
Edit instructional text: "Hover over an item to learn about it." BOLD "Hover...item"


comment:
This screen isn't as critical to dismiss her speech bubble, but please be consistent with other screens.


comment:
Need consistency in the training, use master informed consent.  Also, master includes: "Lilly, TPO and Ethics" Informed Consent per the map....why are you not referencing this activity?


comment:
Need to be consistent throughout the training with use of informed consent vs. consent


comment:
Move period outside parenthesis: (USBs can be inserted and removed ONLY when the analyzer is in Stand By).


comment:
gather trial-level consent source documents


comment:
Please edit the incorrect feedbacks (In all questions, as needed) - "Sorry, that's not correct. Please try again."


comment:
The C is missing in omplete the following training with your group.


comment:
The Study Manager decides that master informed consents are needed.


comment:
Would you mind terribly to put an icon of the book cover instead of the pdf icon? Just thought of that, I think I like that better.


comment:
Here you used TPO but referred to Clinical Research organization earlier in the training.  Please use TPO throughout the training.


comment:
The Study Manager (e.g. CPA) creates the trial-level informed consent documents, and the site manager creates the master and/or site-level informed consent documents.


comment:
Add bullet to last pop-up. "Monitoring of long-term blood glucose control". Narration is missing from this scene (see approved script). Please add back "Hemoglobin A1c determinations are useful for monitoring long-term blood glucose control in individuals with diabetes mellitus." This statement is after "... developing diabetes." and before "I guess it's a good thing..."


comment:
This question has the wrong answer marked as correct - right answer SHOULD be study of fungi


comment:
Please edit correct/incorrect feedbacks to reflect that Mycology is study of fungi


comment:
suggested re-wording: Several roles generally review a Clinical Pharmacology ICF.  
The Operations Manager reviews for protocol-specific content.

Also, I think you had the acronym CP in a previous slide, you should define there vs. here.


comment:
It's Finalize and Manage Informed Consent Content vs. Finalize and Manage Informed Consent.


comment:
Consistency again with use of Informed Consent vs. Consent...


comment:
addendum ICF vs. addendum - please change throughout training


comment:
Suggested re-wording: 
Informed consent documents have been drafted.

The review begins once the ICF developer provides complete drafts of the following: 

Use addendum ICF vs. addendum


comment:
Suggested re-wording: After all requested changes from the quality review have been completed.


comment:
Answer options all have different rollover states - 1 has nothing, 2 bounces (and goes appears differently) and 3 the radio button highlights


comment:
Change "Sample Cup" in 1st popup to "Standard Cup".


comment:
Ensure consistency....ICF or informed consents?  Choose one and be consistent throughout


comment:
I know we talked about this previously - after user defines a term, it should not be able to be selected again


comment:
In Ass Screening....." Pop up should enquires be inquires ?


comment:
Edit incorrect feedback: "Hey are you new here? All of these statements are true, please try again."


comment:
I am not sure how helpful the exercise is....I would prefer that we focus on roles maybe vs. when they do certain tasks.  That seems pretty basic


comment:
Add to question: "Select all that apply."


comment:
Replace pdf icon with book image, and edit instructional text: "Click here to download the chapter 1 study notes."


comment:
Add to text "standard cup, micro cup" in place of "cup"


comment:
Suggested re-wording: That's right!  Note that these are the roles that review the ICFs; however, other roles may review the ICF as well.


comment:
Edit instructional text: "Congratulations! You've completed this course. Click any room to revisit a section, or click exit to end the course."


comment:
Add "Micro Cups" as a correct answer in the popups and in the actual response.


comment:
TPO should have been defined earlier in the training vs. at this slide


comment:
Add continue button below book that takes them back to the menu page.


comment:
Suggested re-wording: Provide Necessary Source Documents.  

We rely on our partners to provide complete and correct ICFs, but they can't do that if they don't have access to up-to-date source documentation.


comment:
Change "Acidic washing solution to prime reagents..." to "Acidic washing solution used during the reagent prime..."


comment:
Suggested re-wording: Even though Clinical Pharmacology isn't directly responsible for developing the ICF, we still need to review to ensure the ICF meets all compliance and Lilly requirements.

Lilly must approve the ICF before it is submitted to the ERB. If the ERB requests changes, Lilly must approve those as well.


comment:
Agree with SV  but where did Dr Thompson come into play? I think it should just be "new PI"


comment:
Should this be study manager?

As the Study Manager, I ensure the TPO has the information and source documents they need to complete their tasks.  I provide the source documents, such as the protocol and risk profile, to the TPO so they can draft the ICFs.


comment:
TPO (e.g. Covance)

As your partner, providing good, solid ICF drafts for review and approval is key to staying on track with the timeline.
Remove the hyphen between "agreed" and "upon".


comment:
The whole trial would only be paused if there was only one site.  I would say "the site moves ahead with the trial"


comment:
Change to "First, the tray containing the samples is loaded onto the Sampler unit."


comment:
On the red button "The trial is delayed at the site until....."


comment:
Could the length of the new video be extended a few seconds so that the learner can see the rack pass back by the barcode reader the second time?


comment:
Can we tweak the first question: Are there sites in multiple countries?


comment:
when you use sites, you don't have to say trial sites, sites is appropriate.


comment:
Change to "If the sample is in an open sample cup or tube, it goes to the S1 probe..."


comment:
Voice over says protocol amendments are added....it's more like protocol amendments occur.


comment:
Suggested re-wording: ....so you can help ensure that the compliance and Lilly requirements are met.


comment:
The process is Finalize and Manage Informed Consent Content process.


comment:
At the end of the information in the popups for the Video Library, Simulator, Learning Checkpoints and Flashcards add (located in Roche Diagnostics University) after the period.


comment:
Add "receive and" between "will" and "use"


comment:
Question says a Couple... there is only one answer with 2 options.


comment:
I would suggest to say:
The aggregate of  ALL countries enrollment projections... (just to make sure is clear that the number defined in the protocol is not a country level, but Trial level)


comment:
Actually I probably would suggest to change the definition saying something like the County projection should represent the particular allocation number given to the country (which is the aggregate of all sites projections) and the sum of all countries is the number defined in the protocol of Study Participants to enroll.


comment:
Watch the use of Practice vs. Activity on these activity tables. You may not care if they are different, but do they mean different things? Also, I'd capitalize practice.


comment:
The activity instructions don't make sense to me. 1 says distribute so they can practice and then 2 says if possible have them practice. I'd change 2.  To say Have them practice... If they aren't able to practice themselves, demonstrate for them.


comment:
I'm pretty sure this is a regular bullet and the ones below it stay subbullets:

Explain that if the System Status is Rack Supply End or Rack Collect End, initiate the run as follows:


comment:
Make sure all objectives end with a period


comment:
Capitalize P in Pipe for consistency: Explain that the Daily pipe may be performed


comment:
This should be a regular bullet and not a sub bullet: Explain that if the needle is not in the yellow area, contact the Customer Support Center for assistance.


comment:
This bullet should be a regular bullet and not a sub bullet: Explain that the Daily Hands-on Maintenance section of the Operator Notebook has the directions for cleaning the probes and cell rinse nozzles.

I'm not sure about the one below it but I think Close should be bolded and it should be a regular bullet.


comment:
Make this a regular bullet: Explain that participants should ensure that the green indicator lights on the sampler unit are lit before loading trays onto the analyzer.


comment:
I would do title caps for all activity table titles: Performing Daily Maintenance Pipe with Wash Rack (24 hour)


comment:
In this line and in the first learning objective, I think Daily Pipe should be capitalized for consistency: Processing of the green wash rack at the Daily Pipe both need to be performed daily.


comment:
This should not be a sub bullet: Explain that if the Refresh button of the History window is highlighted, then choose the button.


comment:
This should be a regular bullet: Explain that if the Refresh button of the History window is highlighted, then choose the button.


comment:
Add a period at end of this sentence: Select the global Start button to display the Start Conditions screen.


comment:
In Jump back to section Subtopics for Dialy Checklist is spelled wrong


comment:
Subtopics for Dialy Checklists is misspelled.


comment:
There was no sound on the start page. Typically courses that use sound include it consistently from the start to end.


comment:
A course overview page is needed to inform the user what the objectives of this course are in short, point form summary.
There is too much information on this slide for an overview.


comment:
The 'Menu' option should probably not be made available on page 3 or 4. Otherwise it is confusing as how to proceed forward, is it by clicking the 'next' button or going through each of the sections in the menu in order to complete the course.


comment:
Please include sound on all slides, along with the option to read the transcript on all slides.


comment:
"Sharepoint/CP library" - can we name the exact library to go to? Is it Clinical Pharmacology ICFs? (SMEs)


comment:
Add the following in the Roche Diagnostics University section after the first paragraph. The document is posted on basecamp.
"Share this document with the learner which contains important facts about using the RDU tools."


comment:
Update time to 3 hours for Self-Paced Learning in RDU.


comment:
change to "The logs are accessible from the Instrument and Setting tabs respectively."


comment:
Make the first bullet point an Activity with the "What do you think caused each of the following error messages?" and pictures in the table. 
Note: I'll add the text to the Activity Table but you'll need to put the images in it.


comment:
Menu- Resources icon - Site Selection Guidebook link needs to be updated to:

http://lillynetcollaboration.global.lilly.com/sites/DCOEHub6/onboarding/SiteSelection/SitePages/Site%20Selection%20Guidebook%20Home.aspx


comment:
Audio will need to be updated to match new process approach (since it's pretty general, could just remove "click the red highlighted boxes" and I think the rest of the audio could still work.


comment:
remove process map screen shot and replace with new higher level process summary approach per earlier discussion.


comment:
if you show participants, there is a new role "Trial Planner" added with additional steps to follow (see July 2017 process for changes)


comment:
Forgot to add - we think we can still include one screenshot to "see the whole process", since it is just one screen that would need to be replaced. This may make sense to just show on the last screen of the process overview (vs. every page)


comment:
Can we be consistent in what we call this system?  In the previous page we used the full name (Siemens Signature Elite System).  Here we only use Signature Elite and in the next slide we use Signature Elite System.  We may not want to use the entire name throughout but after the first time, let's pick one way and use that throughout.


comment:
We usually use ERB instead of IRB. Are these templates called "IRB"?


comment:
Same comment as before on the CP library


comment:
Replace trial participants with study participants


comment:
Should the question be "Do these changes need to be approved again"?


comment:
Should the slide header be re-titled to "Gather & Prepare Trial-specific Informed Consent Elements Process" as that is the actual process map name?


comment:
Because we don't mention re-consent in all three options, I would remove it from the 1st bullet (answer option)


comment:
Can we say in the correct feedback, what risk information is missing?


comment:
Ignore my comment - I just saw that that is the next question


comment:
The next button doesn't let me exit the course


comment:
Link to R&R Strategy Guidebook is incorrect.  I couldn't find the correct link, unless this is linking to the Required tool?

Also, we can't link to process maps as these links could change frequently.


comment:
Assess screening/enrollment pop-up box. This is a blue activity, so more suggested than required. IWRS is not always turned off, even in the same situations. It can also be site manager determined as well as study manager determined, so I would recommend the following changes. 
1st para: "The site manager and study manager determine...."
2nd para: "Examples of when enrollment would be stopped are"...
3rd para: "In any situation, the site and study manager need to evaluate the potential impact on active study participants, as well as the impact if the study/site is still open to new enrollment. IWRS may need to be disabled, depending on the circumstances."


comment:
Agree with SV comment, but might propose following language: "Re-evaluation of site, specific to changes, occurs to verify the site is still qualified to conduct the trial. This should be documented in the appropriate system location and/or form specific to the change and trial type."


comment:
Qualify site pop-up: Recommend "If the changes are found to be in accordance with all applicable requirements (regulatory, ERB, or sponsor), the site is..."


comment:
The start of the voice over in the broken down process screens is very jumpy/abrupt. Not sure if it can be smoother on entry/start-up.


comment:
"Procced" pop-up:
Recommend "Site Manager(s)"...multiple site managers would likely take on those activities, not just the person doing the selecting.


comment:
Lowercase column to be consistent with rest of the page: starting with the Cause Column


comment:
Add period: White: Calibration is valid.


comment:
Delete the comma after reagent resides in


comment:
unbold explain: Explain that Span should not


comment:
Why is requesting not capitalized in the title? I'd say it should be unless there is a specific reason.


comment:
add how to: Demonstrate how to monitor QC and explain how to:


comment:
Rewrite last bullet under first bullet to say: View the Waiting time in the status line if the quality control is processing.


comment:
Take out the extra and: Manual and and review


comment:
I think these should be subullets although the script doesn't say so: 
Ordered(O): Sample has been requested or registered but not pipetted or an open order exists.
Processing(P): System is currently processing the sample.
Complete(no symbol): Sample successfully processed.
Incomplete(I): Sample processed, but a data alarm is present.
Sent to Host(H): Sample results have been sent to the host.


comment:
The information required activity seems a bit odd. They are more informal assessment questions and would fit better there unless there is a strong reason for them to be an activity instead.


comment:
Change to: Micro cups (part #11229290001), which is the original micro cup


comment:
remove duplicate word part: (part part # 11229290001 is to be used)


comment:
Add periods to your objectives to stay consistent


comment:
Add a period: View additional options through the options menu.


comment:
Add a period: Search for a sample ID provided by your instructor.


comment:
Agree with CDH - there are two spots for rewording here. top level info "With trial enrollment paused, the site..." in the first paragraph. Then in the pop-up box, "...the trial moves forward at the site"


comment:
Add colon and periods:
Explain the differences between different types of maintenance:
Manual maintenance.
Automatic maintenance actions and checks.


comment:
Confirm SV comment and should add "study participant safety could be put at risk"


comment:
These are all the same PI change process for the same site, right? Why has the image of the PI changed now? Why not continue with the same image of the doctor from the first screen?


comment:
Activity title: Putting the Analyzer to Sleep with Wash Rack (NON-24 hour operation)


comment:
Delete extra space after sample cups:
Green wash rack
Sample Cleaner 1
Sample cups


comment:
Protocol Change - I don't like the point that we have to physically go to the site for an equipment change. We don't necessarily, it depends on the situation. I would recommend "Lilly must verify that the site has the necessary equipment and can continue participation in the trial."


comment:
Change first sentence of the note to: Facilities that put the analyzer to sleep at the end of the day can have the Daily Pipe performed as a Wake Up Pipe when the system wakes up.


comment:
I would delete step 1 from the activity table. The  demonstration happened earlier in the page. Right now it is just repeated.


comment:
Location Change - If JUST a certain function location is changing, then all information about the site doesn't need to be updated, just the applicable functional location, so I think that statement is invalid. I would recommend, "When a location changes, all information applicable to the new location must be updated and confirmed as still qualifying"


comment:
Same comment as above, suggest removing the first instruction in activity


comment:
add comma: Demonstrate every 3 months, every 6 months, and As-Needed maintenance.


comment:
I would recommend swapping the location of PI Change and Addition of a Satellite Location. Make the Satellite Location last on the list.


comment:
Take the period off: Replace the photometer lamp


comment:
if you too step 1 off the maintenance activity table for the others, remove it here too.


comment:
Put alarm screen exercise after this bullet: Caution: Caution level alarm. System operation can continue. This alarm is yellow.


comment:
I am struggling with the Addition of a Satellite Location piece as changes...I get that it is, but it isn't part of the Change Process documentation path, so it really is a different process and it doesn't alter the ability of the main site to continue in the trial...if keeping here, I would recommend changing the pop-up to the following (or something like it):
"The addition of a satellite site can actually provide positive outcomes if the additional location can help the site with enrollment. If a satellite location is identified after the time of initial site selection, further site evaluation of the extra location(s) must be performed. This is done with a full satellite location evaluation and typical "change" processes, such as notifying all relevant functions (IP, Labs, vendors, etc) must happen.


comment:
Add comma: share the alarm, cause, and remedy


comment:
Take off the A: AThe difference between the first and second measurement (absorbance) of a calibrator is greater than the duplicate limit absorbance values.


comment:
Add a period: The system used an expired reagent for the measurement of a specific sample.


comment:
Similar to the other activity comments, decide if you want your activity to repeat in instruction you gave them above the table. In this case I would just list the case study links above and then go straight to the activity table. Delete the text bullet that says Print the appropriate case studies....


comment:
Information Required is strange. I'd call this Finding Key Information Activity.


comment:
can you center the Submit button under the list of items we're asking them to submit?


comment:
Should you make the questions in the activity green like in previous tables?


comment:
On the resources page cobas e-library and cobas link were trademarked and bolded. This follows what was done in 8000, so I'd add them on this page.


comment:
if audio is used here, the audio would need to change - see edits to the transcript.


comment:
Popup of Understande Changes and Determine Required Actions description has changed - if you are using for new process walkthrough, note that the "Determine Required Actions" process step has been split between the Study Manager (for Site changes) and the Trial Planner (for trial-level changes, e.g. the protocol).  This is the key change that requires retraining for the course.  Have also added notes to the audio about this.


comment:
note also the process starts have changed


comment:
the "proceed as needed" popup text has changed:  last bullet should be "Obtain and Manage Regulatory/Ethics Approvals.  Also add 2 additional bullets for Manage Impact Data, and Request Account Changes. (descriptions are in BWL)


comment:
per Laura and Nancy:  Add to description, information about satellite locations from the activity description:   

For new satellite locations, an evaluation will be conducted using the ISEC or HP SEC form.

A change in an existing satellite location, the evaluation will be conducted using the appropriate change form.

Also a new decision and blue process step was added, Are there follow up items?  The if yes, Log Follow Up Items  (If aver completing the re-evaluation, there are follow up items, the site manager will need to log the follow up items in Trialforce


comment:
This screen needs to be updated per the screen for the "proceed as needed" steps that were added/revised.


comment:
...as identified by the Trial Planner (remove Study Manager).


comment:
add comma after course in bottom paragraph


comment:
am checking with Sophie and Laura whether this screen/audio needs to be updated.  I am meeting with Laura about this next Tuesday.


comment:
Site Selection Guidebook link has changed to:  http://lillynetcollaboration.global.lilly.com/sites/DCOEHub6/onboarding/SiteSelection/SitePages/Site%20Selection%20Guidebook%20Home.aspx


comment:
Requestor - add comma after consultant in third bullet


comment:
Requestor - also remove comma after and in third bullet


comment:
Add period at the end of the objective. Brand cobas in objective


comment:
when they become clickable, could we make the icons glow softly? something to make them stand out a bit.


comment:
This line should not have a bullet and should be a part of the line above it: (can redownload the current lot no.)


comment:
line one, in-person should be hyphenated


comment:
The certificate says 8000 and still has the 8000 training topics


comment:
bullet 3, add "public" before perceptions


comment:
If including Satellite Location addition in this overview, think the Selecting/Activating Sites Process map/procedure should also be linked here.


comment:
Move Maintenance practice activity after this bullet: Clean the surfaces of the analyzer.


comment:
Move first activity up to after these bullets: Complete the Print Range section of the Print dialog box.
Select the OK button.


comment:
Unbold and add True or False: The analyzer needs to be in Stand By to send results.


comment:
lowercase c: cleaning the reaction cell covers


comment:
For RDU Tool update text to:  RDU icon notifies facilitator of the RDU tool learners should access to reinforce the material covered.


comment:
Title of section should be "Configure Calibrator and QC"


comment:
Title of last section should be "Configure Calibrator and QC"


comment:
Text is still cut off on process map and in the pop-out of the process map


comment:
extra period after "process" in the participants popup


comment:
extra space after "IRB." and next sentence


comment:
body text box shortens when you go to "click next" instructions


comment:
please check "practice a review" module header font


comment:
just a callout -- do we want the click next insturcitons on screen?


comment:
be sure to update resources on each slide master... depending on which one it is linking to, it will show that resources page.


comment:
On each of these "Main Menu" slides it is confusing where you have been and which one to click next.  I suggest using something visually stronger to identify this.  Either grey out or a lighter purple where you have been, or have the glowing/pulsing color around the next one to select be a different color or a stronger purple. Just brainstorming ideas, feel free to pick something that is appropriate, I just think what is there now is too subtle.


comment:
Is there a collective term we could for COPM and ClinPharm Study Manager? Rather than specific titles?


comment:
Why are we using "major" and "significant" study requirement? Is it really about how major or significant the change or is about the impact on the continued qualification of the site. This may be misleading.  Suggest removing these qualifiers.


comment:
Change "study" to "trial"
Make sure this change is made throughout, as appropriate.  We are keeping the terminology of Study Participant, Study Manager, and Study Team.  I think all other instances should change to "trial."


comment:
I don't know if this impacts other screens or not.
I noticed we are introducing the term "competent authority" here. Was there rationale for this? In both BWL and the QS Docs we are using "regulatory authorities/ERBs"


comment:
I am not comfortable with the second bullet.  It should be: Select and Manage Sites procedure in QualityDocs
FYI: QualityDocs is branded as one word by Veeva with no spaces


comment:
Blueworks Live is lowercase "w" and uppercase "L"
I don't know if this impacts other screens.


comment:
work stream is a project term and is temporary associated with the initial implementation.  I think we should pick a term that is longer lasting. I think it should be: Engage Sites & Study Participants PROCESS


comment:
In the manage site overview course someone commented that they didn't like the sloppy appearance of the person pictured as the site manager.  If you change to a new person there, I recommend you do that here as well to be consistent


comment:
When you click on the "What" for Enrollment Manager, the text looks like it is coming from the "Who" column. This is confusing and should be corrected.


comment:
I made this same comment on the manage site information training course.  I would grey-out where we have already been on these slides.


comment:
HP trails - abbreviation "HP" could makes confusion in people with less experience.


comment:
Diagram is very difficult to read on laptop screen. Letters are to small.


comment:
For consistency with terminology, please use hyphens for the following:
trial-level
site-level
country-level


comment:
Is there a reason why the associated procedure isn't mentioned?  Unless there is a reason I'm not aware of, please add a bullet for:
Recruit and Retain Study Participants procedure in QualityDocs.


comment:
Work stream is a temporary term associated with the implementation of this project, I would suggest changing to Process.


comment:
within each case study there aren't back and next buttons.  not critical, but would be nice.


comment:
The reference to the procedure is missing.  Unless there is a reason why it is not being listed, please add a bullet for:
Recruit and Retain Study Participants procedure in QualityDocs


comment:
Should there be something here that indicates that there is audio going on?  If people have their audio typically disabled, they would not know that something's happening.

Or maybe text at the bottom as she's talking?


comment:
I hear some man's voice in the background from time to time


comment:
When the "special book" is first introduced, the yellow splash sign around the book looks a little "cheesy" for lack of a better word.


comment:
Still a lot of clicking to close the windows...


comment:
Never mind, I see now you can click from one to another.  Thank you!


comment:
This is great!  Can we have the description for biosafety cabinet as a hover over on this page, rather than on the next page?


comment:
Recommended Reinforcement Activities add second bullet:

Find the coverslipper status by looking under the Instrument tab.


comment:
Under "Point to the CareGiver icon (if applicable) and explain:" remove the second sub-bullet.
Add a note.
Note: The software is not intended for patient data assessment or diagnosis, therapy, or treatment decisions. CAREGIVER remote support does not collect or transmit any personal healthcare information (PHI).


comment:
Add a second bullet & edit third bullet under "Review basic recovery procedures:"
Look inside the blue door and check to see if a tray is in the Transportation System fork. (sub-Sub-bullet)If a tray is seen, it must be removed manually, so, proceed to describing Recovery procedure. (2nd sub-sub-bullet) If no tray is seen, proceed with the auto recovery in the next step.

Once the shutdown sequence has completed tap Start Up. The instrument will perform an auto recover protocol to send all trays to the portal for recovery.


comment:
Demonstrate the Tray Recovery Procedure (only the one in the Transportation System fork) with assistance from the learners.


comment:
Toolkit/Event Logs interaction:
This interaction still seems strange to me. Perhaps we could change it a bit. Here's an idea.
-Start a new paragraph with "The Alarm Test sub-screen is automatically displayed when you select the Toolkit/Event Logs screen tab."
- Next paragraph: "The Alarm Test sub-screen is accessed to test alarms and illustrate the volume and tone to the patient."
- Update the directive "Click the Next button below to review the Pump Off sub-screen."
- Change the text on the red button to "Next".
PUMP OFF:
- delete the 1st paragraph when the Pump Off screen is displayed (incorrect info, says Alarm Test is shown).
- Update verbiage to "The Pump Off sub-screen is used to stop the pump permanently." add space and then 2nd sentence. "The use of this sub-tab is not recommended with the Implantable System for Remodulin."
-Update directive "Click the Next button below to review the Event Log sub-screen."
EVENT LOG:
- delete the 1st paragraph when the Event Log screen is displayed (incorrect info, says Alarm Test is shown).
- Update verbiage to "The Event Log sub-screen is used to view event logs."
- Update directive "Click > to continue" or something similar. Doesn't make sense to click X and then have to click > to continue. Confusing.


comment:
CBSO rep: move comma from after and to after approver


comment:
change "will review and will approve" to "reviews and approves"


comment:
Pre-work, submit consulting agreement request - third line, remove comma after request; sixth line: change "is only overseeing" to "only oversees"


comment:
Should we also say that a satellite location can also be used to store and distribute things needed for the clinical trial (ex:  CT-Materials).  I was just thinking that sometimes there are satellite locations where study participants are not necessarily seen


comment:
change "have been asked" and "has been asked" to "are asked" and "is asked"


comment:
Same feedback as previous screen - or other critical activities related to the study are conducted here (such as storage and distribution of IP)


comment:
change "has been asked" to "is asked"; change "The consultant has asked" to "The consultant then asks"


comment:
For the trial team supply management, we need to ensure that the material is transported, handled, and stored properly.  I think the sentence there is vague


comment:
take out biosafety cabinet from here (and it shouldn't be included in tools for sample collection)


comment:
Under "Agar plate" start "Media can be selective" in a new paragraph to break up the text.

Also the categorizations "tools for sample collection" and "tools for culture make this page look a little cluttered.  Can we put these above the tools instead of below or find some alternative to make the page look cleaner?


comment:
One way to de-clutter the page may be to get rid of the reddish boxes.  When you scroll over the tool, you get the  name of the tool in the popup anyway.


comment:
The image for inoculation loop is too blurry.  Maybe use another image?


comment:
In previous feedback, I had requested to take out the blood containers in the graphic


comment:
Grow and analyze need to be switched in order.  Also please refer to the original document to see what goes under grow and what goes under analyze, because it's different from what's here.


comment:
Thank you for taking a stab at the language on this after shortening, but the language is inaccurate.

Screening - Screening results answer whether or not a patient is colonized with a multi-drug resistant organism (MDRO).

Diagnostic -  Diagnostic results answer what is causing an infection.


comment:
These products are not in the training anymore.  

Can we add back the microtiter plate under "analyze organisms" in the analytic phase and replace the thermal cycler with TSI?


comment:
I feel like this needs to come before tools


comment:
I can't hear any sound in spite of audio button in the screen.


comment:
In the "Qualify Site text box" I would remove the 2nd part of the sentence as the documentation is part of the previous step in the process - delete "and uses the ISEC form to document the qualification."


comment:
Ignore my comments. Re-looking at it it is ok.


comment:
1st sentence - change to "automatically qualified"?


comment:
Site Evaluator term. Delete "The CDL/CDC or RRM is a site manager." Then change the next sentence to start with "This role qualifies and selects sites....".


comment:
I'd like to add some more definition around SPI than just spelling out the abbreviation. Can we add "This is a TranCellerate form and is intended to capture site capabilities during site qualification."? (to confirm with SMEs)


comment:
Qualification Term:
- Remove CDL, and state Site Evaluator
Reword to "The Site Evaluator determines and documents that the site meets all study requirements and is qualified to participate in the trial.? To confirm with SMEs


comment:
Typo: The Site Evaluator uses TrialForce...


comment:
SMEs, is the wording between brackets under Site profile information correct? Should the word "prior" be replaced by "for"?


comment:
For SMEs: do we need to specify who reviews and approves the HP-SEC?


comment:
We'll need to review with the revised HP-SEC if this screenshot is still correct


comment:
The HP-SEC still looks cut-off when opening


comment:
At top says click each red highlighted box for more information but in that slide there is no red boxes.


comment:
Audio- examples mentioned PI name change but not PI Change. Suggest to mention PI Change instead since is more common than PI name change, or to mention both.


comment:
Box 3, questions is only partially bold.


comment:
After clicking all red highlighted boxes, it goes to Required Actions Determined, if you click "see the whole process" or "back" it goes back to the whole process map but there is no "Next" button and red boxes appear again. Do the training stop here? Only way I found to go out was clicking "Back". Can the training have a "Next" that takes you to the Menu instead (if this is where the training it's suppose to go)?


comment:
I meant to ask you for this before, but forgot. For this section, can we find room somewhere to put 2 buttons so that learners can bring up a full version of the ISEC and SPI?


comment:
When you click on "Menu" there are some images. When you hover over them they should mention what's about ex. "Resources", 'Home"


comment:
In red option state that this could cause the site not to be ready for first study participant visit but PI Changes process occur after site has been selected and usually after site is ready to enroll so FPV has occurred. Suggest : The site may not be ready to continue enrolling patients


comment:
Assess the change- "While assessing the change, site manager performed"- or perform?-"...to determine..."


comment:
Agree with SV about removing "we save money..."- could also add: We ensure PI oversight and continued patient safety assessing the change".


comment:
Not sure if it was just an internet connection thing or not, but the video was very choppy for me. I couldn't get through even one of the "boxes" explanation without it hanging it.


comment:
I think we need to always make a statement that the Site Evaluator is also a Site Manager (in the Participants pop-up in this case)...without that, the learner will likely always think they are totally separate people.


comment:
Is this not covering HP trials as well? I thought that the HP world would still have an additional "site selector" - am I misremembering that?


comment:
Milestone box - "Preparation for site evaluation completed" sounds odd. Are these prewritten in the Process? I think "Prepare for site evaluation, Evaluate Site and Select Site" seem better than the "completed" versions of themselves.


comment:
First statement should be changed. Suggest to remove" site assures the site manager the new PI will be ready in 2 weeks"- time frame is out of control of the site as depend on regulatory aspects as well, as ERB approval of PI etc. Suggest wording as for ex.: "After assessing the change and determine what actions are required, the site manager conducts additional site evaluation for the new PI."


comment:
Typo in Prepare For and Conduct blue box pop-up. "...kicks OFF site selection..."


comment:
Obtain Confidentiality Box Pop-Up - change printed to written.


comment:
As a solo item, I didn't know what the "Provide Relevant Trial Specific Info" box was speaking about. It needs to say "...provides relevant trial-specific information TO THE SITE(S)..."


comment:
If PI understand the study, "meet requirements" (remove SEC) and is approved by "competent authority"- use another term for competent authority, -is approved by ERB -or-  receives regulatory approval?


comment:
Conduct Site Eval Pop-Up: What do others think - is there another place to point the trainee to in order to determine if they should do live vs. phone? What is in here is true, but specifically for sites that are active in our trials or recently closed one. A live visit is REQUIRED for any sites we haven't chosen internally and who isn't active in one of our trials. That doesn't come through here, so I am wondering if we should make it more general, or point them to a specific place for criteria on when a phone visit could be acceptable over a live visit.


comment:
Reason for Site Not Recommended - this is quite general. Does this mean provide the reason in our internal systems (we do that through the Stage of the Trial Site and the second level drop down box) or does it mean tell the site they aren't going to be put forward/selected? Or does it mean both (my presumption is it means both)? If it means both, should it say "If a site is not recommended, the site evaluator provides a reason why and notifies the site of the decision"


comment:
Reword- the trial is delayed until all reg. information is updated"- the trial not necessarily will de delayed at trial level. Maybe use: "the trial at the site might be/or will be delayed if site does not submit required regulatory information on a timely manner"


comment:
On this step of completing change activities, these tasks are done by the regulatory role ( as site manager) , how can we differentiate on the training? This might be confusing especially as the woman image is the same as previous slide where tasks are done by CDC/CDL. At least a note should be added under "Complete change activities" for ex. "Please note that site manager here refer to several roles depending on the activity".


comment:
Notify box - add a statement of "Ensure any sites not selected or set as back-up sites are notified of their status." (or something like this to point out the fact that we notify all the sites we evaluated, not just the ones selected).


comment:
Assuring the health and Safety"...(add safety)


comment:
Pop-Up: change 2nd sentence to "As I gain more experience, I see the negative consequences to the patient and customer who can't get medicines they need if trials have poor sites chosen and don't complete in a high-quality and timely fashion."


comment:
3rd bullet, shouldn't setup be "set-up" or "set up"?


comment:
To address SV comments: 
No, we should not reference the Transcelerate form, since ours has pieces of that, but is actually Lilly specific and the Transcelerate piece is variable for the future. We could say "Site Profile Information - A form containing site specific information which is not study specific. Must be reviewed at the time of each site evaluation." (or something of the like). 
Regarding the Site Evaluator term - recent organizational change makes this easier in that we are all CDCs, not 3 labels. I think the definition of that could be "The CDC [or "This role", if others want the name removed] is a site manager who has responsibility to evaluate and select sites. This role is crucial to ensure only appropriately qualified sites are selected. The Site Evaluator also plays a key role in documentation of the site information and qualification throughout the Site Selection process and beyond."
Fine with SV comment on Qualification Term.


comment:
Agree with EB about physically inspect the equipment. Some SECs are phone evaluations, each situation would be different. Important would be to ensure they have required equipment as per study requirements.


comment:
Let's not relegate them to just ISEC creators. How about "One of my most important tasks during site selection is..."


comment:
Does anyone else think it sounds like the COM is responsible for all the countries the way the last paragraph is worded? I think "I am accountable for ensuring my country/region achieves timely..."


comment:
3rd row - I might recommend, Trialforce is used throughout all site selection and management processes, including during site visits.


comment:
Location Change- Good to add-
When a location changes, it's important to ensure the new location meet requirements.


comment:
SV Comment Response - The SPI info is correct because it is labeled as prior to SITE SELECTION. If it referred to QUALIFYING a site, then it would be "for".


comment:
In the selecting sites overview we also address Trialforce documentation on this screen and then as a section in the overview. Shouldn't we be doing that here? Even if just to highlight that the changes need to be maintained, it might be through updating general information in Trialforce or through the Change form for the majority of the later highlighted areas, or through a Satellite Location ISEC for addition of Satellite sites. Just feel like it is unbalanced compared to the Site Selection overview to not include it here as well, even if it is brief.


comment:
Satellite Location- not sure about wording on "competent authority"- if IP location change I don't thing this is submitted to IRB? or is this is country specific? I think important point is addition of satellite location require an evaluation.


comment:
Study Coordinator should be shanged to "Site Manager"


comment:
The country-specific ICF template also contains the same information for inclusion in the ICF...  it is just global/general/non trial specifc.  Should the language align better?


comment:
The TCED is used with the country specific ICF templates to create the master ICF


comment:
maybe add "Click the Next button to continue" instructions at the end


comment:
"The CBSO rep reviews..." - change will be receiving to will receive


comment:
click the arrow to see the next question is still on the screen after i got to the last one


comment:
click the arrow to see next question still on screen on last one


comment:
Bold "helps us decide what our value proposition needs to be"


comment:
For Strategic Fit change text to "Cummins ability to ...given our own strategy..."

Please adjust highlighted color to be less pink looking.  Maybe use yellow since used in section with magnifying glass.


comment:
In the examples I would state previously assessed or not previously assessed.


comment:
Change opening text "Knowing the account goals and initiatives will help you..."

Apply same edits from the manager training to this section (ex. don't highlight financials as missing, fill in metrics tab, etc.)


comment:
Use country level instead of country specific to refer to the master ICFs


comment:
Option 1 should say that the participants will require re-consent.


comment:
This is actually for page 6.  I would remove the informed consent line.  Its superfluous.  thanks.


comment:
Please update text to be:

To access configuration . . . go to the Instruments > Configuration screen.


comment:
Will the demo include demonstrating how to copy a certificate?


comment:
Please remove the version number in the text reference to the training guide to avoid creating additional work in the future.


comment:
Please double check and make sure all settings include "In this example" We observed the first two settings have the text and subsequent settings do not.


comment:
Please ensure all references to training guides do not include version number


comment:
Please update text to be:
Configure the device to follow you organization's . . . 

missing apostrophe


comment:
Please ensure "In this example" is used for all settings. Some settings are missing this verbiage


comment:
The only decision the customer needs to make for CoaguChek should be related to the barcode scanner. There additional decision points do not benefit the customer or help the user experience.


comment:
even on a big screen, the text is too small to read on the process flow. If you enlarge it then you do not get the red boxes and cannot review them


comment:
in the graphic on the bottom of the animation, it needs to be Request for Proposal (no s on proposal)


comment:
update the transcript on all pages to remove "S" from Proposals (we won't fix the audio, but we'll fix the text)


comment:
update last sentence to "Sue is a Transmission Planning Engineer on his staff; ..."


comment:
This organisation does not exist in EU (nor I think other regions outside of the US) I think that we need to reference the role that handles contract negotiation in the affiliates or this could cause confusion


comment:
Study coordinator is normally a site role - do we mean site manager?


comment:
Request for Proposal in Ron's box, last line (no s)


comment:
Are quality expected to be involved in routine site close outs?


comment:
Please update text for New Code checkbox to be:

Check the New Code checkbox if your organization requires an external QC for each new code chip. Otherwise, please un-check the New Code checkbox.


comment:
Please update textbox to be:

"Leave Firmware Update Event Texts as is"


comment:
The Server setup demo continues after the temporary audio ends. What' up?


comment:
Please check spelling of the word acquired in closed captioning . . we think it is misspelled.


comment:
In Captivate for creating an operator, the demo, audio closed captioning shows to the customer "Click on the Is Observer" checkbox

This is a serious, incorrect demo.


comment:
We cannot verify narration using the closed captioning script since it is blank.


comment:
reports popup - cobas IT 1000 application. Application mising


comment:
seems to be missing the big "If you are creating a configuration for the first time..." audio


comment:
Move 'NEXT' in 'DETERMINE NEXT STEPS' to same line as "STEPS' to alleviate padding.


comment:
I'm worried about the purple, since it is very close in hue to the red.


comment:
Bold headings

In some of the screens, the learning agent has parts cut off the screen (i.e. the elbow in this slide).


comment:
KNOW THE GOAL is the only button in all caps. Also, will all buttons be glowing? Maybe make this a hover-only feature. It could be eye taxing to have all of them glowing at one time.


comment:
I can make buttons for these if I know where you want them placed. We might be able to make them little tabs that stick out from the top left.


comment:
Ignore the last comment, since I see the point now, however, when entering the last section "Determine Next Steps" and 'Evaluate The Process" are both glowing.


comment:
Agree with the comments from MVT and SV; in addition, recommend shifting the 'Is trial-level addendum ICF and/or assent needed?' to study manager vs site manager.


comment:
Recommend removal of 'Communication to the study participants begins' under the 'Distribute Trial-Level Consent' box; quite a few additional steps prior to participant receipt; therefore, a confusing location for such language.


comment:
Spell out MDROs to Multi-Drug Resistant Organisms as that has not been mentioned yet


comment:
change all instances of "lab assistant" to "lab technologist" or the like.


comment:
For the course title at the bottom please use the full one (Evaluating a Site: Diagnostic Services, Facilities, and Equipment) throughout the course.


comment:
For the bad examples, put Bad Example 1, 2, 3 etc over top of the information on the left hand side, just so they're clear that it isn't real info that we intend to use.


comment:
Rearrange order: Grow = Incubator, culture; Analyze = Microscope, TSI slants, MS, Vitek 2


comment:
When you hit the Next button on the wrap up slide it closes the course. If anything I think it should take you to the Splash or menu. But we could also just remove it from here since there is no next slide. Whichever is easiest.


comment:
The instrument is called the Hemochron Signature Elite


comment:
Actually the instrument name is Hemochron Signature Elite. The Vendor is not Siemens


comment:
Second Bullet- Setting the instrument date and time match the cobas IT 1000 server date and time.

Third Bullet- Flagging of results with manually entered Operator ID, Patient ID, Cuvette Lot, and/or QC Lot.


comment:
The audio says 5 areas to configure. The screen shows 5 areas to configure, the closed captioning said 4 areas to configure.


comment:
Please remove reference to training guide versions.


comment:
For Date/Time setting it prevents on meter editing. The script says it prevents anyone from changing it, but it only limits on-meter editing


comment:
Please always state these are example settings. Especially since this is a non-Roche instrument we cannot tell someone else how to configure it, but we can tell them the options.


comment:
Can you please remove the favorites toolbar from the video?


comment:
OTS is not suppported on the meter for this meter.  It can only be reviewed and approved with POC Mobile.  The video has to updated or removed all together.


comment:
The Certification Name was already populated before the video showed it being typed. Then the user didnt check near the Non-expiring checkbox and it checked.


comment:
These are also examples. Please state that


comment:
Thank you for reorganizing the layout of this screen, but the left hand menu was never updated to match. Customers will have to scroll up and down to find their spot.


comment:
Please replace Siemens with "your manufacturer's"


comment:
Please add the following collab site link with the text:  Enrollment Data Accuracy and Consistency collab site

http://lillynetcollaboration.global.lilly.com/sites/EDAC/SitePages/Home.aspx

Please add two more resources on this page: Enrollment Guidance Document and Training Materials-Entering Event Dates and Enrollment Breakdowns in IMPACT (use same link as above)


comment:
OTS is not supported unless the customer uses POC Mobile


comment:
The outline boxes for the videos look weird. Is there anyway to clean this up and make it look more professional


comment:
Customers can get help with the driver at 1-800-526-2272.  Which is the Roche Customer Support Center.


comment:
whether a site may continue finding success does not make sense as you don't "find" success.  Either take that out or clarify what that means.


comment:
The site evaluators is not just for Clinpharm trials.  Remove this.


comment:
The script is wrong.  The study manager section about they must assess to puase enrollment is not the case any more.  The script should say that the site manager must determine required actions one of which could be working with the study manager to assess screening/enrollment continuation and active study participant care


comment:
I thought the "click here" would link to the Process overview video? (optional click)


comment:
I think the script says the study manager must determine the required actions.  it is the site manager.


comment:
Call out box - add to the end of the sentence, "Reviewing and Approving Trial-specific site-generated content are required tasks in this process."


comment:
The assess text needs worked on. First, i would say that the site manager may determine a required action is to reach out to the study manager to assess screening/enrollemnt conitunation and active study participant care to determine if either or both should be paused.  Second, another examplew would be if the primary site location is moving.  Last, I would take out that last paragraph as it doesn't even really make sense.


comment:
The notify parties is the site manager and arrows come in from two places so it isn't about just updating a system. It is about communicating to all the internal parties that need to know about the change and the actions that need to be taken.


comment:
Qualify site box - if the changes have been assessed and it is determined that the site is still qualified to run the trial, then...


comment:
Closeout site:  Change to if the site was determined to no longer be qualified to conduct the trial


comment:
Trigger:  would put site location change to be clearer


comment:
I would add a label for the ID sites... process when you bring up the map, just to reinforce the specific map name.


comment:
check with ryan how he wants to proceed, but we have gone through with alpha without the play/pause/replay buttons before. however, by beta, those will need to be on every screen with audio


comment:
The curriculum page/menu shows that the user is past the video, but then the video is included here. May need to adjust this somehow


comment:
For updates internal systems.  I would say in script:  This activity includes updating internal systems (i.e. IMPACT, Trialforce, IWRS, Trifecta, INFORM, etc.) with the changed information. This can include de-activation and activation of site personnel accounts.


comment:
IN the script around documents I would say:   Depending on the change, the required documents are collected or provided to the site.  This could include such things as a new CV, 1572 and updated protocol, etc.


comment:
proceed as needed: change to clinical trial agreement


comment:
So why does the voice over not say, the change may also require various site activation activities to occur such as and say them.  Should also say these processes should be followed.


comment:
This step should be determine next steps box not document necessary change information


comment:
Take out ISEC requirements and says meets qualification requirements


comment:
This whole section needs re-worked.  Needs to say works with site activation processes to determine what things need done.  The re-enabling IVRS does not need to be mentioned here.


comment:
last sentence in paragraph, should read "...advertising content generated by sites that is specific to Lilly's clinical research."  We don't look at all the advertising, only what they are saying about our trials.


comment:
last paragraph, study is spelled incorrectly


comment:
last paragraph - study is spelled incorrectly


comment:
I clicked all 3 purple circles and didn't get the "next" button to appear.


comment:
Comment #2 - spell out IP  as Investigational Product


comment:
Change script for second box to say, "Revoking access removes the users certificate and takes away access to all ISO applications. This is typically done when the user no longer works for your company."


comment:
Change wording in third box to: "Endorsed users work for another company, and have access to your companys data."


comment:
Change wording in fourth box to: "As the UAA, you determine what access an endorsed user has to your data."


comment:
Change last sentence to read, "UAAs can add or remove endorsed user access to your companys data, but their primary access and certificate are managed by their own organization and cannot be changed."


comment:
Would change location change wording to say site location change.  I would also change to say or just where a certain part of the site moves such as the pharmay.


comment:
For satellite location - I never have heard that competent authorities need to know the shipping address.  I think it should say that what is being performed at the new satellite location must be understood and assessed to ensure they meet the requirements to ensure that the site is still qualified.


comment:
For PI change text, the last sentence.  The PI must be qualified (not competent)


comment:
Change definition of Endorsed user to: Employed by another company and has access to your companys data


comment:
Add the following sentence to the rollover text re: the AIM User Guide: This document contains step-by-step instructions on how to complete tasks within AIM.


comment:
The hover text that appears for Endorsed Users without Access should read:
Displays a list of all endorsed users from other organizations who are waiting to be granted access to your organizations data.


comment:
I notice that I've been using "company" and "organization" interchangeably throughout this CBT. (Sorry about that.) Please ensure that we just use "organization" for the sake of continuity.


comment:
Add a sentence to the hover description for Authorized Contracts that says:
For example, this screen shows that the UAA is authorized to provision access as a scheduling coordinator.


comment:
When you hover over Associated Applications, please add an orange box to appear over Authorized Contracts (like you set up to show the relationship between Authorized Entity and Entity: TRAINING)


comment:
"Endorsed" should be lowercase in last bullet


comment:
Change "Before someone" to "Before a person"


comment:
Small edit to text on screen re: Account Type:
Last line of popup should read:
EXTERNALS_SYSTEM is used for a system account.


comment:
The images/screenshots of AIM seem to have faint horizontal and vertical lines all throughout the CBT. I'm not sure what is causing this but it's quite distracting. Wondering if this can be cleaned up?


comment:
Please add some text on the screen that goes along with the options the UAA has to register for the certificate themselves or FWD to the end user for them to do the registration.


comment:
Let's call it the "pencil icon" instead of the "edit icon" to keep things consistent from the AIM user guide to the CBT.


comment:
When explaining the various ways to select users for the access request, please add highlight boxes that appear over the Add or Add All buttons that are in sync with the narrated script. Please also add highlight boxes over the list of users that simulates selecting a block of users or selecting a non-continuous set of users.


comment:
Change script to say, "This tab shows me a list of applications and roles available. I can select multiple applications at the same time using the Control + click and Shift + click methods. I'm going to give the users access to CIDI using the settlements dispute role, which is indicated by the SDS acronym shown on the screen. I'm also adding access to CMRI using the external read-only role. And finally, I will grant access to WebOMS using the external read-write role. I'll press Control and click on each one in the list. My applications are selected, so now I'll click Add."


comment:
This simulation plays as one combined event and it may become confusing for the user to keep track of what we've done and what still needs to be done. Please add some visual markers to indicate progress. Perhaps a floating task list that appears once each item is complete and shows a check mark in front of what we just did and what still needs to be done. Something like 1) Create user, 2) submit access request, 3) view access request.


comment:
I am not sure how to re-word but I don't like the verbiage, recognize why it is important to manage changes well - will it be clear to the learn what type of changes or changes to what?


comment:
Describe how to manage common changes- again not fond of the use common as that implies there are uncommon or out of the ordinary changes that need to also be managed?


comment:
We may want to say manage and document changes well to Erin's point of incorporating the need to pull in the responsibility of updating systems or meeting documentation requirements (whether internal or regulatory driven)


comment:
There was no sound; site and trial changes affect whether a site may be able to continue or be a good fit for a clinical trial; the verbiage of not finding success doesn't make sense


comment:
I like this new approach with the sales rep. Should we introduce the concept of bacteriology here or have her concerned about her lack of knowledge about the bacteriology side of microbiology?


comment:
Can we have the ability to pause during this audio section?


comment:
Again the verbiage isn't flowing. Here's an idea:  By managing site changes promptly we can reconfirm sites continue to meet regulatory requriements, qualify for participation in the clinical trial and minimize delays.


comment:
Seems like the tense changes here. She talks about her dream in the past tense (I had a dream...) but then she talks about the book will be most helpful. Just seems like she was talking about the dream and then when she talks about the book, it becomes present tense.


comment:
maybe the first point should be "provides information to support a clinical diagnosis"? Get Mike L and Beth's opinion


comment:
It isn't obvious how to move to the next question. I tried hitting the dots. Maybe I am slow. It took me a while to see the X.


comment:
For screening bullet point, should we also mention the benefit is to prevent spread  of drug-resistant bacteria from colonized to uncolonized patients?


comment:
To do this we must:
Assess all changes and determine required actions
Notify the appropriate individuals/functions 
Perform the required evaluations 
Make the necessary updates


comment:
Most MALDI-Tof testing is performed on a pure isolate so they need to still culture the sample but some labs (especially in Europe) are using a protocol to test directly from blood culture and urine.


comment:
Beth or Mike - Correct me if I am wrong, but isn't most gram staining done on either blood culture or a raw respiratory sample? Is it common to do it on an isolate? Since we will be talking a lot about the gram stain on a positive blood culture for Bolt, I think it will be confusing to talk about gram staining an isolate even if it is done occasionally.


comment:
Just to be consistent with the testing process, I think this answer should be reworded to mention ID first and then determining whether a drug will work


comment:
I meant to say, "reordered" instead of reworded.


comment:
This slide is hard to figure out what you want the end user to do; at first I thought my computer was on zoom because nothing was showing then I need to adjust and missed what the narrator was saying; the wording doesn't flow & I think a word is missing in the understand changes & determine required action:   Based on the type of change (missing word) he or she will determine next steps.  For example a PI name change due to marriage or divorce will require different action and notification than a site location change.


comment:
notify appropriate parties: don't know that the use of impact is applicable vs just saying, depending on the type of change


comment:
I suggest we not only mention a PI or Site location change as examples as there are well known we should add to the list to include CT material location change; site process change i.e. changing to EMR as source


comment:
For the definition in the pdf, Susceptibility Testing is testing  to assess the activity of an antimicrobial agent against an identified pathogen to assist the clinician in the selection of the appropriate antimicrobial therapy


comment:
I do not like the way the slides are with the scrolling and not being able to see things properly


comment:
Not sure if there is supposed to be any voice but there wasn't;


comment:
Need to update label on exec summary "Our Account Competitors" to 
Account Competitors/Market Share/Status


comment:
Only show possible answers once the computer is clicked to see the text.


comment:
Change possible answers to:

- File the email away for future reference
- Forward the email to your team and update the account plan to reflect the new contact (Correct)
- Make note to mention to the team in the future

[Open to suggestions on the wrong or right answers]


comment:
Do not show answers until cell phone is clicked.


comment:
Remove "well now" in opening of sentence.


comment:
Gray out account plan tabs of ones already visited


comment:
Change text to correct and wrong answers to focus on learning about the customer's needs and gaining insights replacing "answer all their questions".


comment:
Change instruction text to "Do you want to share information from this page with the customer?"

Change answer button text to - 
Yes, share information
No, don't share this information


comment:
Edit response to "....Let's discuss the customer measures that show your performance on what is most important to me."


comment:
Do no qualify for that definition?  What definition?  Should it read "which locations do not qualify for a satellite location"


comment:
Do we need - "This will be indicated in Trialforce"


comment:
Is it the CRA that determines if monitoring needs to occur?


comment:
Dedicated inventory of what??  Specify inventory of what


comment:
This will be determine within the study team - should it read - this will be determined by the study team?


comment:
The CDC needs to document what study supplies need to be shipped to the satellite location to ensure that the satellite location receives the appropriate study supplies.   Should we state where to document?


comment:
It wasnt clear to me if I chose what was expected.  For instance, the metrics page where it detailed Gross Margin  I wasnt sure by his reaction in the course material if I chose what was supposed to be selected.


comment:
Could we find a better picture of a PI - this PI does not look very professional.


comment:
I suggest adding trial sites or investigator sites as well as lilly and pts.


comment:
in alignment with SV and other comments: we ensured the new investigator met the trial requirments and continued study participant safety by having continued PI oversight- or something along those lines


comment:
Not sure the comment about achieving FPV is relevant to the scenario provided therefore it doesn't make sense- if the site has active patients then we are addressing continued PI qualification, oversight and safety if FPV hasn't occured yet then the later is NA and we should discuss how not getting the change in timely affected the site's ability to enroll their first patient


comment:
Help me understand what approved by a competent authority means???? and I would change the end of the sentance to say soemthing like:  the site can begin to enroll patients again and move forward with trial participation; the trial moves forward doesn't flow & seem worded properly as the trial is continuing just maybe not at the site- I can see how it could be interperted differently around the globe


comment:
"efficient study participant enrollment" isn't exactly what this is referring to, it is about reviewing AD type content to RECRUIT patients. I would recommend this read "Effective study participant recruitment at a site depends on..."


comment:
Doing a thorough review is necessary but the result isn't speed, it is quality recruitment materials that meet Lilly and regulatory requirements...


comment:
Pop-up box-shouldn't there be a highlight that it is not only stored appropriately, but the site is notified of the approval?


comment:
unless we are including obtains approvals of the PI change working with different roles for the HP PI change form this doesn't make sense and will confuse everyone- the site manager doesn't obtain approals of the PI change working with different roles the site manager after the evaluation determines, based on teh study criteria if the PI is qualified.


comment:
I HIGHLY recommend using a different image for the Site Manager here than for the Site Selection/Management modules. If someone takes all of these courses, there may be a lack of clarity between the Site Evaluator (also a site Manager) responsible for site selection and the other Site Manager types (e.g. SAMs).


comment:
Clinical Accuracy does not mean the same thing as Protocol Accuracy. I think it might make more sense to say "I review all materials to make sure all information is in line with the protocol." (or something like that). Then refer to clinical accuracy later in the follow-up comment, as currently written. Just a suggestion.


comment:
The # 1 reason we need to manage changes is to ensure the site remains qualified to continue in the trial; don't agree that optimizing Lilly's resources has anything to do with managing site changes and you can check with the SMEs but I don't think it strengthens our relationship with a site- it really keeps us in compliance


comment:
I tried to open the Review Guide and it took me to a "Document Not Found" Page in the QualityDocs. Not sure if it is a global problem or if for some reason access is restricted? If access is restricted, I would have to question that with the document owners...


comment:
I agree with EB I get it is a change if a site now adds a satellite location but I think it will be confusing as people may think a change form is used for this and it will be a satellite ISEC


comment:
I don't love the statement that ads will make the "enrollment go quickly" - I think you can reference the aid to enrollment, but would recommend saying "will help recruit subjects for the trial" or something like that.


comment:
Just to be clear, I got the "your actions delayed this by a week screen" - was that because I missed an item on the "choose what needs to be fixed" situation or is this a default response for all answers?


comment:
"after making the modifications shown below..." No modifications are shown on the screen, just a notice that revision is needed. Can't reference it if you don't show it, or provide a click-able item to show the "should have been" result.


comment:
I tried this again the next time around with all the correct answers and I still got the "you delayed" message - that isn't correct. The process has back and forth to it, it isn't a Site Manager delay if they have to require changes before submission. Only if they MISS something should it say they caused a delay.


comment:
To revise LAL comment:  I think it will be confusing if we use pharmacy as an example as a site location change because of how we have changes outlined in the change form- to be consistant we have a site location change as 1 type of change being that is a full site change and CT Material Location Change as another type of change as it is 1 aspect of a site requiring a partial assessment vs. the full site evaluation change assessment.  I suggest we don't lump them together otherwise it will be confusing.


comment:
Adding to my last comment maybe we say a location change could be a site moving to a new address or the storage of CT material changing within the same building- run it by LRL- I am afraid to use pharmacy since many sites don't have pharmacies but if others think that is clear that's fine.


comment:
first reason should be something that address not being in compliance- I don't believe a result of not doing this well would be site closures?  I would verify with others what should be included.  Also I don't think we need the last sentance


comment:
Should we state the International Conference on Harmonization Good Clinical Practices (ICH GCP)?


comment:
Second paragraph, 1st sentence: Suggested re-word "The TCED sets global expectations for trial-specific ICF content".


comment:
The master ICF may not always be the version of the ICF that is submitted externally.


comment:
Is the term 'multiple' clear enough? Should we be more specific that it is trials with 2 or more countries?


comment:
In the pop-up for 'Participants', the way that is written reads to me as if the Study Manager and CRP/CRS are both involved in the quality review and both involved in the approval.


comment:
Is there any way to move the picture up so that you see the start of the boxes without scrolling?


comment:
Quality Review: Pop-up box states that once the TCED draft is complete, the Study Manager completes a review of all documents....it's not clear what is meant by all documents.  This feeds into Tera's comment that we should either use the generic term of trial-level ICF(S) or list them out as appropriate, i.e. TCED, trial-level assent, trial-level addendum ICF.


comment:
First red box title states 'Record Version History of Approved'....approved what....


comment:
The title of the approval box when you open the pop-up is missing 'Forms' at the end.


comment:
I agree with Iyabode's comment re: removal of statement about communication to Study Participants at this stage.


comment:
Just to clarify my comment about the Record History box, the title is cut-off in the pop-up, not the red box you see in the picture.


comment:
Can we change quality check to quality review for consistency


comment:
This doesn't include the instruction re: using the zoom button as in the next scenario.


comment:
It's probably just me, but in the protocol excerpt I only see study procedures and in the TCED I only see risks....the next screen indicates that a risk was missing but am not seeing the risks in the protocol excerpt on this slide....?


comment:
PLEASE IGNORE MY COMMENT - it was just me...I read/clicked too quickly....got it now.


comment:
I haven't been through the whole course yet but I think I have only seen the instruction re: using the zoom button once on a later slide...would it be best to have that instruction on the first slide where it is used and remove from later slide?


comment:
We talk about re-consent and site retraining, do we need to mention re-submission of ICFs to reg/ERB as an additional impact?


comment:
This states that this is a good example of a transcription error but the TCED and Risk Profile match...can we use another descriptor as what this is getting at is that the source information may not be correct and should be questioned if any doubts.


comment:
Can we just remove the word Transcription?


comment:
When you click on the middle answer, it says it is incorrect but then the rationale given suggests it is correct as does the next slide.


comment:
This graphic needs to better show where the trainee has already been and where they need to go next.


comment:
The slide button approach here is a little bit awkward, all the rest of the training has used the red highlighted box, might be easier on the trainee to be consistent, but I'll go with majority


comment:
Since the answer to needing a strategy is most often yes. Would it be helpful to provide an example of when it wouldn't? or a list of some things to consider that might make it a no?  thinking about the judgment based decision making here, should we give them some information to help?


comment:
Should we provide a little more content around when to know if country  modifications are needed?


comment:
I love the gates and the clearing the gates in the consecutive slides, it is a great approach, My only feedback is on the slide button itself.  Maybe it would help if the slide bar had three sections.  Like maybe a line that you slide to and then the bar area behind the button turns grey? or maybe divide the bar into three shades of purple so you see where to slide to and then they turn grey.  Just brainstorming.  It just isn't a true slide, you are moving the button to a designated spot, so it might be easier to visually see that?


comment:
If you change the site manager based on other feedback, don't forget to replace across all modules


comment:
I don't know what the guide book is?  Is this something on the CDIO site?  if you are referring to the resource document in the quality system, it is not a guide book and should be corrected here.


comment:
The correct procedure name is:
Recruit and Retain Study Participants

Also, I noticed in some of the training modules you reference the procedure and as well as "...in QualityDocs".  I don't care if you reference QualityDocs or not, but please be consistent.  Either always say "xyz procedure in QualityDocs" or just say "xyz procedure".


comment:
Add "overview" to course title and all the title text at the bottom of each screen.


comment:
shouldn't there be audio here?  The Recruit Study Participants course has recorded audio for the objectives.


comment:
Agree with Jenny's feedback on the slide button, it didn't work easily for me (especially without a mouse).


comment:
also agree with Jenny's feedback on why someone wouldn't need a strategy (like Clinpharm, short trials, small #s of participants (10),etc.


comment:
although we eliminated the 4th gateway on filing, the 4th gate is still showing on the screen, it needs to be removed.


comment:
depending on the result of the feedback from Jenny Peters (JP) regarding the form, you may need to revise the feedback on gateway 2.


comment:
first sentence The sponsor-generated (add trial-specific) R&R content...


comment:
streaking: delete comma in last sentence.


comment:
grow different types of bacteria. Remove run on sentence by adding period afer 'growing'. I can also manipulate...


comment:
Separate text by adding line after the 3rd sentence.


comment:
Main Menu - Creating a Training Session. 1. First bullet should be "Select the role for your audience. Tap Confirm Role. 2. Change audience to role in bullet 2. 3. Remove bullet 3. 4. Move last bullet above the bullet "Select the topic you will be training..."


comment:
Content Layout - Change "information assessment questions" to "informal assessment questions"


comment:
In footer "Analyzer" should be lower case "analyzer".


comment:
Combine Daily Operations workflow and Daily Operations checklist tasks into one topic. The title should be "Work in Your Lab".


comment:
Delete 1st section "Ask participants to demonstrate... and the following 4 bullet points".


comment:
Update the Note. Remove "for their specific configurations"


comment:
Update Objectives to so that the objective from Daily Operations Workflow is the first bullet point. Remove "operations" from 2nd and 3rd bullet.


comment:
Recommended Reinforcement Activities / RDU
-Study Hardware Basics using the flashcards which will help you with the Daily Checklist tasks.
- Complete the Daily Checklist Learning Checkpoints.


comment:
Layout for new combined topic. 1. Objectives from both pages. 2. "Determine which checklist..."(from Daily Operations Workflow). 3. "Explain that the order of the Daily Checklist is intentional..." (from Daily Operations checklist and tasks) 4. Important Note - "Watch carefully as participants..." 5. Keep remaining format.


comment:
Remove important note - the customer will have the hardware labels identified in the activity. Move the Ask the participants to point out section below the Hardware labeling activity and remove all items except bullet points 13 (racks...), 14 (rack tray), 15 (system reagents...), 16, 17 and 19.


comment:
I am not sure i get the "strategic fit" part


comment:
I think the post-it message Need to get information might confuse candidates taking the course. I think it will be great if we are very specific mentioning that the Account Manager / Account Team to fill the information on these two sections as they work on developing account plans for identified key customer accounts.


comment:
For me this section is allot more encompassing now, as gives reasons and idea's as to why each team member is selected! Good


comment:
We would not share Cummins Gross Margin & GM% to the client, so whilst they would like to see this detail, we would not be able to provide it. Perhaps the top half could be greyed out?


comment:
Genset image could be bigger, the image is of our largest set and it looks lost on the page


comment:
Not happy with the last line of the bullet points, Locate Sales ??? do we mean find the sales opportunities? We need to reword


comment:
Agree with EK we need to include the Control panel course in the text box or we need find a different way to show that there are three specific courses for the three key components


comment:
Third bullet should be often not usually, as the other primary reason is to prevent economic loss in the event of a power failure, eg IT firms, shops, restaurants etc


comment:
rewrite last sentence:

Use the Resources tab above to access the reference notes from chapter 1 at any time.


comment:
remove ' how long did you say you've worked here?'.

Replace with something positive or encouraging.


comment:
remove 'say'.

delete: If you stick around for the next chapter.

use the following: You and I make a great team! I look forward to working with you in the next chapter. We will learn exactly what happens at each step of the lab testing process.

replace study notes with reference notes (which is the term used in the previous screen).


comment:
Once you start to hover over the different results, is there a way to access the original text in the green bubble?


comment:
When you click on the menu, can you access each room after you complete the course?


comment:
CDC/CDL and RRM. Will we keep all three position name in the future?


comment:
This slides needs to be redone. With the changes announced to roles, there are shifts in who is responsible for these activities. What is the best way to redo this slide?


comment:
The first sentence needs to be re-worded as the CTPM will be responsible for setting up the criteria as they will be conducting the SEC kick off meetings etc. There will be input from the COPMs. Let's discuss how to update this slide


comment:
I have checked and starting form Feb we will have only one position "CDC" instead of "CDC/CDL" and "RRM".


comment:
Suggested re-wording: you will learn about the responsibilities and process for closing out sites, including both routine and early site closeouts.


comment:
For the "Make Decision to Closeout Activated Site" activity, it should be CRP/CRS and CP, right?


comment:
For "Make Decision to Closeout Activated Site" activity, MQR's to MQR


comment:
Notifying IWRS?  We should notify the function vs. the system or revise to say notify of the need to shut-off IWRS??


comment:
obtain approvals and acknowledgements: In the case of early termination, regulatory authorities, ethics review boards (ERBs) and other required committees....


comment:
there is a role for study coordinator, and it says communicates with the site.  The Study coordinator is a site role.


comment:
I would suggest to remove the word clearly where it says each of them is clearly important to ensure...


comment:
Does it really begin when all study participants complete the trial?  I think you would start closeout once database lock is complete?


comment:
Is quality really involved during routine site closeout?  Or are they more for early terminations?


comment:
the email address says TPO.com..this is a site not a TPO


comment:
Which system are they updating which automatically feeds?


comment:
This example is for routine closeout right?  This sentence makes it appear that the site is closing early since it's one site. Maybe revise to say: She and her team finished meeting about site closeout activities as the trial is coming to a close.


comment:
Suggested re-wording if you revise to site closeout as a result of closing the trial: Who should I notify now that the decision has been made to start the site closeout process?


comment:
Site Monitor vs. Monitor to be consistent with how the role is listed on the previous slide.


comment:
This is an interesting question....you have to go into the Obtain Approvals and Acknowledgements Map...do you want to choose a different question?


comment:
Should this be requesting required documentation from sites vs. submission documents?


comment:
I did not have any difficulty opening and this slide came through clear.  I liked the information captured on this slide and the message


comment:
why is legal not listed as a role early in this course?


comment:
ensure consistency with terminology: early site closeout vs. early terminations, etc.....

study participants vs. patients


comment:
For bullet #3 I am not sure about using enable?  Maybe something like Recognize how  judgment based decision making is used throughout the process or needs to be incorporated throughout the process


comment:
wonder if we should replace drug registrations with drug development since trials occur even after registration?  a qualified site means: greater adherence to conducting clinical trials as per regulations & the protocol which results in valid data that can be used for drug development- I don't see us capturing the importance of adhereing to regulations & the protocol which should result in quality and of course the opposite is true if the site is not qualified or one of quality


comment:
agree with the comment about the site evaluator and manager


comment:
things to consider regarding the first comment:  potential risk is referring to what needs to be added for the site risk assessment aspect and I would be very cautious including anything that "one" deems as business related as the ISEC is not going to be the venue to collect much of this as it isn't required to qualify the site


comment:
For the last red box on providing trial specific information; I suggest repharsing:  for example:  provides sites with trial specific information so to conduct or perform feasibility and site evaluation


comment:
Live vs. virtual visits do not have parameters but best practice guidelines which will be captured within the guidebook.  if we highlight a best practice we should say it is such otherwise CDCs will think it is a requirment; virtual visit best practice pertains to sites who are actively in a Lilly trial not for new to Lilly sites or sites who haven't conduct recent research with Lilly; best practice is determined by that and should also be driven by the protocol- is it more complex which could create its own risk which a CDC would want to perform a live visit vs. virtual; there are also no specifics as to how the site is to be notified if they are not selected- the CDC would document notification via a Trialforce activity


comment:
notification of the sites selected happens via Trialforce notification; the part of this process that is still open for discussion is how our monitoring partners will get notified of those selected; if it remains with the COPM or is performed by another role.


comment:
"You will generally skip translation and eConsent steps for ClinPharm ICFs".
Will probably for ClinPharm using eConsent always be low? If not we may need to rephraze this.


comment:
to Erin's point would revise maybe to be a bit more concise like:  I see the negative consequences to the patient and customer who can't get mediciens they need due to poorly chosen sites as there are a lot of reasons a poor site could have a negative impact therefore suggest not listing since we can't be all inclusive unless we phrase it in such a way the end user knows that


comment:
Is the first sentence missing commas?  It seems like it needs pauses?  Also let's indicate that the list provided is not all inclusive as there are other things that one would consider outside of this list and I don't get that from the training


comment:
SPI- to add on to Erin's comments- because some information in the SPI is required and other informaiton is not we need to capture that variability in the definition- the required aspects must be answered & re-verified with each site selection that there are no changes and the other aspects would be completed as best practice


comment:
Is Trialforce cloud based?  we should verify with Di this definition is accurate if she wasn't already consulted


comment:
for whatever reason I couldn't get all the right answers to stay with the columns they need to in order to proceed


comment:
Form is ISEC- also recommend that one of the blanks is SPI vs. ISEC since ISEC was a blank on the prior slide- want to reinforce the importance of ensuring the SPI information is complete specifically the required areas- see what others think


comment:
To my knowledge the COPM is still responsible for the information captured not sure who can be consulted, maybe John, as to accuracy


comment:
suggest....so site evaluators know what criteria an investigator and site need to meet to be considered for participation


comment:
COMs are accountable for their CDCs selecting the right number of qualified sites to meet the, site selection timelines, country commitment, study requirments and enrollment timelines, with quality.  Not sure why we are mentioning feasibility here?  Shouldn't this be reflected in the map that addresses feasibility?  suggest adding country to allocation; suggest rewording next bullet to reflect ensures site selection is achieved within the required timeframe as established by the Trial Planner; and the last bullet should be revised to reflect the information captured in the beginning of my comment; the COM also provides guidance to the CDC if he/she runs into any barriers in being able to meet the trial site selection objectives


comment:
This slide may need revision depending on what is revised on each of the individual role slides


comment:
aligned with EB comments- the expectation is to document while doing the visit which is why I think it states TF used during visit-like EB revision recommendation; I suggest adding a repositiry for site information which is used by downstream partners or to perfrom downstream activities; need to get across the importance that TF isn't just about selection and not just used by the CDC but by the entire business & partners


comment:
suggest making sure our Trialforce partners are consulted on any TF related information to ensure it doesn't conflict with anything they have or are developing- need to ensure consistant messages


comment:
Either add to the 3rd option on the right or another but need to highlight it is used to document key activities to include any follow up activities that need resolution


comment:
Suggest saying:  It is important to select good sites so that trial timelines are met and the trial is conducted with quality; having quality data is important but again if the site conducts the trial with quality then all that is affiliated with that that site should be quality including data- follow me?  Im open to other's thoughts


comment:
Site selection is important for a lot of reasons not sure highlighting the trial running smoothly is what we want to focus on as a closing point?  We want to select quality sites so that patient safety is maintained, valid data is generated and ....


comment:
The Guide Book is the Select and Manage Sites Guide Book- need to verify with Meri Kay that this name is still appropriate with the recent CDO changes as she said we may not be able to use the term Manage?


comment:
Terms and Consistency check:

We are not using "investigator site" we are just using "site"

I don't know if this applies to more than one screen of this course or more than one course in ES&SP.  Please look across everything and confirm consistency.


comment:
We have used this person as the Site Manager in all the other ES&SP training.
1. People didn't like her messy appearance, so if we pick a different person, be consistent here.
2. If we have used her as the site manager, do we want to use her here as the Site Evaluator? or should we pick a different image?


comment:
It is odd to me that we are using the same terms to define a term.  We use the term quality in the definition of qualification, etc.


comment:
Same comment as previous ES&SP modules:  I would like to see a stronger visual of where we have been and where we need to go next.


comment:
I think this lady/image was used in other ES&SP modules as the study manager.  Is it appropriate to reuse her as the COPM, or should we pick a new person/image?  I really have liked how we have been consistent so far with the images by roles.


comment:
Either on this page in narration or on the next page in text, I'm wondering if we should mention appropriate/recommended actions if they are at the site and Trialforce isn't working, i.e., Collect the information and update Trialforce later.


comment:
RDU activities: change 2nd bullet to "Complete Overview Learning Checkpoints." and add a 3rd bullet "Review the Explore the Analyzer section in the interactive simulator".


comment:
Add "the system" to the end of the first bullet point so that it is "Show the logon screen for the Control Unit. Tell the participants to practice logging on and off the system."


comment:
Change the following bullets to:
1. Describe the purpose of the global buttons (bottom) and when they are accessible:
2. Describe the Menu screen and the tasks performed in each menu:


comment:
Change bullets for - Recommended Reinforcement Activies
-Practice navigating the software in the control unit.
RDU
- Study Software Basics in the flashcards.


comment:
Change note to "The Workflow Guide is customizable to meet the needs of your facility."
Change the bullet under show the workflow guide... to - What the colors indicate


comment:
Please review bullets throughout. Sometimes full sentences have a period and sometimes they do not. Please make consistent throughout.


comment:
RDU activities:
1. Add "Deselect Preventive Action" 
2. Remove "on the analyzer" from bullet 2
3. change bullet 3 to "Print Reagent Load/Unload List."
4. Change bullet 4 to "Print the Reagent Status List."


comment:
Change instances of "reagent load and unload lists" and "Reagent Load/Unload Lists" to "Reagent Load/Unload List".


comment:
Remove "Practice deselecting Preventive Action." since this is added to the simulator tasks. Change "simulator" to "interactive simulator".


comment:
the "e-" appears bold in "e-library". It should not be bold.


comment:
all caps the workstream title in top left


comment:
looks like you have default storyline back/next checked on for some slide


comment:
for course title, we didn't put the workstream title in the footer


comment:
Hard to get the slide button to move. I also don't think this section is needed unless the SMEs do.  We did not do this on the other process overviews.


comment:
I think examples are fine just not sure we need to tie it to gates unless SMEs like it


comment:
The Guidebook link is totally wrong.  Take off.  This links to the site selection sharepoint site.


comment:
LA should probably be cut off at the waist and larger, then have the red bars extend so they come from behind her (no white space)


comment:
should have "Click the Next button to continue." that phrasing to click next should be global


comment:
just calling it out: this LA isn't necessarily in the style as the others. not sure if you plan to revise or if they approved this one.


comment:
buttons can be sentence case. instructions should change for when you need to click the next module. "Click Know the Goal to continue."


comment:
is the brown text a note to the reviewers? if not, there shouldn't be brown behind the text boxes unless you want to use it as a special callout or something within an activity.


comment:
this course is a new workstream. we will need to update colors globally. this should be doable and applied to just about everything in the master/theme. the purple needs to change to the color for this workstream as designated in their initial files.


comment:
ignore my global comment about colors (talked to ryan)


comment:
icons will need to be purple with white icons inside of them


comment:
instructions text always in the darker gray color in the color palette


comment:
for screens with no audio, make sure the Transcript variable gets set to 0 so the CC button doesn't show anything


comment:
i wouldn't bullet any of the question text


comment:
Is there a way to incorporate understanding who the strategic sites (or portfolio sites) are?


comment:
there should be an example in the most recent template file (which you can get the link from the curriculum design and management whiteboard) with the type of slider we have been using


comment:
conduct site evaluation visit is not the place that the trial specific SEC questions are added. it is in the previous step where the site evaluator is the trial planner.


comment:
Concerned how the example with the avocado will translate.


comment:
conduct site evaluation visit is not the place that the trial specific SEC questions are added. it is in the previous step where the site evaluator is the trial planner.  Need to remove the text or show the previous steps.


comment:
For providing reason not recommeded - I would say, after an evaluation is done and it is determined that the site will not be recommended, then the site evalutor.


comment:
In order to complete the site evaluation, need to say that the site evaluator needs to provide the completed evaluation to the CPM advisor who must approve the selection.


comment:
Also serves as the trial planner in that they customize the SEC to contain trial specific questions.


comment:
In a report it would never state "cause of infection" it would say gram stain: GPC in clusters
Identification: Staph aureus
Susceptibility: drug listed with  R, S or I


comment:
Is it really true that we would use an assent for vulnerable populations other than minors?


comment:
Activity Assess Impact of Changes & Determine Consenting Needs- suggested re-word: The CRP/CRS/CP determines the impact of changes to compound and/or trial-level ICF source documents on the ICF(s), whether the ICF(s) need updating and what, if any, consenting guidance to provide.


comment:
Agree with PH- need to be more positive about being excited to learn how we could provide better solutions to our customers
Lab in background does not show plates or hood. need to change what is in the background.


comment:
Activity Gather & Prepare Trial-specific Informed Consent Elements  the pop-up states that the writer develops/distributes the trial-level consent documents  for ClinPharm I think this is only relevant if addenda/assents are needed but Teri can confirm.


comment:
Activities Develop Master Informed Consent and Develop Site Informed Consent -  the pop-ups state that the team develop  which team?


comment:
Could use better definitions. would pictures be possible? some people are visual so could showing a bacteria vs a fungi vs a virus be helpful


comment:
Need to say FHD and Monotherapy Escalating Dose Trials


comment:
Clicked on them all but all did not check.  The more button did not come up


comment:
Pre-analytical plating should occur in the hood however the pictures and examples are not concise or consistent (ie a sterile urine cup is shown they the explanation refers to a swab and preservation of a specimen. A urine specimen is preserved in a boric acid tube if it cant be plated right away.


comment:
WHO:
ICF Developer: 
Suggest to change like Covance to such as Covance
I think CPA stands for Clinical Pharmacology Associate  please verify with Teri that this is the correct role performing this as BWL has Study Manager (Pharmacology)
ICF Reviewer:
Am not sure I understand the statement Several managers generally review a ClinPharm ICF
Need to confirm those roles with Teri/Tera as do not seem to correlate with BWL


comment:
Can this be shortened?  It seems too involved and off-topic for this course.


comment:
WHEN:
ICF Developer: 
Would suggest to remove (TMF) from the names of the documents
ICF Reviewer:
States &&.provides complete drafts of complete drafts&&
Suggest to change After all review changes have been resolved to After all review comments have been resolved.   This comment applies to Question 2 as well.

Am not sure that question 4 adds anything to previous questions


comment:
This slides needs organizations and updating, ie on bottom where it says grow organims vs analyze organisms is wrong. TSI tubes are typically used for stool work ups. Not sure exactly the points that trying to be made on this slide.


comment:
Had trouble getting the button to pop up


comment:
mod 3 and 4 buttons are showing the initial glow incorrectly


comment:
first time we see a scrollbar like this, we are using a purple glow layer callout. this is in template


comment:
A screen will typically say things like "MRSA screen"


comment:
Study/Site Manager: Typo in second paragraph  Team members should not to wait&.
Would suggest to remove Covance from the TPO pop-up


comment:
These are not the key items I would test the sales force on. I would suggest media, AST platforms, a spot test etc


comment:
TCED = Trial Consent Elements Document  not Contents
Country/Site-Level  - suggest to put for example ahead of the bulleted list


comment:
Think of saying or before trial begins, should say before the site has its FPV.


comment:
Can the scroll bar be removed and that part of the screen only show the relevant parts in the middle?  The top and bottom swim lanes are not relevant


comment:
I think this needs to be more positive. A learning/teaching moment to empower people to do there job. Yes lab assistant should also be lab technologist or laboratory scientist.


comment:
I wouldn't use this example if we don't have to as this question will be modified in the future probably.   I would use the process for monitoring temperature range.


comment:
The font is difficult to read as it is light and on a grey background.


comment:
Gram staining can occur directly on a specimen or from a colony.  I think this slide can be improved but again what is the take home message on this slide?


comment:
What does the note to reviewers even mean?  Are you saying the screenshots may change?  Take this comment out unless it is necessary


comment:
It seems like sometimes there is audio and sometimes not.  Is this is how it is supposed to be?


comment:
Instead of showing 'Prescribed fluid' on the first bullet should we just say Remodulin?


comment:
Can this say 'click the image below' rather than click the general information tab.


comment:
Can the enrollment comment be updated to say 'watched' instead of 'watch'  This must be a typo in the example I sent.


comment:
Should the first circle be highlighted as this is the start of the refill process and we would click there?


comment:
when it shows Emmas refill it should show 40ml of 10mg/ml Remodulin.  The ml after mg is missing


comment:
Is the pump icon correct on the display when you go to interrogate?


comment:
The narration says something about completing with red text.  It should say something about changing the areas containing red text instructions.


comment:
Same comment about the scroll bar as earlier


comment:
This slide initially appeared with the study coordinator pop-up showing.


comment:
This is repeated (I think verbatim)...is this intended since this is for reevaluation?


comment:
i know they said no hyphen for trial specific but..... shouldnt there be a hyphen.....?


comment:
remove "Deselect Preventive Action" from the RDU activities.


comment:
bold "Evaluating a Site" and "Why is this important?", maybe also bold or italicize the course name for more emphasis.


comment:
make button titles title case. so change KNOW THE GOAL to Know the Goal. you will need "Click the Know the Goal button to continue." as instructions in the body text. That will need to update as you get through the course.


comment:
this is ok for now i think, but ultimately, it will need to say exactly "by clicking the magnifying glass icon." I would also put that icon on the lower right corner of each form.


comment:
ok, i see why you put the icon up there. could we make that a "form" icon rather than magnifying glass? we have been using that icon deliberately in other courses. i think you could do something similar to how we have "see the full process" button, only change the text to "see the whole form" or something. that way there's some cue on these other screens what that button does.


comment:
ignore my icon comment. see edit on next slide.


comment:
update directions to "click the next button to continue" when all clicked.


comment:
an automated instrument that conducts biochemical identification of isolated colonies from cultures. It also automates antimicrobial drug susceptibility testing. Pictured here is an example of bioMerieux's Vitek 2.


comment:
For this example can we go with what was shown in the video for the actual removed volume?  It was somewhere around 4ml (instead of using 6ml).  I just like the 2 to match


comment:
It is hard to see the red box around the tool kit icon here


comment:
I would suggest changing this and perhaps say things growth for characterizations phenotypic characterization is important to understand for investigations. in some cases  both Genotypic  and phenotypic characterization is important to understanding.


comment:
I am unable to click the non-critical alarm test button and get it to work.


comment:
When I select the low reservior alarm volume tab (highlighted in red) it tells me I did not make the correct selection


comment:
When we talk about the screen showing the refill date (after changing the low reservior alarm volume) should the screen seen reflect that?  I am unable to scroll to see that part of the information.


comment:
For change alarm interval again should the screen shown depict what we have changed (showing lower on the scroll bar)


comment:
I can see this question coming up:  What if this happens to me...Can I re-inject the Remodulin that I removed after activating the reservoir?  Or do I need to get fresh Remodulin?  What is our stance on this?


comment:
I do not know the answer to this but if the pump has stopped for 48 hours or more, will the central venous catheter still be patent?


comment:
Since many of our physicians titrate by 2ng/kg/min would we want to show a titration of greater than that?


comment:
Medtronic: Is a longer length (2 inch) needle provided in the refill kit?


comment:
place a , after 'symptoms' in the first sentence please


comment:
Or change the first sentence to read:  If your presents with any of these symptoms they may be ...


comment:
change to: "collection device"

A specialized container to collect and transport specimens.


comment:
incinerator - sterilizes the inoculating loop in between plating


comment:
Can we make the button bigger, and maybe add text on it to say "START?" - I agree with Allie's comment about the confusion with the arrow as well


comment:
Can we crop out the dates in the image? It gives away one of the answers if we leave the date on there? :)


comment:
Also - can we make the box referencing the Data Dictionary stand out a bit more? I almost missed this the first time I looked at this screen.


comment:
Do we want a certificate for each piece of training? Or just one for the entire training? Just want to clarify this as a group!


comment:
icons under the "Use the menu to access" part are misaligned


comment:
will need sharon to comment if need for this delivery: add play/pause/replay buttons


comment:
FES Bob, Second scenario: After placing the "Follow-up call" On the correct place on the board, we get the "Great Job" on left. Button underneath says "Call Janice"


comment:
i dont recall giving you these map pieces; could you send me the PDF needed here to add or let me know if I need to send?


comment:
i jumped back to this one so just confirm that the intro text and red bubble hide until audio completes


comment:
lets add icons here for each of 3 blurbs. will send


comment:
can we fit a line under the super script with a bold and underlined term that says "Rollover any bold, underlined term to see a definition."


comment:
click > to continue should come up at end of animation.


comment:
does text for patient case studies and determining candidates have a red border (when they're in their grey state)? Or am I losing my sight?


comment:
this animation was awesome. only edit is to move your red button to be to the right of the body text (so just move higher up)


comment:
can we make sure Next button isn't active until the audio is done?


comment:
also we need to post whatever pdf you are referencing for it


comment:
move the red button to same location as other screen


comment:
system implant - bullet 2 - patients who have "A" presence... needs the "a"


comment:
make your feedback bubbles cover the submit button, or hide/show it as you advance. i definitely would have it hidden when you see the correct feedback to continue.


comment:
anticoag tab - the bullets are inconsistent colors.


comment:
i'd either move your show next button triggers to be on the click of the objects, or i would prevent the learner from click the base layer (i was clicking the objects without clicking the x buttons)


comment:
remove the shadow you have behind the text on the paper. i'd just make it a little darker.


comment:
comorbidities - add comma after healing in line 3


comment:
Again - not sure this is relevant particularly if you are focused on bacteriology as the take home. Perhaps use screen time better for what you want to sales force to walk away with at the end of this module.


comment:
in this case, they didn't want to lock the next button. Instead, update directions to say "Click the buttons below to understand how the pump calculates flow." as one line. Then as line to say "Click > to continue."


comment:
same thing here - next can be active. Just need to add a second line of directions (below the current) that say "Click > to continue."


comment:
Suggest rewording. When referring to the benches it relates to the workflow for that laboratory and the different culture work-ups. Not all labs divide the work into benches. 
"Bacteriology laboratories often divide the work-up of the different specimen cultures into benches to optimize workflow ie reps, urine, stool and blood.


comment:
now seeing the shadow is a weird thing that's happening on your visited state maybe? the normal versions are good


comment:
Make "Review the patient's case." grey and not bold - update all 3 patients.


comment:
if possible, move click next instructions as one sentence with the click the image... or hide it until after they click the image to enlarge


comment:
Suggest rewording; Microbiology laboratories can help improve antibiotic stewardship by providing timely accurate results to physicians for the diagnosis and treatment of patients with infections. 
Change answer: Stewardship is a program to provide management of antibiotics to help prevent teh misuse and overuse of antibioltics.


comment:
You must Identify before you can determine the drug bug combination of that will work on a patient


comment:
lock > on this screen until they complete the exercise. (but make sure it's unlocked if they use the back button to come back here.)


comment:
Trigger "Click > to continue." when button activates. Remove second line of directions from main screen.


comment:
USE THIS ONE ONLY: ignore any and all red button edits in this file


comment:
the answer choices need to be different. they need to be more definitive. one could argue that a liquid medium for growth is a broth culture.


comment:
hide next button until both buttons clicked?


comment:
i see what's happening now. i would move the click "PS Training Content Dsign Tool" instructions to be first. i would hide the next button.


comment:
I don't hear the updated audio. The revised transcript is correct and I don't need "final" audio, but it does have to be updated to show we made the edit.


comment:
Example of a better definition of what immunoserology laboratories do:

Immunology is the study of the body's immune system and its functions and disorders. Serology is the study of blood serum (the clear fluid that separates when blood clots).

Immunology and serology laboratories focus on the following:

Identifying antibodies. These are proteins made by a type of white blood cell in response to a foreign substance (antigen) in the body.

Investigating problems with the immune system. These include when the body's immune system attacks its own tissues (autoimmune diseases) and when a body's immune system is underactive (immunodeficiency disorders).

Determining organ, tissue, and fluid compatibility for transplantation


comment:
References popup = there shouldn't be any references, should mirror the language in the course.


comment:
check the submit button roundedness on hover for these questions


comment:
capitalize "Next" for next button directions... and do darker color


comment:
the link icons were overlapping and in wrong spots. may have been messed up in handing things back and forth


comment:
Bacteriology as written is the definition of what the study of bacteria are. However in the diagnostic laboratory they are working this up cultures to determine what is the pathogenic bacteria. Ie in some cultures there will be bacteria that are part of the bodies normal flora.


comment:
Change the title to "Make the connection:  Inputs into BAAOP"


comment:
tw = teri Womack
the tabs in the HP SEC in the training haven't been updated to match those in the Veeva (e.g. training says "IP & Pharmacy"; draft tool says "CT material & ..."


comment:
Under review and trial specific - should we reference filing in appropriate location in TMF to be consistent.  The last step is about filing.


comment:
For the second bullet we may wish to add unlimited hours (subject to the normal shutdown periods for routine maintenance)


comment:
same comment as with continuous regarding maintenance shutdowns


comment:
We need to discuss EK comment re the rating


comment:
Need to clarify the 10% overload wording, also the same as previous re maintenance periods in unlimited hours running


comment:
As we cant use the click and drag on a tablet need to keep the genset still. Also consider the genset in the middle of the four images so it looks like it could go to all of them


comment:
In the email, it should read 'is an engine coupled to an alternator' not 'coupled with'


comment:
I have a next button in Red in top corner that does nothing, I clicked this twice before seeing the 'Continue' button


comment:
In the intro - change the words "key terms" to "key inputs".


comment:
Change instructions to "Match each input to its function."


comment:
On contacts tab, I would say "some information on this tab may be..." not "... will be.."

Also to help address Japan's feedback, we may need to start this with "When working with CPSDS, CPSDS may provide some information on this tab.


comment:
Topology errors - Indicate errors in the system configuration.


comment:
same as before abou the CPSDS comment.  may need to say "when working with CPSDS, then CPSDS..."

In first sentence I has that "...separate fields that required for evaluations..."  something seems off in grammar here.  Also, I think that we may want to specify that CRUs that have been assessed (according to CRU assessment procedure).


comment:
not sure what "acting differently to their established ethics process".


comment:
Add a sentence to the introduction that reads "All of the inputs below can be potential causes of pricing anomalies."


comment:
Remove "Market instruction errors" as an option and remove the "Identifies..." phrase.


comment:
I'm not sure that it is necessary to include the tab specific instruction (such as "in addition, there are fields that required specifically for Non-CRU sites, including EETs" on every training slide.  We've already covered that each tab has its own instructions.


comment:
not sure if it is covered later, but I think it will be important to point out that the CPM advisor approving these evaluations consults with appropriate staff including the Medical Director for all FHD and monotherapy escalating dose trials before approving the site evaluations.


comment:
the FHD tab has changed a bit.. it is for FHD and monotherapy escalating dose trials now.


comment:
Outages - May indicate why bids or self schedules may not be utilized in the market.


comment:
EET stands for early exploratory trials so remove "studies" at end of sentence as it is redundant.


comment:
The two window shades, the up arrow and the light bulb are not intuitive.  Not sure how they tie together.  Can you find one picture to represent all three?


comment:
In the previous section it does say that assessment debarment can come from CPSDS so this is not consistent.


comment:
Remove Master file adjustments from the script. These types of adjustments are not done quickly.  They are a long term solution.


comment:
Change the instruction to read "Move the slider to see the different points in this timeline."


comment:
Please note when you build out this page - all the times are approximate.


comment:
Reword second sentence of script to say "I need to troubleshoot by checking in the outage summary to ensure that the resource does not have an associated active outage card."


comment:
Add another bullet - it should be the first thing they check - Check the master file parameters.
In the script you should add that they should check the master file parameters to make sure that minimum off time is correct.


comment:
while timelines are important, I think the focus of this should be the study's conduct, subject's safety, and data integrity.  If something in the evaluation isn't conducted well or documented accurately then all of those avenue as well as the timeline could be impacted.


comment:
Change title to "See it in action:  Check for outages"


comment:
Change the instruction to read:  "I need to start by checking to see if there is a valid outage associated with this resource."


comment:
Change the title "See it in action: Validate ETSR limits."

Change the instruction to read "Now we need to validate if ETSR limits are too restrictive.  Let me show you the steps."


comment:
We need to align this with the 101 Roadmap on the previous page.  Let's talk about the steps that need to be taken.


comment:
We need to update this roadmap.  Heidi will provide this to you.


comment:
Agree that "experimental" should be noted but we are allowed to advertise as "free" or "low cost", it just cant be front and center.


comment:
Please ignore my previous comment.  ETSR limits are not part of this example.


comment:
This is not part of the example.  This example should follow the steps in the 101 Roadmap.  Let's discuss this further.


comment:
shouldn't there be a way to remove your selection in the event you click the wrong text?


comment:
When clicking "Done Selecting" it does not show the correct or incorrect responses.


comment:
disagree that "clinical" needs to be added to "research".  it doesn't hurt but does already state "research study"


comment:
We need to discuss how when we will talk about the path on the roadmap if there is a "Consistent" or "Global" issue that will take them down the path of "ETSR detail".


comment:
remove the word "and" which appears before "which" from red box


comment:
CPA stands for Clinical Pharmacology Associate.  please correct middle word


comment:
for the icf reviewers, the reviewers actually review the whole document but they focus on the elements mentioned.  could you rephrase the statements to indicate their focus?


comment:
approver for the amendment can be study manager, CP, or MQR depending on the type of change.


comment:
complete drafts of is repeated for the When on ICF Reviewer


comment:
SharePoint library is for the templates.  the approved ICFs for a trial are in the TMF


comment:
Match the text to the buttons. Should be Effective PS or just Effective?


comment:
Per new consistency updates, add the text about the magnifying glass.


comment:
Can we just say training is delivered, completed, and documented for Ensure Completion popup?


comment:
Yeah I agree that this page needs something else.


comment:
Adjust CoLab so that the system thinks it is spelled right after feedback.


comment:
I'm not sure what to do here. Do you want me to click both buttons and then next?


comment:
Does the font in the purple box have a shadow?


comment:
What happens if they fail? Must they get 80% to move on?


comment:
Add CC - also it's fine in the audio for now, but I'd remove "way to go" from your transcript. They didn't like that in my course :)


comment:
In the VO transcript decapitalize "R" in red.


comment:
The VO transcript wouldn't open for me (from the Menu button)


comment:
Typo in "Initiate Do Not Use Site Process:
second bullet:... reported to local ERB and/or regulatory authority...


comment:
To review with the SMEs - I find it quite hard to find the right answer


comment:
Tera, the site is writing to Erin, who is the monitor. The monitor would be at the TPO.


comment:
Be sure to update here as well with the edits from the process map review at the beginning of the course.


comment:
Study Coordinator should be Site Manager?


comment:
Change study coordinator to site manager


comment:
The links for the Quality Work Pland and Operational Plan are not correct. They are not in Veeva. I will send the links.


comment:
These are the links and document names to use: (I added one, indicated in red)
-	Quality Work Plan (delete the word Quintiles): http://lillynetcollaboration.global.lilly.com/sites/sc/Operational%20Documents/Forms/QWP.aspx 
-	Operational Plan: http://lillynetcollaboration.global.lilly.com/sites/sc/SitePages/OPandTools.aspx


comment:
Add as a resource:
-	Do Not Use Collaboration Site: http://lillynetcollaboration.global.lilly.com/sites/DCOEHub6/onboarding/SiteSelection/DNU/SitePages/Home.aspx


comment:
need to use higher res map... need to have the magnify glass


comment:
add play/pause/replay buttons to all audio screens per discussion yesterday


comment:
please provide location of wherever you found this image... I will need to purchase it


comment:
need location of all of these images unless someone already downloaded them for you


comment:
need "click the next button" instructions somewhere.


comment:
need back button. text also looks way bigger than other slides. for all instructions make sure to bold action words and make it the darker gray color like on other screens.


comment:
"Country-level ICF" in the yellow folder is blurry


comment:
need click the next button instructions on every screen


comment:
i dont think the click the next button instructions switched over when next became visible


comment:
make sure the "Required text is bold." is set to DinPro bold. It is not bolded right now.


comment:
extra space before "Sample text is italicized..." sentence in 2nd paragraph


comment:
make the "Optional text is black." black (not the template gray.


comment:
move "KEY TO TEXT COLORS AND FONTS" to be outside of the purple box (make the shorter. Center align it above the purple box, make it bold font, purple color


comment:
make sure directions text is formatted correctly (colors, bolding)


comment:
have the rounded bubble either be bigger so the top text isn't so close to the edge, or have it extending out from the side of the screen. you have some room on the right side of the page. also need the back button here.


comment:
update your instructions to have the "Click the TCED element for more info"  be a part of the main body text and before the instructions to Select the best answers. add "TCED" or "TCED Template" in bold purple in the paper where the instructions were. reduce font size for risks and either align it with the rest of the text on the left, or add a rounded bubble around it like you did on previous screens. (i prefer alignment)


comment:
if time allows, order the elements numerically in the drop-downs. right now it goes 9-8-12-6-11 rather than 6-8-9-11-12


comment:
back button should be on every screen other than the story that uses the big triangles


comment:
locked out when i tried to come back. have it reset if possible -- and show next if you have been here before


comment:
font sizes in the boxes are not the same.


comment:
update instructions to better reflect the interaction: eg "Match the ____ to the ____" Not sure what I was doing here. and if possible, change the colors of the right-side draggables so they don't look so similar to the left


comment:
extra space before "Use the grade level...." sentence in last paragraph


comment:
can we add an interaction here? even if it's just click each readability score to see what they do? and add a microsoft word icon with the header "Determining Readability Scores"


comment:
can we have instructions/text with the popup to both review your answer to compare to the example and to click next


comment:
make principles in the list tabbed like a numbered list


comment:
replace question mark in first example with period


comment:
this is a lot of text on the screen at once. can we remove the examples/incorporate what you have into the paper and just call them out in the chart somehow?


comment:
can we differentiate the final example version a little differently? i wasn't really sure where to look on this screen


comment:
do we need this example? we have been on principle 1 a long time


comment:
if we are not showing the animation for the feedback, i think we need to differentiate the feedback boxes to call it out a little bit more. maybe red box all the way through, with white text?


comment:
again, not sure we need a second practice, but up to you


comment:
do we have a before/after example we can put here?


comment:
use different photo to call back to that slide


comment:
ignore my Carole comment. I guess that was the spelling Sorry!


comment:
i think you need to callout the scrollbar somehow


comment:
In my opinion, you can lose the example and just have the 3 clickable areas. you already have that in the body text above.


comment:
unless "Tim" comes up later, I think you can remove his name. makes the sentence read weirdly


comment:
need LA to be cut off at waist like other courses. also 3rd link has a weird line break


comment:
need click next instructions on every screen (unless using continue)


comment:
Page title needs to be "Study Participants' Perspective"


comment:
I need whatever image you are using here. we have to make sure we purchase it for the courses


comment:
for first layer, need back button. remove the back arrow.


comment:
replace cervical cancer image. i will provide


comment:
stretch your captions for each panel to be the full width of the panel


comment:
at end, remove next arrow. add next button. back button always needs to be there to go to previous slide.


comment:
im not sure we can use all these image unless they are public domain


comment:
need to lock the draggables to only desired locations -- snap back to original location if dropped outside a dropzone


comment:
this is programmed incorrectly. i was able to select all of them -- including "not the best answer"s -- and it gave me correct fdbk


comment:
remove extra spaces before directions for Downstream Impact module... and move "more" to the same line


comment:
same comments about back/next/arrows as before


comment:
either make this text as if it's being said by the person or take it out of a speech bubble


comment:
"...what would be some of the most likely impacts on Lilly?"


comment:
can we have a photo here to represent the case study and remove the clipboard? look at istock.com for something if so. just put the question in a rounded question bubble.


comment:
having seen what you're doing, i would also put images of lilly icon in the question for #1, person icon for question #2, and person icon with ICF for #3


comment:
replace case study bubbles either with purple circle buttons like rest of course, or make them look like folders/papers


comment:
i like this setup the best for all case studies: 
Remove the question from base layer. Have the entire scenario with a photo on the base layer. click next to answer the 3 questions and add icon of case folder to show layer with the info on each question page (like you have here). keep same edits for icons as on previous screen (ie show lilly icon for q1, etc)


comment:
can we update the body text too when the directions/next button change? that was a slog to get through, and it may be nice to have a "congratulations" sentence in the text box.


comment:
this should always be the first screen in the conclusion. having seen it here within the scope of this module, it should move to the conclusion.


comment:
I believe planning should come before actions.  Therefore, suggest to have "The Study Manager decides that master inform consent is needed" comes before "Gather trial-level documents".


comment:
when/reviewer: please add ICF amendment too besides ICF.


comment:
Question to Teri W.  Should we train Covance to use the TCED?  We have not so far since usually trials that needs TCED were managed by CPA.


comment:
This needs to follow the template and include audio, and correct instructions. You don't need to record audio, but have the transcript available on screen is fine for Alpha.


comment:
study participants vs. just participants.


comment:
Call it this: International Conference on Harmonization Good Clinical Practices (ICH GCP)


comment:
We'll need to host this document somewhere.


comment:
The transcript appears on this page, and it shouldn't so make sure your variables are set.


comment:
If we don't give them the protocol, how will they know this answer? I suggest removing this. I think we've done a lot of exploring the Template up until now and we want to focus on writing.


comment:
Suggest changing to: "Click Lisa to hear her story on how she learned to select  good sites by using  elements judgment-based decision making that focus on gathering useful information."


comment:
unbold "the" before button names in instructions


comment:
see if you can cut the text box off at "learn" so that it doesn't run so close to Menu


comment:
Although I like the matching, I think we're trying to just quiz them too much on what is in the TCED. Let's remove this.


comment:
Next takes you to the main menu and skips the screen with the objectives.


comment:
"Click > to continue." directions don't show up.


comment:
When we last talked, I thought you were going to compare two versions of text so they can see the good and bad of readability. We need something for the learner to see vs. just read.


comment:
You need to add variables to all pages otherwise transcript pages will keep appearing.


comment:
third bullet in fast facts has an extra period


comment:
can you left align the * statement at the bottom with the rest of the onscreen text?


comment:
This is really the important section of the course and I feel like we need more of an introduction to this activity, it's importance and what you would like the learner to do.


comment:
Need directional text once I compare my answer. Also - how do I compare my answer, what am I looking for?


comment:
when last tab is clicked, trigger directions to change and say "Click > to continue."


comment:
We need more examples of them to type in and compare their responses to. They also need to get feedback for how they did. Don't they have the opportunity to rate themselves?


comment:
move the "Click the icon" directions to the next line.


comment:
don't trigger "click >" directions until they click both terms - not both icons.


comment:
I couldn't access the improve the TCED button even though it was purple.


comment:
can you lock this so they can only click one tone at a time? right now it can play both at once.


comment:
bullet 3 on the main screen - needs to have "implant" on the previous line so everything is on a single line.


comment:
I like the principles, but can we show them an example of a "good" and "bad" sentence example? And also highlight the reading level?


comment:
move "click > when you wish to continue" to be at the bottom of left of the screen, in line with teh arrows. See the Refill course in Phase 3 if you need an example.


comment:
doc on the right has a slight grey box around her - maybe the hotspot?


comment:
I don't think the learner will check the reading level in this activity, so let's remove that.


comment:
you keep saying "Example" when I think this should be "Expert". We want them to compare their responses to the expert. I also agree with Matt in that it is hard to follow where to look or what to do.


comment:
I agree. One example per principle should be fine. Also is the period necessary in the header?


comment:
study participant vs. participant. do a global check for this.


comment:
I don't think this Expert rewrite is that much better than the original. I don't think this would keep people from participating in the trial if it was written this way.


comment:
Ignore my focusing edit. Just remove the "the" in this sentence before "what".


comment:
check the transcript - it's cut off a little on the right.


comment:
Missing the word "to" before understand.


comment:
Is there more to this story? Can we show them a conversation going more positively with the new information?


comment:
Remove the big yellow box from pnuemo please


comment:
Study participants and trial need to be used here.


comment:
pnuemo - sentence two should say "...symptoms include..." (no comma and no ING)


comment:
Just make the bullets into a sentence about why they are more likely to comply vs. bullets.


comment:
trigger "Click > to continue." directions when the next button happens.


comment:
update your slide master resources with the resources inforamtion.


comment:
just kidding - the directions are there, but they're grey, not blue.


comment:
does this screen include the new references you added for pnuemo? I don't think I see them


comment:
I see they're in the references popup - make this screen match that


comment:
I don't think the review guide is the correct reference here.  All the requirements are in the Appendix in the procedure.


comment:
The review guide doesn't help you determine if the content is compliant, the Appendix in the procedure has these requirements.  The review guide only has best practices.


comment:
Both "Ss" in specific need to be the same, either both uppercase or both lowercase.  Currently BWL map has the same discrepancy, I'm following up with Cheryl.
This is noted in both the swimlane text and the milestone text


comment:
Their review is against the Appendix in the procedure most critically, they can also use the review guide as additional best practices.


comment:
I think approve and reject need to be plural.


comment:
This content is wrong. They do not have to adhere to the guidelines in the review guide! Please change this text.
The content must adhere to the requirements in the appendix of the procedure.  Additionally, they can reference the review guide during their review, but the review guide only provides best practices, the guidelines in the review guide are not required.


comment:
This is wrong.  Not using bold, italicized or enlarged fonts is in the appendix to the procedure with the requirements.  This is not in the review guide.


comment:
This is wrong! The guide does NOT provide rules.  The rules are in appendix A of the procedure.


comment:
I confirmed the link is accurate.  It doesn't work for all end users yet because the document is not approved.


comment:
This is wrong.  Change review guide to Appendix in the procedure.


comment:
should we change the end of the sentence to "...and how the system works." ?


comment:
WHEN SELECT THE POOR COACHING OPTION IT PROCEEDS ON TO THE NEXT VOICEMAIL, DOES NOT REVERT BACK TO ALLOW YOU TO SELECT THE RIGHT OPTION.


comment:
Image needs to be corrected if we're going to use it.  Pump size is too small and catheter placement is incorrect.


comment:
This slide is referencing a follow up but the follow-up call indicated that there was a customer incident. It should be more clear that there was an incident which is prompting the followup call.


comment:
Seems as though the last paragraph should be in bullet point format:
- The refill procedure is performed under sterile technique.
- Refill intervals vary depending on the flow rate.
- The programmer calculates flow rate based on the prescribed dose and patient's weight
- Average refill intervals are 4-16 weeks.


comment:
CAN WE HAVE A SKIP THE INTERACTION AFTER VIEWING ONE TIME?


comment:
Delete the bullet from the first statement (it's the lead in statement).
I agree with Susan, change 3rd bullet point to "The patient's refill interval is confirmed and the next refill appointment is scheduled."


comment:
Image needs to be corrected if we're going to use it.  Pump size is too small and catheter placement is incorrect.
I don't like the animation eiter. The syringe is too big and the pump is too small. Out of scale. Do we even need an animation on this page? Doesn't seem to be adding anything.


comment:
I know that we have agreed to these bullets before so I hesitate to say anything, but maybe the 3rd bullet isn't needed (because they won't really know enough to understand it at this point), and to address Susan's comment perhaps something like "Patients refill appointments are based on flow rates; higher flow rates result in more frequent refill dates, lower flow rates result in less frequent refill dates"


comment:
agree with Carolyn. The syringe is as big as the humerus which in itself is quite humerous!


comment:
INSTEAD OF GOING TO THE YOU CAN DO BETTER. SHOULD THIS NOT GO TO THE RESTART CONVERSATION. WE WENT WRONG WRONG.


comment:
Last 10 seconds of the video - I don't think the intent was to show prescribing information, I'm thinking instead we should show the box that drug comes in, or the vial of drug itself? or nothing at all.


comment:
Another idea for rewording this screen would be to change the tense...(need to discuss)
Trained clinicians, with access to advanced cardiac life support equipment and staff, perform the refill procedure. They:
- Monitor patients for one hour after the refill procedure.
- Evaluate the accuracy of the drug delivered at every refill visit.
- Confirm the patient's refill interval and  and schedule the next refill appointment.


comment:
Change all references to the review guide!  The requirements are in the Appendix to the procedure.


comment:
Change IP to Clinical Trial Material (or CT Material)

Change the reference to the review guide to the appendix in the procedure.


comment:
Change the narration.  The review guide doesn't provide compliance requirements.

The appendix in the procedure provides the requirements.  The review guide provides best practices.


comment:
Update the screen that's shown on the programmer. Show a more relevant screen such as the Pump Status screen or the Infusion screen with the Reservoir Volume window open. It would be fine to use a straight on image of the programmer with the corrected screenshot.


comment:
change SRR text about storing master content to match the site manager text.  need to reference the appropriate TMF location


comment:
We need to add a reference to the procedure here.


comment:
Remove the red outline around the whole image.
Either make the weight of the red outline around the tab wider or use the light red highlighting like in the videos, so it's easier to determine what you should click on.


comment:
Yep, I agree. I just had a discussion with a group of SME's who think to themselves "yeah this course is over!" when they get to this screen.


comment:
Be consistent with language. Informed Consent - not just consent.


comment:
Note - my comment is referring to the pop up text


comment:
Toolkit/Event Logs window:
We need to change how we present the additional sub-tabs. It's not clear to the learner which tabs are highlighted or what's being described.  
Perhaps we could update the text:
"Three(3) sub-screens are available from the Tool Kit screen tab." (show 3 buttons)
- Alarm Test sub-tab
- Pump Off sub-tab
- Event Log sub-tab

Click each sub-tab button to learn more.

When you roll-over each of the sub-tab buttons, the appropriate sub-tab screenshot is displayed on the left with the sub-tab highlighted in red or with a red border. And a pop-up is displayed with header/text that's currently listed after the : for each of the sub-tabs.


comment:
Remove the red border from around the entire image and place it around the 6 tabs that the user should be choosing from.


comment:
from Update the 2nd Find the Screen question/ Infusion screen tab pop-up wording: delete "go to". Should say "...is where you would locate and enter the drug..."


comment:
Add a paragraph break between the 1st and 2nd sentences so it's easier to read the information.
Update the 3rd sentence to "To enter data on the N'Vision programmer, you use the touch pen located in the storage compartment on the side of the programmer."
Delete the last sentence, I don't think it's necessary. We haven't directed them to use the mouse in any other interaction so far in the course.


comment:
The weight of the red outline needs to be wider or we need to use the light red highlight (similar to the videos) to direct the learner where to click.
For the first interaction, should we have the learner click on the drug button? So they see a real keyboard instead of a number keyboard?
The directive for the 2nd interaction needs to be updated to "Click the Prime Bolus button to see the drop-down list."


comment:
Drop-down List pop-up text. I think we can delete the last sentence "Select a value using the touch pen." I don't think it's needed since we're saying in the main text that they would be using the touch pen.


comment:
Why are we assessing this? Why do we care?
Need to know they have capability to complete protocol. Must be sponsor responsibility.


comment:
Update lead-in: Meet our patient, Emma, who is getting her pump refilled today. Its November 9, 2016 and its Emmas third refill visit. Her planned refill is 40 mL of Remodulin (treprostinil) Injection, with a 10.0 mg/mL concentration.

Update last sentence before bullets to: "Based on your review of Emma's medical records, you are aware of the following:" (Reorder the bullets and update text)
- Previous refill date: September 7, 2016
- Refill volume: 40.0 mL of Remodulin (10.0 mg/mL)
- Dose: 65 ng/kg/min
- Dosing weight: 70 kg
- Expected refill interval: 7.9 weeks


comment:
Video
00:03-00:06 - update text to match earlier screen that was updated.
- Previous refill date: September 7, 2016 
- Refill volume: 40.0 mL of Remodulin (10.0 mg/mL) 
01:02-01:10 - Show Remodulin label 
- Dose: 65 ng/kg/min 
- Dosing weight: 70 kg 
- Expected refill interval: 7.9 weeks


comment:
Need a link to the full document and site selection guidebook.


comment:
As requested by Susan, update on-screen text at 00:02 to: "...40.0 mL of 10 mg/mL Remodulin..."
01:17-01:45 - The screen is showing a Bolus in Progress, I think this is incorrect. There shouldn't be a Prime bolus in progress during Refill. We need to update the screenshot.


comment:
Video 00:42 - 00:56
There shouldn't be a Bolus in Progress. Screenshot is showing Prime Bolus with time remaining.  This will need to be corrected.


comment:
Video 00:23-00:40 
The screenshot is showing a Prime Bolus.  This is incorrect. The screenshot will need to be updated.
00:40-00:43
Screenshot says "(After Prime Bolus)" at the top... this is incorrect. This screenshot will need to be updated.
01:00 - 
The screenshot shows an Infusion Bolus with **Bolus in Progress**. This is incorrect. Screenshot will need to be updated.


comment:
Delete the 2nd sentence "This is the accuracy ratio."
Add a last sentence: "The accuracy ratio is calculated using the following formula."
- Previous fill volume pop-up text is not centered in the window. It's riding near the bottom. Also remove "(tresprostinil) Injection" and just say "...volume of Remodulin injected into the pump at the last refill."
- Actual removed volume pop-up: Update 1st sentence for consistency "The actual removed volume is the amount of Remodulin removed from the pump during the refill procedure."
-Expected removed volume pop-up: Update 1st sentence for consistency "The expected removed volume is the Reservoir Volume recorded.."


comment:
2nd sentence: update to "At Emma's last refill visit, the pump was filled with 40 mL of Remodulin (treprostinil) Injection."
3rd sentence: "Today, the expected removed volume was 5.0 mL and the actual removed volume was 6.0mL." (or 4.0mL if we change as requested by Susan.


comment:
Can we combine the 1st and 2nd sentences?
"Next, verify that the accuracy ratio falls within the expected range based on the number of pump refills. Today was Emma's third refill and ...."


comment:
Red outline around fields should be brighter red and wider.  Hard to see.  Either use an outline or the lighter shade of red as used in videos.


comment:
Think we need to change the name of this training to review site generated recruitment and retention content.


comment:
The first couple of sentences does not even make sense to me.  We have to review trial specific content to ensure that it is compliant with lilly's and external requirements.  This whole slide is really not correct. I think we should delete the whole slide or re-write it.


comment:
I think that just focusing on the milestones that these activities occur in is what should be detailed (the final two).  just like you only focus on the role involved in the swim lanes.


comment:
Should say more text around what they should be reviewing for and against and who else they may need to involve.


comment:
It is reviewed against what is outlined in the recruit and retain study participants procedure, not the review guide.


comment:
The materials received are not just advertising materials. I would also say site-generated recruitment and retention materials that the site will use to aid in their recruitment efforts.  I have no idea what the last sentence even means.


comment:
Actually they don't make sure it is clinically accurate.  As Erin said, they make sure it aligns with the protocol.


comment:
Once again, we do not review for clinical accuracy, we review to ensure it is consistent with the protocol.  Also, does not review against the review guide but the procedure.


comment:
Bad clinical accuracy example.  Use one where the inclusion criteria is wrong.  Like you have to be over 65 to participate in trial in protocol but advertisement says that you have to be over 64.


comment:
Do we want to list just some of the specific things are just refer them to the procedure?


comment:
You cannot say that the banner will make enrollment go quickly.


comment:
Also, the site submits their content to the IRB, not Lilly.


comment:
I am confused how to select a section that needs edited.


comment:
I think this example is too hard.  Unless you have the appendix in front of you, I wouldn't expect someone to find out all these problems.  I think this example should be taken out.


comment:
Also this flier doesn't match the previous one as the $ amount is not in this one in the banner.


comment:
So right after review, it is not submitted to the IRB by the reviewer.  It is submitted to the IRB usually by the site so we just need to say that we provided reviewed copies to the site.


comment:
We need to check these edits to ensure they are correct that they were need required.


comment:
Both of these are wrong. They need to review against the procedure and ensure that the materials are consistent with the protocol.


comment:
Say review trial specific site generated recruitment and retention content


comment:
The sentence should not say just advertising.  They rely on recruitment tools to help in recruiting.  The materials have to be reviewed to ensure they meet Lilly's and external compliance guidelines.  If the materials are submitted to the IRB that do not meet compliance requirements, the approval process will take longer which cause delays in sites being able to recruit study participants.


comment:
The step is red because there is a requirement associated with the step, not a required task!  Take this example out.


comment:
Take the example from site activation and enrollment plan and put it in here.  I am not sure about these case studies.


comment:
The third section does not say that the site is underenrolling by 50 percent it says the trial but the answers act like you are talking about the site.


comment:
To make this example right, you need to say that the Canadian sites anticipate enrolling 150% over the initial planned enrollment.  Otherwise, this example does not require any action.


comment:
i thnink you could move your circle icon to the left and up a bit, and with that text with it on one line, youll be able to avoid the popups overlapping the button


comment:
nitpicky so ignore if time is tight: color of numbering on first popup is different from rest of text


comment:
add visited states to the question buttons to see which ones you've already seen?


comment:
Edit answer:
True. The VENTANA HE 600 system will error and stop processing the trays in the system.


comment:
Edit second Q & A:
What can you do if you notice a tray or specimen had the wrong protocol run on it?
Try to recover the tissue by removing the coverslip by one of the two options (lab verified).


comment:
Create an Activity from this page. I'll place it in the table but you will need to put the picture into the table.


comment:
Can the "Tap a topic below to get started." be changed globally to say "Tap a subtopic below to get started." I noticed that this is a different sentence than used on the Topic screen, so, I thought it could probably be done.


comment:
Comment #2 on the header. I don't think "investigative" is right...I think it should be investigational medicine. If others disagree, that's fine, just found it odd.


comment:
Comment #3 on last screen of the radio ad. It says remove bolding, which is true in that you are reviewing a written script, but is a radio ad, so technically it would be "emphasis" in the end result of a recording. Not sure if that should be changed in this or not, since the end result of this ad would not be written. Just a thought, if others don't agree, it is fine.


comment:
This audio doesn't sound like a professionally produced final audio. It is a female voice we haven't heard before and I swear I heard a cough in the background. DId the placeholder audio get left in??


comment:
I couldn't get the red box text to pop-up. The audio played, the red boxes displayed and then the Next button automatically displayed without me looking at the red boxes...


comment:
The first screen on this did not let me click the boxes, it just moved on to the second screen where the role boxes showed up. I think there are issues with this whole process map walkthrough over all.


comment:
Typically we don't have the voice overs reading each box contents as they come up do we? That is what is happening with the roles here and it is seeming odd to me, as it isn't saying anything different than is on the screen...


comment:
While site managers are identified as a role here, there is nothing that speaks to the fact that the Site Evaluators are the SPECIFIC site managers who be obtaining the Site Level Enrollment Projects (although perhaps not entering). I think it would be wise to add a Note to the pop-up for the Site Level Enrollment Projections box that says something like: "Note: Site Managers responsible for site selection activities will obtain the site level enrollment commitments during the site selection process" Just want to make sure it is clear to any new SAMs or other personnel that they aren't going to be doing that.


comment:
What would it be like (or would it be possible) to have a bunch of branches coming out of the "Conduct Site Evaluation Visit" Box that are the list of modules underneath that topic, with the current one highlighted in Bold/Red text? Thoughts?


comment:
For the first objective, I am thinking it maybe needs to be "Recognize what ACCURATE and COMPLETE ISEC and SPI documentation looks like for the ...section."


comment:
Why is this important section. Update first bullet to "...facilities to implement protocol procedures properly."
Update second bullet to: "Appropriate equipment, facilities, and related processes are required for a site to be qualified to conduct Lilly trials."


comment:
I think there should be a button for the person to open the entire map if they want. I think the voice is clear that this is part of only one box within the map, BUT, if a person wants to look at the whole map for some reason, I think they should be able to.


comment:
I like the analogy. Would suggest updating audio to say that we are concerned about the care/safety of subject participants along with ensuring the site is set-up to ensure data collection integrity.


comment:
In this course you will learn...Needs to be updated to reflect SPI. Thinking it should perhaps reflect that they will learn about the evaluation and documentation of ...and leave the ISEC and SPI classification for later when the questions are outlined.


comment:
Is it "recruitment AND retention AND review guide" or is there 1 too many ANDs in there.


comment:
in pop up check grammer on approve or reject in second sentence


comment:
Ignore previous edit. Update to "This rack is all black and is loaded with C.f.a.s. HbA1c calibrator in a standard cup or open tube. The calibrator is pipetted by the S1 probe."


comment:
not sure about the comment on the clinical registry number.  I wouldn't know that ABC123 wasn't the number.


comment:
Keep the original answer and response "Excellent! Open tubes and standard cups can be used on the Calibration rack."


comment:
4th paragraph ... participants may receive s trial-related.  what is s? typo?


comment:
I would say that the phone number needs to be marked as a needed update since it isn't a real number


comment:
timing is important, but I would comment about how lilly could look if the ads were coercive or inaccurate.


comment:
next button wasn't working for me on this one.


comment:
105 kg = 231 lbs...is that believable based on the picture of Nick? do we need to update the information?  Originally we had 90 kg with a dose of ng/kg/min which didn't meet the avg of 4-16 week refill interval.  Maybe we should change Nick's information to 90kg dosing weight with a 90 ng/kg/min (or 100 ng/kg/min). That would give him a 4.4 week interval (or 4.0 with 100 ng/kg/min).


comment:
The needle used to with draw drug from Remo Vial is different from needle used to inject pump.  In illustration the same blue needle is used.


comment:
Link does not work.  Should take to the Guide.  And it is a "guide", not necessarily rules.


comment:
Site manager comment doesn't make sense since the CT Registry number is included.


comment:
The use of Glendale Adventist is too close to referencing an actual site.  Would prefer that you made up a more fictitious name.


comment:
Nothing about what the IRB thought needed revision.  Doesn't make sense.


comment:
Agree with feedback.  Do not have to have the word "clinical" as it does say "research study".  Use clinical trial material or say this is a comment as subjects won't relate to IP, at all.


comment:
Video 00:15
Need to add the programmer screen that shows the Remodulin Implantable System Button.  
00:14
May also want to update the narration to state "Select the Pump icon and the Remodulin Implantable System option from the desktop screen" vs. the appropriate programming session


comment:
should the infusion tab show Remo instead of water and actual dosing info.  The alarm screen has remo info not water.


comment:
Study Coordinator should be Site Manager


comment:
Quality is not involved in routine site close out, only early termination.


comment:
Regulators do not come to close out visits.  Perhaps it should say site audits.


comment:
The monitor wouldn't be handling budget issues.  They could only forward those along.


comment:
-The 1st screenshot needs to be of the Summary screen (final screen) with the Slider Bar highlighted (instead of the Pt Info screen)
-Make the highlight/outline a brighter red so it's easier to see.
-3rd screen - to move the highlighted report, click on one of the 3 available print/view buttons. This will move the session to the box above. I would suggest showing a screenshot with a session moved to the upper box and then put an outline/highlight around the 3 print/view buttons to coincide with the text on-screen.  Sonja...do you agree?


comment:
3rd bullet: combine the 2 sentences "...after refills for signs of an overdose, such as a drop in blood pressure..."
4thbullet: "...to avoid depletion of drug in the pump reservoir."
5th bullet: combine the 2 sentences "Patients and caregivers need to be reminded of the signs and symptoms of Remodulin overdose and underdose, as well as the importance of seeking medical attention if symptoms occur."


comment:
Seems to me that some of the information on this screen should be moved to the next couple of slides.  I would suggest leaving the on-screen text with 'critical alarm' and 'non-critical alarm' bolded and underlined (as a rollover, similar to what we talked about doing for the acronyms in the Select the Right Patient course). When the learner rolls over 'critical alarm' or 'non-critical alarm' the pop-up window is displayed across the bottom of the page. The alarm sounds should be moved to the N'Vision programmer alarm test page, since we want the clinician to demonstrate for the patient.


comment:
-I think the first screen we see should be the final Summary screen after updating the pump instead of the Patient Info screen.
-Make the outline weight around the Tool Kit screen tab wider so the learner can see it.


comment:
- On-screen text: delete numbers "1.", "2.", "3." (inconsistent from screen to screen and not needed)
-Update on-screen text for screen #1 to part of the directive (similar to #2 screen) "From the Alarm Test sub-tab, select the Critical Alarm Test button"  
-Make the outline around Critical Alarm Test wider/darker so the learner can see it.
-Make the outline around the OK button wider/darker.
-Add the telemetry complete sound and then the Critical Alarm tone (as stated in the text on-screen) prior to the learner clicking the OK button.  This interaction should be as close to the 'real thing' as possible; therefore, tones need to be added.
- I think we should add the non-critical alarm procedure also, so the learner walks through the interaction again and hears the Non-critical alarm tone. This could be an optional step, but I think it should be made available.


comment:
Are these icon colors consistent with other pages that have similar options? Please verify.


comment:
-Update header "Low Reservoir Alarm Volume" (delete s on Alarm).
- update the image of the N'Vision programmer to show a screenshot of the Alarms tab screen with relevant settings.


comment:
make the outline/highlight around the Alarms tab wider/brighter so the learner can see it.


comment:
The baxes are too big and we cannot see where the bowxes to review are located. It wold be good to see them at a glance


comment:
CBSO is not a common acronym within Lilly (at least in EU). may be worth to fully rewrite teh role of the person.


comment:
-Delete on-screen numbers: 1. - 5.
-Make outline around all screenshot buttons/fields wider or brighter so the learner can see where they are supposed to click.


comment:
Please provide a title with the role of this person so that when listenning the trainee can understand what' responsbilities do have this person.


comment:
I do not understand the aim fo this question and do not understand what teh answer is bringing as knowledge ..May a pb of wording question and/or answer


comment:
Since the Low Reservoir Alarm Volume default is 4.0mL, I think the 4.0 mL value should be pre-loaded on the screen and the learner should review the value and select OK. Update the on-screen text to say "Confirm the Reservoir Alarm Volume and select OK." 
The interaction isn't accurate anyway. The font and number display is incorrect and the interaction is not necessary.


comment:
All screenshots in this interaction need to be updated. The Current Pump Settings at the bottom of all screenshots is showing Minimum Rate. Since we are at Emma's 3rd follow-up visit, Remodulin with Emma's last refill visit settings should be reflected at the bottom of the screen. BLP- you will need to enter Emma's information and Update the Pump prior to capturing these screens for the information to be correctly displayed on the emulator.


comment:
Unclear question to me. What if we ask : 
-Which roles are responsible to obtain regulatory approvals and to make sure appropriate documentation is on site ?


comment:
The 5th interaction screenshot is showing 100 ng/kg/min with 95 kg. Needs to reflect Emma's information. 
- Update on-screen text "Using the scroll bar, review the New Pump Settings."
- Make highlight around the scroll bar wider/brighter.


comment:
The answer is stated correct when both study coordinator and study manager is selected while teh answer is considering only study manager. To be clarified


comment:
7th action (Select Yes)... The prescription Confirmation screen is incorrect, it's showing Minimum Rate with 0.006 mL/day.  Should reflect Emma's last visit information.


comment:
8th action: Add on-screen text in grey "Position the programming head over the pump."
Then the blue directive "Select the OK button."
Make outline around OK button wider/brighter.


comment:
9th action: update on-screen text "Once Telemetry is Complete, select the OK button again."


comment:
Last screenshot: show the Pump status screen scrolled with the low reservoir alarm date visible and highlighted (will want to highlight in a different way, so the learner doesn't think they need to click on it).


comment:
All screenshots need to be updated. The Current Pump Settings at the bottom of the screenshots show Minimum Rate. Info should reflect Emma's last refill settings.


comment:
Make the outline around the Alarm tab and all other buttons, etc. wider/brighter so the learner can see them.


comment:
6th action: update on-screen text "Using the scroll bar, review the Low Reservoir Alarm Date."
- update New Pump Settings information - needs to reflect Emma's settings. same goes for the Current Pump Settings at the bottom of the screen (should show Emma's previous refill visit settings).


comment:
8th action: Update on-screen text "Confirm the prescription information and select Yes."
- The Prescription Confirmation info is incorrect. It should reflect Emma's settings. Same for the Current Pump Settings at the bottom (should reflect Emma's previous visit settings)


comment:
10th action: Update on-screen text "Once Telemetry is Complete, select OK."


comment:
Last screenshot: Show the Pump Status screen scrolled with the Critical and Non-critical Alarm Intervals displayed.  Highlight the information (will need to highlight differently so the learner doesn't think they need to click on the info).


comment:
Last screen: Update on-screen text to "Confirm the alarm interval values on the Pump Status screen."
Move the directive to below the grey on-screen text (for consistency).


comment:
Since I suggested we remove the alarm tones earlier in the course, would it make sense to move the horn icons to this page and let them click to hear the sounds(if they choose, it wouldn't be a required action)? or is that overkill?


comment:
On script, Why do we say before we dig into early termination, this map covers all site close-outs, not just early termination ones.


comment:
For participants, I would say there are 5 key roles that participate in this process.  I would also say that there are other processes and roles that are triggered off of this process.


comment:
Actually, I would say there are 5 key roles that may participate in this process and that there are other processes and roles that are triggered off of this process.


comment:
Notify/consult other parties need to be expanded to say:
This triggers the following processes:
"Generate Randomization Tables and Provide IWRS Services
"Lab & Diagnostics: Complete Trial After Final DBL
"Manage Closeout of CT Material 
"Manage Closeout of Ancillaries
"Supply CT Material through vTeam


comment:
Provide instructions to sites.  That verbiage is actually wrong.  The instructions to sites is really only around the early termination.  The equipment, etc. occurs later in the process.  The map on this step says:  If the site is terminating from the study early, instructions regarding ongoing medical care for active study participants is provided to sites and the site should be instructed to notify active study participants that the site is closing.  The text should be changed to this.


comment:
I am not sure why the send contract termination letter box is not highlighted. It should be and the box should say that the negotiator should have been notified by the study manager of the need for a contract termination letter to be sent to the stie and the negotiator must ensure that the contract termination letter was sent.


comment:
In the voice over it should say that they document the site is closed.  This is done by updating internal systems to indicate the date the site was closed.


comment:
If you don't want to change voice over, I think it is fine as the wording says to update internal systems.


comment:
I would highlight the site closeout activites box and put the following:  This activity includes doing the required site close out activities. This can include contacting the site to schedule closeout visit, working with the site to resolve all outstanding issues and ensuring that all activities related to closing out a site are completed.  As part of site close-out visit, the TMF site binder owner and the site manager work together to ensure that the TMF sponsor and site binder is complete.


comment:
Who the heck is study coordinator?  Do you mean site manager???


comment:
Didn't we make a global decision to have consistency when using buttons? Should these question buttons be similar to the red buttons we're using in the Select the Right Patient course (Medical History screen)? It would be nice if the questions turned color after they were completed also(the buttons in the course mentioned above turn blue)instead of having a check mark next to them.


comment:
The image needs to be cleaned up, especially the lines and the text.


comment:
On the PPT version of the course (slide 64), there were Notes in red that should be added to this page or be placed on a new slide after this one. The text is:
Notes:
-Audible alarms can be silenced once activated; however, silencing the alarm does not resolve the alarm condition. The alarm condition is recorded in the Event Log.
-All activated alarm events are time-stamped and logged in the Event Log.
-Critical alarms take precedence over non-critical alarms. A non-critical alarm will not sound if a critical alarm is sounding.
-If a motor stall is detected and recovered in the shelf state, a pending alarm will be set.


comment:
I don't like the format of this page, it looks sloppy.  I would prefer having buttons for the alarm messages. When you click the button, a pop-up displays the Alarm message (header), the definition, and the recommended action. Again, red buttons that turn to blue for consistency would be nice.


comment:
Pump is in Safe State message/recommended action text:  I think there was a typo in the Tech Manual..."Infusion" should be capitalized as it's the name of a screen.


comment:
I do not think that the SRR stores the master R & R.  Per the map, they ensure that the non-reviewed translated versions are stored.  Carrie - check the wording on all the roles - or maybe we just take out all the TMF references as it is not really value added?


comment:
I think we need to call out the site manager and the activites that they do.


comment:
I don't like the format of this page, it looks sloppy.  I would prefer having buttons for the alarm messages. When you click the button, a pop-up displays the Alarm message (header), the definition, and the recommended action. Again, red buttons that turn to blue for consistency would be nice.
-Correct the orphans in the 1st and 3rd alarm messages and all recommended actions statement.
- Non-Critical Memory Error Occurred/recommended actions text: remove the hyphen in "programmed" (The tech manual has a typo - currently shows program-med).


comment:
In the PPT version of the course (slide 67), we requested that you make this easier to read. Perhaps make it a check list?  Other ideas?


comment:
-Delete numbering (1., 2., 3., etc.) not necessary.
-Make the outline around the Infusion screen tab wider/brighter so the learner can see it.


comment:
3rd action: make the box/highlight around the Dose button ONLY. Also, make the outline wider/brighter.
- The screenshot needs to be updated, the information in the Current Pump Settings at the bottom of the screenshot is incorrect. It should show Emma's last refill visit settings.


comment:
What is the answer to this question?  The answer should be CLO, site manager, and site monitor.  Quality is not routinely notified.  That is why there is a decision point in the map to determine if quality should be involved


comment:
Take data manager off as an answer.  The map makes not reference to data managers. it may in the future but not now.


comment:
4th action: The Dose interaction needs to be corrected with the appropriate screenshots.  The numbering font/interaction is incorrect. Make sure you use screenshots pulled directly from the emulator for this interaction.
Again, issues with the Current Pump Settings information...this needs to be corrected on all screenshots.
- make all outlines wider/brighter.


comment:
5th action: I clicked on an incorrect place on the screen and the Try Again box displayed, but it never went away. This needs to be addressed.


comment:
Why is this duplicated.  Didn't we already see these slides.  I wouldn't repeat


comment:
8th action: update on-screen text "Using the scroll bar, review and verify the New Pump Settings are accurate.
- Current Pump Settings information is incorrect.


comment:
Is this the study coordinator or the site manager or the study manager?  I think this guy was the study coordinator earlier....


comment:
8th action: I was able to click the > button and move forward before I scrolled and Updated the Pump in action #9. This needs to be corrected.


comment:
I do not even know why this is here.  it doesn't make sense.  In the early termination section, you go to the approvals and acknowledgements map so the answer isn't even correct.


comment:
Now the guy is a study coordinator again.  It looks like he was a site manager before.


comment:
You click on the study manager and get a study coordinator response.  The problem with the quesiton is that the answer is either the site manager or the monitor as the monitor is a site manager.


comment:
Action #9: Current Pump Setting info is incorrect
- make outline around Update Pump wider/brighter


comment:
Action #10: Update on-screen text "Review the Information and select Yes to accept all changes."
- make outline around Yes wider/brighter.
Update 2nd on-screen directive text "Confirm prescription information and select Yes to accept the changes."
-Make outline around yes wider/brighter.
-Current Pump Settings information is incorrect.


comment:
Action #11: For consistency, make 'Position the programming head over the pump.' in grey. Then place blue directive underneath "Select OK."
-Make outline around OK wider/brighter.
- Current Pump Settings information is incorrect.


comment:
Action #12: update on-screen text for consistency "When Telemetry is Complete, select OK again."
- Make outline around OK wider/brighter.
- Current Pump Settings Info is incorrect.


comment:
This screen has problems moving on. I also think this question is not related to the process at all.  You should have decided up front to not close the site.


comment:
This is not in this map so would not put this in.  Maybe put consult quality as that is in the process map as an expert???


comment:
Final screen: Show the Pump Status screen scrolled so the dose information and the Low Reservoir Alarm Date are visible.


comment:
Susan - Yes, there are two 22-gauge needles in the Model 8551 Refill kit. One is 1 1/2" long and the other is 2 inches.


comment:
Perhaps we should add a sentence at the end "Note: The Model 8551 Refill Kit includes both short and long needles."


comment:
Do we need to come back to the landing page before we continue? I don't think so, but we should discuss.


comment:
Can we add an image here?  Maybe a doctor with a patient or something?


comment:
1st sentence: "If your patient presents with any of the following symptoms, he/she may be experiencing..."
"Headaches" is a different shade of grey.


comment:
Just realized this... but shouldn't we be using the same Emma (picture) that we used in earlier courses? Either that or change this patient's name to something else.


comment:
Just a suggestion, but can the Onset/Severity/Resolution graphic be made a bit smaller to give this page a bit more white space?  The screen seems very busy, like there's too much information on the page.


comment:
Similar to the Telemetry Failure page, can we make this easier to read?  Checklist?  Other ideas?


comment:
The study manager is responsible for making decision.  They consult quality.  I would change to say, who should the study manager consult with when there are safety risks?  I wonder if we should take out because site issues map can trigger a site close-out


comment:
Also all sites have to be closed out before the trial can be closed out.


comment:
Consider changing the first sentence - don't like how it ends with "goes"  Suggest: You play a key role during site closeout.


comment:
I didn't hear any audio with this slide.


comment:
The vertical scroll bar did not highlight on this slide.  As we the previous slide, we should call this out to that learners get in the habit of looking at the entire flowchart


comment:
Agree with comments - not a good question to include.  Maybe something like:  A site was closed as a result of an early termination decision by the study team. At the close out visit, it was determined that some of the required regulatory documents in the site binder were missing or outdated.  What could have been done to prevent this from happening?


comment:
Im not sure this question has a place in a discussion around early termination. Yes, having the other sites enroll additional pts to offset this site closing is an issue, but it is not the main focus.  I think we need to have questions that come from the process and the steps that are outlined there.  For example, What are the things to consider when assessing impact (one of those is enrollment mitigation).  Or, we could have a question about what needs to happen is an early terminated site had active pts on study.


comment:
Not important to call out who performs the required steps to enter data.  Just important to understand the required steps.


comment:
Take out the second sentence.  Not true.  Add Planning enrollment at the site, country, and trial levels and planning enrollment ready dates of each site in the trial, this provides a framework for which the trial can be measured against and provides a detailed understanding of how two key aspects of the trial (enrollment and site activation) are planned to occur.


comment:
Take out entering data into internal systems and updating data when necessary.


comment:
Add Finalize the enrollment projections at the trial and country level and enter them into the internal systems.


comment:
Add:  Discuss with sites their enrollment strategy and enter their enrollment commitments into internal systems


comment:
Change to:  Discuss with sites their enrollment stragety, solidify their planned enrollment numbers, and enter them into internal systems.


comment:
This process begins at final country allocation.  The first sentence is incorrect


comment:
How widely known is the acronym CBSO?  I have never seen before this?


comment:
Audio:  This is not about documenting trial risks.  The map does not say this.  This is about developing and documenting any contingencies/mitigations for the trial around site activation and trial enrollment


comment:
Site manager managing multiple trials.  that is nowhere in this map and not important at all.


comment:
What needs to be said for the site manager is that they are responsible for working with each of the selected sites for the trial to plan the site activation activites to achieve sites being enrollment ready.


comment:
For study manager, add. They work with the site managers and the enrollment managers to establish any appropriate mitgations/contingencies for the enrollment and site activation plans for the trial.


comment:
For enrollment manager, say, depending on the trial, there may be one or multiple enrollment managers that are responsible for each of the levels of enrollment:  trial, country, and site.


comment:
For the site manager change the following:  I work with selected sites to determine enrollment READY dates


comment:
For study manager, also add.  I am responsible for documenting all of the contingencies/mitigations for the trial.


comment:
For enrollment manager say: I am responsible for establishing and entering the enrollment projections for the enrollment level that I am responsible for with the different levels being trial, country, and site level enrollment projections.


comment:
Take out the last comment for update enrollment projections as necessary throughout trial.  That is in the other map


comment:
Take out the supplies comment.  That doesn't make sense in this context.


comment:
Change contingency strategies to say site activation and trial enrollment contingency strategies. 
Also change the text to say, enrollment contingency strategies....


comment:
Take out ensure the successful operation of the trial wording.  I would put text to say that setting plans for trial enrollment and site activation are critical to the success of a trial.


comment:
I would change the why of realistice enrollment expectations to realistic site activation and enrollment expectations


comment:
Would change the text of realistic enrollment expectations to say:  we need to know realistic site activaton and trial enrollment expectations


comment:
Maybe create a study manager question that says, who do I have to work with to develop contintgencies/mitigations for site activation and trial enrollment?  Answer site managers and enrollment managers


comment:
Need to change answer to say:  enter trial, country and/or site level projecctions into internal systems depending on what level I am assigned as the enrollment manager.


comment:
Change to say, the site activation and enrollment plans are established. That is what the map says.


comment:
Take out country level enrollment dates.  Not covered int his map. What you do establish is site level planned enrollment dates for all selected sites.


comment:
Create a new box that says:  Site activation plan and say in description:  the plan contains the planned enrollment ready dates for all of the selected sites for the trial.


comment:
How does the heat transfer to the air, we should mention that either the radiator has a fan integrated to it or the fan is fixed to the engine, This fan is driven by the engine and forces air through the radiator


comment:
We cant say that the controller has sub systems including..... and then finish with 'other options', suggest dropping 'other options'


comment:
Suggest changing text to 'Some smaller genset base frames also contain the fuel tank'


comment:
All the components can be accessed by clicking the 'i' without closing the previous information box except the Alternator


comment:
last significance of requirement box: remove extra space between interim and the comma


comment:
first box, second bullet: too should be tool


comment:
maybe consider changing the last text from charge to current and then adding that the current leaves the alternator via the output terminals located in the top of the alternator


comment:
Need to add site level enrollment projections and say that site level enrollment projections should reflect the site's best estimate of how many study participants they think they can enroll with the site's planned recruitment strategy.


comment:
Would change to say, along with the appropriate mitigations/contingencies for these plans, allow


comment:
Study coordinator role in EU is different than this one s=described in the training. Course doesn't cover all regions.


comment:
I think a verb is missing in the last 2 objectives "recognize..." or "describe...."


comment:
Please add the instruction for the scroll-bar


comment:
Last select option (or bullet) - change LoA to CTA


comment:
1st bullet: after Clinical Trial Agreement add "(CTA)"


comment:
What is the difference between the 1st and 3rd answer option?


comment:
"Obtain Approvals & Acknowledgement" should come after "Determine Ongoing Study Participant Care Instruction", just before "Send Contract Termination Letter".


comment:
"... trial has officially been rewarded by the procurement team..."
This seems strange - need to confirm with the SMEs


comment:
Develop, Finalize & Execute Clinical Trial Agreements is an activity within Finalize and Manage Investigator Budgets/Contracts and Administer Payments...it is also its own process.  I think you should either say the Develop, Finalize & Execute Clinical Trial Agreements process or an activity of the FInalize and Manage Investigator Budgets/Contracts and Administer Payments process.


comment:
I think the sentence: It is critical that budget negotiations are efficient and fair needs to be reworded a bit.  It is critical that budget negotiations are done as efficiently as possible.  Prolonged site-level budget negotiations can delay contract execution, ultimately delaying the activation of a site.....

Also, it is important that site-level budgets are fair.  Lilly must ensure that sites are consistently paid at fair market value and ...


comment:
Where you say budget, please use site-level budget throughout the course if referring to the site-level budget.


comment:
Country target budgets vs. country budgets


comment:
Step 1 - After reviewing the site-level budget, sites may need to request additional items to be included or higher costs than what are included.


comment:
Step 2- request additional items or higher costs vs. request for additional costs.


comment:
Step 3 - If additional items or costs higher than the negotiator's limit are requested..


comment:
The exception approver does not negotiate....Once the exception is submitted, the exception approver reviews and either approves or rejects the exception request.

Please check the process map for more info....


comment:
The voice over mentions the target budget....this shouldn't be mentioned.  Can I see the script for the voice over? I would like to take a look and make some updates.


comment:
Knowledge of budgets....I think we need something different here.  I would say something like Remember it is important that Lilly pay within fair market value to avoid the perception of....The next sections provide more information about how Lilly determines the pricing for country target budgets as well as more detailed information regarding negotiating exceptions.


comment:
Should be Country Target Budgets throughout presentation.  This is how it is stated in the BWL process maps.


comment:
I think there still needs to be work on ensuring consistency of drug vs. CT Material.  When we are referring to the line item in the budget, we can use drug administration fee, etc.  If not, we should use CT Material.


comment:
I think there is an issue with proceeding in this screen?  It might be my connection, but I can't move forward for some reason.


comment:
I think we need to look at the responses provided depending upon which answers are selected..I selected drug reimbursement, and the response said..drug administration fees..


comment:
study participant vs. patient unless we are mentioning the fee that's included in the budget.


comment:
UT - This is written at a very basic level because we anticipated refill clinicians to be reviewing this eLearn who may only view this piece. But I am a little worried that physicians viewing these first few slides will be slightly offended. Perhaps we simply say something like "For those of you unfamiliar with the Implantable System for Remodulin, let's briefly review the components and how the system works." That way physicians reviewing this course can see that they could quickly skip through these screens?


comment:
Not sure we should show the pump as an item to gather?


comment:
1:02  The pump reservoir volume should be pointing to the 40 mL under the pump model number 8627-40 40 mL, not the current reservoir volume. 
Also at about 01:25  not sure that we can change this, but since this is her 3rd refill her ERI would not be 81 months  it would maybe be 75 months. Not sure if there is a way we could edit screen without it looking horribly mocked up?


comment:
Wondering if we need to add a box on screen to indicate that the color of drug is only for illustration purposes and is not reflective of the appearnace of Remodulin?


comment:
Either delete the "To empty a 40mL reservoir pump, a second 20 mL syringe may be needed." or adjust to something like "To empty the entire contents of a 40 mL..." In a normal refill they shouldn't be pulling out 40 mL of fluid.


comment:
In addition to CSL comment - the ERI wouldn't be 81 months; and the critical alrm interval should be 10 minutes (didn't catch that one earlier, but I'm sure its in both places)


comment:
SImilar comment as previous - drug color yellow vs. clear Remodulin color. Will that confuse people or is it ok because its just an animation? Also, I think the filter color is now blue but that shouldn't matter, right?


comment:
We need to change the image here. Patient would not be in a hospital bed in their Pajamas with an IV running. Susan/Terri - are they physcially monitored or do they just hang out in the waiting room for an hour? Not sure what image would be better.


comment:
Perhaps we can add a point or star on the graph with Emma's data?


comment:
at the very beginning of this narration, there was a problem with the title "Time & Effort". Looked like there were two titles on top of each other.


comment:
The interaction is talking about changing the Low Reservoir alarm volume, but it is already at 4 mL - so either we are going to talk about changing it to someothing less than 4, or it should start with something greater than 4.


comment:
Note about the yellow fluid - whatever we decide we need to be consistent. Yellow is not the color of Remodulin.


comment:
Agree, I do not like this page. Needs to be in a table or something. Too difficult to track the text.


comment:
I don't have a problem with the screen layout - but I'm pretty sure there is nothing more severe than a pocket fill - thinking it should be all the way to the right?


comment:
Site-level budgets have been sent to sites and negotiations have begun.


comment:
For the answer...I would revise to the site's request is acceptable given the site's costs.


comment:
I share the same feeling - its a very text heavy screen. Wondering about converting to a flowchart? But a lot of these activities would be happening at the same time so I'm not sure exactly how to convey. Could look at flow charts used in clinical trial? Or maybe UT has other flowcharts?


comment:
In the response, instead of ignored, please use the word rejected.


comment:
Slight wording revision: is a high workload for sites to set up the trial...vs. set up for the trial


comment:
set up the trial vs. set up for the trial


comment:
should it be aligned with the country target budget vs. appropriate to the?


comment:
I would stop the sentence at can delay getting the site activated.

Remove the rest of the sentence: so the site is unable to enroll....


comment:
is there any benefit to also including the Develop, Finalize and Release COuntry Target Budgets process map?


comment:
Recognize the IMPACT of keeping the vendor budget and contract process moving forward.


comment:
Suggested re-wording: Vendors employ physicians and other site personnel who meet the definition of non-Health Care Professionals (non-HCPs).  It is important to ensure the budgets and contracts process moves forward smoothly to ensure we are able to maintain effective working relationships with our vendors.


comment:
The voice over talks about the budget, contract and administer payments but the title doesn't match.


comment:
Instructions say to click each red highlighted box, but there aren't any on this screen?


comment:
The voice over says obtains the study outline from the site.  They are obtaining the budget from the site.


comment:
When clicking on the Determine Budgeting Organization activity, the title of the description says Determining vs. Determine.


comment:
For Determine Budget Organization, revise the description: Based upon the scope of this course, follow the non-HCP path...or something similar.


comment:
The description for Obtain Budget needs to be revised: The request for the budget from the site is the first step in initiating the budget process with the non-HCP vendor.


comment:
Several different roles are involved in the vendor budgets and contracts process.


comment:
CPSDS Representative vs. REpresentatives in the description when you click on the guy.


comment:
Disregard message regarding CPSDS representative:)


comment:
Study Managers review the budget for content and ensure the amount is within the overall trial budget.


comment:
CHeck section titles....should this one have a "?"?  I think the last section did.


comment:
This question is confusing because if it affects the budget, I assume you will want to check the budget too?  You might have a different scenario where it just focuses on contract language change request.


comment:
I don't think we typically have anyone signing the budget.  The budget is typically an attachment included in the agreement.  Should we say something like: The site requested an update to their budget, so the contract needs to be amended.  Who signs the amendment?


comment:
regarding the response, it would be sign the agreements throughout the process vs. budget.


comment:
Slight revision: Now that you know a bit more about the process and the roles involved, let's see if you can determine who is responsible for certain steps in the process.


comment:
Regarding the response...track of all documentation related to funding for the trial and can make this available as needed.


comment:
Regarding the response....In additional to maintaining trial funding documentation, the Study Manager should be able to respond to questions regarding the protocol.


comment:
In the email..do you approve?  vs. do you approve of it?


comment:
I would revise the response slightly: Initiating a preliminary contract with the vendor can ensure the process for declaring the CRU ready to enroll study participants occur more quickly??  or something like that.


comment:
Please be consistent across ALL the training regarding whether or not we include the associated procedure on this screen.


comment:
I will work closely with JTB Health during contract negotiations to ensure everything is covered for them and Lilly.


comment:
He has just started working with a vendor (or use CRU here), JTB Health, who has been selected to run a trial for Lilly.


comment:
Add new bullet & sub-bullet list after "Explain why Hematoxylin set at Level 1 changes..." and before "Demonstrate how to edit the existing protocol;"

Explain that the Roche-Supplied Protocols can not be adjusted. These include:
H&E Coverslip Recovery - to be used when the coverslipper becomes disabled for any reason and completes the staining but does not complete the coverslipping. 
Coverslipping for IHC, ISH, and Special Stains - to be used to coverslip slides after they have gone through the IHC, ISH, or Special Stains staining process from a Roche Tissue Diagnostic system. 
Dry Deparaffinization - to be used to dry and de-wax slides before loading the slides onto a Roche Tissue Diagnostic system without deparaffinization capabilities.
Note: Laboratories must validate Roche-Supplied Protocols to ensure that the final slides are acceptable quality for the medical director.


comment:
Delete second objective & replace with:
Check the Sleep Timeout and Backup Enabled Settings.


comment:
Recommended Reinforcement Activities change second bullet to:
Practice checking Sleep Enabled and Backup Enabled settings.


comment:
The first step in the process is to obtain the budget and payment schedule from JTB Health, but I know there is something else I need to double check too.


comment:
is it protocol outline or protocol schedule?


comment:
I would remove the last sentence in the answer.


comment:
Negotiations are occurring with the vendor contract.  While this is occurring, Andrew is waiting on the final protocol to be approved.  What happens when the protocol is approved?


comment:
Instead of trial protocol, I would say protocol.


comment:
Now that everything has been approved, the final step is to begin the contract signature process and purchase order creation.

I don't think it's accurate to say that they can begin to enroll study participants as there are other regulatory requirements that need to be met.


comment:
Check terminology.  I was thinking we were using vendor given the statement in an earlier screen vs. non-HCP or CRU site.


comment:
Course title needs to be updated - Liat System needs to be Liat Analyzer


comment:
legal screen - needs to say "1216" in where it's "xx16" now, right above the return button.


comment:
resources popup - update number to "1-800-526-2272"


comment:
there looks like there's an extra space before activate in bullet 1


comment:
There's a random number on the middle of this screen, by the robot.


comment:
transcript - bold cobas IT at the end of line 1


comment:
Rather than send this to Roche, I'm going to ask you to do a little photoshopping. On the screen that says "In this example, we select cobas Liat" that shows the Instrument Type drop down, please cover cobas b 121, cobas b 221, and Bio Triage with a white box so it's not visible to the learner.


comment:
transcript - very list slide, Certificate needs to be Certification


comment:
Can you photoshop the same names out of this Instrument Type list too? cobas b 121, cobas b 122, and Bio Triage


comment:
transcript needs to be updated so it says cobas liat analyzer, not cobas liat system


comment:
remove the extra "the interim stage is then automatically checked" - make sure it's timed to the highlight and check


comment:
you also have an old audio file that on interim tab that says Enter 6 in the duration months field. - need to remove and make sure the slide is timed correctly.


comment:
don't show the reminder screen - make sure you're clicking the OK button the certified tab


comment:
remove Customer Support, but keep the phone number.


comment:
for the first OST box, only have the text that is said onscreen. Also update the Transcript to match what the audio says.


comment:
this whole practice will come from Roche - when you get it, please unbold the "The following settings are ..."


comment:
You still have it auto-playing one slide. Everything must be click driven. When we get the files back from Roche, let's have a call to discuss this one.


comment:
same edit to instrument type drop down - need to remove the cobas 121, cobas 122, and Bio Triage


comment:
Please update the first OST box and the transcript to actually match the audio.


comment:
update instrument type drop down box here too


comment:
transcript and OST for first box is missing Analyzer in product name.


comment:
need to remove same products from Instrument drop down


comment:
they need to select OK after they enter the Max attempts. The should not go into the reminder tab at all.


comment:
rball needs to be superscripted in transcript


comment:
change blue Customer Support to say "For Support"


comment:
resources popup - change Customer care to say "For Support" as well


comment:
left nav - please move the legal section in the left nav down to the very bottom


comment:
updated "or" to "for" in transcript but audio still says or.


comment:
Menu is still in wrong order. They want it to go vertically from Programmer Screens to Programming for New System Implant, then have Programming a Prime on the right.


comment:
This screen should have been updated to exactly match the same screen in the Refill course. As far as I'm concerned, please copy paste from that course - just make sure to update the course title at the top of the screen when you do.


comment:
alarms feedback - need to move "the" down to line 3 so pump isn't alone.


comment:
Update transcript by replacing the bullets at the end with the attached script.


comment:
Update first paragraph of transcript with text being provided.


comment:
last line of gray text, update Remodulin to be "Remodulin (treprostinil) Injection"


comment:
add a final sentence to the transcript that says "Review the current pump settings and select the OK button."


comment:
and add one more after that which says "The pump is now updated."


comment:
Make "here you see Susan's information..." grey text.


comment:
all of the steps need the text wrapping, so the second line is indented appropriately. Please apply globally.


comment:
the red highlight for the drug box appears behind the screen shot where I need to click the alarms tab


comment:
when click ok directions appear, the scroll bar highlight is still visible on the right


comment:
some of the screens get really blurry in this one. Can you let me know if you need new screen shots of those?


comment:
when telemetry complete appears - the grey text comes back. Instead, it should say "When Telemetry complete displays, you can select Ok and see a summary of the update."


comment:
when you come back to this page, it doesn't reset like the rest of them do -you can only click infusion and move on.


comment:
same issue here - when you return, it doesn't reset the exercise.


comment:
Can you have these red boxes appear one at a time - so first highlight the 0, then the 4, then the OK?


comment:
the first screen shot for this screen should have come from the second tab of the Excel edits sheet, per my initial notes. They shouldn't have to scroll to click Update Pump. Let me know if we need to talk through this interaction, because it's not right.


comment:
Matt needs to provide new screen shot on programmer.


comment:
prior to this screen, there should be a new screen that is the in the PowerPoint I sent- slide 2. I will ask Matt for the image of Susan.


comment:
in transcript line 2, change "plus button" "arrow button"


comment:
delete "confirm there are no active alarm events, and" from the transcript - make "Select the ok button..." the last sentence.


comment:
after "Select the dose button..." in transcript, add "Since Susan's dose is 80 ng/kg/min, enter 80."


comment:
update transcript to after "Select the dosing weight..." sentence to include "Susan's dosing weight is 75 kg, so enter 75." then continue on with "Select the prime..." as is


comment:
starting at "Record the time duration..." through the end, use the updated transcript provided.


comment:
Lilly decided last night to remove these videos from the course. Delete the screen and be sure it's deleted in the menu as well.


comment:
This edit wasn't made: As a solo item, I didn't know what the "Provide Relevant Trial Specific Info" box was speaking about. It needs to say "...provides relevant trial-specific information TO THE SITE(S)..."


comment:
to confirm - don't just copy this over - i just think you need to revise that first sentence without the all caps crap from Erin :)


comment:
update entire transcript with what I'm sending.


comment:
when entering Dose - the OK button should be white. Let me know if you need a screen shot, although I think we probably have one that we can crop the button out of.


comment:
for dosing weight - again, the OK button would be white.


comment:
when you come back to this interaction, the next button needs to be active.


comment:
for all blue directions, make sure only "Click" or "Select" and the button they click are bold. For example, "Review the information screen and select Yes." only "select Yes." should be bold.


comment:
Telemetry complete message needs to appear before the "Click the scroll bar and confirm..." step. So they have to click "OK" on Telemetry complete screen, then get this step, then trigger Next when they click ok on the scroll bar screen. Let me know if we want to do a call to review this one.


comment:
Have screen locked until they click all of the numbers. Then have directions appear that say "Click > to continue." and activate next button. Make sure that when they click back, the screen "unlocks"


comment:
when you click 3, 4, etc. the red box for the previous step (on the screen shot) needs to go away.


comment:
Is it possible to have the number buttons grey out after you click them?


comment:
Where's the video? Per the edits, the previous screen was new - then there was still the video screen. We sent a revised video that should go on that screen.


comment:
Conduct site elaluation visit, missed edit: remove the last sentence. Replace with" Refer to the Select and Manage Sites Guidebook for recommendations on conducting site evaluations"


comment:
Where's the programmer screen? The image still needs to be here - line 86 of the spreadsheet was to another page in the course, not this one.


comment:
This screen should not have a screen shot. The directions should say "Click > to continue."


comment:
Pump Alarms screen 2 has the wrong provide feedback number so I couldn't enter edits there. On that screen, please trigger the "Tip" box to appear after the learner has clicked both critical and non-critical alarms and the "Click > to continue." direction and button appear.


comment:
can't get past pump alarms screen 2 as I can't click "non-critical" alarms; next is never triggered.


comment:
pump alarms screen 2 - you can still click both alarms at once. Please lock it so you can only click one tone at a time.


comment:
Let's talk through this one - I think we need to eliminate the last two sentences of both correct feedback boxes and instead adjust the onscreen directions. So if the learner clicks one answer, the directions update to say "Click another tab where you can find the information." and then when the second correct answer is selected, the directions change to "Good work. Click > to continue."


comment:
make "Once selected, view..." grey text please.


comment:
Try again feedback stays onscreen, even when I then make the correct selection. It should go away when I get it right.


comment:
The protocol has been amended to add a new procedure which will impact the trial budget.  The site has already reached out to the Study Manager, and the Study Manager has reached out to the CPSDS Representative.


comment:
we will maintain strong and effective working relationships with vendors.


comment:
step 2 - i think there's an extra period


comment:
There is not a map called Vendor Budgets and Contracts in BWL...you would want to refer to the Finalize and Manage INvestigator Budgets/Contracts and Administer Payments process map.


comment:
The Vendor Budgets and Contracts process map does not exist in BWL.  Need to refer to the Finalize and Manage Investigator Budgets/Contracts and Administer Payments map.  Please update throughout course.


comment:
edit not made: Confirm - change to "I see the negative consequences to the patient and customer who can't get medicines they need due to poorly chosen sites"


comment:
remove the last sentence you added to the grey text - per the spreadsheet, there was no change required to address that edit.


comment:
for SPI, delete the "must be reviewied" sentence


comment:
Change the ISEC definition o: Investigator Site Evaluation Checklist


comment:
For the COPM role, we need to only use what they've already seen in the course. So, taek the two sentences that are on that one slide and turn them into bullets for this screen,.


comment:
Edit speech bubble: Delete "Well, I have!" and add: "Turn on the sound and click the play button to see what happened in my dream." (bold instructional items)


comment:
I see, you split it into two poses - Please make text edit, and delete the second pose. I'd like there to be one landing screen before launching the animation.


comment:
Music at the beginning sounds weird - like, skippy or something (?)


comment:
Please double check - hot spot for back button seems like it's actually above the button itself.


comment:
can the terminology come onscreen sooner? it's on so short right now, there's not enough time to read it


comment:
End of animation: extend this timeline so there's time to do a music fade out


comment:
3rd button down the right, chnage to: Site evaluations, including past and current ISECs and SPIs as well as documentation of follow-up activities that need resolution


comment:
mag link is broken. It doesn't oepn anything


comment:
There's something weird going on with this where the red box is showing up sometimes and moves around when I move the slider


comment:
ok - now i see what's going on. I would disable the slider until after VO is finished if possible.


comment:
This is a nice to have, but your process maps are stretched on most pages. Not sure why that's happening.


comment:
Missed edit: Use country level instead of country specific to refer to the master ICFs


comment:
ok - now i see, this accepted edit contridicts the accepted edit below. Still think we should change to country-level


comment:
Realize that "Turn on the sound" is confusing. What do we normally say? Make sure your computer speakers are on?


comment:
I think the audio is actually too low now. Can you bring the volume level back up?


comment:
Replace "Let's listen in" with "Let's see what they have to say."


comment:
first sentence: Add comma after "Lab results," and comma after "input,"


comment:
Edit bullet 3: "...can be treated by certain antibiotics and helps to improve our antibiotic stewardship."


comment:
Please un-bold - Sorry, the bold was to show my comment in the spreadsheet.


comment:
Edit Inoculation loop rollover: "A simple metal or plastic tool...at the other. Used to inoculate or streak plates for isolation using a method that dilutes a sample across the four quadrants of the plate."


comment:
Make sure all three references to MALDI-Tof use the little "of"


comment:
Lord have mercy. Edit question: "Observable characteristics of an organism are called:" 
Sorry :(


comment:
Please add "an" to the feedback as well. Sorry again.


comment:
Insert the word "testing" after the second space/before the comma


comment:
Did I rewrite this? Spreadsheet edit says to change to: "You and I make a great team! I look forward to working with you in the next chapter. We will learn exactly what happens at each step of the lab testing process."


comment:
Maybe at the end of the catheter sentence (after prescribed flow rate), add "which is calculated by the programmer?"


comment:
If we keep the animation, can you make the transition of the syringe from the vial to the pump smoother?  It looks shaky.


comment:
Delete 2nd & 3rd main bullets & all content.
Replace with:
Demonstrate where the Sleep enable time is located. 

Explain that when the sleep mode option is enabled the system enters sleep after the set time has passed and no additional trays have been loaded
the last tray finished processing.

Explain that to exit sleep the operator can:
Insert a new tray into a portal
Remove a processed tray from a portal
Or tap the Eject button on the computer touchscreen.


comment:
Need to add information re: underlined text links (in this course and any others that may have that interaction).


comment:
General system issue - I literally went into the 'Lab' room 10 times and checked all four items and my only option was to select 'Back'.  It then took me back to show the four rooms and each time, 'Lab' was not checked as if I had not completed it.


comment:
Since we have underlined rollovers on this page, need to make sure we have information on the Navigation page so users know they can rollover the text. 
Formatting issues in non-critical alarm pop-up needs to be corrected.


comment:
Should the first sentence say '...discuss a site's sample collection, processing...'?


comment:
1st directive: for consistency, state "Click the Testing Alarms icon to learn more." or "Click the Testing Alarms icon to begin." 
Delete "Click the icons to practice"... it's not needed and the double directive is confusing.


comment:
1st page/2nd sentence: update to state "Periodically, re-demonstrate the alarms for the patient to confirm he or she is still able to hear the tones."


comment:
Update on-screen text when the Tool Kit screen tab is displayed. "When the Tool Kit screen tab is selected, the Alarms sub-tab is automatically displayed."
Update the directive "Select the Critical Alarm Test button."
See Sonja's comment...should just hear the tone


comment:
The Technical Manual (page 99)states "The programmer sounds a telemetry complete tone." Let's discuss since Sonja doesn't think there's a tone.


comment:
Non-Critical Alarms
-Update red header accordingly. Should say "Testing Alarms: Non-Critical Alarm"
-Update directive: "Select the Non-Critical Alarm Test button." delete lead-in.


comment:
Last screen for Testing Alarms: Update the red head to "Testing Alarms", delete ":Critical Alarm"


comment:
2nd directive: Change to "Click the Low Reservoir Alarm Volume icon to continue."
Also, update the label on the icon to "Low Reservoir Alarm Volume" and update the lead-in verbiage to "low reservoir alarm volume"


comment:
Reword the option 'Tell her you'll need to check with the study team/CLO to see if a loaner can be provided and that you will follow up with her later.'  CLO would not approve or arrange a loaner centrifuge - this would be a study team decision/approval (budget impact).  Can discuss in review meeting Friday.


comment:
I agree with Sonja's comment. We may want to discuss what to show here.


comment:
3rd directive:Change to "Click the Change Alarm Interval icon to continue."


comment:
update feedback - after the first sentence add "Since Lewis, her supervisor, is a non-decisional employee, he should not be asking her about the results or outcomes of her work connected to this process."


comment:
Not specific to the training module, but why is PK/PD sampling specifically called out in the SPI (vs. other types of samples with special processing or collection)?


comment:
for correct feedback, add a new second sentence that says "Sue redirected the conversation away from the confidential information. Since Lewis, her supervisor, is a..."


comment:
Is it necessary to return to a Congratulations slide?  I don't think so, especially since we have a review on the next slide.


comment:
the first answer shouldn't be correct - only the last paragraph


comment:
Directive on 1st slide of Difficulty Palpating Pump or Locating Refill Port should state "Click > to learn more.", not "Click > to troubleshoot another issue."


comment:
correct feedback needs to say "While social media is a great tool to connect professionally, it's important to remember the importance of confidentiality. MISO employees should not share any information that is not already public information shared on our public website or public social media sites."


comment:
Troubleshooting Refills: Correct the orphan in the 1st sentence/paragraph.


comment:
Correct the orphan in the directive "Review the Information and select Yes to accept all changes."


comment:
After selecting OK on the Telemetry Complete screen, the image on the Pump Status screen should show the top of the screen (it's currently scrolled to the bottom). 
- Seems as though we should give a directive "Use the scroll bar to review the new pump settings." and then "Select OK to close the Pump Status window."


comment:
I agree with Sonja, go directly to the Recap.


comment:
Correct the orphan in the Pump Pocket Fill pop-up box.


comment:
Correct the orphan in the lead-in statement.


comment:
Change the first sentence to read "Every person in EIM has a role with a set of applications to help accomplish their tasks."


comment:
The beginning of this animation is very sparse.  There's lots of white space.  Is there some way to jazz this up by changing the text and the icons larger and more interesting.


comment:
Recommend that if the Processes objective stays written out as it is, that it moves up under the conversation piece, since they will likely go together.


comment:
If you try and go back and review a screen tab, you must go back through  all screen tabs in order, which is frustrating.


comment:
Suggest highlighting the section of the ISEC we are looking at in bold and another color, so it stands out in this list.


comment:
Also at the end int he screenshot the critical alarm interval is 1 hour, should be 10 mins


comment:
Maybe do something similar to the accuracy ratio where you had the red boxes over each element so you know where to click?


comment:
Reason #1: The site must have the necessary equipment and facilities to be able to conduct the protocol procedures safely and appropriately.
Reason #2: Equipment and facilities are key aspects of ensuring that trial subject safety is maintained, along with providing key data for evaluation of our investigational products.


comment:
Sample Loading Area text change at the end:

...SurePath, as well as a range of primary and secondary tubes for serum and plasma used for Virology assays.


comment:
Dossier for cobas 4800 has the title above the table as cobas 4800 but the document contains the information for cobas 6800.  Need to change the dossier here.


comment:
The SPI section that will apply for this module is: Site Managed Laboratory Information And Associated Processes


comment:
Unless you are going to have a SPI screen titled the same with the same set-up, I think this should be "Explore the Required Information for Site Evaluation" or something that includes both the ISEC and SPI and then have all the questions included here (probably a two page set-up based on the number of questions).


comment:
Wondering if this should be a build?  It's a whole lot of information in one screen.


comment:
Agree with layout- too much information.  Need a better way to structure the info.


comment:
If we have to wait for CTNG to finish to run HPV why is the CTNG sample rack still onboard?


comment:
Agree with Sonja.  I would think we should have all extremes for a pocket fill, but maybe UT can confirm.


comment:
SPI Question: Does the investigator site have a defined process on the collection, processing, storage, and shipment of laboratory specimens?
Why is it important?: Proper management of samples is critical to the accuracy and reliability of testing; Laboratory results influence therapeutic decisions and can have significant impact on patient care and study outcomes if not accurate. Not having an established process or consistently following the process for the collection, processing and shipment of specimens can lead to inaccuracies and also audit findings which could result in data from that site not being included, putting our submission for a compound at risk.


comment:
Nice work!  The cobas 4800 System is easy to use. It has the ability to run different assays in staggered processing. Once the first assay has moved to amplification/detection you can begin extraction for the next assay.

In this case, we used 24 format kits, but with 96 format kits, a lab would increase the throughput of the system to adapt to changing workload demands.


comment:
Can you add the schedule here so they can look at how many HIV-1 and HCV tests to run?


comment:
For the wrong answers can you say something at the beginning like..

Close but that is not quite correct...


comment:
SPI Question: Investigator site  laboratory accreditation - Choose all that apply [Not sure if you need the full list of options here?]
Why Important?: If the site prepares and/or ships laboratory specimens they need to have the required training & certifications based on local requirements.


comment:
Wrong answer (Yes....) should be in red.


comment:
The pop up box is confusing is there a way to have the keyboard that is being discussed pop up?


comment:
SPI Question: Does the site study staff that prepares or transports dangerous goods have training that meets the IATA (International Air Transport Association)?
Why Important: It is a GCP requirement that anyone who prepares or transports dangerous goods is IATA trained.  Sites need to be able to produce supportive documentation that any staff performing these tasks have the training.


comment:
cobas z needs to be in bold font

The "No" answer is correct and should be in green

These were switched.


comment:
I tried to go back to review the previous screen and it took me all the way back to the beginning of the six screen tabs.  I had to work through all the screens again.


comment:
Does the site have access to the following critical equipment needed to participate in this trial:
[Note to show somewhere...this question is an example as customized by a Trial Planner]
1. Centrifuge: does NOT have to be refrigerated. 
2. Refrigerator: 2°C to 8°C /36°F  46°F
3. Freezer: -20°C (or colder) and that is not automatically defrosting.
4. X-Ray Machine (Digital preferred) 
(Formatting note, final screen shots of system *may* have each equipment piece with a checkbox next to it)


comment:
Need a statement to say if they got the answer right or wrong. 

Need to spell out cesarean section (c-section) and then can use c-section throughout. Should be hyphen when c-section.


comment:
Correction comment...  
Does the site have access to the following critical equipment needed to participate in this trial - this is an ISEC question


comment:
Following the "you got it right and/or wrong" statement, move "Fortunately..... to the top.

Then bullet point the next 3 sentences to ease readability


comment:
ISEC Question: Does the site have the basic/general equipment used to conduct standard of care treatment procedures for patients on clinical trials?
Why Important: While this may not be called out as critical equipment, all interventional clinical trials have basic SOC procedures included and require this equipment to be available.


comment:
Ok..so we get the same answer regardless of the choice we make on the previous screen. If this is the case and there is no "right or wrong" then we should start with the Fortunately statement..


comment:
Instead of 500, can we put 188 as an incorrect answer?


comment:
Video is specifically walking through Emma's refill, previous screen stated that last refill was 40 mL refill, in video it states and list the option for supplies to obtain either 1 or 2 (20) ml Vials of Remo.  It should state 2 vials, since will be 40 ml refill


comment:
ISEC Question: Does the site staff understand and are they willing to comply to the expectations for critical equipment calibration and maintenance, as per manufactures guidelines, and certification documentation?
Why Important: This equipment is used in determining trial objectives (including safety objectives), in addition to equipment used in IP and/or samples temperature control or preparation. It is critical that this equipment has defined process of calibration and/or maintenance as per manufacturers instructions. Site's must understand and be willing to comply with Lilly requirements for Critical Equipment in order to participate in our trials.


comment:
For the last quiz section we got it wrong the first time but could not go back and try again (just to test it correctly). Kept jumping to the feedback screen.

Also, should not group assays in this assay if they can't be run together on the system in mixed testing - could be misleading.  Ex: HIV-1 and HBV should not be together.


comment:
SEC Question: Will the site be using a local laboratory for this trial?
   If Yes - Provide the name(s) of all the local laboratories that will be used.
Why Important: It is a requirement of the sponsor to collect the name, address and description of clinical laboratory facility(ies) involved in the research to enable the assurance that the investigator has adequate facility(ies) available. If a site will use a lab other than a central lab, the name must be collected and further documentation will be documented as appropriate during site activation activities.


comment:
There is an optional "Comments" box available at the end of both applicable sections in the SPI and ISEC. I might call out a separate box that speaks to "section comments" and says something like: Additional relevant commentary that is not captured in a specific question but demonstrates the site(s) qualification to participate in research/the trial can be documented in the section Comment fields."


comment:
I didn't realize this was called out separately. If it remains called out on it's own for the form, I recommend it comes before the ISEC (often an SPI may be initially filled out before an ISEC). Personally, I think having all the questions tied together and just identified as SPI vs. ISEC on the screen helps to show that all the questions have to be reviewed during the site evaluation process, regardless of the form type.


comment:
...make sure you understand their needs and then decide how to correctly position the cobas 4800 System for their laboratory.


comment:
Add more description to "Dossier"...maybe say "cobas 4800 and 6800 System Dossier"


comment:
Would not say "highest"...

Flexible workflow to increase routine testing efficiency with mixed and staggered testing, loading of primary/secondary samples, ready-to-use reagents and minimal hands-on time.


comment:
Good Example, ISEC Question: Does the site have access to the following critical equipment needed to participate in this trial
(possibly checkbox list of items, if not, just a list). CT Scanner, 12-Lead ECG, Bone Density Machine (DEXA) 
Appropriate Response: (If checkboxes, check yes for all except CT Scan) Site does not currently have an established relationship with the local CT Scan facility.  Site understands requirements for the equipment and has multiple facilities they can reach out to for the potential to partner with them for this procedure. PI understands that this will need to be in place prior to the site being declared ready for site initiation.  If the site is unable to find access to a CT scanner they will not be able to participate in the trial.


comment:
First Example - Why it is good: Clearly identifies the equipment access that is missing, along with the site understanding clearly what is required. It outlines that they have options to get the equipment in place and that if it winds up not being something they can get access to, it is understood they will not be able to move forward in the trial.


comment:
video states: Depending on the assay there can be positive and control cassettes.  All assays need positive and negative controls. Qualitative assays have one positive and one negative. Quantitative assays have low positive and high positive controls plus negative controls.


comment:
Maybe change label to "Volume per Testing Day".  It is bit confusing saying Volume per day and then having an average per day and the numbers are different. You can figure it out based on the frequency but let's spell it out for them.


comment:
...it has stability for up to 30 days on board the system.


comment:
...leave reagents on board for up to 30 days..


comment:
SPI Example - Does the investigator site have a defined process on the collection, processing, storage, and shipment of laboratory specimens? - Answer: Yes
Optional Comments: Site has defined process in their training procedure that outlines all personnel involved in laboratory specimen collection and management will be trained on the protocol specific laboratory manual and will follow all required laboratory processes outlined for the trial. Site confirmed that they document all required laboratory information for trial specimens as part of their study specific source documentation, if not captured as part of the laboratory requisition.


comment:
delete the part about cobas 8800...we said at the beginning of the module that we would focus only on cobas 6800.


comment:
SPI Example- Why is it good: It provides clear , pertinent information on what how the site ensures process is followed (all people handling labs must follow the trial lab manual) and their process for ensuring documentation is maintained (lab requisitions and study source documents).


comment:
Bad Example, ISEC Question: Does the site have access to the following critical equipment needed to participate in this trial (possibly checkbox list of items, if not, just a list). CT Scanner, 12-Lead ECG, Bone Density Machine (DEXA) Incomplete Response: (If checkboxes, check yes for all except CT Scan) Site does not have access to a CT scan.


comment:
ISEC Question - Why Incomplete: There is no documentation of the plan to obtain access or evidence that the site understands this is required equipment that will halt their participation in the trial if not available.


comment:
Bad SPI Example - Does the investigator site have a defined process on the collection, processing, storage, and shipment of laboratory specimens? - Answer: No Optional Comments: Recommended site put this in place


comment:
Bad SPI example: Why insufficient?: This does not provide enough information about what IS in place at the site, is it simply not a robust process, how do they handle samples now? It does not provide any clarity on what exactly was recommended for the site to put into place, better documentation, whole new processes, etc. Proper management of samples is critical to the accuracy and reliability of testing and without better understanding and documentation around a "No" answer to this question, it would be hard to defend why the site was selected, especially if laboratory processes came into question during an internal or regulatory audit.


comment:
I simply merged the SPI and the SEC together - think they should occur in the same screens, especially as we don't have 3 examples of good/bad for each document specific to this section.


comment:
Reagent cassettes can hold enough for 96 tests (HxV, CMV & LDT) and 480 tests for (CT/NG & HPV). Because reagents are stable on board for at least 30 days, we can load the reagents we need for our week of testing.

You need a total of 8 reagent cassettes:


comment:
Adding 7 control cassettes to Bay C brings the total to 15 cassettes in the refrigerator which has a capacity for 16 cassettes.


comment:
Since you do not have enough tips for the week of 910 tests, the system will alert you when you need to load more tips.


comment:
Same feedback as for tips....ie having to load more during the week and system alerts them


comment:
You have loaded enough amplification plate for 768 tests.  
Then add same message as for processing plates...system will alert you blah blah


comment:
Great work!  You now know how to load reagents, controls, consumables, and samples on the cobas 6800 System. The system will alert you when you need to load further reagents, controls and/or consumables. After you load the rest of your samples for Monday maybe you can use your "work-away" time....


comment:
Great job loading samples. Now you just need to start your run! 

You can see your first 96 results in about 3 hours.


comment:
You have already loaded the reagents, controls and consumables for almost a full week of testing so you can wait until the system alerts you to load more or you can top off the reagents and consumables Tuesday morning. 

We will add 4 tips racks to Bay D to fill up the system.

Dewi check this


comment:
4 or 3 plates?  Dewi?

We did 190 tests.


comment:
Top statement is repetitive...can we just say..Now time to load samples.


comment:
Should show the samples completely mixed - all colors in different combinations on each rack of 5 so looks like an Easter egg basket. This shows how no sorting of samples is required. In this example they are still being grouped by test type.
This will require some re-recording of voice over - please send the script to Cheryl.


comment:
Also need to think about the impact of preanalytics for some sample types (like HPV, CTNG) - at least to note they require aliquoting before they are on the RD5 rack. Could be text or voice over mention need to address this....
Dewi?


comment:
The cobas 6800 System has a priority lane and I can use that to run this sample.


comment:
The tech disappeared before we could finish reading the correct answer.


comment:
Indicate whether the answer is correct or not in words vs just color.


comment:
You would only need to return to the system to load new samples if they arrived later in the day to the lab, plus more reagents, controls and consumables when alerted by the system.


comment:
Need to add more feedback:

"possibly..."  This is not wrong but also not correct.


comment:
Change "They" to "It" at beginning of second sentence


comment:
im not totally sure why the slider for this one? in this case i may just have 2 purple buttons to click "Example 1" and "Example 2" Either way, I would move the slider and stuff down, so you can make the text bigger in the form.


comment:
These questions do not compare to competitors but highlight features that differentiate us from competitors...


comment:
Check question with LDT and HBV - feedback answer had "optimize" vs "optimise"


comment:
Question 2 where I can choose multiple answers once you answer it you can't do it again... like issue for cobas 4800 system


comment:
Add LDTs are run on a separate plate from IVD test.


comment:
Please check copy in text boxes... cobas x 480 Instrument needs a capital I for Instrument and cobas z 480 Analyser needs a capital A for Analyser. I recall seeing a small i somewhere...


comment:
Remove all of the "More explanation goes here." text


comment:
What is this report? text, 2nd sentence: "It also includes a designation if it is an EIM transfer tie" (add the word "it"


comment:
Remove all "More explanation goes here." text


comment:
When to use it text: Change to "Use this report to get the scheduling constraint shadow prices by constraint type per the 5- or 15-minute market. Some examples of constraint types include ETSR limits, BAA transfer limit, and BAA power balance."


comment:
When to use it text: Add 2nd sentence "This report is used to develop the bid adder price."


comment:
When to use it text: Add 2nd sentence: "This report shows the price you will get paid if you were awarded a greenhouse gas allowance."


comment:
Popup callout box: Capitalize "Name" (TAC Name) since it is the name of the filter.


comment:
When to use it text, 2nd sentence: Change to "For instance, if a scheduling coordinator wants to know the base scheduled energy for each hour of a particular day, they could use this report."


comment:
Popup text: "The Energy Type filter can be used to limit the energy types displayed." (missing the word "to")


comment:
When to use it text: Change to "Use this report to look at the total base schedules for a BAA used for each sufficiency test."


comment:
Popup text: Put NEGATIVE and POSITIVE in all caps to be consistent with the text from another report.


comment:
Popup image: Recommend, if we have the source image, that this be cropped to exclude anything beyond the Interval column. The text is so tiny that even blown up, it's impossible to read.


comment:
What is this report? text: Change to: "This report provides 5-minute uncertainty movement MW for each resource category in a BAA."


comment:
Popup image: When the image is blown up, the original can still be seen and is distracting. Can we make the background image disappear when zooming in?


comment:
The Advisory ISO Demand Forecast button links to the CAISO Demand Forecast text and popup image. Change What is this report? text to: "This report provides the demand forecast for the first advisory interval. This applies to both the 5- and 15-minute runs for ISO TAC and other BAAs." Change the When to use it text to: "Use this report to determine flexible ramping calculations." Replace popup image with placeholder box (unless separate image is buried in the programming). Place a callout on the image that says: "The Date Range filter is used for the trade date. The Market Hour Ending and Market Start Date Time can be from the previous day, because it shows the advisory forecast for the trade date that was produced on the previous day."


comment:
The Sufficiency Evaluation Demand Forecast button links to the CAISO Peak Demand Forecast text and popup image. Change What is this report? text to: "This report provides the demand forecast, updated for 23 hours from now." Change the When to use it text to: "This report enables scheduling coordinators to line up resource to meet the next day's flexible ramping needs." Replace popup image with placeholder box (unless separate image is buried in the programming). Place a callout on the image that says: "Data granularity can adjusted to be 15 minutes or hourly, or both."


comment:
This was already in the DP, but in all other scenarios we gave the example people names. Let's replace "a participating resource scheduling coordinator for an EIM Entity" with "Susan". This applies to the correct and incorrect feedback at the end of the scenario as well.


comment:
Intro text: change "fifteen minute" to "15-minute"


comment:
Question 4 of 10 answer options (Ctrl+F "No - these are the only reports that will help...") - when I hover over the last answer option that starts with "No", the answer pops up. This doesn't happen when I hover over the other 2 answer options.


comment:
Add yellow callout box that says: "CAISO: OASIS QRG will be provided once the alpha is approved."


comment:
Remove gray callout box onscreen. Why are we making the Next button visible all the way through the DP? That isn't consistent with what we've done with other DPs.


comment:
Let's move the "Entering bids with SIBR" flag to be centered, otherwise it's skewed too far to the left.


comment:
The "Passing score" text (2 paragraphs) are low on the screen. In the other courses, the period at the end of the first sentence is between the 1st and 2nd white stripes on Edwin's right arm sleeve.


comment:
Intro text, 2nd sentence: Capitalize "Scheduling Infrastructure Business Rules".


comment:
Intro text, 2nd sentence: "...and is used to enter bids, including daily and hourly bid components."


comment:
Intro text, 2nd paragraph: "The modules below provide information and practice on entering daily and hourly bid components, and interpreting data and bid statuses from the bid summary."


comment:
Master File popup text: remove "as well as many other characteristics."


comment:
Last answer option is a duplicate of the 3rd. Change text to "Provides feedback concerning submitted bids." This is the 4th step of the process.


comment:
Change the red Canceled arrow to be a brighter, more red color. Change "Canceled" to "Canceled or deleted"


comment:
Incorrect answers on this screen should read the same as the answer options presented. I put one of the tasks in the wrong place, and it now says "Megawatt scheduling". It also shows that "Master File has been read in" is correctly in the 4th step, which is not true; it belongs as the 1st step. Let's talk about this one.


comment:
We've seen this character before, as Ariel talking to Sonnee in course #14. Do we have other characters we can use here?


comment:
3rd bubble text: Remove the double period at the end, and change "MW's" to "MWs"


comment:
Self-schedule popup box, image: This image doesn't have a magnifying glass and doesn't zoom in.


comment:
Economic bids popup, images: Please add a magnifying glass here so the learner knows they can blow the images up.


comment:
Hourly bid adder (GHG) popup, image: The title of the zoomed-in image should be "Hourly bid adder (GHG)" instead of "Miscellaneous bid component". Also, the red box doesn't line up on the image.


comment:
Please change "Generation capacity" to "Generation capacity limit" both onscreen and in the popup window. For the generation capacity limit image, there should be a red highlight box around only the column directly to the left of what you currently have highlighted. We can talk about this one.


comment:
Functionality: Once a term is clicked, it should change color to a visited state. Once all 4 terms all clicked, the right arrow should appear and the directional text should change to "Click the right arrow to continue."


comment:
The Play button doesn't work here, so the next screen goes to the next task rather than the one shown in the DP script.


comment:
Slightly ignore my comment on the previous screen; the play button doesn't work, but the information presented here doesn't match what's in the DP script. This screen is a duplicate of the next Captivate description.


comment:
Play button should advance the screen here, not the Next arrow.


comment:
Transcript: capitalize the first word in the sentence.


comment:
Intro text: Change to "It's your chance to practice entering daily and hourly bid components in SIBR."


comment:
Remove white background from 2nd bullet text. Change text to "Need to identify an example of a time when an SC would submit a supply bid."


comment:
Yellow callout box: Change "submit a supply bid" to "submit a miscellaneous bid component (GHG)"


comment:
Remove white background from 2nd bullet. Change text to "Need an example of a time when an SC would submit daily bids."


comment:
Capitalize the first word in the transcript, even if it is placeholder.


comment:
When the transcript is pulled up, the intro text appears again, but is blocked by Key Point 1. Make the intro text gone for good once the learner clicks on Edwin to hear the audio and see the key points come out.


comment:
Intro text: Change to "Example question text." (include the period)


comment:
See previous comment: "Example question text."


comment:
The lorem ipsum text looks wonky - at the beginning, it shows up as a double-row and doesn't meet up with the 1st drag spot.


comment:
Resources link callout: 2 spaces between "SIBR" and "Quick"


comment:
The physician is not making a "tentative clinical Dx"


comment:
back button is not working on this screen


comment:
On Video under it highlights the catheter volume when it is discussing pump volume


comment:
Under prepare injection site, is the direction of the pump correct?


comment:
Should the video show periodically withdrawing back on the syringe to confirm placement.


comment:
The alarm date is missing on the programmer


comment:
Should it be print reports instead of printing reports


comment:
How does the user know to clink on the calculation for additional information/definitions


comment:
Should we define what accuracy ration means?


comment:
Under scheduling next appointment, should we discuss the max refill days as 112?


comment:
I was not allowed to continue past post refill schedule was stuck in a loop. Had to go to main menu to proceed


comment:
The red around box to select should be more visable


comment:
Low reservoir alarm volume, what are we trying to communicate to user in this paragraph ?


comment:
should we  show an example of changing a critical alarm to 20 minutes


comment:
should the red check appear after you have reviewed the troubleshooting topic, when you return back to main page you are unsure of what topic to review next


comment:
should a standard dose change be listed as a challenging refill?


comment:
Site reaction being immediate, do we mean during the refill process, or 15 minutes after or 1 hour after?


comment:
remove the red border around the image on the main screen.


comment:
here, and every other screen where we have the red outline, the client wants it to match the captivate files. Use the current stroke, but make the item C72300, with a 20% fill.


comment:
all screen shots - crop so the top white line (with the date) isn't visible.


comment:
Infusion tab - use new screen shot provided by BLP


comment:
toolkit tab - see the attached PowerPoint for revisions. We basically need to tie the bullets/directions to the sub tabs.


comment:
remove the red outline around the image here and on the other screens.


comment:
can we make this screen so when they return they not only have access to Next but they also can select the tabs in any order?


comment:
correct feedback - remove "go to" from first line.


comment:
update the directions that appear after you click dose to say "Click the Prime Bolus button to see the drop-down list."


comment:
update main screen text to say "Now that you know more about the programmer screens, let's review how you enter information into the device. <NEW PARAGRAPH> When entering new data, some fields use keyboards and others provide drop-down lists. To enter data on the N'Vision programmer, you use the touch pen located on the side of the programmer."


comment:
dose popup - replace grey text with "Patient information can be entered by using the touch pen. Once a field is tapped, the input box pops up."


comment:
bolus popup - remove "Select a value..." sentence from the popup.


comment:
all new videos will come from BLP - client made a global update that impacts all captures.


comment:
here's another area where there needs to be a global change to the highlight applied.


comment:
remove all numbers from the directions - new global revision from MDT.


comment:
same thing - remove the numbers from the steps.


comment:
these screen shots are still too blurry - we will need to supply new ones for this screen.


comment:
I don't remeber learning about TSI before?


comment:
uses vitek 2 system again?  I don't remember the first time?


comment:
can we wrap the text in the popup boxes so they're indented with the numbers?


comment:
need to update the transcript - see attached.


comment:
Directions don't update and next button never appears


comment:
can we anchor the tip on the right side, in a box?


comment:
Update the red boxes to have an "X" so it's very clear that's the incorrect tab.


comment:
You can't crop this screen - leave it as it is when you update all other screen shots.


comment:
ask Matt for a new image here, with the programmer showing the Update Pump summary screen.


comment:
I think the main 3 things are: 
Know the Goal (includes why the evaluation of this topic is important)
Evaluate the Site Process - this should really be an evaluation during the DISCUSSION
Determine Next Steps (I can't recall what we had outlined for this, but know a wrap-up area makes sense).


comment:
I wouldn't use freezer space as an example (since that is a fluctuating thing and not a deal breaker anyway). If you want an equipment example, I would use a REQURED refrigerated centrifuge. Options for mitigation could be: 1) Site says they will purchase/rent one for the study specifically. Good, need to make sure that is in place before Enrollment Ready.
2) Site says they cannot obtain one themselves, but if the study team can provide one for the study, they would love to participate. CDL has to follow-up with study team/CLO to see if a loaner refrigerated centrifuge can be provided from the lab vendor.
3) Site says no to getting one and study team has already confirmed they can't provide, stop the SEC and let them know that without meeting the requirements, you won't be able to consider selecting them for the study.


comment:
Alternatively, you could use a process here rather than equipment (need to make change to comply with Lilly requirement that they can do on their own without needing study team involvement). Some options:
1) don't keep temperature logs on sample fridge/freezer 
2) Site doesn't maintain equipment per manufacturer requirements, just does it once a year regardless of equipment manual guidance.


comment:
Changes made per edit requests, however, I think the 2nd & 3rd sentences should change to: Qualified sites are those who have the necessary set-up and processes to conduct clinical trials according to external regulation and sponsor requirements. Partnering with qualified sites means we can expect greater adherence to conducting clinical trials appropriately which ensures we have the ability to bring medicines to patients faster and with high quality.


comment:
Comments during last review of the SPI definition included what is here, but also asked for some statement regarding the fact that the SPI has required elements for Site Evaluation/Selection processes. That isn't here - did we determine that wasn't needed during the last phone discussion??


comment:
Wasn't there a slide with more detail than this? I looked back at Christine's emails and she had 3 bullet points:
"	Implement the clinical and regulatory strategy for site selection based on the regions development strategy.   
"	Manage the clinical allocations strategy to align with the regional development strategy
"	Provides regional expertise in clinical planning and study development process including input into study design, protocol feasibility, study timelines and investigator/site profile


comment:
I don't remember which one it was on, but at least on of the process map call outs (maybe the one where we made edits about if a live vs. virtual site evaluation visit is needed?) still refers to the Select and Manage Sites Guidebook. If the name was changed here it should be consistent throughout.


comment:
The flag and course title itself should be centered; see http://www.bottomlineperformance.com/clients/CaliforniaISO_EIM/Bundle1_GM/Course2/story.html as an example


comment:
FYI, the menu says that this screen is called "What can it do?" Change to "How does SIBR work?"


comment:
This screen is still a duplicate of the screen 2 ahead - please replace with DP script slide 14 text below:

Full screen captivate demo plays automatically when users come to the screen. Edwin explains the step-by-step process of submitting a self-schedule. Focus on a common situation, with outliers mentioned (NGRs, e.g.) and where to find more information on how to do them.

Key points to demo:

1. Choose the product type (Self-schedule)
2. Enter the MW quantity.
3. Click Apply.


comment:
Can you use the layout of the "Important Point" here that is seen on the current See it in action: Submit a self-schedule slide? It looks better bolded and set off rather than as a bullet point.


comment:
Intro text has a comma instead of a period at the end.


comment:
There is a "Checklist" resource in the Resources tab at the top. It doesn't link anywhere, so I suggest we remove it.


comment:
Should we be so specific to iodine or can we say iodine or hepadine


comment:
what are you palpating for...need to state what you are palpating to feel the two things they were taught in trial

Also, should not fan the site to dry it.


comment:
describe- feel a slight vacuum pull when you have entered into the rubber port. a few more words to describe you are there...feels firm and secure within the device. You will advance the until you get to the bottom until you feel the metal (:29)

you will hit metal if you hit top of pump so want to be careful to describe other feeling that lets you know you are in


comment:
Are we not going to discuss the need to pull back to ensure clear fluid not pink tinged before starting and between syringes? Describe what that appearance is (1:10) between syringes you should clamp tubing...needs to be restated.


comment:
Don't like the idea of applying firm pressure...should soften this. could cause more harm than good (at very end with gauze statement).


comment:
add or significant pain at injection site, significant redness or site pain reaction.


comment:
I am thinking we should not make the equations mandatory to move forward.


comment:
Change Select and Manage Sites Guidebook to "Site Selection Guidebook".


comment:
Change "Trial Planner" to COPM as we use the COPM term in the 2nd bullet we need to be consistent.


comment:
i would have the directions update once both examples have been visited, rather than putting the click next instructions floating at the bottom


comment:
should it say example 3? also, same edits as previous screen


comment:
could we add a photo of a site on the screen floating at start (with storyline white image frame)... then have the text box come on with the text? This is nice-to-have


comment:
i think ultimately i would break this animation up so they can step through it in chunks, unless the conversation as a whole is the larger goal. for alpha, i think it's fine as is with coloring, but i agree that that's a good idea if you keep it altogether as one long animation. if you go to b&w, i may try making the background colored though (just lighter)


comment:
gah im sorry im sorry im sorry. the font thing is such a pain in the ass. luckily this is the only place ive seen it -- check your feedback master that the button font is set correctly. it looks like gotham here.


comment:
inconsistent, but you can remove "click continue" from feedback boxes


comment:
i would add the CDC character to this screen. maybe move submit button to be centered under the answers


comment:
got locked up here when i chose the wrong answer. after clicking try again, i couldnt select a new answer.


comment:
in terms of locking up, the continue button did not take me to the next screen


comment:
maybe ok for now, but i would make these red callout boxes (like the start of the course) that come out in line with audio


comment:
Need a period after facilities at the bottom


comment:
i think ultimately this should be a landing page of all the rooms to jump through at user's choice to check off. that way it's not just always click next and there's some visuals here.


comment:
The TCED sets global expectations for trial-specific content for ICFs.  In that sentence, you aren't actually talking about the trial-level ICFs.  It is about content specific to the trial, so I would also not include the definition there.


comment:
Please update the definition of Master ICF.  The master ICF is a generic definition for country-level ICFs, country-level addendum ICFs, country-level assents and approved TPO or ERB templates.


comment:
You already defined ICF in the previous slide.  Use either Informed Consent Form OR ICF....don't say both here.


comment:
Title of this screenshot is Trial-Level Informed Consent Created....I would change to Trial-Level ICF Created to align with the milestone in the map....I think that's the intent?


comment:
in the activity description for Create Trial-Level Addendum Informed Consent Form....A Trial-Level Addendum ICF vs. Trial-Level Addendum Informed Consent.


comment:
Perform quality review activity...in the description should draft be plural?  You had plural in the record version history.


comment:
Use full title of activity within the description for Distribute Trial-Level Consent Documents & Consenting Guidance.

Also in the description, you don't need a comma after affiliates.


comment:
Title of screenshot should align with milestones as much as possible: Trial-Level ICFs Quality Reviewed and Approved.


comment:
in the response, Future and discontinued study participants should also be addressed in the Cover Letter to Distribute Trial-Level Documents required tool as applicable vs. ICF tool.


comment:
An inaccurate or hard to understand TCED leads to a confusing or incorrect ICF for my trial vs. ICF form for my trial....


comment:
If you want to include the definition of Trial-Specific ICF...it should be Trial-Level ICF instead and maybe you can include in the first sentence: The Trial Consent Elements Document, or TCED, is a Trial-Level ICF that is used to provide....


comment:
Cours title to be changed as "vendor" is too broad of a term. Discuss alternatives with SMEs.


comment:
Start with "I'm so glad to see you again!" then cut out remainder of first paragraph

"Click Play to hear the story of my dream again or click Continue to start following a sample with me"


comment:
First sentence is okay. 
Second sentence, take out and replace with "Today I want to dig deeper into what actually happens in each phase."


comment:
The book doesn't look like our book, and the talking box covers it so doesn't look like a book at all.


comment:
Centering is off on the numbers and the steps.


comment:
Sources are overlapping with "continue" button


comment:
Content says "clerical staff" does this but this example shows physician entering the order.


comment:
This step 3 is different from the introductory page step 3, where a Health Care Professional collects the specimen.  I think the introductory page is more accurate than to say a lab / med tech collects the specimen.


comment:
Since we are following the sample, does it make sense to make this more specific to our nasal swab sample - show in the picture that you're swabbing the nose?


comment:
Third bullet mentions "infection site", but this is a MRSA screening example so we need to add something like "specimen taken from common sites of colonization (in this case the nose) or replace the third bullet instead


comment:
I'd like to see the same information just organized differently on the pop-up.  So for example, for Stool sample, info could say:  "Diagnostic specimen collected for GI infections:
- suspected intestinal infections (campylobacter spp, escherichia coli)
- patients who present with loose stool (claustridium difficile)


comment:
Agree with yellow box that typical transport pathways is more interesting & relevant.


comment:
I think we agreed in Module 1 to not have this screen anymore


comment:
Do we want to bring this back to our specific example?  Do we want to say that MRSA is streaked onto differential and selective media like the BD or Biomerieux products?


comment:
For each of the three pictures here, can we say what it is with a rollover?  1) Streaked plate  2) Incubator  3) Result


comment:
The third picture here is not a MRSA result.  It's a urine result.  The result should have four quadrant streak and this is an example of a "lawn" streak


comment:
I think this is out of order?  Doesn't it need to go after transport?


comment:
We don't really cover testing methods in detail until Chapter 3.  Do we want to include here?


comment:
Are we still following the MRSA screnning sample at this point?


comment:
Another pose where she doesn't project confidence - please change.


comment:
I don't think we had one of these for the analytic phase


comment:
Take away the stars and also delete or change the first sentence to be less alarmed.


comment:
Delete last sentence of script.
Both examples are 45 year olds?


comment:
Need reminder to turn on volume and pausing option.


comment:
Gram staining is done for preliminary classification and can be done direct from sample or from a isolate after culturing.  In general I like the video!


comment:
I'm not sure whether the answer to this question is true.  Can someone please help with this one?


comment:
After going through the entire thing, I'm not sure that "see it, try it" is the right characterization for the two sections


comment:
If we keep this as two discrete examples we could call it "screening example" and "diagnosis & susceptibility example" but then the screening example is full of other, extra information that doesn't pertain to screening.  We could call it example 1 and example 2, or if we decide to do away with the case study in the first example, we could just say "learn it, review it"


comment:
Catheter Access Port: it would be great to indicate this is a direct line to the catheter and any injection through this port would go directly/immediately into the body


comment:
At the end of system overview, it does not direct you back to the main menu to review the other sections


comment:
On additional contraindications: why do we say CAP kits are contraindicated? we require our CAP kit to be used.


comment:
Are the hemodynamic and Dx measures sections intended to show the PAH clinician to consider ensuring their patient has PAH?


comment:
changes in a patient's dose WILL impact the flow rate


comment:
refill interval calculation should say "refill interval" rather than "refill" on left side of equation.
define variables in the equation


comment:
Define variables in the flow rate calculation


comment:
I think we have to introduce this chart and provide an example patient for how to use it.


comment:
Suggest to move this slide prior to the previous, and then re-title the previous to be how flow rate affects refill interval and pump longevity.
Also, define variables of equation


comment:
I'm not sure if breast cancer makes venous access difficult- it would be a consideration for tunneling. 
Cellulitis is an infection, so they shouldn't be implanting in this scenario.


comment:
Under adipose tissue, we could recommend they consult their implanter if they are unsure.


comment:
Suggest: After surgery, the patient will be transitioned onto the implanted pump using the programmer and subsequently off the temporary external line.


comment:
Remove the words ", including daily and hour bid components"


comment:
Please change the second paragraph of the SIBR wording to read "After validating the bids against SIBR business rules and the Master File, SIBR provides feedback on whether the bids are market accepted or need to be adjusted.  If a bid is market accepted the status will be "valid" or "modified".  If the bid needs to be corrected, the initial status will be "invalid" or "rejected".


comment:
Since we talk about the business rules and the master file in the SIBR explanation, having separate sections for these topics seems redundant.  Let's discuss.


comment:
If we keep the SIBR business rules chevron, we will need to reword the second sentence, since it is not accurate.


comment:
If we keep the Master File chevron, we should add a second paragraph to remind SCs that master file data is updated via the RDT and it takes X days before changes become effective.


comment:
In the voiceover, it says sites to initiate the trial.  I would say implement the trial vs. initiate.


comment:
Identify the key risks and process for the trial and identified potential operational challenges of the trial


comment:
When you click on the Print Activities it brings up the print preview - is there any way the headings could be formatted that when they print it would be with the table?  Also - appears that at the end clean uneccessary paper will print


comment:
Change the box that starts with "Last...." to read "Accepted bids (Valid or Modified status)can be edited or cancelled.  Invalid or Rejected bids can be edited or deleted. After the close of the market market-accepted bids become "clean bids".


comment:
In in the box that shows the content check and the validation check, in the last row the validation check should be blank, because they failed the content check and never made it beyond that step.


comment:
The arrows for Modified and Canceled or deleted are confusing.  Let's talk about the intent of these arrows.


comment:
Please remove periods from the end of each phrase.


comment:
In the introduction change the wording to read "EIM participating resource scheduling coordinators must submit their base schedules into BSAP before they submit their bids in SIBR. Once bids have been submitted SIBR performs a validation."


comment:
Change "Accepts bids for energy" to "Accepts bids and self schedules"


comment:
Change the phrase that starts with "Validates..." to read "Validates bids and self schedules against business rules"


comment:
Change the phrase that begins with "Provides..." to read "Provides feedback on bid status"


comment:
Change the "That's right!" box to read "SIBR accepts bids from each SC and validates their submissions.
If the bids don't meet..."


comment:
Change the bubble that talks about number of MWs available for specific hours to read "I can use SIBR to submit economic bids. That way the market will optimize the use of my resource."


comment:
Change "and take any price that is set" to read "regardless of price."


comment:
Change the phrase that starts with "The ISO..." to "The market uses the clean bids from SIBR to help resolve market imbalances."


comment:
Please remove the generation capacity limit.  It is not applicable to EIM.


comment:
Self schedule - take out the words "buy or"


comment:
On the Economic bids box - remove "or purchase"


comment:
On the Economic Bids box remove the words "and demand offers monotonically decreasing bids."


comment:
On the Economic bids box - reword the last sentence to say "There is a limit to how high or low you can bid, known as the bid cap and bid floor.  These are enforced in the SIBR rules.  Check the tariff for the current bid limits.


comment:
Hourly bid adder (GHG) - change this title to "GHG  bid adder" 
Change the wording to read "This optional component of a bid or self schedule is for EIM participating resources that may be subject to a GHG obligation if dispatched in California. 
When entering this component remember to enter a price and a MW value."


comment:
Clarify that this refers to existing at implant anticoagulant therapy and ISR does not require initiation of anticoag


comment:
Contraindication is missing the skin or soft tissue poor healing wording.  This may seem odd, but scleroderma is very prevalent in PAH population.

Addressing Kara's comment on CAP kit.  Market release will have an ISR Patency Kit.  Neuro CAP kit should be contra indicated.


comment:
Once the implant manuscript is published, add it to the anticoag page as a reference


comment:
High BMI may be more of an issue; add pump placement secured to fascia and 2.5 cm from skin for refill needle access.

Comorbidities add life expectancy as a consideration


comment:
Too engineering like.  Just leave formula in the manual.  Instead includ range of flow rates implanted in the trial (0.2-1.8 ml/day) and corresponding expected pump longevities..

Can you include an example of the typical patient in the trial and how th look up table displays the rough estimate


comment:
Previous external lines can make venous access more difficult

Scarring and Brest cancer surgeries can make tunneling more difficult.  Not sure that patient with cellulitis should be implanted


comment:
The table gives a rough range, the programmer will calculate the actual days to low reservoir alarm.  Not sure that this is clear or just needs to be in live training.


comment:
Second paragraph should say: '....paid consistently and within fair market value' I think we should remove the 'viewed as kick back'


comment:
Country budgets are used as the guideline for negotiating a budget with a site, but sometimes the budget may need to be adjusted. 
I don't think this is called an exception or could cause confusion.


comment:
for each of these activities, do you want me to click both options before I can click next? Right now I only need to click one option.


comment:
This is a ton of text. Is there any way to shorten it up? Even if it came directly from Erin/SME, I think it's too long.


comment:
Remove the 's from What's for the Complete Site Evaluation of Changes section


comment:
The "And again" is strange. Can't you just say, putting study participant's safety at risk or something like this?


comment:
Is there a new PF for each of these? Right now they seem to merge. For the Proceed as needed, the first sentence reads strange. should it be "the site managers work together to ensure all steps are done....."


comment:
Lock the next button until all options are selected.


comment:
Missing a period for site Location change popup.


comment:
Hide the next button until the animation completes.


comment:
Did we have the link to BWL in the past? If so, please add it back.


comment:
I thought the title was Manage Site Information Overview?


comment:
add the common name for S. pyogenes (Group A Strep, Strep A, beta-hemolytic Group A Strep, etc)

*Most should be familiar with Strep A from the cobas Liat test


comment:
replace red top tube with a blood culture bottle for blood sample


comment:
Here you call it the managing site information process, but the process map earlier just calls it manage site information. We need to be consistent.


comment:
I'm not sure I get this. you're asking "what should she do?" and then there are two options. It doesn't flow right. Also your icons are different sized. How can i see an impact from understand the change and determine required actions?


comment:
Agree with LS, a Health Care Professional should be used rather than the lab/ medical tech.  

It is rare to hear of lab techs going to collect specimens, it's usually the nurses or phlebotomists.


comment:
Instead of lab tech, use nurse, phlebotomist, or Health Care Professional


comment:
Replace lab/medical tech with Health Care Professional


comment:
Agree with LS, resume our patient example of MRSA screen


comment:
Replace blood tube with a blood culture bottle


comment:
add: (Strep throat) to the third suspected infection


comment:
Can you show a picture of a change form to being the animation? Or even just a generic form that flows into Trialforce? This animation seemed pretty bare.


comment:
This question is confusing.  

Reword:  After a specimen arrives in the lab, how long does it usually take for a clinician to receive a final report from the culture work-up?

OR:  What is the usual turn around time for a final report on a specimen from start to completion?


comment:
We never really followed the first MRSA specimen.  It went from specific sample to very generalized specimen following.


comment:
Step 1 is incorrect as the physician is ordering the test, the microbiologist is not performing the work-up of the culture


comment:
On this screen, check that titles are consistently capitalized in boxes


comment:
In understand changes, add comma after For example,


comment:
Do a global check of titles and wehther they are capitalized


comment:
These screens should be in the menu. Just having one title isn't great


comment:
This image of fingers on a key board doesn't mean anything. get matt to help you!


comment:
Is it necessary to include "or fatal".  There is no data to support this.


comment:
should add "designed to" prevent kinking, crush failures... There is no guarantee.


comment:
Should "Neuromodulation" be changed to "Pain Therapies"?  How are these referred to with customers?


comment:
when i came back to this page, the check marks didnt keep showing up. not sure why


comment:
per line 31 edit: Need to say FHD and Monotherapy Escalating Dose Trials (not MED)


comment:
maybe hide next button and instructions change until email shows completely?


comment:
was able to click on the body textbox and change it to visited


comment:
might have messed up by jumping around, but double check that the third module instructions are programmed to show up the same time as the others. (right now it opened mod 3 button, but is showing mod 1 instructions). mod 1 and 2 was all good


comment:
per edits, shouldnt CPM Advisor become Site Approver?


comment:
move red popup box so it's not covering the flag if possible


comment:
I agree with Tera's comment about the second paragraph, i.e. re-word and remove the definition pop-up.


comment:
Re: Jennifer's comment, would suggest to say country level rather than affiliate level.


comment:
Add after new "Explain that to exit sleep..." Add more bullets for Backup and Restore topic.

Explain that the VENTANA HE 600 system database is backed up periodically according to the settings in the Backup function.
It is recommended that backup occurs during a time of infrequent activity, so, 3:15 AM is the default setting.
NOTE: By default, the VENTANA HE 600 application creates a backup of the database once a day to a path on the local drive. It is recommended that a local network be used to back up the database. Work with your local IT support to determine a network location to be used. Another option to backup the VENTANA HE 600 system is to connect a USB on the back of the VENTANA HE 600 computer to continuously backup data.


comment:
First sentence should be 'two or more countries'


comment:
Click the Effective...should 'the' be bolded and capitalized?


comment:
the voiceover says we are going to focus on the box for development and delivery of PS training...it's only development (not delivery)


comment:
can we make the click next instructions replace the instructions at the top? or just add it to the end of the instructions like other courses: "...we will review in this module, then click the Next button to continue."


comment:
also bold "button" in Click the Next button


comment:
extra space before "You may also need..." in CC


comment:
should this come before the process map?


comment:
move "easy to understand" (bubble 1) and "and increased" (bubble 3) to second lines


comment:
can we bold the words "Trial Consent Elements Document" and "TCED" in paragraph 2


comment:
extra space between sentences 1 and 2 in paragraph 2?


comment:
bold "button" in each instructions to click the module button


comment:
could we have a TCED icon on screen for most of this, then have Carole come on in time with the audio, then have the text/instructions/arrow all fade on at the end? it was distracting to read the body text that wasn't syncing up with the audio


comment:
any way to cycle through a couple poses?


comment:
For local labs, we should highlight that the cost of local labs includes the cost of all supplies.


comment:
can we make the health literacy stuff a little bigger?


comment:
change instructions to be "Click the magnifying glass icon to..." and bold the appropriate words


comment:
A feel we should amend wording as the site does not request an exception, they will provide their costs or we provide our costs and they request some costs or items which we will review and determine to be an exception.


comment:
do we want them to click first before advancing? if so, hide click next instructions and button until they click, then update the existing instructions with the click next


comment:
move the instructions to be in the same paragraph as the body text


comment:
check extra spaces in the body text box for Create the TCED.


comment:
Have this come before the process map, yes. And also add the click next directions.


comment:
either make the click the next button box solid white or (my preference) slightly reduce the size of the laptop so that you have some room up top to put the instructions


comment:
theres a very weird comma in the second paragraph


comment:
Agree with Matt - bring up the text of Carole after the introduction.


comment:
keep click the next button instructions in same paragraph as the body text


comment:
Delayed site activation also delays enrolment, which means the site could have less OR EVEN NO time to enrol...


comment:
add a hover state for the icons. change instructions to "Click each document icon to...."


comment:
lilly drug/device risk profile popup: extra spaces between sentences


comment:
for all popups, reduce the transparency of the purple box a little. we had a comment in another course that it was hard to read the lighter gray text when it was on a darker purple background


comment:
same thing with click next instructions... have it replace the existing instructions


comment:
change the icon to "magnifying glass" and bold "best answer"


comment:
make your purple buttons wider so the words don't go onto 2 lines.


comment:
can we combine all the text into one paragraph? also do the replacement of instructions thing ive been saying for the click next stuff


comment:
bullet points in readability popup are different color


comment:
same thing about magnifying glass written out in instructions


comment:
yeah, after we make edits and you send us the file back, we will need to update the PF for the 2 activity screens


comment:
keep click next instructions in body text, not centered at the bottom


comment:
Fix spacing after purple words and before periods.


comment:
This says 9th grade. Didn't we say 8th grade earlier?


comment:
put examples in white purple outline boxes


comment:
bullets in the Did You? feedback boxes are boxes, not bullets


comment:
ignore my comment about the bullets in the Did You


comment:
add instructions to click Done when finished typing for these activities


comment:
tip box: change to "Does it sound..." not "is sound"


comment:
always "Click the Next button" not Click Next


comment:
widen purple button so text isn't so cramped


comment:
Ignore my earlier hint comment. I expected to see highlights. Sorry!


comment:
use study participants in original version vs. participants.


comment:
Click the protocol...., then click Submit to compare...

Don't separate


comment:
Click the Next button. also note this is a place we need new PF #


comment:
I don't feel like these are buttons. Can we say documents or something else?


comment:
Greater Adherence just doesn't sound right.  A qualified site means that they meet all the requirements to conduct the clinical trial.  I agree with what Erin says


comment:
If you click on the magnifying glass, it takes you into the map but they you have to get out to click on the red boxes.  Maybe the magnifying glass should say something like link to map because it doesn't really magnify, it takes you to the map.


comment:
Should we say that the trial planner tailors based on trial specific elements that are identified in the protocol or through the trial's risk assessment process?  The map says:  due to potential risks associated with the trial. We should add something like that.


comment:
Instead of the magnifying glass should use the see whole process and go back like the next screen.  This is an add on to my original comment as I saw how it was on the next screen.


comment:
Should we add to confidentiality box: confidental verbal or writtne information ABOUT THE TRIAL (without this it is rather open ended what we would share)


comment:
Any way that we can see any of the red boxes to click when you first come in the screen? Having to scroll down will confuse some people


comment:
move "activated" to second line with "site" in the title for Make Decision to Closeout Activated Site


comment:
im sorry these are so nitpicky... move "closeout" to second line with "activities" for complete appropriate site closeout activities popup


comment:
agree on the two site manager buttons. i would make one purple and one red -- remove visited and hover states for both


comment:
Change call out box to:  I used to think that sites were automatically qualified for a trial based on discussions during the site evaluation.  Now I use a judgment-based decision making approach, which includes asking myself some key questions to help me evaluate what I learned from the site visit to determine whether the site should be qualified or not. (the content of the 2nd sentence may not be accurate, but the key thing for me is that what she is doing is part of judgment-based decision making).


comment:
ive stopped checking against the spreadsheet at this point unless the edit was clear as it seems like things moved around/changed. going through for functionality/consistency


comment:
3 or 4 of the characters disappeared at the end of the timeline


comment:
extra space before period at end of second paragraph


comment:
The information box for Develop Protocol-Specific Training Materials....should be 'The' add the 'T"


comment:
All training is delivered, completed and documented.


comment:
cepheid gene expert which for diagnosis?


comment:
should 'the' be capitalized and bolded here?


comment:
Under the training owner, I would say develop and deliver interactive training instead of implement.


comment:
CoLab outputs vs. outputs from the Colab


comment:
Update Legal Language with HE 600 Trademarking - remove Cobas


comment:
The voiceover says that the site is told why they were not going to be recommended,  but the text box says we document internally.  Should we update the text box to say that we document internally and notify the site or should we change the voice over or both?  It is just inconsistent.


comment:
Under qualify site, shuld we say, uses the required site evaluation questions or criteria identified for the specific trial?


comment:
Same as previous comment about the scrolling issue.


comment:
Just put in a generic description vs. placeholder. I realize we don't have content yet.


comment:
Document site information.  I would change has to be documented to must be documented.  I would also add a sentence to the end to match the map: This site information is used downstream to support key activities such as safety mailings, initial supplies, account setup, CT Material, etc.


comment:
We probably should say study participants instead of patients in the voice over but this is not that big of deal if hard to fix.


comment:
Feedback that pops up after advancing the swimmer, change "Great Work" to "Great work" (lowercase w)


comment:
Is there a procedure from the list that can be added?


comment:
Not sure I fully understand what is the potential impact of my observations?  potential impact to what. i think it is potential impact to the site's ability to successfuly conduct the trial.  Maybe we should add that if SMEs agree.


comment:
For a new person how would someone knows what SPI and TF and ISEC are if they haven't been previously covered. We need to make sure all these termas are on the  previous slides.  We can add TF, iSEC, and SPI sentences to the site evaluation and qualification boxes.  We need to work on beefing that up to explain that this is how you document the site evaluation visit using the required SPI information and the ISEC.


comment:
I cannot choose next without doing the exercise again even though I already did it.  Is there any way to let me move on or is that just the way it is?


comment:
The last sentence, I feel like both qualification and selection are right.  Is that true?  If so, we should take out the qualification as an answer?


comment:
Same navigation issue as previous screen.  Cannot move on even though I have completed.


comment:
They don't provide input on the investigator.  They identify the trial specific criteria that needs to be used as part of the site evaluation and qualification processes.


comment:
I think this doesn't flow with next slides.  The next one says who does what but this one doesn't have that.  Maybe we need two slides?  Who does what and put Christine's stuff in the first slide.  And then keep this second slide and change the wording as I said.


comment:
First word is missing a "y" should be "you" not "ou"


comment:
For last sentence, I would says which help ensure that a trial is successully completed which hopefully will ulitmately lead to patients getting the medicine they need.  A trial can be successful and the drug not work.


comment:
Do we want to say that a critical piece is collecting site information and maintaining it?  I think that is important.  Note to discuss:  Even if they don't enter the data in all the systems like IMPACT, the CDCs are the ones who provide the data.


comment:
Is there a concept of past SPIs?  Erin/Sara question.


comment:
Sorry, I know this is picky, but the sentence isn't structured correctly, it isn't parallel.  I think it should be:

"...following activities: refining the list of identified investigators to be evaluated, completing the site's evaluation, qualifying the site, and selecting the site."


comment:
When you complete a module it sends you back to this screen but you are not sure what box to click next.  Can you gray out what has already been completed when you jump back to this screen after a module is done?


comment:
The three boxes, conduct site evaluation visit , complete site evalution and qualify sites is where we say that the ISEC, SPI, and TF are used. We need to say that the required SPI and the ISEC are used to guide the site evaluation visit and the site evaluation is completed by filling out the required SPI and ISEC in the TF system.  This has to be done before a site is qualified in TF.   We can work ont the verbiage. It will help with the learning exercise later.   We should work out wording with Erin.


comment:
Instead of successful I would say a site may continue to be qualified to participate in the trial.


comment:
align instructions Title Case of button names to the buttons (I would change the buttons, not instructions)


comment:
Same comment from identify training.  The magnifying glass should be a see the process button (or whatever it says). It is not a magnifying glass.  Replicate like in identify.


comment:
When I first clicked this page, the audio automatically started recording and when I clicked on the CC to read the text script, it showed briefly and then disappeared.  Once the audio quit playing, I clicked on the CC again and the text appeared and stayed.


comment:
I would change would be stopped to could be stopped or most likely would be stopped.  It is not a WOULD be stopped in each situation.


comment:
Qualify site to continue trial. You should change to say if after additional evaluation based on the site and/or trial changes, the site is still qualified to continue in the trial.  Some changes are trial changes, not site changes so this sentence is not fully correct


comment:
I agree.  The susceptibility report would include the organism ID, S. aureus.  Gram positive cocci in clusters would be released with a preliminary report.


comment:
I cannot click on the next button to continue after I chose the right answer


comment:
Never mind.  Re-read.  Have to click both options.


comment:
I would change cannot to should not in the first sentence


comment:
There is something wrong with the sentence that starts with "In this case,..."  It doesn't read correctly.


comment:
I am not sure that the second button is totally correct or makes total sense.  You assess and then you decide whether or not if new enrollment is shut off and/or additional visits for active study participants.  Erin/Sara - thoughts?


comment:
In the "Sorry that's not correct" for Bid information, change the text to say "An SC's specific bid information is not public information...."


comment:
On the EIM Transfer Limits by Tie wording remove the word "displays".


comment:
Master file wording - please change the second sentence to read "A scheduling coordinator can find resource characteristics in the Master File application on the Market Participant Portal."


comment:
On the Atlas Reference page change the word "annually" in the disclaimer to "as needed".


comment:
To Laura's comment on the confidentiality agreement - I would NOT change this. Ultimatey, site's may have master agreements already done, we may do compound level agreements, etc. Ultimately, the CDC just needs to ensure that they have an applicable/appropriate confidentiality agreement in place before sharing information.


comment:
To Laura's first comment on the Trial Planner...I don't think further expounding is super necessary here personally.


comment:
Publications and Revisions - 
When to use it - Use this report to determine if there is new or revised data available on OASIS
Helpful tips:
Before running a large report, the ISO recommends that you query this report  to determine if revised or new prices have been posted.


comment:
Scheduling Point and Tie Definition
When to use it - change "CMRI" to "the Prices Tab in OASIS".


comment:
On Price Correction Messages add a Helpful Tip:
"Real-time prices are final by the end of the 5th business day after the trade date."


comment:
Addressing Laura's comments:
Site Not Recommended-we previously said the voiceover was fine and it is. I think we can leave the box alone personally (since the voiceover identifies it and that is not a required step), but if needed you could change it to "updates internal systems and notifies the site, as appropriate"
Qualify Site- I agree this is not reading right now (not sure if I missed it first time around). It was supposed to identify the documentation part (the "clicking of the button") I thought. Recommend this update to "...and completes qualification process internally." (addressing the clicking of the button once the CDC has confirmed qualification)


comment:
FMM Locational Marginal Price - Add this wording to the end of the When to use it:
Use the Scheduling Point/Tie Combination report if you are looking for LMPs for an intertie resource whose scheduling point does not match its tie point."


comment:
Regarding Laura's comment on the Site Not Recommended - we actually comment on the next screen with a reminder in the pop-up that any site not selected or put as back-up is notified of their status. Think this is covered well enough with the implication here and the outright statement on the next screen.


comment:
Remove "based on the system configuration" in Materials Needed


comment:
Change the objective "Download calibrator information..." to "Address Downloadable Calibrator Found alarm"


comment:
Remove "Request Calibration and QC" and "Load required Calibrator and QC" from the RDU activties.


comment:
Move Sample Processing Tasks to be the last task in this list.


comment:
Janice bubble: "I didn't get into specifics, but she knows it is working again." (change it to it is)


comment:
First answer option: "Yes, you need to speak with the supervisor." (lowercase s in supervisor)


comment:
After "If needed, you can manually program samples on the global Test Selection screen." add "This will be discussed in the Patient Processing and Review section."


comment:
Janice speech bubble: Text needs to be aligned to the left.


comment:
Duplicate the bullets from "Explain that if the System Status is..." after "Close the covers of the analyzer." which should be changed to "Ensure the covers of the analyzer are closed."


comment:
3rd answer option: per alpha edits, should be "You need to provide minimal details to make them happy and let them know it is working again." (I updated the Excel spreadsheet as well)


comment:
For 'treading water' feedback, the coach should be neutral, not giving a thumbs down. Overall, good coaching = thumbs up, neutral coaching = neutral stance (original stance from alpha), and bad coaching = thumbs down.


comment:
Change "Explain that if Photometer Check..." to "Explain that if the Photometer Check..."


comment:
Will the tab for FHD/MED Requirements need to be updated?


comment:
Change "Explain that if the needle is not in the yellow area..." to "Explain that the needle of the pump pressure gauge should move into the yellow area during the Air Purge. If it does not, then contact the Customer Support Center for assistance."


comment:
next button at the very end when restart convo comes up is hidden behind the guy a bit


comment:
I would also add the following sentence before "Click the Next button to continue".

To learn more about the Judgment-based Decision Making approach, refer to the "Judgment-based Decision Making Framework" (in the Resources section or link to it).

Here's the link:  http://lillynetcollaboration.global.lilly.com/sites/CDCI/SupportMat/SUPMAT/Forms/JBDM.aspx?RootFolder=%2Fsites%2FCDCI%2FSupportMat%2FSUPMAT%2FCDCI%2DLD&TreeField=Folders&TreeValue=CDCI%2DLD


comment:
remove hover and visited for site manager button thing. it shouldnt be clickable


comment:
having issues at the end of opening the menu and it messing things up. check how your layers are being displayed.


comment:
I entered changed text for the previous screen onto the spreadsheet. I made it clear that Janice had made a new mistake in the updated text. Change "Good Job!" text to: "Janice made a new mistake and you need to follow up with her immediately. This gives her a chance to correct the mistake with the customer and to schedule a follow-up with them, too."


comment:
Sorry I didn't catch it earlier. Recommend adding the statement about Site Evaluators also being Site Managers from the Selecting Sites Course. Don't include the verbiage about selecting sites, but something about the fact that Site Evaluators remain connected to the site throughout the life of the trial.


comment:
Change "For NON-24 hour FACILITIES ONLY,...." to "Demonstrate how to check probes and reaction cell rinse nozzles. Non-24 hour facilities will perform this task before operation. Facilities that operate 24 hours a day can do this during Daily Hands-on Maintenance".


comment:
Should we say study participant safety instead of subject's?


comment:
First answer option: replace with updated text in the spreadsheet.


comment:
After selecting No for the first answer, the Not quite feedback says "Listen to his voicemail and try again." it should not say "his", change it to the updated text in the spreadsheet.


comment:
I am OK with "would most likely be stopped" in the last pop up box, per Laura's suggestion (although Laura, specific to NEW enrollment, I actually think those all WOULD be show stoppers, until the change is fully implemented, it would likely not halt ACTIVE patients, but NEW ones, yes).


comment:
Not quite feedback says "his" feedback again. Make sure that this whole module says "the" or "her" instead of "his". Use updated text in the spreadsheet for this one.


comment:
After listening to the voicemail again, I couldn't select a new answer option to continue.


comment:
Add Huber or non-coring needle.  These are special needles and any 22 or 24 G neeedle can not be used


comment:
I couldn't choose an answer after listening to the voicemail again.


comment:
Make screenshots bigger wherever possible.


comment:
Septum is qualified for up to 500 punctures  or will withstand up to 500 punctures with non-coring needles without leaking


comment:
Please include the task listed as "End of Day" from the provided Activity List"  in this section. The task is "Putting the analyzer to Sleep with wash rack (non-24 hour operation).This should be located above the "Performing Daily Maintenance Pipe with Wash Rack (24 hour).


comment:
Sutures are tied from the pump suture loops to fascia to anchor the pump


comment:
Need to make sure that all the "Review the scenarios" provide the correct scenario


comment:
Why do we have a submit button?  Can we just submit by pressing the correct/incorrect answer?


comment:
Change Materials Needed from "Checklist" to "Daily Checklist"


comment:
Stopping the pump. .... can damage the system and require surgical replacement.


comment:
Update the Simulator tasks:
-Request calibration and QC.
-Load required calibrator and QC.
-Monitor calibration and QC run.
-Review calibration and QC results.


comment:
Do we want to include the default alarm intervals 1 hr and 10 min


comment:
After sutures are tied, anchor sleeve secures anchor to catheter and to fascia


comment:
Coach bubble: the audio says "You need to be honest with your client..." update the onscreen text and the answer option for this to include the missing word "your". I've added this to the spreadsheet already.


comment:
Venous access side and pump location are on the same side, i.e. Both on the right side


comment:
This one let me re-answer after listening to the voicemail again, so just make sure all 9 voicemails work that way.


comment:
First sentence doesn't work as written. Believe this should say "is addressing trial level and site level changes." Also, impact on the manage site info process is for Lilly, the Site and Study Participants. Feel like the site should be included in that sentence, not just sponsor and patients.


comment:
Correct call out - need a dash AFTER Dr. Thompson.


comment:
In the scenario, instead of "published" write "regularly published"


comment:
To Laura's comment below, it is difficult and I had a hard time working on this question. What if we took out the sentence in the top intro that says "For this reason..." and leave it to the pop-up to describe that there was discussion and planning between the site manager and the study manager?


comment:
Difficult to determine where to click for underdose


comment:
Red Pop-up, 2nd sentence - use "Site Evaluator" instead of "they". The "they" as written refers back to the PI in the prior sentence, since the Site evaluator has not been mentioned in this paragraph.


comment:
To Erin's point- site managers encompass several roles not just the site evaluator so I am not sure we can call out that the site evaluator is also the site manager- is there a way to incorporate the roles that equate to the site managger - one being the CDC or maybe add a comment that highlights that?  The site evaluator will remain constant and the study manager it is the site manager that encompasses several roles - if I recall


comment:
To JP comment, perhaps the sentence could read: "There are multiple steps, including training and paperwork, that must be completed before the change is fully implemented." ?


comment:
To Laura's comment - the full sentence says that if a PI leaves BEFORE a new PI is in place, regulatory requirements are impacted. Which is true, so don't think that should change.


comment:
Do we need location after system?  Can we say in the appropriate system and/or....


comment:
To Laura's comments:
Change forms updated, I thought the same thing when I heard it, but don't think it is huge enough to have re-recorded.
Regarding the second comment, I think it is well covered previously that the site needs to remain qualified, and don't think we should force a voice over change here. If you really think it is needed, perhaps a floating "Does the site remain qualified?" graphic could hang out on the bottom of the screen while the other images are progressing?


comment:
Ok with Laura's proposed change, but would say "remain qualified to participate in the clinical trial" (just shorter than "continue to stay.."). Also I think we need the "THE clinical trial" in there, because depending on the change, it may only impact their qualification for one specific trial, not their ability to conduct all trials.


comment:
Suggest revising the wording under notify site change is complete:  the following doesn't flow:  implemented at the sponsor- maybe revise to just fully implemented (it may be both the site and sponsor who needs to ensure full implementation) and once it is fully implemented the sponsor will notify the site the change has been approved and they may proceed.


comment:
Agree with EB. Maybe revise to: addressing both trial level and investigator site changes.


comment:
Maybe word smith the following under the right option:  she knew she needed to verify that the new PI Dr....


comment:
Agree with Erin; purple pop up-the first sentence isn't flowing for me-  ....completed the site evaluation of changes how about the site evaluator conducted an evaluatiion of the changes and determined that Dr. Thompson was a qualified PI- rather than appropriate


comment:
Rather than regulations may not be met would it be better to say:  we may be out of compliance which could result in inspection findings or change the later half of the sentance I don't think the big issue with not meeting regulations is causing delays- the consequence is much greater and if we use this statement we should communicate the ramifications


comment:
purple pop up- any chance we can add, ....helped to avoid delays, maintain compliance and ensure ....  I don't think we are stressing the full impact of not doing things- if we focus on timelines I think we loose site of the real reason we need to do most of what we do- adherence to external & internal standards


comment:
Can we add a bullet here speaking to compliance?


comment:
I see what you are both saying and therefore it may be interperted differently so maybe we should think about revising?  Otherwise this section is very well done Erin!


comment:
I thought we weren't mentioning the transfer of information from Impact to TF or maybe I heard wrong?


comment:
Laura should we use Site Selection Guide book or leave since the maps all have the same title and change in July?


comment:
Yeah, I'm confused too but I've missed most of the questions in this module.


comment:
question about last bullet:  "Finalizing enrollment projections...".  I see that is the milestone, but I didn't see that as a task.  Are projections ever "finalized"?  If not, should this just be changed to "Enter enrollment projections at the trial-, country- and site-levels into the internal system.?


comment:
script/audio for Site Manager will need to be changed to compliance and business requirements.


comment:
At one point, I thought the difference between a mitigation and contingency was defined, Mark, Laura or Sara is that still needed?


comment:
The directions in the layer popup should be "completed" vs. complete per the title.


comment:
for the Site Manager "why", I think there's another level of "why" needed (e.g., why is knowing the realistic site activation and enrollment expectations important?).  The other two link the why to a successful trial, can we make that linkage here too?


comment:
I think it should be "Ensures approvals are obtained and the acknowledgement process is performed" Maybe?


comment:
question for Sara...in the feedback meeting with Erin, Kate, you, etc., there was some concern about the professional appearance of the individual portrayed as the site manager, e.g., would be dressed less casually (may even be in a suit).  Are you okay with the appearance of the "new" site manager photo?


comment:
don't forget to add the link to the BWL process to the resources area too.


comment:
I answered correctly, then I went back to see what would happen if I answered incorrectly and wasn't allowed to change my response.  Is that how the functionality is supposed to work?


comment:
for the enrollment manager, I answered incorrectly twice.  My first response was not removed, so two responses were checked...the feedback flashed up quickly (I didn't have time to read it) and automatically moved to the next page.  I couldn't check to see if this happened for all per my previous comment when I answered correctly for the site manager role.


