# Feedback

comment:
also, in the feedback for the 2nd try, I didn't get the correct response.  I moved forward and then back again and incorrect responses were both still checked.  I tried to answer correctly and I couldn't. So as  learner, I didn't get feedback on what the correct response should be.


comment:
Question for Laura:  It looks like you requested that the Site Activation Plan box be added.  I didn't think we were using an actual Site Activation Plan terminology (implies a document) since ClinPharm may not have a Site Activation Plan. If that works for them, I'm fine with the add.


comment:
Will need to have Jenny Peters check the procedure link - I don't have access to this document.


comment:
IMPACT required fields collab site link is incorrect - it takes me to BWL.  Here is the correct link.

http://lillynetcollaboration.global.lilly.com/sites/CTManApplications/RequiredFields/default.aspx


comment:
Site Activation Collab site link is incorrect.  Here is the correct link.

http://lillynet.global.lilly.com/sites/glcosa/SitePages/Home.aspx


comment:
onscreen still says Patient ID - need to update to just say Patient. (In last 1/3 of captivate)


comment:
the continue button comes up several screens too early.

Also, we need the audio added to the last few screens. Please send me a script with those that don't have audio yet and I'll have Mike record them ASAP.


comment:
need to duplicate the last screen that says "you have now completed the configuration for the cobas Liat Analyzer" at the end of the captivate too.


comment:
actually, this isn't the right captivate - it's the practice not the demo...


comment:
transcript the POCC non-Expiring doesn't show up


comment:
for the first OST text box - still only need the text that is said


comment:
This still doesn't have the all the text on that slide together. I want "Double click the cobas..." on the previous slide.


comment:
There seems to be some wording missing...  such as the "will" in "you see why it is important..."


comment:
For the Country-specific ICF template, please ensure that it is clear is created and maintained at the Affiliate level for use in all trials by the ICF Template Owner.


comment:
Add "The Study Manager provides all source material" to addendum pop-up.  Also, should it be clear that the study manager provides the study specific source material?  The writer obtains the templates.


comment:
Maybe clarify "proper interpretation" to say that this is proper interpretation of the protocol?


comment:
The work at the country level does not necessarily have to stop until the TCED is updated.


comment:
For the first answer, revise to say "...trial-level documents will indicate which study participants..."


comment:
Study manager does not have sites or ERBs.  Change to say that "The Affiliates say that Ethics committees from around the global...."???


comment:
I thought we added "overview" to this (and the Recruit Study Participants and Manage Enrollment, and the Develop Recruitment and Retention Strategy Content courses).  I didn't see this reflected anywhere.


comment:
the links that need to be changed will also need to be changed on the resources link form the Menu icon.


comment:
so, typically we talk about using judgment-based decision-making in the context of NGD, we are looking at complex decisions and it denotes using a specific framework.  
Comparing it to choosing a piece of fruit is okay if you are emphasizing it is a complex decision and why.  You covered the why, but if it's not late to change this, but I would emphasize the complexity of the decision when choosing to use the judgment-based decision making process.


comment:
the verb tense grammar seems awkward to me.  Starts with past tense, then present.  After the "When I first started..." sentence, I was expecting something like.  As I gained more experience, I could see the negative consequences...Judgment-based decision making has helped me to holistically evaluate..."


comment:
don't think that your transcript has been updated. Please double check on all audio screens


comment:
3rd bullet - judgement should be spelled "judgment".  Although is not incorrect with an "e", we are consistently writing it without the e.


comment:
provide instructions to site - in first phrase, study should be trial. uncaptalize study particiapnts throughout


comment:
Since I am leading the effort with JBDM, I'm very sensitive to how the terms here are being used.  using judgment is not just asking questions, it is about using a framework to make a judgment-based decision.  I'm concerned that what you are representing as judgment-based decision-making is not representative of all the elements working together, it's only considering one of them (identifying uncertainties and gathering information).  I am going to suggest some tweaks to wording to give that context and will add the JBDM framework to give info on the full approach.


comment:
i don't see this on any of the edit spreadsheetS? I  know we moved it, but can't remember what the changes were? regardless your mdodule title isn't right on the screen and in the feedback tool.


comment:
ok - i found the edits, ingn ore that part, but your module title still needs to be updated


comment:
i don't understand the two buttons for the site manager. when i clieck each button, the text doesn't seem to change?


comment:
had an issue with the checkbox text disappearing after a while


comment:
dont we need the procedure link in here?


comment:
move "Closing Out" to same line as "Sites!" Make it "CLOSING OUT SITES"


comment:
I find the text for the "complete site evaluation of changes" to be a bit odd.  I think the "this" needs more information and/or the documentation information needs to be clarified.


comment:
think "etcetera" where used is redundant (e.g. after an i.e. and after a "such as")


comment:
on the cc the last line is not bulleted.  shouldn't it be?


comment:
please reword or bullet the text for the "allow the site to handle..." option


comment:
think the purple bubble needs site manager in it so it is a clear opposite of the red bubble.


comment:
grammar off in red box.  "a new PI" then "he or she" not "they".


comment:
purple box ... recommend removing "successfully".  
Also, Dr. Thompson could have already been involved.  Would change to "... continue with Dr. Thompson as PI."


comment:
ok.  upon reading next slide, it may be that "... continue with Dr. Thompson as PI" isn't sufficient.  perhaps change to "... continue with Dr. Thompson as PI once all change activities are documented and implemented"


comment:
the second sentence on the slide says "below is a list of other common changes".  If these are "other" what were the first ones?  Could we just eliminate "other"?


comment:
the bottom edge of your photo is going over the footer


comment:
clicking a button didn't make anyu feedback or trigger happen


comment:
perpare for kick off- the box states the meeting is to align the study staff and personnel responsible for site selection....this is accurate- the goal of the kick-off meeting is to educate all the necessary personnel responsible for site selection on the protocol and all of the study requirement.


comment:
To Laura's comment about the LOC- the LOC doesn't have to be trial specific so leaving it broad is appropriate as they can be compound and even population specific.


comment:
To SV point- are we able to change since all of the maps say Select and Manage Sites Guidebook?  I had the same question in the other training.  Agree with LAL comment about the red boxes- I was like what red boxes.  I had the same thought regarding notifying the site they aren't selected- that should be added.  If we can, I align with adding in the additional information as to what the evaluater needs to do as we heard when individuals were looking at the maps the additional detail would be nice however we don't have the luxury of that in the maps so this would be the space to do it- we can discuss tomorrow


comment:
Select Site- the flow of the 2nd sentence isn't working for me.  wouldn't a qualified site have a completed evaluation?  that is how they were deemed qualified.  Maybe something like this or a variation:  If a site has been evaluated and found to be qualified but not needed or used (pick what works best) for the trial, the evaluation can be documented and the site identified as back-up, to be selected later, if needed.


comment:
Agree with the comment about verb usage just needs to be tweaked- I would like to better understand the comment about judgement based decision making- not clear as to all of the elements working together.  I would suggest revising the last sentance:  My suggestion for the last sentance ....Using jusgement based decision making I consider all the inforamtion I have gained through discussions & observations during the site evaluation, past performance and other data points, holistically evaluating the site & potential risks to determine if they meet the necessary qualifications or can say determine if they are qualified....I don't think JBDM makes a person do something- I think one uses the JBDM approach to determine level of risk and qualification & highlight that this is done in totality- all things contribute


comment:
here's my thought...2nd sentence..I use judgement based decision making and ask myself some key questions...or I ask myself some key question and use JBDN to consider the impact of.....I can't see LAL's comment to comment- didn't know there was a JBDM framework tool?  Should this be added elsewhere also if applicable (Guide book etc.)


comment:
align with Erin on SPI and Laura on term usage which is why being broad like using "system" may not always be the way to go?  For ISEC can we add more context- Like the form which contains the required documenation to support why an investigator and site are qualified to conduct the trial...or somthing like that & the ISEC acronym?


comment:
I couldn't select one of the boxes because it was incorrect but I think the user should be able to do that and it not stick to show it is the wrong choice-is there a reason we cant say the site evaluator doecuments information about a site within Trialforce- I don't know that the verb usage here is correct- the evaluator uses TF- TF is a noun and documentation happens within TF-


comment:
1st sentence:  select the right number of sites to meet the country allocation, within established timeline...or a variation


comment:
I would put #2 as #1; to my last comment you can just note that in the 1st sentence they select the right number of qualified sites to meet the country allocation or strategy....


comment:
Understand the ICF PROCESS vs. Understand the ICF creation PROCESS


comment:
I want to be cautious with the 2nd sentence- select the sites that are agreed upon with the COPM and COM- the site evaluator selects the sites and I interpert this comment in that the CDC will review every site they want to select- prior to qualification with the COM and COPM and this is not the case- how about- collaborate with the COPMs and COMs during site selection to ensure all objectives are being met or the strategy is being met....


comment:
trial-level, country-level and site-level in the box that provides more information regarding the addendum ICF


comment:
Milestones have ICF listed but when you click on more information it says Informed Consent FOrm ....need to be consistent


comment:
Before the SPI section the SPF forms were completed in paper and attached to trial sites...is there any way we can include in one of the bubbles documenation of follow up items- this is a huge sticking point that we have been asked to focus on and I think it is appropriate to note here


comment:
Because before the SPI there was the SPF and we really aren't viewing prior SPIs I think we should revise- Do we have to call out past and current and just say ISEC & SPI information as well as.....dsorry I didn't see follow up items here- my fault disregard my comment;


comment:
They will always use this process regardless of whether a master is created or not.  We need to update the voice over and the language to the following: Click on the red highlighted box to view the process when developing site-level informed consent forms.


comment:
we need to change the voice over and language for this because they will follow this process when developing site-level regardless of master or not created.  Regarding the wording on the slide, I would update to: You will follow this path to create site-level ICFs.


comment:
The language in #2 seems a little different than the others.  I would suggest updating slightly: Determine that master informed consent documents are required.


comment:
For ICF Reviewer, I think we need some updates to the language: The Medical Quality Representative (MQR) reviews to ensure the International Conference on Harmonization Good Clinical Practices (ICH GCP) and Lilly Legal required language is included, as well as, reviews the privacy section.

You don't need to spell out CRP/CRS/CP in this section.


comment:
For ICF Approver: The initial approvers are the CRP/CRS/CP and MQR.


comment:
Under when, should it say: After all requested changes from the review have been resolved


comment:
Should it be Gathers source documents instead of source document under What?


comment:
I think we need to be consistent with our use of ICF, ICFs or ICF(s) throughout....


comment:
Suggested re-wording: We rely on our partners to provide quality ICFs vs. to provide complete and correct documentation.


comment:
when creating ICFs vs. when creating consent documents


comment:
Suggested revision: Not only do I need the timeline from the TPO, but I also need to discuss the turnaround times and expectations with the Site Manager.


comment:
Find the Trial Consent Elements Document template on the ICF Collaboration Site vs. at the ICF Collaboration Site.


comment:
In the more information box....I don't think you need to capitalize Template and you don't need to bold the templates.  Revise to: Find them on the ICF Collaboration Site vs. at the...


comment:
I don't think you need to bold Guidance and Standard Language Appendix in the information box.


comment:
Let's check your knowledge about ICFs. vs. Let's Check your knowledge about consent documents.


comment:
The correct answer says country-level ICF, site-level ICFs and site-level assents...shouldn't this be country-level ICF and site-level assents?


comment:
In the response, site-level vs. site level


comment:
PRovide Consenting Guidance: One of our responsibilities is to communicate consenting guidance to personnel with site management responsibilities, including third party organizations, so they can provide this guidance to sites.


comment:
Provide a timeline: When changes are made to risk profiles, trial-level documents, protocols or other source documents which result in an ICF update....


comment:
ICFs are vital to the success of the trial and the safety of the study participants.  Incomplete or incorrect ICFs....


comment:
Regarding the title of this section...I would revise to Why the ICF Process Matters vs. Why the ICF Creation Process Matters


comment:
again remove creation from text above the buttons and on the first button


comment:
For title, I would revise to ICFs: Who, When, What


comment:
Update objectives:
1. Review HbA1c calibrator package insert.
2. Review Calibration section of reagent package insert.


comment:
Add to "Show a calibrator package insert and explain:" the following as the first line.
Where you can view package inserts - cobas® e-library or USDiagnostics.Roche.com (US only)


comment:
Remove word "That" at the beginning of the 3 bullet points.


comment:
Change remaining bullets in "Show a calibrator package insert and explain:"
Bullet - Where you can find key information on the insert:
Sub-bullet - How to prepare calibrators.
Sub-bullet - Storage and stability requirements.


comment:
Will provide new calibrator and control loading chart.


comment:
I'd like to see this zoomed in on the parts she's talking about in the VO. The VO goes on way too long with nothing happening on screen.


comment:
can we make exclusions doc a little bigger and easier to read?


comment:
this example refers to the PED, which is the old name. I would ask Lilly to provide an updated document that refers to TCED


comment:
Change to "Onsite Training Facilitator Guide for the..." by removing 's  - it's not present in the cobas version.


comment:
The content approval number will be 6078-02-0217 (if we can hit the February finalized date)


comment:
Global Edit - removing 's to "Facilitator Guide" - present in a few places throughout.


comment:
Change second sub-bullet to "tray portals and tray portal LEDs" by removing the s from second "portal"


comment:
Disregard previous edit. I will put this into an activity table with the corrections.


comment:
Correct Tray Transportation System to:
Tray transport elevator


comment:
USB port - can be used to save reports or system settings to a USB drive (point out the USB ports located on the side of the computer / touchscreen)


comment:
remove the following from this section - it will be covered under Software Overview & needs edited.
Verify instrument status:
Tap the Instrument tab to monitor status.
Tap  to pull up the status key.
Review instrument status:
Green  ready for processing.
Yellow  starting or recovery mode.
Red  error.
Grey  stopped (shutdown mode has completed and instrument is stopped).
Purple  solution exchange in strainers during shutdown or start up modes.


comment:
Should we include a step before step 6? seems like we jumped from accessioning to examination of a culture. What about the steps needed to get growth? Inoculation and incubation?


comment:
Continuing with my first comment - can we edit it to say- "The analytical phase is from the first examination of the sample until the final results are analyzed"?


comment:
visually, this screen needs some headers for different sections. hard for my eye to know where to land.


comment:
i'm not sure what the rating scale is doing for the learner?


comment:
I feel like the pre and post steps have a lot of detail but the analytical phase is the most important for us and there is very little detail. Can we add steps to examine and assess the quality of the specimen, inoculate and incubate to produce colonies, picking and streaking to produce a pure plate for more analysis, conducting tests to identify the colonies, and testing to test susceptibility


comment:
Will provide an updated table for bulk reagents.


comment:
the direction to click on the bold text for definitions was a little confusing because there were four definitions but only one bolded set of words


comment:
I might be confused for where pre-analytics stops and analytics starts. Who does the initial assessment? Are the samples not accessioned if they fail the assessment? Is a Q score for a sputum sample considered an initial assessment? and is this considered pre-analytics?


comment:
Change What's Next for Learners? (like cobas 8000) to 
Recommended Reinforcement Activities
RDU 
Study hardware identification by reviewing the VENTANA HE 600 system Basics eLearning course.


comment:
I agree that we would should bring it back to our MRSA example and we should tie it together by showing a nasal swab being streaked


comment:
is the Training owner always the GSTM?  I thought we weren't using specific functional role titles?


comment:
I would do a little more setup to introduce the scenario...something like "Let's walk through a common example of developing PS training..."


comment:
We seem to spend a lot of time on specimen types.  Can't we just mention the different types of benches and go into more detail about the MRSA sample. Then provide more content to define the difference between a chromagenic media culture vs using a traditional enriched broth culture.


comment:
If we are going to mention antibiotic susceptibility tests and mass spec at this point, I think we need to provide more detail as to what info they provide and how they fit into the overall process and more specifically for the MRSA screen (which wouldn't use mass spec)


comment:
would a CRA wear scrubs?  I think they would be dressed in more office professional style but someone who is more familiar can answer.


comment:
So is this question asking - " Based upon the initial examination of the cultured sample, what are some common follow up tests?"


comment:
Per my previous input, I think we need more details on the testing processes during the analytics phase and we need to add time for any types of testing discussed to provide perspective and to be able to answer this question.


comment:
ARe we going to refocus this on the MRSA example? and if yes, wouldn't the answer be a range depending on which test they used - chromagar or enriched broth?


comment:
Can we make the goal for this example - guide therapy - rather than rule out MRSA as this is the ultimate goal for the treating physician.


comment:
It seems like we are focused on specimen containers a lot in this module.


comment:
Is the handling of the specimen important to us? Why stop and focus on this?


comment:
I feel like these breaks in the video are "tests" and tests are an opportunity to reinforce  info that we feel is most important to us. But if that info wasn't covered previously, it is awkward to be testing on it. So my feedback is two fold - I don't like the construct of doing a "test" in the middle of providing info and I don't agree with the focus of the test but maybe that is due to the way it is being handled.. For the test construct - is there an alternative approach rather than this multiple choice test?


comment:
Don't you love the what? I couldn't understand the word.


comment:
I think we should provide an example using a blood test as this better matches the tests we will have in the future. And wound specimens can be more complicated so the testing process is more varied.


comment:
Agree with Lydia. Keep 2nd paragraph though. Tie it to the second chapter to give context.

This second chapter will help me to understand the process of sample flow. Let's spend some time around the hospital following a sample from start to finish  during the testing process.


comment:
Engage Sites to achieve enrollment is a task not a process.  Replace process with "task"


comment:
Number the phases 1-3 with numbers in circles. Add the label testing process above it to tie it together.


comment:
rewrite:

"During Chapter One, I learned about the three-phase testing process and some of the equipment used in each phase. Today I want to understand what actually happens in each phase....."

'dig deeper' may not be understood by non English speakers.


comment:
I re-read this question and now it doesn't make sense to me.  None of these are within the Engage Sites to Achieve enrollment (task).  Suggested rewording:  As I'm performing my tasks within the Recruit Study Participants and Manage Enrollment process, what must I make sure does NOT occur?"


comment:
-use numbering system introduced in previous slide.
-Also, change the header to read 3-Phase.\
-Can we have a short description of the phases in the Resource section.


comment:
suggest "take action" instead of using "intervene"


comment:
In steps section, please start each step with a noun or verb for consistency.

Is that the correct citation notation?


comment:
Jenny will need to check procedure link. The title of the 2nd link should be "Enrollment Guidance Document".  the 4th link should be listed as "Training Materials-Event Dates and Enrollment Breakdowns in IMPACT" (all one title)


comment:
what is 'see it'? Can we have an instruction above it?


comment:
I don't believe Roche is indicated on the order form but only type of test. MSA to confirm.


comment:
Start the second bullet with the individual for consistency.

The person responsible for the sample collection will receive...


comment:
Second bullet:

Proper sample collection is critical so that the specimen can be used. Otherwise, we will need to repeat this step which will delay the testing.

Use bullets 2 and 3 as sub bullets to the one above.


comment:
Add common names in parenthesis:
E. coli
C diff


comment:
Agree with yellow box, we will discuss transport to centralized lab vs decentralized lab transport with MSA.


comment:
Based on group feedback, I'd suggest replacing current image with two 'generic checklists' to show different protocols for in-house vs. central lab transport.


comment:
Edit bullets under "Show learners the coverslips consumables area on the instrument and explain:
-The Coverslip Activator works by activating the glue once placed on the coverslip.
-There are 170 glass coverslips per Coverslip Cassette.
-Storing the Coverslip Cassettes horizontally is essential to prevent them from sticking together."


comment:
If the entries are incorrect, can you highlight which ones are incorrect?

I had it correct at one point and it didn't accept it.

Also, step 2 with clerical staff processing test request can also apply to receipt in the lab. There may be some processing that happens at receipt.


comment:
Add intro sentence to put it into context. Will ask MSA.

It is critical to meet all sample collection requirements so that the sample can be used for the lab test.


comment:
During our last review with Legal - she requested to use more confident poses. Agree with LS.


comment:
Change: Let's sort some samples to 

'Click here to begin sorting samples.'


comment:
Recommended Reinforcement Activities
Keep same 3 bullets


comment:
check with MSA on 48 hr turnaround and question below.

Indicate that final reports should be issued as soon as test results have been confirmed. Are we missing a step in between?


comment:
change second bullet (It displays current system status.) to 
Provides an overview of the system.


comment:
indicate all professionals who have access (clinician, pharmacist, etc.)...


comment:
based on individuals, add other figures including pharmacist, etc.


comment:
Mention antimicrobial stewardship to reintroduce this concept from previous module. Can we check against module 1 on other concepts to be reinforced in this module.


comment:
Can we replace this question with a teachback on antimicrobial stewardship?  

Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.


comment:
Too much to read in one screen so please cut down on text in green bubble.


comment:
I will provide a new screen capture for this page


comment:
Can you create a 'See it' page with the 3 bubbles grouped to appear within the page. Same for 'Try it'. Perhaps use a different color for each grouping. Open to suggestions.


comment:
Are there going to be two buttons "See the ISEC Section" and "See the SPI Section"? Or are you expecting "the form" to be related to the specific questions on this screen only (meaning the forms will be split up officially)?


comment:
Think second box should have  further indent with "Options:" instead of the bullet before the list.


comment:
I think there should be something associated with this page and/or the questions that identify they are part of the SPI (vs. the ISEC on the next screen). If you are going to leave it as one "see the form" button per screen, then I definitely think it should be labeled here as "See the Form - SPI" and "See the Form - ISEC" on the next screen.


comment:
Q1 pop-up: Not in love with "therapeutic decisions" (unsure if I called it that earlier). Thinking it should read more like "Laboratory results may influence study participant care and data during a trial. Participant safety and trial data/outcomes could be negatively impacted if lab results are inaccurate due to poor sample collection or handling."

Also - I think maybe the second paragraph should read "Lilly's ability to study and bring medicines to patients can..."


comment:
2nd box pop-up: If the site prepares and/or ships laboratory specimens, or runs laboratory testing at their site, ..."


comment:
first signif of requirement box: remove comma after "responsibilities"; "...to determine if..." - change if to whether


comment:
Start with 'Following...." Rewrite the second sentence to remind them of objectives and get excited for the next round.


comment:
Text moved from Start Up section:
Add these as the 3rd & 4th bullets under - Ask learners to demonstrate how they know the instrument is at "ready."
o Tap the Instrument tab to monitor status.
o Tap [insert "i" icon] to pull up the status key.
[insert screen capture of status key] to be provided.


comment:
Remove bullet "Sleep - (future software release)"


comment:
I disagree with Jean here - "The main goal" is different for vivoDx relative to Liat and 4800 so I prefer the current, broader wording of the second bullet point.


comment:
Edit bullet item:

Stop - All trays will stop processing. If trays are being processed when the Stop button is pressed, the system will ask for verification of the system stop.


comment:
Recommended Reinforcement Activities

Practice navigating the Operating and Instrument tabs.
Confirm that the system is on and its current status.


comment:
Group A Strep Testing method should be PCR!


comment:
Add note under the coverslip cassettes section:

Note: Coverslip waste logic & recovery will be covered in the Troubleshooting section.


comment:
Recommended Reinforcement Activities

Keep 1st two bullets and add:
Practice loading and unloading coverslip cassettes.


comment:
Edit:
Recommended Reinforcement Activities

Practice reviewing trays for foreign objects.
Practice loading slides into trays.


comment:
Edit "portal LEDS" to "LED status indicators" 

Tell learners to compare the LED status indicators and the tray portals on the Operating tab of the software.

Add additional picture as a "side by side" image with real photo of LED status indicators. To be provided.


comment:
Recommended Reinforcement Activities
same bullet point


comment:
To provide new image with stained slides.


comment:
Will create an Activity for the rest of this section.


comment:
Recommended Reinforcement Activities

keep same


comment:
You need to define PS before you use it in the objectives.


comment:
the last milestone is Training Completed & Documented vs. Delivered.  Please update the more information box.


comment:
The voiceover says Clinical Pharmacology won't have a training plan.  I think it would be better to say will not likely have a training plan vs. not.


comment:
Suggested slight revision to the information box: 
The following is completed during this step: 
-Strategy, timelines, milestones and training delivery methods are discussed.
-Training requirements are determined and documented.
-The plan for training document is finalized.


comment:
The voiceover says the study follow the inline process to develop PS training.  I think it should be called embedded process vs. inline.


comment:
In the Plan for Training Delivery info box: Agendas are set and materials are developed and delivered.


comment:
In the Conduct Training Kick-Off Meeting info box...use Study Team vs. Study Team members.


comment:
Develop Protocol-Specific Training Materials info box: I would remove This is where...The Study Team develops the PS training material used to train affiliate, CRA and key site personnel.  The Protocol-Specific Training Content Design required tool ....


comment:
I understand that you are using the milestones when you go through the process for section titles, but I think you maybe should use the full process title like you did in the slide with the overall process for consistency throughout these slides.


comment:
Protocol-Specific Training Content Design required tool vs. Protocol-Specific Training Content Design Tool


comment:
you have an extra "for a" included.  please get rid of one of them.


comment:
Our team includes the Study Manager, CRP/CRS/CP and representatives.....


comment:
Once planning is complete, development of the PS training materials begins.  Let's look at the Obtain Protocol-Specific Training Materials embedded process, which is where development of PS training materials is described.


comment:
title of slide...I would use the title from the previous slide when we are going through the tool


comment:
Gather several sources to complete step 1, which may include feedback from CoLab, if conducted for the trial, ...


comment:
Select the resources the team should investigate to learn about the key risks and points for their Biomedicines trial.


comment:
CoLab Results: 

Identifying that some tools/resources need translations to local languages vs. needed


comment:
Click the PS Training Content Design Tool button to view Step 2 of the tool, which includes considerations for your training audience.


comment:
Click the PS Training Content Design Tool button to view Step 4 of the tool, which includes best practices for developing PS training materials.


comment:
Operations were implemented correctly at the site and blinding site staff were not unintentionally unblended which kept the data integrity intact.


comment:
We failed to provide information on unblinding processes, and unfortunately site staff were unintentionally unblended.


comment:
Yes, you should have it reviewed again as the trial design is critical to PS training.


comment:
It also diverts the trainee's attention from what you are saying as they are trying to read the slides.


comment:
Create a tool to use during the training and build a practical exercise, or use scenarios to help your audience understand the complex process.


comment:
We had decided to remove TSI Slants from this course. Please remove it as one of the options and replace it with the Vitek 2


comment:
Ignore edit "Will provide cause column screen shot". The screen shot that is included under "Demonstrate how to identify Calibration > Status screen components, starting with the Cause column." is incorrect. Remove the screen shot.


comment:
Circle the Waiting time on the Rack Monitor screen that is displayed.


comment:
Change "active reagents" to "current reagents".


comment:
Add to the RDU Recommended Reinforcement Activities:
- Complete the Calibration and QC topic in the flashcards.
- Complete the Calibration and QC Learning Checkpoints.


comment:
Combine QC and Manually Requesting QC into 1 topic "QC" since Calibration is 1 topic.


comment:
Updated the definition for "Ordered(O)". This has been updated in the Operator Notebook to "Sample has been requested or registered, an open order exists."


comment:
Change question 2 to "What area (color) should the needle on the Pump Pressure Gauge be in when the analyzer is in Stand By?" Answer: "Green. Technical Support should be contacted if the needle of the Pump Pressure Gauge is not in the green area of the gauge when the analyzer is in Stand By."


comment:
Add a question 3:
"What area (color) should the needle on the Pump Pressure Gauge move into during an air purge?" Answer: "Yellow. Technical Support should be contacted if the needle of the Pump Pressure Gauge does not move into the yellow area of the gauge during an air purge."


comment:
Change question to "What is the name of the screen used to guide you through routine tasks?"


comment:
Change answer 2 to "The reagents to load or unload. The Reagent Load/Unload List does not include expired reagents."


comment:
At the end after "expired reagents" add "unless they are empty."


comment:
Answer 2 - Add "Conditions" between Start and screen.


comment:
Change question 1 to "Show me how to manually request controls for standby reagents." Answer: "Have participants demonstrate the process." Move question 1 to question 2 and move question 2 to question 1. Change "active" to "current".


comment:
Change bullet 3 to "Explain that the Barcode Read Error button is used..."


comment:
question 3 - Change to "When would you use the Barcode Read Error button?"


comment:
Update "O - Ordered" definition to "Sample has been requested or registered, an open order exists."


comment:
Remove entire bullet "Refer participants to the Operator Notebook to review the Data List information...". Replace with "Refer participants to the Data Review - Data List page of the Operator Notebook. Review information included for Routine View and Backup View."


comment:
All our products include these options as do the competitors products. These are not what I would call options.


comment:
clicking on second required step - the associated signif requirement won't appear...


comment:
Don't like having the right answer first, they may not even bother reading the others


comment:
This time we have a next and continue button that both work, are we ok with this?


comment:
first signif of requirement box: first sentence parenthesis is confusing/wordy


comment:
Add to the end of question 3 "to the LIS.". Change answer to "False. The analyzer does not need to be in Stand By to send results to the LIS."


comment:
Remove "Daily" from "Daily Maintenance Log".


comment:
Change "NON-24 HOUR..." in objectives to (Applicable to Non-24 hour facilities that turn the water off."


comment:
A previous edit in the Checklist Basics section was for the information on this page to be included. This topic should be removed from this section and added in Checklist Basics section.


comment:
There is only 1 Maintenance Log. Remove "Monthly" from "Monthly maintenance log"


comment:
Remove leading "a" from bullet 3 and 4. Upper case the first letter on each bullet.


comment:
remove "appropriate" in the Note. Should be "You'll need to print the Maintenance Log for each participant."


comment:
Add the following to the Recommended Reinforcement Activities for RDU.
Complete the Maintenance Learning Checkpoints.
Complete the Maintenance topic in the Flashcards.


comment:
Capitalize Flashcards and Learning Checkpoints.


comment:
the link and entry process is being updated: bi.cummins.com is a new landing page Cummins is using as a portal to the various BI tools - we should point people there and then show them which link in that portal to click on


comment:
"Journal entries and ledger accounts are not SALES OPERATIONS reporting, so they are NOT INCLUDED IN DSA."


comment:
Market: "so this field isn't used." we might want to say something like "yet. As source systems are improved and standardized this will be included." ??


comment:
"it is a self-service tool to provide access to sales operational level of data."


comment:
the navigation pane shown is only available in "report edit mode" and not "read mode." Read Mode has a page navigator but it looks different


comment:
even in "Read" mode a user can select filters to apply to a report (the visual shown is in Edit mode) -- in "edit" mode the editor can add or delete filters and decide the state of the filters while in "read" mode the user can only decide what state the filters are in. -- I think we need to be consistent in how we want to show the screen - in read mode vs edit mode


comment:
not sure the "pricing projection" scenario is the one we want - we might want to stick to something more basic and we might want to weigh "finding and reporting something" vs. "forecasting"


comment:
please remove screen capture of masked button


comment:
Remove the Recommended Reinforcement Activities


comment:
Update "Complete Learning Checkpoints" to "Complete Troubleshooting Learning Checkpoints."


comment:
Remove Learning Checkpoints since those are already included in the previous section.


comment:
Change objective to "Know the resources available and when to use them."


comment:
Change first bullet to "Explain when and how to contact Roche Customer Support. Refer to the Operator Notebook for the information that will be needed when calling."


comment:
Ignore the "Refer to the Operator Notebook..." information in the previous comment since this is included in the next section.


comment:
Add additional Objectives.
- Search for the Operator's Manual in USDiagnostics.roche.com
- Search for and demonstrate the User Assistance Tool in USDiagnostics.roche.com


comment:
Confirm: Do we use the verb "Rollover" in other courses in this series, or should it be "Hover over..."


comment:
Change Explain bullet point to "Explain the following:"
-  When and how to contact Roche Customer Support.
- How to access the Operator's Manual and the User Assistance Tool in USDiagnostics.roche.com


comment:
Edit instructional text: "Drag the correct CMRI tasks into..."


comment:
I got stuck here - I dragged all of the answers over, including the wrong ones, and the next arrow never appeared.


comment:
This screen should be unlocked when user returns - not set to return to initial state. What is the precedent for this setting in other courses?


comment:
Also, incorrect feedback appeared when I clicked but dropped an incorrect answer (without moving it to portal). I think it should only appear if I actually dropped the draggable onto the target.


comment:
Change "Explain Installing QC materials" to "Explain the following:"
Change following bullets to:
- Roche controls are downloaded via cobas link. (keep formatting, cannot bold or add registered trademark in comment)
- Non-Roche QC materials are installed manually.
- Keep last bullet point but move it to here.
- Select the global Menu button then the Install button in the QC menu to manage QC materials. 
- Downloading or adding new QC material information when you are changing to a new QC lot number.
- Manually updating target values for an existing QC lot number.


comment:
Add a final bullet in the Explain section.
- How to assign QC material to the correct rack and position.


comment:
Text edits: "need to" is duplicated in line 1 of top left bubble
Also, is "tie" in bottom left bubble supposed to be "time?"


comment:
Confirming - I haven't seen Cindy refer to "after-the-fact" base schedules (top right bubble). Is that what she called them, or should we edit that reference?


comment:
I would add, if needed before implementing appropriate mitigation/contingency strategies


comment:
Correct Instructions in the Installing QC activity.
Insert "to" between "participants" and "download" in the first bullet point.


comment:
There's two sets of instructional text on this page.I think the first one is actually better (field instead of tab)


comment:
Delete Learning Checkpoints Reinforcement Activity. This was a direction in the Basic Calibration and QC section.


comment:
Text edits: Delete "the" before CMRI in sentence 1. Add space between sentences 1-2.


comment:
The activity icon is missing on several activities. Please make any updates here for any edits that were made to the activity in the individual topics.


comment:
I feel like there should be a back button or something that can take me back to the tab screen.


comment:
Update the Print Reports for the reports that were provided. 
Calibration Load List, Calibration Report Failed, Cell Blank Measurement with Abnormal Cell, Cell Blank Report, Photometer Check (failed), Photometer Check (successful), QC Load List, Reagent Load/Unload List and Reagent Status List.


comment:
Move this screen title in the drop down menu to come after "what does it do" screen


comment:
add commas to offset 'commonly referred to as sourcing'


comment:
Providing updated List of Simulator Tasks on basecamp.


comment:
Change the first bullet under "Practice the following tasks on the simulator:" to "Deleting reagent lot information for calibrator."


comment:
Are the sties competing for other trials and the enrollment plan not met at country level pop ups reversed?  These don't seem to make sense.  The site should be a site specific one.  Need to re-work with Mark and Sara


comment:
all 4 red highlighted boxes appear without needing to scroll so should this reference be removed and remove the slider bar?  Makes it seem there could be more below but there is not.


comment:
Do we want to put supporting materials here?  Concerned that training will get out of date


comment:
really no need for slider bar but if we leave it, then the instruction should be present (similar to previous slide)


comment:
same comment as previous about slider bar.  if we leave bar then instructions should be present.  seems we should be consistent on all slides (bar + instructions)


comment:
Remove word "Basic" from the Learning Checkpoints.


comment:
Add "Complete Reagents and Consumables Learning Checkpoints." to the RDU activity section.


comment:
Should be Flashcards not Learning Checkpoints in previous edit.


comment:
Seems like a word is missing.  should it say "Then the site manager or the site must submit...."


comment:
Add RDU Activities:
- Complete Patient Processing and Review Learning Checkpoints.
- Complete Racks and Samples topic in the Flashcards.


comment:
First pop-up: "Required critical equipment for the trial is listed within this ISEC question."


comment:
2nd pop-up. I might add a second paragraph "An example could be basic vital sign equipment, such as blood pressure equipment, thermometers, and scales."


comment:
Update last sentence to say "If a site will perform required laboratory testing for the trial at a lab other than a central lab... This does not include on-site laboratory testing such as urine pregnancy tests performed at a site."


comment:
last pop-up: "site's" - should be possessive, not plural, since each SEC is specific to ONE site location.


comment:
Would change the part where the CDC says that the site is responsible for the calibration...they are responsible for ensuring that any equipment IS calibrated and maintained per manufacturer requirements and that they can prove it was done (the documentation of such).


comment:
Critical and Non-Critical equipment are Lilly Terms. The site wouldn't know those terms without the CDC explaining them, which she didn't do. I would update this to start-off explaining the terms.


comment:
I don't like Valid or Not as I read this. I think "Acceptable or Not" is more appropriate. The questions would all need to then update to say "is this acceptable?"


comment:
On the NO answers (incorrect options) the pop-up is good except it doesn't provide what the site requirements are like the correct answer does (namely that they are responsible to ensure appropriate calibration and maintenance are available).


comment:
Best answer...sites don't actually "take responsibility" as that sounds like they actually conduct. They must understand and agree that critical equipment maintenance/calibration is performed per manufacturer requirements and that documentation is available when requested.


comment:
Incorrect pop-up. Might recommend "is responsible for ensuring the vendor they choose to partner with properly maintains equipment and provides documentation of that process."


comment:
Unless my suggested changes are made, both of these answers are actually correct, as she could have explained the terms up front better.


comment:
I think the second wrong answer on this screen is too close to a true statement (if it said "documentation" it would be 100% correct. Perhaps it could be something off-base, like "It's important to know the difference, since the site isn't required to have non-critical equipment" and then the pop-up speaks to why that is incorrect (including a "site is required to have all equipment, critical and non-critical, to conduct the trial procedures...")


comment:
Last bullet (and associated voice-over)... "if applicable" - there easily may be sites that have everything they need and have no mitigation plans or changes needed.


comment:
There hasn't been any commentary on observing and seeing if what you observe looks appropriate and/or matches what you have been told. This might be an area to add that as a bullet.


comment:
I find this cartoon a little hard to distinguish. The scale and biohazard box were OK, but the blood pressure monitor and thermometer weren't clear equipment to me visually. Not sure if there are other images that could work. Possibly a free-standing/rolling blood pressure machine?


comment:
Blood pressure pop-up - technically there *could* be a case like with an observational study where SOC equipment might not be a true requirement, if there aren't procedures required.  I might say something like "In almost all instances, vital signs equipment, including blood pressure monitors, would be expected standard of care equipment at a site."


comment:
The BP machine especially would likely have a calibration sticker as well, just an FYI. It is not necessarily a requirement (some have manufacturer's calibration statements that they never need to be calibrated), but it might be something to point out can be looked for.


comment:
I don't think the second sentence is necessarily true, since CDS doesn't own/manage the equipment. The maintenance of the machine should be per manufacturer instruction...it might be good to point out that this is very often identified as critical equipment.


comment:
Fridge - think it needs some updates:
1) the fridge needs an outline to it. It is super grey and blends in with the wall, doesn't look like equipment until you hover over it.
2) I don't like the identification of CT Material here. We would NEVER want samples and CT Material stored in the same fridge and this is a LAB area, so CT Material shouldn't be mentioned.
3) Verification that the refrigerator is properly maintained may be through fridge maintenance records and/or continuous monitoring with a properly maintained thermometer.
4) Temperature monitoring (and min/max documentation) is expected of the fridge, even if the equipment itself is "maintenance". Could you put a "Log" on the front of the fridge where it is clear they write down min/max temperatures every day?


comment:
Ignore the last part of my #4 on the fridge. :) Also, would update this to simply say "must track refrigerator freezer min/max temperatures" - they don't necessarily HAVE to have a "written log" they just have to provide the documentation. SOme do this with electronic tracking that isn't specifically "using a log".


comment:
For study manager: 3rd bullet should be "reviews and approves"...missing the s on approves


comment:
Change "Complete Learning Checkpoints." to "Complete Troubleshooting and Support topic in the Flashcards."


comment:
Change "Complete the xx topic in the Flashcards." to "Study the xx topic in the Flashcards."


comment:
should links go directly to map?  it does not.  Procedure link does go directly to procedure. last bullet should be "Recruitment and Retention Guide" not guidebook and same question re link---it doesn't go directly to guide.


comment:
have to click twice on each red box for the more information to come up


comment:
review guide link doesn't go directly to document


comment:
Edit instructional text: "...why it's important and WHEN to use it." (not how - we're not miracle workers.) :)


comment:
Base schedule reports: Line 2, "reports." ALSO, in when to use it, line 1: "A participating"


comment:
FMM schedules - add period to When to use it stmt


comment:
Edit image caption, put period inside of quotes, "Forecast."


comment:
Confirm with Dennis: I believe Cindy said that FMM should NOT be spelled out as Fifteen Minute Market?


comment:
Looks like the FMM FRP and RTD FRP layers are linked to the same feedback link, if this matters.


comment:
I just clicked all of the reports, and didn't get a next arrow... also, I see a lot of Cindy's comments, but it appears these are from a previous release?


comment:
Confirm wording in when to use - "It is used FOR flexible..."?


comment:
I think we should add to either this screen and/or each tab screen that this information can also be found in the quick reference guide by clicking the resource tab above.


comment:
Edit: Replace dash in line two with period: "CMRI. Now it's your turn to practice..." 
ALSO, delete the hard return before "But don't worry"


comment:
Can select two options even though it only recognizes one as my answer


comment:
I don't think the question 2 incorrect feedback makes sense - "Sorry... does not show prices" doesn't make sense for every answer, does it?


comment:
I got this scenario wrong, but clicking the X sent me to the next scenario


comment:
Please do a global search to make sure all instances of 5-minute and 15-minute are hyphenated.


comment:
This scenario also advances to the next scenario when I click the "X" of the incorrect fdbk


comment:
Abby, let me know if you need help creating this fill in the blank question.


comment:
Does not show my score, just that I need to RETAKE THE COURSE FROM THE BEGINNING?! Should that be "retake the QUIZ from the beginning" ?


comment:
Are these scenarios supposed to contain audio?


comment:
Took quiz a second time, and pretty sure I answered everything correct but 1, should have gotten 90% but it says I didn't pass; still doesn't show my score


comment:
Remove the checklist/dead link if it does not pertain to this course


comment:
add ex: to  plan, baseline, forecast because not all trials have to have all fields.


comment:
Maybe we should say finalize initial enrollment projections - because we do come to an agreed upon initial enrollment numbers.  I think this addresses Sara's comments.


comment:
I would add to site manager sententce:  site activation activities, include determining the planned enrollment ready date,


comment:
i think we should say initial enrollment projections to Sara's point.


comment:
I don't think that you have to distinguish between mitigation and contingency.  Sara/Mark


comment:
Add to site manager, including establishing the planned enrollment ready dates,


comment:
The voice over is actually running two differents ones at once


comment:
This slide appears to be out of order when I go back through the slide deck.


comment:
site manager, second paragraph:  say once the appropriate planned enrollment ready dates are determined.  Take out plan, baseline, and forecast


comment:
I would not say enrollment projections could turn out to be inaccurate.  I would say enrollment projections could turn out to not be as expected.


comment:
I would say document the defined contingency or mitigation strategies that could be put in place to address the situation.  You also missed the point that there can be a mitigations/contingencies if getting sites enrollment ready according to the plan does not goes as planned.


comment:
Enrollment manager paragraphs. I would switch order.  I would also change the first sentence of the first paragraph to say, In addition, some enrollment manager work with sites after they are selected to determine their enrollment commitments.


comment:
Maybe not change order but we need to work on the wording of this section.  It just doesn't flow very well.  Maybe just take out the whole first paragraph. or maybe say at the end of the paragraph:   Site level enrollment projections are determined by  discussing with the site their recruitment strategy and solidifying enrollment commitments.


comment:
Why do we talk about enrollment expecations with the site manager.  They don't do anything with that.


comment:
For site manager, we can say.  We need to know realistic site activation timing which forecasts when enrollment can begin


comment:
I don't understand this chart. Do we read straight across.  The Why does not match


comment:
This whole slide just needs streamlined or eliminated.  it just doesn't add that much value.  Want to get Sara's and Mark's input.


comment:
Maybe eliminate all the pop up boxes and make the why's line up with the roles and what they do??


comment:
The trial level enrollment also has to match the protocol.


comment:
Should say site activation documentation to match map, not plan.  I think changing the name addresses ClinPharm


comment:
Notify/Consult box - appears to have typo in first sentence. Should be close out (missing the space).


comment:
I am not sure of the content in the Notify/Consult box. I don't like the 1st bullet, since randomization tables are actually a study level activity, not a site specific close-out activity and I also don't know what provide IWRS services means. Is that supposed to read suspend IWRS for the site? Also not sure what bullet 2 or 5 mean. Think this box needs thorough final review by the authoring SME.


comment:
Provide Instructions box. I think the last sentence should read "notify active study participants that the trial is closing at the site." (The way it is currently written it looks like the actual site is shutting its doors, which is not necessarily the case).


comment:
Contract Termination letter box - Does Blue works say it is the study manager who notifies the negotiator? That isn't the case in the US, the CDC submits forms through CCGO to get a study closed out...


comment:
Complete Appropriate Site Closeout box. The last sentence is speaking about two binders, the sponsors and the sites. Should it read "that the TMF sponsor and site binders are complete." ?


comment:
Site Managers pop-up. 2 things:
1) "Both site managers"...I know we show two, but theoretically there could be more (since a CDC is also a site manager and gets involved sometimes. If others agree, I might change that to "All"
2) last sentence is referring to two binders. "...sponsor and site BINDERS are complete" (I think).


comment:
MQO pop-up - there may be cases where no MQO involvement is needed, esp in routine close out. Should that say "consults with...AS NEEDED." ?? I am OK with it as is if no one else agrees, but think it seems like they are more involved than they are usually with the way this is worded.


comment:
Study Manager Pop-Up - if no one agrees with me fine as is, but I find this to not be entirely truthful, as a CDC (site manager) is likely to be a key person in notifying the Study Manager of close-out needs in early termination cases especially.


comment:
The CRA is a site manager, are they not? We called them a site manager on the Roles page (Site Manager with Onsite responsibilities...). THink it needs to be consistent here.


comment:
The last pop-up in the conversation is odd. All the prior parts of the conversation make it seem like she is done with her visit (it went well, she has verified everything...) but then she says she'll "move forward with the closeout visit"...I think it should be something more like "Everything is good on my end, but should anything come up after I am gone, please just contact me." or something else, just signaling finalization.


comment:
The study manager is missing here. The voiceover is good overall, but the image should be either of the Study Manager at first, then add in the Site Manager, or it should be both of them together. If you look back at the role definitions, the Study Manager should be in here.


comment:
The 2nd answer option acts like this is a multi-pick answer option, since it says "is also responsible" when no initial responsible party was identified in the question. I think it should just read "The Study Manager is responsible."


comment:
second signif of requirement box, third line: remove "then"


comment:
for the 90's we were already branding Cummins on the sets outside of North America, we may need to find a different image


comment:
Why we are saying that Study Manage is responsible to document Site activation? That should be the site Manager... Study manager should know about Site activation, or what is exactly what we are including in this "documenting" process?


comment:
As I still think that having 3 "apparently" separated roles, in Enrollment manager, Could it be possible add something like: Ex. "Site Manager and Study manager may be Enrollment managers at different points and levels(trial/country and site level) of the study"


comment:
Not sure if would be better put first Trial-Level Enrollment projections and Country Level in second place... just to maintain the order we follow: TRIAL, COUNTY, SITE


comment:
In the explanation of the answer maybe we could include at the end something like: "Remember, that as a study manage I can be an Enrollment Manager itself"


comment:
Inadequate Trial Drug Supply
Potential Contingency Actions: Affiliate to maintain enrollment projections updated into systems.


comment:
Trigger: I would suggest to put: Actual enrollment is behind PLAN for a country of an entire region.
Potential Contingency Action: Reallocate study participants between regions OR between COUNTRIES (not necessarily pts. will be re-allocated in a different region)


comment:
I think the scenario is good, but I don´t see why the name is "Sites competing for other trials"...


comment:
1st paragraph: ... used in HP and Early Exploratory Trials (EET).
(use trials instead of studies)


comment:
Ethics ICF tab:
2nd sentence reads oddly. a word is missing: Ethics-ICF tab it's best practice to review FOR all CRUs. ?


comment:
FHD tab - 2nd sentence doesn't read well. For an FHD trial is mentioned twice. Change to:
For FHD trials the CRU must be approved by a CRU Assessor. This is usually completed through CPSDS.


comment:
review with SMEs:
Change "This means he will need to visit the site" to "He decides to visit the site"?
As it is a best practice rather than a requirement.


comment:
.... The form can be found in QualityDocs.
(remove Veeva reference - confirm with Jenny)


comment:
Special pops tab:  Can we replace 'studies's' with 'study's'?


comment:
Can we replace 'the person in charge of...' to 'the CPM advisor in charge of...'


comment:
Typo in the "Determine Need for R&R Strategy" remove the extra word "to"


comment:
Should we use the overall process button (or whatever it is in the other overviews), instead of the mangifying glass?


comment:
The description of the Study Manager's review implies a required order: 1st Scientific review, THEN other review.
There isn't a required order.  I would remove the word "then" and re-write the information to remove the implication that there is a required order.


comment:
I like this, but the screen seems hard to see and the text on the screen is hard to read. Not sure how we could fix this?


comment:
Agree with Sophie's comment. Recommend to revise to, "Understand  how the SITE-LEVEL budget development and negotiation process occurs." and "Learn the techniques for an effective BUDGET EXCEPTION management process."


comment:
I think in the site evaluation box, you can say the trial planner (often the Clinpharm study manager) may help clarify the trial manager role for ClinPharm


comment:
Should we have CPSDS as a role listed here as you have the site.  in previous slide, you said that both provide information.  Just a thought.  fine with what Teri and Larry want


comment:
GCBC would like for the phrase "viewed as a kick-back" to remain in the course.


comment:
I think the word "then" at the beginning of the "Obtain Approvals and Acknowledgements" box is a typo, I think it should just be "The"...we shouldn't begin an activity description with the word "then"


comment:
Agree with Tara's comment on Step #4 (could revise by removing the phrase "and negotiates").


comment:
In the "Develop Site-Level Budget" pop-up box, I think this may be more clear if the sentences are re-ordered ("The negotiator receives... The budget negotiator develops...").


comment:
On the ethics tab, I do not understand the sentence about review all CRUs.  Think soemthing is missing


comment:
Should we add "is" in the last bullet for study manager? 
...content is stored...


comment:
Site Manager
4th bullet
need an 's' on approve


comment:
Question for Teri and Larry - does the FHD tabl also cover the Montherapy Ascending Dose trials now?  If so, should we reflect that?


comment:
on the BA/BE wording - change study to trial


comment:
This was tricky for me because I wasn't sure if I was supposed to choose the tabs that can have trial specific quesitons or just the trial specific ones. If this is good for Teri and Larry I am fine with leaving wording as is.


comment:
Should you change up the order to make it harder?


comment:
Can the speed of this narration be slowed down at all? It seemed a bit rushed.


comment:
The correct pop up box sentence seems to be incomplete. Maybe - These tabs are completed when a trial is one of these specific types?


comment:
SRR Rep
3rd bullet
I'm struggling with "selection and contracting for" Unless anyone else has any great suggestions, the only thing I can suggest is to add the word "of"
...selection of and contracting for...


comment:
I'm struggling with "selection and contracting for" Unless anyone else has any great suggestions, the only thing I can suggest is to add the word "of"
...selection of and contracting for...


comment:
I purposefully selected an incorrect answer, but got a "Correct!" pop-up box. Can we review the programming of the Correct vs Incorrect responses on all "Knowledge Checks"?


comment:
This question needs re-worked.  He cannot complete almost all of these tabs with just CPSDS data.  The question is what tab can he not partially fill with CPSDS data and then the answer is right.  I would just say, which ONE tab to make it easier on the end user.  Teri and Larry - thoughts?


comment:
Agree with previous comment. Could we revise the final statement to state, "All lab fees, including the cost of locally-sourced supplies, are reflected in the..."?


comment:
I am getting stuck at "How Lilly Determines Pricing for Country Budgets", even after completing that entire module. No access to "Negotiate Exceptions".


comment:
This should be revised to either ask, "...when determining Fair Market Value for the Country Target Budget." Alternatively, revise the first bullet to "Standard Pricing".


comment:
So this screen is confusing when all three are blue.  How am I supposed to know which one to choose.  I had this issue on another training.  Shouldn't Re-evaluating a site be gray as I have not done yet or the ones I have done should be grey?


comment:
Do we say where you can find the HPSEC form in the previous section. If we did not, I think we should say it to be consistent.


comment:
The official title is:
"Recruitment and Retention Review Guide"
The link is wrong and needs to be corrected.
Here is the correct link:
https://lilly-qualitydocs.veevavault.com/ui/#doc_info/4543/


comment:
The correct "pop-up" says that use of an infusion center is not common in Oncology trials, which is not accurate. Please revise to state, "Use of an infusion center is common in Oncology trials, so additional site fees may be appropriate for the work required to collaborate with the infusion center if those fees are not included in the Site Prep Fee."


comment:
There is an extra _____ in the approvals questions


comment:
The box review and approve site-generated needs changed to Review and Approve Trial Specific Site-generated


comment:
Same comment as before- should we replace screenshot with one not in Demo mode?


comment:
In the text for the review and approve trial specific site generated.  Should we reference taht there is additional training available regarding this process (so people know why we did not go into detail).


comment:
Any chance to have a cleaner programmer image?  Looks too stretched out.


comment:
Would it be helpful to have a programmer screenshot on the right side here since you are describing where to go in the text?


comment:
I completed my review and have no edits.


comment:
clinical pharmacology delivery solutions is an organization so I believe should be capitalized.


comment:
Since Procurement can also approve some contract language (i.e. MSA and MSA-Study Work Orders), can the window for "Procurement Representative" state: 'Procurement Representatives are in charge of signing all vendor contracts and can approve Study Work Order language.'


comment:
Can you re-state the GCBC window to read: "GCBC Representatives approve non-MSA contract language changes."


comment:
Please change the question to:  "There has been a change to the non-MSA contract language that might impact the trial.  Who approves it?"


comment:
Need to reword text in pop up for the "determine budgeting organization"


comment:
Not sure that I like the phrase of "in charge of" in the procurement rep pop up.  Not sure what that exactly means.  do they have to do it or just make sure it is done?  I also thought that CPSDS has been delegated certain tasks by procurement.  Should we mention this delegation?


comment:
For the explanation in the Correct Answer, add to the end of the sentence: " , but subject screening cannot yet occur."


comment:
do regulators actually request trial funding proof? This seems like an odd question to me.


comment:
should the cpsds roles be represented in any of the questions???


comment:
Is there a specific reason we mentioned the actual version of the software in the pop up box. Doing this ensures we will have to update as soon as the software is updated.


comment:
Some of the text pop-ups go by so fast that you are unable to read them especially when there is no voice over.


comment:
I know this is training but from a good documentation perspective these emails are weak.  they need to at least have some study identifiers and perhaps some budget versions.


comment:
Again, remove CT Material comment here (it will be covered in CT MAterial section)


comment:
Fridge: "likely need refrigerators for..." I would add to this pop-up something about the temperatures need to be monitored in CT Material fridges the same as in lab fridges.


comment:
Chair: Perhaps identify that they are a nice to have and commonly seen in sites who frequently give infusions (as we wouldn't turn down a site just because they don't have a comfy chair)


comment:
Can the market visual be centered better so that it that the white space around the borders is more equal.  For example, look at how much space is above BSAP vs how much space is below BAAOP.


comment:
I suggest to change the phrase Lilly "monitors"... in order to avoid confusion with our 3rd party responsibilities


comment:
On MRI-S there is a blue arrow that goes along with the document movement, but with CIDI there isn't.  Please align the two whichever way makes sense.


comment:
I heard the sound effects louder than voice


comment:
Remove "ISO environments" which is above the three environments.  It is not necessary.


comment:
In the Map Stage explanation box, add "The purpose of connectivity testing is to ensure that the EIM participant's systems seamlessly interface with the ISO's systems."


comment:
I review the -Guideline for Good Clinical practice E6 (R1)- and I did not locate any refrece to naither  IATA or Transports to dangerous goods.


comment:
Please add in the "Stage" explanation, "Market Simulations provide EIM participants the opportunity to use and test ISO systems before parallel operations.  The parallel operations phase occurs prior to go-live and provides EIM participants the experience of operating in the ISO market."


comment:
In the Production box add "At go-live, EIM participants will transition to this environment."


comment:
Please move the "Find your role" slides to a "A closer look". Since everyone sees the next two things, let's not segregate the roles yet.  So the next thing after the animation is the application access screen.


comment:
We will give you another screenshot for caiso.com.


comment:
In the important note, change the sentences to read (and the script also)  "The intent of this course is to show applications provided by the ISO. Your organization may make this information available to you in a different way."


comment:
I am not sure if a thermometer for subjects are really a basic piece of equipment. I remember that some ER checklists do not even list it.


comment:
Timing issue with text boxes going by too fast to read.


comment:
do we need to refer to the applicable procedure too?


comment:
This may be a bit too picky, but is the planet able to have any defining features?


comment:
Is it possible to allow the users to highlight and copy the url that shows? That or make the picture of the url into a hyperlink?


comment:
Recommend changing the question to: "What step do I need to take next?"  In the previous slide, it already said the budget was approved.  Then the correct answer is to "Merge the budget with the previously updated contract language."


comment:
should 2nd paragraph have that the HPSEC should be filled out for all initial site evaluations.  It would be done for change evaluations.


comment:
there will be some sites where the CPSDS isn't really involved since an CRU assessment wasn't conducted.  I think it is fine to leave as is.


comment:
Consider moving the blue works box to the the center of the slide or making larger - too much white space on the slide


comment:
could we spell out FHD and MED on this tab even though it has already been mentioned before.  I think since the tab is specifically about these study types it would be important to have it listed here. 

wrt Laura's comment: decision was to call this Monotherapy escalating dose (MED) trials instead of monotherapy ascending dose (MAD) trials.


comment:
the row 6 response has spelled Japanese incorrectly.  PD should also be spelled out. 

on row 15 font for yes is different. 

Shouldn't every row after row 20 have n/a?


comment:
far right column of the "No" example is cut off


comment:
per Laura's comment, can you show the sub-process in the pop up box?  The walk through that process, as there are 2 requirements in that process.


comment:
should the pop up for Obtain Approvals and Acknolwedgments, have text that reads something like, The Site Manager should follow this linked process to submit the final R&R content...  (Question for Carrie or Laura, is the site responsible to submit this content too?)


comment:
I thought I clicked on each red lined box (and was allowed to click next but when I got to the Main Menu, I was taken back to the "click the process screen, I couldn't move to the Gateways (was grayed out) and the instructions stated I needed to click on the process to go through all of the screens again.


comment:
instructions should read.  Click the second gate to continue (not get started).


comment:
I would change a site LPV to a site's LPV has occurred and the study team is ready to close the site(or something like that). See what SMEs think about wording.


comment:
VO - review the process and procedure on the Blue Works Live site, only the process is in BWL, the procedure can be reviewed from the Quality Docs system.


comment:
I would not list all the triggers (as this will get oudated quickly).  I would say that this decision triggers multiple other processes in the operating system.  This will eliminate Erin's comments.  These are process map names that we cannot rename.


comment:
For the Assess impact, I would add the text that matches the map:  This activity includes discussing the early termination of the site with the appropriate parties and determining the required actions prior to closing the site.  I think it is fine to keep the sentence about during an early termination, it is important that study participant safety and data quality are assessed.


comment:
Further update.  I would say this includes the study manager discussing the early termination of the site with the appropriate parties......  Then you can eliminate the last paragraph.


comment:
Under obtain Approvals and Acknowledgements,we should match the process map which says:  Notification must be made for early site termination due to non-compliance and/or according to country requirements for notification regulatory authorities and/or ERBs.


comment:
per the map, the site manager notifies the negotiator that a contract termination is needed?


comment:
provide instructions to sites - say ongoing medical care for active study participatns can be provided (note to developer:  blue steps don't have to be done)


comment:
Site manager notifies to negotiator, not the study manager - I didn't mean to put a ? behind that comment.


comment:
Why in the voice over we say visit blueworks live?  I don't know that this was ever said anywhere?  Can we just take that out or what was the purpose of that?


comment:
I agree with Erin's comment about the last sentence.  It is two binders not one.


comment:
TO CRP, I would add, ensure study participant safety...


comment:
Agree with Erin's comments about multiple site managers and there are two binders.


comment:
I agree with Erin's comment on MQO.  Many times they are not involved in this process.  I would say, As needed, especially in early site terminations, as Erin suggested.


comment:
I agree with Erin's comments about the Study manager.  I just suggest that we simplify it to say that the study manager has oversight of the whole process and ensures appropriate parties are notified of a site's closure.  Erin - what do you think?


comment:
I would add off the study and the site has completed all necessary tasks related to the trial (see what SMEs think - I am thinking like queries, etc.)


comment:
For answers we should be the two different site managers - site manager responsible for site facing activites and site manager responsible for sponsor activities.  The CRA term has not been introduced


comment:
Would change her to the site manager responsible for site level activities (ex: CRA) or something like that to keep with our descriptions


comment:
To add to previous comment:  I would say one of the site managers responsible for site level activities....  This is in response to the fact that there can be multiple of these


comment:
I agree with Erin - this conversation is odd. We need to have the CRA acknowledge that everything is good on her end. That she has checked all the site issues are resolved and all outstanding documentation has been received.  We need to work with the SMEs on this converation some more.


comment:
I would say, in some cases updates the Lilly internal systems.  This is not true for Clinpharm, they have to enter in directly.


comment:
Agree with Erin's comments.  Also, what about ensuring site termination letter sent - that is a red box in this process!


comment:
Blue boxes are not required!  Ongoing study participant care instructions do not have to be done!


comment:
this question needs re-worked. How about using the contract termination as the right answer as that is the red step


comment:
I don't think sites are approved to be fully terminated.  Need to confirm with Kate and Catherine.  TNeed to re-word this.


comment:
Is the quality work plan valuable here? Need to ask SMEs


comment:
Did we say this on all the other trainings?  I don't remember it.  Should we remove if this is the only training course that has this?


comment:
I suggest to state "locked refrigerator" or highlight the "restricted access" requirement


comment:
I have conducted some trials in rheumatology and none of them required CT scan, Xray and maybe MRI. 

oncology really requires CT scan


comment:
We need to decide if we want to make the box displaying each application smaller, the font bigger, or spell out the names of the applications.  The boxes are too big.


comment:
Please use the correct person on the screen who is aligned with the role.


comment:
Change the name "Open your toolkit" since there is no toolkit.  Let's discuss a better name.


comment:
I did nor here audit after select "What about equipment that needs more tan anual maintenance?" option


comment:
Can we get a copy of all of the scripts in one document?  It will make it easier for us to provide edits.


comment:
Also in conversation 3, I did not have sound for final question


comment:
If you pick the wrong answer the question "counter" can exceed the number of questions, for example "Question 7 of 6"


comment:
If you pick a wrong answer the only option is to press the left arrow which take you to the previous question.  There is no way to try again.


comment:
Agree with Sonja, specifically on the 4th bullet- could probably consolidate this with the 4th bullet on the previous page.


comment:
Rather than highlighting all boxes at the same time, could you start by first highlighting and clicking on Previous Fill Volume, then move to Actual and then Expected?


comment:
Agree with Sonja, could consolidate those bullets


comment:
For motor stall, do we need to be more specific and say contact Medtronic Technical Services?


comment:
Is this repetitive since we talk about monitoring for symptoms of overdose earlier in the course when talking about monitoring the patient for an hour after refill?  I don't think its information that doesn't warrant reiterating, but wanted to ask the group.


comment:
I think the scrolling functionality while trying to follow the process flow is clunky...I for sure think we should have a detailed process outlined like this, but maybe in a printable tip card or cheat sheet to give to clinicians.  Perhaps we could just provide high level boxes on this slide so it all fits in one view?


comment:
Maybe say: or your Medtronic implantable system representative versus local medtronic rep which could imply to call their normal pain pump rep


comment:
Re-word "...content and quality standards..." such that you remove the word "standards" from the sentence.


comment:
I think the first bullet could be more clear.  Confirm with SMEs, but maybe something like "Identify trial-related procedures and potential risks"


comment:
Need to confirm with SMEs:  The voice says "early stage" instead of "early phase."  The voice also mentions "Clinical Pharmacology." Do we want to limit it to our internal org (clinical pharmacology) or by type of research (human pharmacology exploratory)


comment:
The Make Training Materials Available text is a really long sentence.  Can we break it up into two? or use bullets? or something?  Also, why are we mentioning Non-Protocol-Specific training here? Although it is an accurate statement, It is out of scope of this training and I don't think we should mention it.  If any other voice or text mentions Non-Protocol-Specific Training, I would have the same feedback.  I think we should only include PS training or change the name and scope of this training module.


comment:
transcript here doesn't match what's said


comment:
I would recommend adding content about the "Contacting Roche Customer Support Center" from the Operator Notebook pages 111-113.


comment:
Ignore edit regarding Customer Support Center. I found the content in the Resources section.


comment:
sorry, re-write  answers and the question. Make the question "What impact did your answers have on Susie's perception of Citizens Energy Group?" and make this a select all. answer 1 "Your answer helped Susie understand the value Citizens provides the community." Answer 2 "It showed that Citizens takes rate increases seriously." Answer 3 "It lowered Susie's bill." Answer 4 "It showed how Citizens is a responsible steward of our natural resources." (Answers 1 & 2 are correct.)


comment:
the transcript doesn't show the right text.


comment:
The decisional staff includes:
-Competitive Transmission Administration department
-Competitive Transmission Executive Committee
-Staff that is actively involved in the Competitive Transmission Process


There is not a RFP Team or Proposal Evaluation Team or Variance Analysis Team


comment:
Non-decisional staff includes MISO consultants and staff who have not been assigned to or perform work for the Competitive Transmission Processes


comment:
Amendment to my 1st comment need to add in "MISO consultants" as well


comment:
Sue doesn't indicate whether she is a decision or non-decisional employee is that intentional for training purposes?


comment:
Larry

I'm on the Evaluation Team. I receive a question about the Request for Proposal and have to specifically trained to direct all questions to Client Relations, even though I have the capability to answer them.


comment:
I think the preanalytic section looks good.  I like the knowledge check before proceeding to the analytical section.


comment:
In step 6, it seems a little vague as to what happens in culture, any way to animate or place pictures of the sample being cultured?  This would help in the learnings


comment:
Any way to have a-c be able to be larger.  Where you can click on it and it enlarges to get a better idea of what a gram stain vs an antibiotic susceptibility test?


comment:
On this page it says "lets review the steps of the pre-analytic phase"...it should be post-analytic!


comment:
I think for this question there should be more detail in what is being asked.  I dont think this information was really highlighted in the section either.


comment:
Where was this information covered in the previous seciton?  I am not sure this is really important.  Most people taking this learning module know good lab safety.  I dont think this should be a main point of the walk through.


comment:
Where was this information shared?  I feel like the questions being asked while they might be relevant are not truly covered in the module. Perhaps there should be a part in the analytic part that goes through all the types of tests and why? Could be too much but if we are having questions like this it is important.


comment:
I think overall the section is good but it needs some work so that all the stages link together and the questions asked have answers provided in the learning.  I also think it might be useful to be able to select different scenarios and follow those through the phases.  I know that is done here but perhaps there needs to be 5 in total and they have to pick 3.  Something like that


comment:
Might want to show the logical order clearer of which modules go in which order


comment:
really like this look. Might be cool to have the stars in the background?


comment:
I like the design of this. One concern is that the x's are covered if other tiles are placed next to them.


comment:
for some reason my back button isn't working for this screen. for the last screen I think it would be nice to have the CMI logo or something on the computer screen


comment:
the scroll bar arrow isn't instinctive to me


comment:
I actually was going to say the same thing as Kaitlin- I do worry the text is a bit too small.


comment:
text for published reports is really hard to see


comment:
overall design flows nicely with the other module. good job!


comment:
Course title on banner: Need to add "Generation" after OMS just like the 12a GM edits.


comment:
duh, ignore my previous comment entirely :) I'll drink my coffee first before I enter comments...


comment:
Intro text: Add sentence "This course focuses on the outages submitted for transmitting resources." (transmission resources, do you know if that's the term?)


comment:
Create a generation outage feedback box: spell out A/S as "Ancillary Services"


comment:
Equipment/Equipment ID box: Remove "in" between "Enter" and "part". Applies to Resource Name/Resource ID box as well.


comment:
For my other comment, it isn't the Resource Name/Resource ID box, but the Station Name box. Apply that edit there.


comment:
In the audio say "Mrs. Lacks" or Henrietta Lacks" instead of just "Lacks"?


comment:
The transcript has some red text, please change to black


comment:
Combine 3rd and 4th sentences: "You must submit a transmission outage in OMS to change the resource's availability, otherwise the market won't have accurate information."


comment:
Transcript and VO don't match: Ctrl+F "but we'll leave it as is." and change to "but we'll leave it as it is." (add the word "it")


comment:
ACLINESEGMENT highlight box: isn't centered on the text onscreen. slide 38/43


comment:
Transcript, 2nd and 3rd bullets: Capitalize Planned Start Date and Planned End Date since they refer to a title of the section onscreen.


comment:
General feedback here: For transmission outage submitters, they only need to know about searching for an outage, submitting a transmission outage, and modifying a transmission outage with overlaps? I ask because of the DP edits; I know that a number of items are covered in the generation course, but nothing about inconsistent or invalid outages is in this correct. This may be fine, but just want to check!


comment:
Intro popup box: capitalize Planned End Time since that's the title of the line item you are changing.


comment:
Huh, I just checked 12a and see we didn't do any audio for the You try it summary slide in that course either. Do you recall why we chose to do that? Shouldn't there be audio for the summary points here to be consistent with the See it in action section?


comment:
Lookup field question 2/10: I won't be surprised if they ask us to blur out Radha's name off this screenshot. I don't suppose we have one available that doesn't have her name on it? If not, I wouldn't spend the time on it right now.


comment:
Question 3/10 about Inconsistent column: The screenshot shows the options "Column Configuration" and "Grouping Configuration" as singular, so I would remove the "s" from the answer options.


comment:
Question 7/10, new transmission outage: shouldn't "causes" be capitalized since those are the titles of things selected in OMS?


comment:
In this sim, Radha's name pops up at the very top when the Equipment Picker tab scrolls up. If you were intending on removing her name entirely, wipe it from those motions slides as well.


comment:
Callout box text: Is your question to them whether or not the generation QRG can be the same one provided here? If so, I would change your 2nd sentence to: "Can the same QRG used for the Generation course be used for the Transmission course, or do we need any changes/updates?"


comment:
The spacing on this screen seems a little off. I would recommend mirroring the OASIS course by doing the following: End the first sentence after "data." Change "...with an assessment at the end." to a new paragraph that says "You must pass an assessment at the end of the course to receive completion credit."


comment:
Incorrect feedback boxes: The title says "Sorry, that's incorrect." so we don't need to say "sorry" again in the feedback. In OASIS, the incorrect feedback boxes explained where that task is actually performed. I would recommend we update the Display outages incorrect feedback to "Generation and transmission outage information is displayed in the Outage Management System (OMS)." You already mentioned that nodal prices are displayed in CMRI so no need to update that feedback.


comment:
Intro text: for consistency with OASIS, change "As you know" to "As you've learned" and start the 2nd second sentence with "For ease of use,"


comment:
Title: I would change the title to "See it in action: The filter pane"


comment:
For all CMRI report sets, we have a disclaimer at the bottom in OASIS. Check out those tab screens, but the disclaimer should read: "Disclaimer: Reports are updated annually; please check CMRI for the current set of reports."


comment:
Intro text: per DP edits, change to "Each report contains a filter pane so that you can choose the type of information you would like to see. Many reports contain similar selections fields - let's take a look at a few common ones."


comment:
Resource options popup: per DP edit - this should say "Resource(s)" instead of "Resource options". Change first bullet to "Select a resource name from the drop-down box". Change second bullet to "Use the filter builder to select multiple resources (must use caps)"  DC comment - do you have anything that says differently from after the DP review?


comment:
FMM FRP Price Breakdown popup - What is this report? Change 15-minute market run to FMM.


comment:
Resource-specific VER Forecast popup - What is this report? - Change to "This report displays 5- and 15-minute VER forecasts."


comment:
FMM Movement Points popup - What is this report? - Change 15-minute market run to FMM.


comment:
RTD FRP Price Breakdown popup - says "FMM FRP" instead of "RTD FRP". Change 15-minute market run to FMM.


comment:
Note to CAISO box - Change to "Some of these tabs only highlight one report. Do you want the learner to click the report tab and automatically go to the report instead of having to click the single report on this screen?"  DC note: Please review grammar and word choice since the box in its current form is a bit confusing.


comment:
Copy over text I provided for the other Note to CAISO popup box to clarify the instructions here.


comment:
Mirror the OASIS course See it in action: Summary screen. Copy its directional text, and have the tabs slide in automatically without having to click Edwin. Otherwise the current directions indicate that there should be audio here.


comment:
Intro text - add a space between the paragraphs. No audio here.


comment:
Scenario popup box - add a space between paragraphs here as well.


comment:
We should give these scenario characters a name and identify them by their role. Example: "Charles works for an EIM Participating Resource Scheduling Coordinator. He want to confirm how many MWs were used in the real-time market for a particular date and hour." Use the name throughout the scenario, including onscreen, popup boxes and feedback.


comment:
Mirror the layout of the OASIS course. Indicate which report they chose at the top, then list the second question.


comment:
Change my edit below to "Charles is an EIM Participating Resource Scheduling Coordinator."


comment:
My comment on layout for the introduction text is global for all scenario questions.


comment:
Correct feedback and answer option for this feedback - "SRE, or standard ramping energy, is an energy type..." add a comma after energy


comment:
Is it "Trial-level" Consent Element Document, or "Trial"?  I thought it was "trial-level".


comment:
For Trial-level Assent...  could we specify that it is for minors of certain ages?  7yo and older?


comment:
Add "template" after "Country-specific ICF".


comment:
Can we do a screenshot of a long list of complex scientific risks?


comment:
Would add that in addition to being a lot of procedures...  say that the procedures look difficult, complex, confusing?


comment:
As the name of the document is being changed only with the new procedure, we do not have any actual versions.  Perhaps Maria can take the old PED and put it into the new TCED that we creating (still in draft form)?


comment:
Maybe say that the CS-ICF templates are owned by the Affiliate?  Created by using the Elements for Consent Content Guidance?


comment:
For the answer, I would emphasize too that the information should be something that most people would generally know.


comment:
THis is not language that would appear in a TCED.


comment:
No need to say where the blood sample will come from or who is drawing it.  Expert version would be "If you decide to be in the study, we will take a blood sample from you.  The blood sample will be about 3 tablespoons."


comment:
What is the difference between the before version and expert version?  The before version should be long and include risks for each procedure.


comment:
We actually do not recommend using F-K. We actually recommend using Flesch Reading Ease.


comment:
assents are only prepared for children over 7yo


comment:
It should be "treatment and compensation" as the correct answer.


comment:
Edit title - remove Review Details of Package Inserts
should be:
Staining Protocols: Informal Assessment Questions


comment:
Will provide new screen capture for Protocols.


comment:
I don't think this is grammatically correct:  "...delivered, and completed, and documented."  Maybe remove the first 'and'?


comment:
We typically don't use the clarifier of "clinical" before site and protocol.  In the first paragraph, I would change "...clinical site study coordinator..." to just "...site study coordinator..."  And I would change "...clinical protocols..." to just "...protocols..." And I would change "...for a clinical trial." to just "...for a trial."


comment:
In the first paragraph, I would change "Simulations with the site and study participant..." to "Simulations with site personnel and study participants..."


comment:
Bad Practices: Not using resources, not consulting with SMEs, not having a quality review, etc...


comment:
Edit to say "I volunteered for this study.  Can I quit at any time?"


comment:
The first is correct.
The second one is wrong - it is not unethical to do research as long as you have consent.
The third is wrong - consent is needed to take samples AND do data analysis.


comment:
Need consent to take samples - and need additional consent to take additional samples.
Need consent to tie samples to original medical records.
Need consent to do research.  If doing more than just an analysis, then need to provide some type of limits to research.
Need to code samples so you cannot link the sample/research to the person.


comment:
Change #1 to "Pregant women should never take ANY drugs".  THis is wrong because some drugs have been proven safe and effective to take during pregnancy.
#2 is wrong.  Pregnant women are a vulnerable population.  Should not be included without having certain knowledge about drug risk profile and scientific knowledge about it passing to unborn child.
#3 is correct.  However, should elaborate.  Drugs are tested...  Before pregnant women can use the drug, scientists must understand if the drug could be passed to the unborn child and what risks could occur?


comment:
Need to carefully test drugs both for short term and long term side effects.
Side effects need to be disclosed.
When using with a vulnerable population, additional research is needed before this should be used.


comment:
Modify #2 to say that if the legal guardian of a pediatric participant is under age OR illiterate - that additional consent from a literate guardian of legal age must be obtained.


comment:
This is confusing.  Perhaps there is not enough information.  The last paragraph does not lend anything either.


comment:
Based on the scenario provided, options 2 and 3 are plausible.


comment:
One of the downstream impacts could be that the study drug may not receive approval - impacting not just Lilly but patients who may have benefited from it.


comment:
Would change lack of disclosure to say that no consent was obtained for taking samples, using study data, etc...


comment:
Study participants could feel obligated to stay in the trial even if they wanted to stop.  May sue Lilly.  Violation of ICH/GCP.


comment:
Focus is on creating better forms...  Not about actual process of obtaining consent.  

Informed consent process includes both the form and the actual discussion between participant and doctor.  We can only control the information presented in the form about our study and our drug.  Need to ensure it is correct and appropriately explained to the study participant.

Need to ensure that they apply health literacy best practices, include only the information truly needed to make a decision about participation, if there are questions or concerns - then use the ICF site, QualityDocs resources, or ask a SME for help.


comment:
Toolkit event logs - still don't like functionality of this section. Wording should be Use the Alarm Test sub-screen tab (?) to test alarms and illustrate the volume and tone of the alarm to the patient. 

But they won't know what the next tab is called so telling them to click Pump Off seems strange to me? It also is confusing because the red highlight is on something other than the current screen. I am not sure exactly how to fix - maybe instead we just say Click here to review the next sub-screen.  Then add the red box around the Pump Off sub-screen tab and change the text (delete first two sentences)to "The Pump Off sub-screen tab is used to stop the pump permanently. Use of this feature is not recommended with this system." "Click here to continue"
Screen changes again - put a red square around Eveng Log; delete first two sentences;New text up for discussion " Use the Event Log sub-tab screen to review events, or pump conditions, including the date and time the event occcurred." Finally they would click X to close this screen.


comment:
How about "Click the Dose field to view a keyboard"
Maybe delete the Input Box with Keyboard. Change to "Patient information is entered using the touch pen. Once a field is tapped, an input box will appear."


comment:
We have place the N'Vision programmer telemetry head over the target twice in the video. We only need it once. I'm thinking we should delete from the beginning of the video and keep further down where we say "Once the Interrogate dialogue box appears..."
Add "Confirm the pump calibration..."


comment:
I know that I've commented on this before but I really don't think we need to show the device being passed off into the sterile field. I would rather show the device on the sterile table already followed by the sterile sleeve - which we now have a video for.  That video portion should only be a few seconds. We can perhaps draft something up and then have our video team put together a new video?


comment:
The Low Reservoir Alarm Volume field should start with 0 and the video should show it changing to 4


comment:
THe video cuts to the sterile programming wand twice at 00:29 and 00:33 - only one of these is needed. Also, we have a new video segment that you can use with proper sterile technique.


comment:
Globablly we need to try to remove Demo Mode from our screen shots - If you catch it right you can get a screen shot without Demo Mode running across the top.  For the final Sumary Screen perhaps we can white out Demo Mode?


comment:
AFter you have completed all of the various updat pump screens can the wording on that slide change to "The pump is now updated. Click > to continue"?


comment:
Change the title of the figure on the left to "Field Observers & Sulfuric Operators".


comment:
Remove the "Note to Mosaic:" that is in the text.  Keep the big one on top of the callout.


comment:
for participants pop up, I'm not sure how other roles are triggered off of this process.  I would just remove "and roles" from the 1st sentence.


comment:
crp pop up ... wouldn't the CRP only be involved for early term?


comment:
agree with laura.  need to update this that internal systems are updated.  either trialforce or Impact.


comment:
Remove the note to Mosaic on this slide.


comment:
Change the instruction here to "Click on the map objects to see a description of the roles, responsibilities, and tools used for startup in each location."


comment:
In the feedback for sulfuric operator, remove the Content Need text.


comment:
In the feedback for field observer, remove the content need text.


comment:
Remove content need text from the feedback.


comment:
Remove the content need text from the feedback.


comment:
We don't need this screen since the last screen said the exact same thing.


comment:
Remove all of the content needs text from this point forward.  We're working on content gathering in separate meetings -- they don't need to see it here too.


comment:
To the "Plant-wide PA" box, add "action" after "corrective"


comment:
Edit to say "Demonstrate where to locate the VENTANA HE 600 system Operator Manual."

"Tell each learner to navigate to the Operator Manual and then return to the Settings tab."


comment:
in the bottom box on this page, change "shut fown" to "shut down"


comment:
For the popups here, instead of "Content Need" let's say "Content about this step goes here."


comment:
Change the 2nd bullet here to:  Review the information provided on the screen.

Remove the 3rd bullet


comment:
This should be a question/answer screen like the one for the guys at the big plant.


comment:
Remove the "can you start up the plant yes no" from the instruction box.


comment:
Change "I'm Ready" button on this screen to say "Continue"


comment:
Weird screen - Course title doesn't show and I have a button that says "Cancel Test" in orange on the upper right of the slide.  Prev & Next appear at the bottom.  No X to exit.


comment:
Has the funky title, etc. when I go through as the other role too.


comment:
Copy and paste the instructions from the previous scenario section and put them here.  These no longer apply.


comment:
Instead of the written out scenario here, say "Content for Scenario 2 goes here"


comment:
Instead of the scenario currently on this screen, say "Content for scenario 2 goes here."


comment:
This isn't the right screen for this end of course.


comment:
Agree with above comments 

Also - Consider changing the "Regulations were met" to "Ensured compliance with regulations, procedure and GCP"


comment:
Change wording in first sentence from "low recruiting efforts from the site"  Suggest ....is closing early due to poor enrollment


comment:
will send checkmark you can use, i would have that be on the visited state


comment:
I think in general, we could make the popups much smaller and put them closer to where the items are.


comment:
i would move the text box up so it isnt overlapping the medicine cabinet


comment:
yea i would make these popups a little smaller, and make them solid white with purple outline.


comment:
extra space in body between "for" and "collection" in first sentence


comment:
the old activity for these had the text she says in a speech bubble so you could quickly read it once the answer options came up.


comment:
this character is a GCBC in our list of characters. i honestly dont know what that is, so im not sure if she would be wearing scrubs. again, we may need to swap her out at next phase. there are some "scrubs" characters in the graphics package i would swap her out for


comment:
yeah, for these screens i really think they should be the red callout bubbles


comment:
agree. i also think you need to callout what the icons are supposed to be


comment:
same thing here with red bar. this screen also always has audio.


comment:
I am not wild about this one box on here. They used to represent the entire workstream and lean towards keeping it that way. Matt may have an opinion, but it looks weird with just one box on there. IF we leave it as a master header regarding site evaluation - we need to reformat the screen and get Lilly approval to change this template.


comment:
You don't have to read each red box verbatim. You can always read just part of it and let them read the rest to keep it a little tighter as far as timeframe goes. This is nice to have for alpha


comment:
I want a graphic for this list that you can highlight which course you are on in all six.


comment:
in general, we want something happening every 6 seconds to support the audio. We go a long time with nothing happening at the beginning. How can we manage this on this screen?


comment:
to matt's comment - we need the std lilly player buttons on here. they are used to them by now and we don't want it to look like a "miss"


comment:
Change the title - How site evaluation is like a job interview


comment:
Again, you are going to need someting more than a screenshot on this screen to support all of the audio and/or get some of the audio into on-screen text.


comment:
where does these questions live - on the SPI or the ISEC? I can't tell from the screen


comment:
for first pop-up that has so much text - find a way to help my eye land some where - use bullets and/or bolding and/or tighten up the language


comment:
this screen is out of order in the menu. It's the 4th menu item, but is the first or 2nd screen if you just use back/next


comment:
Keep LA in the same spot throughout the course on either side. I noticed her jump transitions.


comment:
Put a break in the paragraphs when text is giant like this. Don't overlap on to icons.


comment:
Maybe resize popups to suit the text size within?


comment:
Enlarge characters. Wasted headroom space.


comment:
Can we have these items fly in one at a time as the audio mentions it?


comment:
Ok - I'm going to just make this comment for the last time....we have audio going on too long with nothing happening on screen. This is something that needs to be checked globally.


comment:
ryan - can you confirm that the site coordinator is in scrubs? I heard when we were working on the video that they would be in business casual?


comment:
The reason that the org version of hte watch and learn worked is because you could see clearly who was talking as they scrolled up the screen. Agree that we need to a clearer way to know who's talking. if we can get that figured out, then I don't think we need to break it up


comment:
Recommended Reinforcement Activities keep same


comment:
this is confusing because you already gave them feedback and are trying to use the same "why" screen for both answers. Ryan, we can discuss....but it's going to be confusing going from the first screen to the why


comment:
agree with matt - these screens look great!


comment:
Change answer:

Tap the Settings button in the upper left part of the screen.


comment:
Ryan - I think you need to tie this observation more closely with the ISEC. Where is this documented/shown? tie it back into what they will look at - i almost envision a button that shows an ipad screen and they see the isec there and can see what's checked off or not?


comment:
on these screens, you need a way to then see what they said after they said it.


comment:
can we get the first option a little shorter so that it's not so obviously wrong?


comment:
Milestones box - your X needs to get into the corner


comment:
Milestones - 2nd bullet - you've got an extra space before the words start


comment:
in milesontes - specific did not get capitalized


comment:
or in the participants box - per spreadsheet line 13 we were supposed to update. please confirm?


comment:
Change last bullet under "Describe default protocols. Explain:" to
The Auto Start Delay option can be used to allow the default protocol to be run after the set delay time. This allows a user to load a tray without selecting a protocol when the default protocol is desired.


comment:
site manager is not capitalized in this pop-up but it is elsewhere. do a consistenty check


comment:
last sentence of intro paragraph - add dash between site-generated


comment:
push your menu bujttons down on the screen a bit so that there is more white space between them and the instructional text.


comment:
confirm with sharon - but i believe site manager is capitalized in other courses. if it is, do a global check for it


comment:
in pop-up - change "is in line" to aligns


comment:
top yellow box - add the word appendix after procedure and make the box slightly bigger so that all text fits easily within it


comment:
4th paragraph change wording to $10,000 compensation instead of spelling it out


comment:
if they get it right - why give them the same info if thye got it wrong and have them look at it? i would just delete all of the text about the button and the active butons and just have the intro text that's already there - you got it right - and the image of the banner


comment:
check back button throughout - doesn't work here either


comment:
Put paper clip images at the bullet points


comment:
again - if there were no changes needed, the instructional text of "each represents a required change" is confusing cause there weren't any.


comment:
Can these points fly in one at a time as the learning agent talks?


comment:
I clicked everything on this screen and the next button didn't appear


comment:
For all of these types of intro and closing screens, have bullet points fly in one at a time as learning agent speaks.


comment:
can we make the comment box longer so there's less scrolling?


comment:
this is the only screen where you've highlighted the incorrect text. Ideally, this should be done everywhere to help them see it. If we can't get that done in time, then remove it from here.


comment:
fix the red box so it covers the circles at the bottom completely.


comment:
making the box bigger will also allow you to put a little more space between the words and the edges of the box


comment:
confirm that your text size on the bullets is the same as in other courses


comment:
LAL Comments on Make Decision Box:
1) Don't think the first bullet on site LPV needs to change, it refers back to the fact that this is a discussion about closeout to decide if the site WILL be closed. 
2) "A quality issue at the site" is fine if needed.


comment:
I like Laura's suggestion on the Study Manager "oversight and ensures" process.


comment:
I agree with Laura, looking back at the map, there is no "wrap up" after the discussion of plan to close the site. Suggest "Since all the study participants at this particular site are now off the study and the site's data has been fully reviewed..." (there are trial related wrap up activities that occur DURING close out, but the data wrap up is the biggest one needed before a COV occurs).


comment:
I agree. Let's add an intro statement. "When you're ready to make your final decision about the site, you need to ask yourself some questions. Here are a few questions to consider."


comment:
We can discuss this further, but I actually like the fact that it is calling out something specific needs to happen when a site is closing early and has active patients. We do a lot on our end to see what goes on, whether patients will just stop the study (with an appropriate close out visit for the patient) or if we can find a site to transfer them to and if they need more information to know what to do for further medical care outside of the study...I think the word "ongoing" in the answer is a little misleading, since they won't for sure be ongoing (site is closing). Perhaps reword that to ACTIVE. And maybe make this a multiple choice where the Contract Termination Letter is also an option? (and a live COV is also a required thing, when they have active patients/drug)...


comment:
DCL Comment - We don't close sites who have Poor enrollment usually, we close sites with NO enrollment or those that aren't trying/doing the work to get patients at all. I am actually OK with the language as is, but if it needs to be changed, I would suggest "due to NO enrollment" (not Poor enrollment...if they have 1 or 2 of their goal, we wouldn't close them as that wouldn't be fair to the patients).


comment:
Recommended Reinforcement Activities add second bullet
Practice saving reports to a USB drive.


comment:
Could we add an instruction to scroll down to see the highlighted boxes?


comment:
Disregard the Delete 2nd & 3rd below. Do place the additional content above the 2nd & 3rd main bullets.
(I can submit it via a Word document if that helps.)


comment:
Agree with Tera's comment; either need to make draft plural or remove 'of all documents'.


comment:
I will create a Word document with these settings. I think maybe another Super User section is needed with the amount of information that needs covered. Let's discuss.


comment:
Can we amend the title to 'Your role in creating the TCED'?


comment:
Can we also bold the 'with' in the instruction at the top?


comment:
States to click on the title but nothing happens when I do that.


comment:
As per Tera's comment on the previously slide, 'in the TCED' rather than 'on'


comment:
I know I shouldn't focus on graphics, but the mosaic logos on the character are backwards.


comment:
Remove the red text in parentheses (are these real possibilities...)


comment:
There's no way for me to get back to the map.  Continue button is missing.


comment:
There are a few scenarios in this deck.  For the first one with the QA, they need to go through the whole lot of questions (I think there were 7?) (the section right before this screen (and at the end of the module for the field operators).  The next time the approvers go through, they only answer these two questions.


comment:
The logo on his shirt is backward here too.


comment:
When I clicked the buildings, read the QA and returned to the map, the buildings didn't go grey.


comment:
This is the screen I see when I click Continue after the "So you think you're ready..." screen.  It shows the learning agent and short SAP START-UP flow chart.


comment:
IN 2nd speech bubble, change "for make sure" to "for making sure"


comment:
For whatever reason with this font, when I clicked the GM role, the apostrophe in "I'm" looks like it's missing -- even though if you look closely you can see it.  Check spacing or change to "I am a General Manager..."


comment:
Edit 3rd sub-bullet under "Explain what daily maintenance is required on the system:"

Execute a daily shutdown/cleaning cycle (if it is not scheduled)


comment:
For Sulfuric operator, change "proper" approval to "get the right approvals"


comment:
Same feedback for Shift supervisor text (I'm).  May need to change to "I am..."


comment:
For all plant employees, add "for our safety and for the safety of others in the plant."  or something like that.


comment:
We may have a replacement picture from Adriah before this goes out.  If not, we'll need to add a note that this will be replaced with a picture of a sulfuric plant.


comment:
For interlock 2nd question, change "even" to "event"


comment:
Interlocks answer 1, change "flow t the" to "flow to the"


comment:
On Announcement Systems, the 2nd question changes.  In the first state (reading when 1st Q & A are visible) it says "Are there any rules about alarms and testing.  It changes to a different question when you click it.


comment:
Can you italicize the name of the standard document?


comment:
I moved all of the icons (LOVE these, btw), but there is no submit button.  How do I check my work?


comment:
I wonder if we need additional instruction on how this page works?


comment:
Sometimes changes to the TCED impact the ICF, not impacts


comment:
Crash Cart - I would say "Crash card and/or defibrillator". This is not actually a requirement for all trials. It may be for some, I think it is good to call this out as a "best practice" and/or "common to see" especially in sites giving infusions.


comment:
The color on this screen is MUCH better than the others. Recommend trying to fix the coloration on the other screens so things are easier to see as actual equipment.


comment:
There was no checkmark on the fridge after I clicked on it. I got the pop-up, but not the checkmark.


comment:
Technically, all equipment needs to be maintained properly and records *available* but it is GOING to be asked for specifically for Critical equipment. Each trial varies in it's critical equipment designation; while I would expect these machines to be critical, it isn't a guarantee, so I might suggest pointing out it is "common for them to be critical" or something rather than just saying they must be maintained and documentation provided.


comment:
I might say "Many trials, such as rheumatology trials, use X-ray equipment"...I might also suggest discussing the image type, digital vs. analog with the site personnel to better understand how images might be available as study data.


comment:
The equipment in here falls under the "SOC" question on the ISEC, so it really wouldn't have a "checklist" to go through. The tablet pop-up may just need to highlight that SOC question and have a "thought bubble" or something where the CDC is thinking about the general procedures in the protocol that will use this equipment.


comment:
WAY too grey...please figure out how to make this look better. Also, if you can, it might be nice to put a lab chair in here (the one with the folding arms where the patient sits) and possibly another, bigger centrifuge which could represent a refrigerated centrifuge. Finally, can you call out the storage areas and show with the doors open and either kits/lab boxes in there and/or binders (i.e. lab manuals)? None of these rooms highlighted storage of materials.


comment:
"lab trial staff" doesn't make sense. Just say "lab personnel". Also, didn't she say at the outset that only the coordinator and back-up were responsible for labs? I might suggest that is clearly stated that either 1) coordinator and back-up are responsible for ensuring all labs are drawn correctly or 2) lab personnel along with the coordinator and back-up work on lab processes.


comment:
IATA is pronounced as eye-ate-uh in the real world. Think she should probably say it that way, if others agree.


comment:
She didn't comment on documentation at all, nor did the CDC ask about it. It might be good to call that out as a question or have her comment on it. I would suggest commenting on the lab requisition and that the source documents key required information that may not be called out in a lab requisition.


comment:
1, Lilly Expectation. Might update to "evidence of maintenance/calibration for equipment identified as critical by the study team."


comment:
3, Why it matters: add "and trial participant safety." to last sentence


comment:
3 - How to say it...not in love with this. Ultimately, you've already discussed equipment maintenance in #1. The goal here was to highlight the need to look at back-up equipment or process should something go wrong with necessary equipment on the trial. It isn't always a "said" thing. Perhaps "Do you have access to back-up equipment, in case something should go wrong with your current equipment that is required for the trial?"


comment:
I would add a documentation piece here. The site and conversation steps were good, but there was nothing that commented on ensuring a plan was in place and documented as part of the ISEC.


comment:
I walked through all the options on these trees and never got a "Next" button....couldn't move forward from this screen.


comment:
The highlighted boxes need adjusting to better align with the picture.


comment:
The comment callout for the "Notify IWRS..." step is pointing to the site manager swim lane instead of the IWRS activity box.


comment:
Something needs to be adjusted with either the question and or a different correct answer needs to be written.  The question asked what should they make sure does not occur, but the correct answer is based on Roles & Responsibilities.


comment:
For the second bullet; Instead of saying "Include the right information for the audience" I would recommend updating the wording to "Making the training content relevant to specified site roles in the trial".


comment:
The opening intro for this slide indicates that the Training Owner starts planning for face to face training. I think this statement should be updated a bit since face to face training is not always the method for initial study training. I would simply refer to it as site training.


comment:
The NEXT button is not automatically coming up to navigate to the next screen.


comment:
Global Study Training Manager should actually be Global Study Training Management Associate


comment:
"Develop Protocol Specific Training Materials" Most of the topics are identified during the Plan for Training part of the process. 

I would say that this part of the process further refines the relevant topics for the trial and develps the training material.


comment:
"which may include outputs from the CoLab if conducted" This is my suggested update to the wording.


comment:
I think it would be nice if you would colour the procedure that this training topic is associated to.


comment:
I think it would be good to spell out IE ...just to make sure that all people understand.


comment:
Screen resolution: what happens if I do not change it? Would be good to understand impact


comment:
technical comment: is there a way that I can go back on this screen after I paused? I think this would be helpful if the course had the functionality


comment:
first bullet point: I think it would be better to day key risks and processes.....


comment:
I agree that we should highlight all the defintions. Within definitions I would first list key site personnel after PS training - then Main PI support and then Non-key


comment:
General comment to future recording: the real actor would speak a little bit slower, right? Otherwise this might be hard for non-native speakers to understand.


comment:
instruction to click on the red highlighted box may not be fully clear as in the process there are red boxes too. Maybe use another colour?


comment:
Window with Participants: using "key roles" here may create confusion as we have been referring to "key site personnel" as "key roles" in the past. suggestion: The following four roles are responsible to.... OR the following four roles are key....

I do not think that the AV vendor should be part of this list - we will most often use an AV vendor but HP studies do not use AV vendors as far as I am aware, nor is it a requirement to use an AV vendor. I suggest to focus on our Lilly roles being involved - Training owner, Study Team and site manager.


comment:
Plan for training document: should this be Trial training plan? I think this should align with the name of the document that is in quality docs

regarding Tera's comment: I think Clinical Pharmacology do have a plan but they do not document - is that correct? I think Teri will need to confirm.


comment:
I would add at the f2f training part that this is an option e.g. add "if applicable"


comment:
If you go to see the whole process and then click to get back to the milestone, the whole recording starts again. This is a bit annoying. needing to hear the recording again if you once listened to it already so that you can finally click on the boxes. Can this be changed?


comment:
This seems to be the last page of this section - no NEXT button...but there are also no instructions on how to get to the next section - can you add please?


comment:
Training owner and study team members links don't work for me


comment:
visually, this screen could be more interesting. I can't remember - was there no VO budget? If there is budget, do it as VO with relevant visuals. if not, add relevant visual to each box


comment:
preliminary training strategy: f2f meeting or online training are two equal options in this example. f2f and online are both for site personnel


comment:
what's the purpose of the bells? how do they support the learning?


comment:
i don't think any of these screens in the rest of this module are currently reflected in the menu. Make sure menu gets updated before this goes out


comment:
i think you need to clarify the instructions - Really what you want them to do is: Identify whether each type of work can continue during start up. Drag each type of work to the right box.


comment:
agree with Juanita: the information in the box is not correct - the topics will be determined already in the Plan for training discussions  - at this point in time the content of a topic is determined.


comment:
andy is not going to like how the boxes just end up all on top of each other.


comment:
i had to look for the submit button - it wasn't where i expected it to be. maybe have someone else review cold and see if they could find it?


comment:
if this is scored, it's a little weird to me that you have to get this question right before you can move on. Have you confirmed this functionality with the client?


comment:
my computer crashed twice after having reviewed the additional information - I could not click the NEXT button - not sure if this has to do with my computer or a general problem. I managed to go to the next page after a refresh and without answering the question


comment:
When I open up the additional windows, there is placeholder content sign - I assume this will be removed.


comment:
The line beginning with "Click Glossary" contains a typo and should read "Click Glossary to open a list of terms used in the course."


comment:
window correct: I would keep the 1st sentence focused on our trial example - this does not mean that ALL ps training has to contain points below. suggestion: These topics should be included in our Psoriasis PS training. (or use similar wording) - currently too general


comment:
audio around topics being the same for both audiences: say "may" instead of "will" - this does not mean that for all trials the compound training will be the same for both audiencs - it may be the same


comment:
Can we point out more that these are optional considerations and not required content? Just to ensure that people don't misunderstand


comment:
I first did not realize I needed to click on the person and not on the bold wording ;-)


comment:
building slides: this suggests that there is a presentation  - we would like to get away from the "presentation thinking" so I would rather suggest not to talk about "presenting", "slides" etc. use "creating training material" instead


comment:
It's a bit much on the screen - maybe you can do a smaller link to module 1. As we do not have a further exercise around step 4, I suggest that this is referenced directly in the training - in case people do not click on the link they miss the info.


comment:
It took me some time to realize that what's ont he screen are the positive results...could this be pointed out more?


comment:
I only see this now...can we add to the first answer that they should consider for a different training delivery method so that they do not deliver 70 slides.


comment:
This time the Next button is greyed out and I only have the continue button, consistency?


comment:
add comma after communication; capitalize bullets?


comment:
Red next button again but it doesn't work,


comment:
remove extra comma after "forms," in Site Manager


comment:
The text describes QSK60 powered gensets, not the C2000 D5 genset which is one of the range of QSK60 sets


comment:
study manager/communication and documentation - remove extra space after "list."


comment:
not in all cases when updates were made it needs to be peer reviewed again -only in case of major changes


comment:
for some reason I could not select an answer - my technical issues or in general?


comment:
I think we can consider adding the Training Owner as a resource if further quesitons


comment:
I did not realize before but I think these scenarios should go before the RESULTS of the traning - makes more sense in the flow I think....the outcomes we see at the end and these scenarios are still part of the developing process


comment:
I think the results pages would fit perfectly in here!


comment:
remove GSTM website - this is a group collabsite and people from outside cannot access (and are not meant to access)


comment:
The text balloon stems don't match up with the characters who are speaking, except in the case of the plant employees.


comment:
Answer for interlocks question 2: Do we need the indefinite article ("a") before 2000PPM?


comment:
Is it correct to say "...the appropriate trial file master location..."  OR should it be "...the appropriate trial master file location..."


comment:
I think we need the word "the" before protocol


comment:
Change "...must adhere to the guidelines..."  TO: "...must adhere to the requirements...."


comment:
Looks like there is an extra space between the words "review" and "and" in the first line.


comment:
Remove the word "compliance":  "Check the appendix for requirements"


comment:
Delete sentence "the default value is 4.0 ml". I think we might need to say the "recommended value is 4", but I need to check on this wording. Or maybe we say We have selected 4.0 mL, at this setting...


comment:
Before 00:11 Let's add Note again the time to stop the external line (highlight this in red), and the dosing information table (highlight the table).


comment:
At 00:31 I do not think it is necessary to cut down the telemetry head. Can we delete this?  A couple reasons a) I don't think its necessary and b) I think we are replacing that part of the animation?


comment:
what about adding "Prime Bolus ends (16 minutes)=..." ?


comment:
Add after - "4. After external line turned off..."


comment:
Fix the graphic - I admit this is from me - but there is a faint line in the far right of the solid maroon color that should not be there. Can you fill in?


comment:
I like this menu. It provides clarity on order and where this fits in with the larger picture.


comment:
the science of selling is the main topic, but this series is specific to Distribution Sales Analytics


comment:
When the interaction ended, the role and responsibility tiles were not matched up in the same way that I had matched them during the interaction. I can't tell whether or not I matched roles and responsibilities correctly.


comment:
I defer to David and Cameron as subject matter experts here.


comment:
one challenge I see is that if you get a wrong answer, it doesn't reset between tries.


comment:
In a different training course, there was similar verbiage regarding the collective term and then it referenced the BWL for specific titles, would the SMEs want to do something like that for Enrollment Manager?


comment:
The Site Activation Collab Site link doesn't work for me.


comment:
Only highlight one tab at a time (the tab you are directing the learner to click on).


comment:
I agree with Sonja.  The Toolkit/Event Logs tab information needs to be reworked. I like Sonja's idea of highlighting the Alarm Test sub-tab initially and have a button/link to click to take them to the other 2 sub-tabs so you can highlight the sub-tab and show the information at the same time. Let's discuss.


comment:
On previous screens (and in other courses), we've always highlighted the button/field we want them to click on. I think we should place the red highlight only around the field (not 'Dose' and 'ng/kg/min') for consistency.


comment:
looks great! thanks for making the requested changes


comment:
I think we should add Unblinded Site Staff - for drug preparation. This would fit in better for the rest of the scenario. I think we should just have Assessor as another key role.


comment:
I would add trial to the the first sentence - ends after the trial's last patient visit


comment:
I am wondering if it is necessary to call it a BioMed Psoriasis trial. Can we just call it a psoriasis study?


comment:
Under enrollment manager - is the last sentence adding value.  If not, I would take it out


comment:
Instead of functional role should we say, an official job title?  It is a role so not sure if this is misleading.


comment:
This is pretty small, is there anything we can do here?


comment:
Same comment about functional role - if everyone is ok, then I am


comment:
We say nothing about what the site manager does.  Shouldn't we say something?


comment:
You say in previous screen what the enrollment manager does. Shouldn't we say they engage sites to meet the site's enrollment projections and track when the site is done enrolling?


comment:
The CoLaB content is ok for the most part; I would recommend the bullets read as follows;
 - Instructions around maintaining the blind at the site, since the drug will be unblinded when shipped to the site and there will be specific unblinded site staff designated to prepare the drug
 - There were tools for the Unblinded site staff such at the Unblinded site staff manual that were recommended to be translated into local language.
 - There are various psoriasis efficacy scales that are going to be utilized to determine eligibility and efficacy of the drug. It is important that the training included the rationale for these scales and the qualifications of these assessors in the trial.


comment:
The proceed as needed description is wrong.  This proceed as needed is to signify the site manager and enrollment manager do tasks as needed.  This has nothing to do with contingency yet.


comment:
In Take action to meet enrollment:  Fist sentence, change to because enrollment is GOING as expected.


comment:
The last sentence for the align pop-up needs some work, needs a verb I think


comment:
For the update internal systems:  Would add to the last part of the sentence with the agreed upon changes


comment:
This is not a regulatory requirement, it is a business requirement. (confirm with Jenny - do not think it is a compliance requirement)


comment:
I would say their enrollment plan for the trial. Each site has its own enrollment plan


comment:
Take out the send notification to close sites.  This is not true at all.  We send notification last patient visit complete to the appropriate processes that need notified.


comment:
I will be sending through an example of a RACT document - Can I have some help pulling out some specific risks from this documents that would be relevant to our scenario?


comment:
I think we can take this whole thing out honestly.  You can keep voice over and replace with the higher level screen.


comment:
Information provided regarding the PFT/STEAM meetings is sufficient.


comment:
Please remove the distractor - "Detailed instructions on how unblinding is maintained at the site" 
Please replace with the following distractor; Detailed training on all standard electronic case report forms and are common amoung all trials.


comment:
Instead of the following risk" Clarify critical imaging process with external facilities" 

Replace with provide detailed operational information explaining what systems and trials information Blinded Site Staff can access vs. Unblinded site staff. In a trial similar to the one in our scenario, it is very important to make this information very clear in order maintain the blind at the site.


comment:
I suggest to take out "kept on track" in second paragraph... it looks repetitive put two times "track and tracking": Maybe: " Actual enrollment is monitored and managed through managing, tracking and if needed.... "


comment:
In Enrollment manager if we will say Under-enrollment, we need to say; Under or over enrollment will negatively impact.... 
If we don´t put both then I agree with the other comment to taking out.


comment:
I think it will look better if we say: "Enrollment Managers have the critical responsibility fro tracking and managing trial...."


comment:
In site Manager, the last sentence I would suggest again to reinforce that may be less or more participants than expected: "It´s possible there will be not enough or more than enough study participants to complete the clinical trial...


comment:
Why are we repeating the definition of Enrollment manager, is that necessary?


comment:
At the end of the map, the "no" from "Has trial LPV been achieved?" is not clear where it goes back


comment:
In the recording says: Click each of the red boxes... but, is only one option each time, one for E. manager and then for S. manager... I think it should say: Click the red box to understand...


comment:
Site manager red box is not explaining anything, do we need to have it? also is not pointing Site Manager box... it appears in E. manager line.


comment:
In the recording, I would suggest to take out the word "central" as usually it is referred only for NA campaigns.


comment:
In Internal systems: change enrollment plans by Projection.


comment:
In the Drug supply scenario... Not sure about the contingency plan... affiliates must have systems updated all the time, not as a contingency plan... Maybe, have a less aggressive backup breakdown with sites. If pts. are enrolled then, use the maximum window allowed per protocol or, if enrollment already started, move IP from the site that still has and focus all pts. to the same site.


comment:
Affiliate to maintain enrollment projections, is a mitigation plan.


comment:
I still think that we should not specify the 100%, it is not a rule to make a mitigation or contingency plan.


comment:
In contingency, I think should be changed Regions per Countries, re-allocation is not between regions necessarily.


comment:
Centralized campaign, is more related to NA, I suggest say only Recruitment campaign.


comment:
If the Recruitment and enrollment aren´t met as planned, could be that the trial is delayed or OVER enrolled...


comment:
How about site managers that are also serving as enrollment managers since they are really serving both roles?


comment:
I do not like the wording of the question.  I would say, what is not my responsibility?


comment:
Should answer be must not occur in the answer.  If it is clear to everyone else I am ok


comment:
AGree with Sara's comment.  Not sure we need contingencyy on inadequate trial drug supply


comment:
Sites competing for other trials - not sure mitigation or contingencies are good


comment:
It feels like this should be a new section as it really isn't part of Programming a Prime. Is it worth exploring the idea of making this a new section titled Administrative tasks or something? These would include: Determining the date of next refill, printing a report and demonstrating alarm tones.
Additionally - there is so much information on the two alarm screens. Information is repeated on both screens. We need to find a way to make these screens better.
- Delete "three second" from the critical alarm screen.


comment:
Video (00:43) - on-screen label and narration should state Select the Patient Information screen tab. (vs. Patient Information tab).


comment:
Video (00:00)On-screen label should state 'Select the Pump and Catheter screen tab.' (vs. Pump and Catheter tab)


comment:
Video (00:02) On-screen label should state 'Select the Infusion screen tab.' (vs. Select the infusion tab)
(00:25) Should we update the narration to state 'Note: The default value automatically populated in the Reservoir Volume field is 40 milliliters."?
(00:30)Need to select the OK button. The video does not show this, instead there's a jump cut. This needs to be corrected.


comment:
(00:00) on-screen label should state 'Select the Alarms screen tab.' (vs. Alarms tab)
(00:05)I'm confused by this interaction. Is there a default for the Low Reservoir Alarm Volume (4.0mL) or not? The Technical Manual/pg 72 says "Confirm that the Low Reservoir Alarm Volume is set to 4.0." Our narration states "Set to the desired value. The default value is 4 mL." I believe Sonja verified what the 'live' version of the programmer will show and the field starts at 0.0 mL. Needs clarification.


comment:
(00:00)On-screen label should state 'Select the Summary screen tab.' (vs. Summary tab)
delete video clip shown at 00:29-00:32?


comment:
When given directive to "Select Remodulin from the Drug drop-down list, only the Drug field should be highlighted in red for consistency with other interactions/courses. Currently the highlight is also around 'Drug'. 
When directive to "Select 10.0 mg/mL...", the concentration field should only be highlighted, not 'Concentration' and 'mg/mL'.
Then the entire field (box) with 10.0 should be highlighted, not just the value '10.0'.


comment:
When directive to "Select the Low Reservoir Alarm Volume field." is given, the red highlight should only be around the field (box)for consistency with other actions/courses.


comment:
Update directive to "Click > to follow her throug the steps for programming a prime."


comment:
video (00:16) - when the window opens, the top of the screen should be shown, then the screen is scrolled, prior to clicking on OK. This should be corrected.


comment:
Change the name of the pop up box from Participants to "Roles".  And the information in the box is not correct, it should read, "The Site Manager performs the Review and Approve Trial-Specific Site-Generated Content process..."


comment:
Title of Screen.  The process name that is focused on here is "Review and Approve Trial-Specific, Site-Generated Content.  is there a reason that the title is "Reviewing Site-Generated Content?"


comment:
(00:00)on-screen label and narration need to be updated to state 'Select the Infusion screen tab.' (vs. Infusion tab).
(00:24) on-screen label should say "Enter the dose..." (vs. input)
(00:36) Narration should state "and select the OK button."
(00:52) Narration should state "and select the OK button."
(01:04) Highlight all information in the window, not just 2/3 of it. 
(01:43) Highlight the area of the screen that says 'Stop external line in 1 hr 9 min' to coincide with narration?


comment:
if this is the first time we are using ERB, spell out and then abbreviate.  Ethical Review Board (ERB)


comment:
Delete "you will" in on-screen text. Just state 'Next, update the pump to save the settings.'
(00:00) on-screen label should state 'Select the Summary screen tab.' (vs. Summary tab)
00:16-00:18 - narration different? I'm assuming this will be corrected on final version.
(00:30-00:39) footage being shown is being updated by MDT animator. This will need to be swapped out once the new footage is available.
(00:39) There's some strange flash prior to showing the Telemetry Complete screen. Please delete the flash and just start with the Telemetry Complete screen.


comment:
Delete 'you will' in on-screen text.  Just state "When the update is complete, start a timer and stop the external line..." for consistency in tense.


comment:
I'm confused by the feedback.  I get the "remove no cost medication".  Should there be replacement text suggested or just left out?
Also, for the "Can't overemphasize compensation by putting $$ front and center", I don't have anything on my screen that shows a $$ amount for compensation.


comment:
When directive to click Mode field is given, highlight should only be around the field/button for consistency with other actions/courses (not around 'Mode').
Update 2nd directive to "Select Simple Continuous from the drop-down list."
When directive to "...enter Susan's dose..." is given, only highlight the button/field (not Dose and ng/kg/min).
Need to add a directive for "Click OK." after entering 80 ng/kg/min dose.


comment:
Comment #1 Since this is feedback to the site instead of "We need to change the title..." should it read "The title needs to change."  Same comment about do we give them a recommendation for what the change should be or let them change it themselves?


comment:
When directive for "...enter her dosing weight..." is given, the highlight should only be around the button/field (not Dosing Weight and kg).
Directive needs to be added for "Click OK." after entering Dosing weight.


comment:
For the instructions, change to "Click a box on the left side of the screen, then click the (Purple icon) to see the...).  (I clicked all of the icons but never got the "Next" option to move forward.)


comment:
Directive for "Select the Summary screen tab." needs to be updated (vs. Summary tab).


comment:
"high" reading level is subjective.  Suggest replacing 2nd sentence with Ads should be written at an eighth grade level.


comment:
For consistency, should the corresponding information on the programming screen be highlighted in red?


comment:
This screen basically repeats the screen that is shown after you click "Practice a Review.   (Text on that page is very similar to the audio on this page.  I would eliminate one of them.


comment:
Q for Laura or Teri - This ad uses study and the other uses trial - either one is okay?


comment:
Actually, trial and study are both used in this ad as well, same question to Laura or Teri...


comment:
Feedback on Section 1 of ad, Comment #2 - typo on first word, should be Change


comment:
This doesn't make sense to me at all. I believe we discussed showing the Tool Kit screen in the review WebEx, I just can't remember what was decided. ??
I agree with Jenny, if we are going to leave the on-screen text as-is, we need to show the Tool Kit screen here. Let's discuss.


comment:
Practice a Review (Ad, Section 3) - I tried to highlight where the CTR # would go (after work "study") but when I tried to click that passage, it wouldn't highlight...I had to highlight the "Monday to Friday..." so the placement of the highlighted text to change seemed odd to me.


comment:
Practice a Review - Section 2 - Review Radio Edits.  Comment #2 2nd sentence was confusing to me.  is it the word "Amazing" that claims a benefit?  If so, then that needs to be called out more obviously.


comment:
Why is highlighting of the tabs green now instead of red highlight as before?  Consistency?
I don't understand the whole red/green and red X interaction. There are too many things being outlined/highlighted. Can't we just highlight the correct tab in red when they choose it? and tell them incorrect if they choose a different area?


comment:
Not sure what we decided here, but I'm assuming we'll show the report eventually.


comment:
Radio Ad in Review - Section Two
Title of feedback should be Comment 1


comment:
I would put trial specific in the title and in the first sentence


comment:
I am not sure we should say meeting regulatory and ethical requiremens.  Maybe meet all external and Lilly business requirement.  SMEs?


comment:
Instead of word participant should we just put site manager?  Not sure we have used participant


comment:
We say roles a lot.  Should we say that the site manage role can be performed by individuals with various titles?


comment:
What about if we reject it, should we say what has to happen?  Work with site to fix it until it can be approved?


comment:
Title should be Comment #2 I think?  I'm confused with the comment numbering.

Agree with Erin's comment as well, I had the same reaction.

Lastly, Q for Teri or Leslie, for a radio ad, does the CTR # need to be listed as it is for the flyer?


comment:
dark purple box - is this the course name/focus or is it supposed to represent the process...if it is the process, then it should read "Review and Approve..."


comment:
Is adding the registry number a suggestion or requirement.  If suggestion I would state as such


comment:
Should we have a link to the procedure here?


comment:
Should practice a review be flashing.  It seems like sometimes they flash and sometimes they don't


comment:
So I suggested an edit and I got a window that said something like, you did not follow procedure.  It should just tell me no edits were needed.  That was very confusing.


comment:
add "course" to the end of the first sentence


comment:
It was a little hard to know all the sections that could be highlighted.  Can you highlight them to start?


comment:
Disregard first comment, this is consistent with the other courses.


comment:
It should say that I did edits when I didn't do any.  Also, I would change study to trial but both are fine


comment:
To confirm the registry number has to be listed?  Just checking


comment:
Once again, if it was right, I didn't do any edits.  My review was right, not my edits.


comment:
Confused about the comment that radio ad can be used but it has to be modified.  It cannot be used until modifications are made.


comment:
Same comment as last one.  The ad cannot be used until after the edits are made.


comment:
...COACH CWANSON HIS FIVE COACHY, NOT COACY


comment:
Add course ID and Version # to course title page


comment:
Change Get Perspective to Get perspective


comment:
Coach Swanson needs to speak and provide direction. Roll-over cannot be initiated until audio is complete.
Rolled over swimmers immediately and coach disappeared.


comment:
change first up is Derrick to this is Derrick


comment:
Change text...Click Continue to learn how to keep tabs on your FES's using the meters...to Click Continue to learn how to monitor your FES's progress.


comment:
See the Whole Process button - doesn't really add anything here as it's the same whole process as on this screen.


comment:
change text...Click Continue to learn how to keep tabs...to the same text we entered earlier


comment:
Change text to...Click Continue to get started.


comment:
Audio required for direction. Hold roll-overs until audio is complete.


comment:
on feedback for what is NOT a key task for Enrollment Managers, in the feedback, it should read, "...is not a key task for the Enrollment Manager in this process" since that was the question.


comment:
Audio is stated incorrectly. States click on a swimmer to get started but we are clicking continue?


comment:
combine with previous slide and we do not mention the customer...if we are not remove image


comment:
Why is Derrick treading water already prior to even clicking on him.


comment:
we are not in a car so change text to...You have time scheduled with Derrick


comment:
Change text...We don't share that kind information to...We don't share that kind of information


comment:
change them to him and themselves to himself


comment:
derrick text should say I'm not really sure.


comment:
Can the click anywhere to continue be removed. conversation fluid


comment:
gave 2 out of  6 with derrick scenario b


comment:
change to several service calls. Change PM checklist to resources from the service manual.


comment:
derricks life jacket has issues (Scenario C- 0 points)


comment:
Janice and Coach are out of proportion with the background.


comment:
text boxes are side by side can one be moved up or down


comment:
font to small and there seems to be a lot landscape above coach and Janice


comment:
Note: The header bar for this in my browser says Negotiating Exceptions. Please update.


comment:
Please flow the ISI content that was provided into the pop up for safety information.


comment:
Should the screen shot be labeled Country Target Budget too?


comment:
The text and your first menu item box don't match up.


comment:
The K in your title is too close to the bar on the left.


comment:
On the first FMV animation, the Next button was always there. Should this one wait until done to move next?


comment:
Confirming that this section as a whole should be "Country Target Budgets" since your comment said Tera wanted to leave it as budget. You may just be referring to the animations though.


comment:
check all your knowledge check headings. Some of the K is in the bar


comment:
The yellow box covers the bullet box that comes onto the page and you can't read it;


comment:
Confirming that it is okay to say "patient" in the correct feedback since we're referring to the fee.


comment:
Text in the animation was duplicated (so you saw two lines of text over each other) around the personal transportation section.


comment:
Do you want to remove the word "country" from the text at the end of this animation?


comment:
I went through the animations and Knowledge checks and when I came to the menu, the second menu option wasn't available to click. The text also didn't update.


comment:
Check these case studies. Once I finished Site 103, it showed me a question for Site 102.


comment:
Agree with Erin's comments & The click next button after the speaker stops talking is duplicated over top of one another


comment:
I concur that there should be an ISEC & SPI button so it is clear where the CDC will find the associated questions


comment:
Again suggest having a button for each - naming the SPI a form may confuse folks when in fact it is part of the site profile & certian required questions get pulled into the final site evaluation


comment:
the use of theraputic decisions comes from the information I pulled from the regs; here is what is captured fron the regs: 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; we could have a variation of that for bullet 1:  like:  Proper management of samples is critical to the accuracy and reliability of testing having a significant impact on patient care and study outcomes if not accurate


comment:
can we add to the 2nd bullet for the first statement:  if sites done't have or follow an established process for collection, processing and shipment of specimens data inaccuracies and  audit findings could occur and result in data from that site not being included, risking Lilly's submission for compounds


comment:
Since we talk about training in the 3rd block's bullet I suggest removing the word training from the 2nd block's bullet


comment:
To Erin's point can we have the statement above the bullets reflect: click each ISEC question...I suggest we have the question(s) as they are in the ISEC & suggest revising to the following: Does the site have access to the following critical equipment needed to participate in this trial: critical equipment will be listed
The bullets associated with this:  as customized by the trial planner not sure we need to say for a trial I think that is implied
Using the x-ray as an example implies the CDC needs to see that documentation when in fact it is the site's responsibility to ensure the radiology center maintains the necessary documenation therefore should we include this as an example since we can't further explain? Is there another example we could include?


comment:
The 2nd block should reflect the following:  Does the site have the basic/general equipment used to conduct standard of care treatment procedures for patients on clinical trials?


comment:
suggestion for the bullet associated with the 2nd block:  all clinical trials have basic/standard equipment that is used for standard of care treatment which is also required to conduct clinical research
2nd bullet:  each theraputic area will identify what constitutes basic/standard equipment which will be included as part of the site selection kick off


comment:
agree adding Erin's example of standard equipment as a bullet


comment:
3rd block:suggest making the following revision:  some of the equipment at a site is identified as critical equipment because it is used to determine trial objectives (including safety objectives).  I am concerned the next sentence is confusing as it doesn't seem to flow- not sure how to reword at this time.  also our requirement is that only critical equipment has to have a process for calibration or maintenace not all equipment which contradicts what we have in the first block's bullet. since this question is referring to the site's responsibility maybe we remove the 2nd and 3rd sentence since we stated it in the first question's block and we speak to the site's responsibility.  Something like: It is the site's responsibility to produce the necessary documenation to support they calibrate and maintain their equipment.  This would include ensuring that any third party vendor the site uses for testing also maintains the required calibration and maintenance documenation i.e. radiology or MRI center documenation to support


comment:
For the last block bullet suggest revising based on quality input:
Additional comments should be objective, self-explanatory and understood by internal/external reviewers who are not familiar with the site, trial or site processes.  If comments are necessary they should provide further clarity specific to the questions within that section and further demostrate the site's ability to qualify for the trial.     
Stick to the facts, do not draw conclusions unless necessary


comment:
will we have the yes and no and the appropriate answer checked?  I can't tell from the way it is set up?  also should we have the comment that comes up if no is checked?  which is: Provide additional detail and mitigation if applicable


comment:
revise the comment a bit: ....they can reach out to and partner with for this trial or for this procedure.


comment:
Can we add that this would be a follow up item the CDC needs to ensure is resolved and the resolution is captured within Trialforce or the required systems?- need to add reminders as to follow up items and what is required for documentation


comment:
Would like to see the commentary for this slide as I think it needs to be slightly revised; also same comment regarding the SPI and ISEC button options- I would like this to be in all of the training where applicable


comment:
Suggest revising first bullet:  having the correct facilities and equipment optimizes the site's ability to provide valid date for compound submission or something along those lines


comment:
The 2nd bullet can be a bit more robust:  is critical to include in your overall assessment as you establish the level of risk you may be undertaking by selecting the site.


comment:
The site isn't responsible for the CT scanner maintenance but that the CT center has that documentation and can produce it if requested


comment:
revise....over the maintenance of the third....


comment:
Change the thought bubble to say - Only users approved by a Scheduling coordinator can receive access to that SC's proprietary CMRI information.


comment:
Agree- also would use the term CT scanner to be consistant or CT center


comment:
Change the thought bubble to say "As a PRSC, when I need to view a summary of my base schedules, I'll look at the Real-Time Base Schedules report in CMRI."


comment:
The first wrong response doesn't make sense to me


comment:
I don't think the learner should be able to proceed if they select the incorrect answer


comment:
Change the top right thought bubble to say:  "When I need to see the price my resource was paid in the fifteen minute market, I should use the FMM schedule prices report in CMRI.


comment:
I would add to the commentary use objective languge-we may want to revise and rather than saying be detailed say include all the necessary details or information- if we tell people to be detailed I am concerned we will start to see over documenation which is what got us into difficulty before


comment:
Change the bottom right thought bubble to read "What I'm looking for a list of all of the scheduling points at a specific tie, I would use OASIS, not CMRI.  This information is available to the public."


comment:
Because much of this falls under SOC maybe we note that so we connect the basic equipment question with the visual aspect???  could we add a button that takes the learner to the associated question??


comment:
I could only identify the scale the other equipment was hard to identify


comment:
Suggest adding Temp log to the clip board


comment:
Please change the intro to read:  "As you've learned, CMRI is used to find a scheduling coordinator's proprietary information about their resources.  For ease of use CMRI groups reports into categories that appear as tabs across the top of the screen.  The tabs that will be most useful to you are:  Real-Time, Post-Market, Defaults Bids, and Forecasts.  If you are an EIM Entity Scheduling Coordinator, you will also have access to the Energy Imbalance Market tab."


comment:
Infusion pumps are considered standard in oncology so we need to be careful how we qualify this piece of equipment- we may want to not for this trial the Infustion pump is considered critical equipment or somehow diffrerentiate so the learner knows it could be either


comment:
Agree would revise and say for some trials sites are required to have a crash cart and/or defib....


comment:
Since the words in the tabs are capitalized, let's capitalize them on the title of each page.


comment:
I clicked on the refrigerator several times  and it wouldn't let me move to the next option


comment:
Change the Base Schedule Reports to read:
Title - Real-Time Base Schedules
What is this report? This report focuses on real-time base schedules information submitted by base schedule coordinators.  
When to use it?  This wording is ok
Helpful Hint (or whatever it's called in the OASIS CBT):  There are also day-ahead base schedules located in the Day-Ahead tab.  This report will provide non-binding day-ahead base schedules.


comment:
FMM schedules - What is this report?  this report displays the resource-specific MW that  cleared the fifteen minute market.


comment:
When to use it:  This report is used to validate fifteen minute energy settlement information.


comment:
In What is this report - change FMM to fifteen minute.
In When to use it add the words fifteen minute.


comment:
Reword the green box to say "The Price Type shows the LMP and also shows the breakdown of its components - energy, congestion, loss and Greenhouse Gas.  Flexible Ramp Up and Down are prices also available (not shown).


comment:
Correct the name to "Real-Time Dispatch (RTD) Schedules"
What is this report - change "cleared the market" to "dispatched in the five minute interval."
When to use it - add "five minute" after the word "validate"


comment:
In the green box capitalize the word "type"


comment:
Remove "FMM" from the title.
Make the same changes as the RTD schedules report.


comment:
In the green box make the same changes I identified in the FMM schedule prices report.


comment:
As requested at Alpha review: 2nd Find the Screen question, correct answer (Infusion screen tab) pop-up box. Delete 'go to', just state, "...is where you would locate and enter the drug and dosing information for your patient."


comment:
Change the title to FMM Flexible Ramping Product Price Breakdown.


comment:
Change the name to "RTUC Advisory Schedules"
When to use it should say "To review the next fifteen minute advisory schedules."
There is another report called "Real-Time Transfer System Resource Limits".  What is in this report:  This report provides the upper and lower  transfer limits.
When to use it:  This report is used to determine net import and export capability for flex ramp up and down credits.  BLP - do you have a screen shot of this one?


comment:
In the green box capitalize "movement points"


comment:
Spell out Flexible Ramping Product instead of FRP.


comment:
There are two reports - the FMM Flexible Ramping Product Price Breakdown and RTD Flexible Ramping Product Price Breakdown.  They do the same thing - one on the fifteen minute basis and one is on the five minute basis.


comment:
We should add the commitment cost details report here.


comment:
Change the green box to read:  You can filter by hour and interval.  
Put the green outline around the "Hour:" and "Interval:" filter boxes at the top.


comment:
Response to note - I'd still like the report to be a separate click.  Otherwise they may assume there is only one report available, when there are several, we are only focusing on one.  Also, we may add other reports in the future.


comment:
Change "Load Serving Generator (LSG)" to "VER"


comment:
Currently this tab has only 2 reports, so the word "multiple" is overstating it.  Can we say "a couple" or "a few"?


comment:
Please change the intro to read "The EIM tab includes information for EIM Entity Scheduling Coordinators.  There are multiple reports...."


comment:
Change the disclaimer from "annually" to "periodically"


comment:
See my previous comments and update this page.


comment:
Second sentence of the scenario  should say "He wants to confirm one of his resource's base schedule MW values used on a particular date and hour."


comment:
Change "You need some assistance figuring out how to bid.  Which report will be most helpful?" to "You are interested in seeing a locked hour ahead forecast for your variable energy resource.  Which report will be most helpful."  The answer is the VER Forecast.


comment:
Change "The FMM MPM report is used to determine if bids were mitigated" to "The Real-Time Base Schedules Report represent forward energy schedules for EIM resources."  The answer is True.


comment:
Please correct this verbiage based on previous comments.


comment:
Can we say "In the resources tab above?" - not clear that the resources tab is within the training!


comment:
Again, need to clarify that the "resources" tab is within the training and not within the DSA site


comment:
Will there be screenshots on this screen at all?


comment:
for #1 why it matters I would revise to read...to ensure data integrity and patient safety or somthing similar


comment:
How to say it #1- add maintained and calibrated


comment:
#2 why it matters:  ...the accuracy of the trial data ....


comment:
Disregard my comment about #1 as maintenance is covered in #3


comment:
I had mentioned before that the use of heart may not translate globally - I know what we are getting at- that there is a gut feeling that you need to factor into everything- John agreed being he works with our Asia colleagues- not sure of other options or we just go with it?  Maybe see what the other reviewers say


comment:
change continue discussion to begin conversation


comment:
Background does not seem to be proportionate to Coach and Bob


comment:
need to remove the text box You decide to have a private convo...
Not liking the size of coach and bob


comment:
customer interaction with bob. Change when bob is talking have customers arms crossed and when customer is talking have hand out.


comment:
Font size in blue box. Closeout change to debrief


comment:
remove client incident, add text Follow-up call on Thursday


comment:
the Site Activation Collaboration site link is not working for me either.  It is trying to go to www.bottomlineperformance.com


comment:
was coach swanson supposed to be there and have a text bubble after all cross river. Swimmers are very crowded. Bob is slipping back into the river.


comment:
Coach swansons text box, text to low in box
add audio for the coach and customer
rocks re-appeared in the river


comment:
If user selects to go back from a later screen it starts you over in the entire sequence. Can this be updated to just go back to the previous screen?


comment:
Feels like there should be something on the slide that speaks to the need to place the telemetry head over the pump to interrogate it gets lost a little in the demo screen and then jumps to telemetry complete window.


comment:
Once you have played the video and try to go back using the back arrows you are stuck only going back to the full screen video instead of the previous screen. Can this be fixed?


comment:
Clinical Pharmacology Study Delivery Solutions vs. Clinical Pharmacology Delivery Solutions


comment:
In the more information for Determine Budget Organization activity, we need to update the language: This activity includes determining the path in the process to follow based upon whether HCPs are involved in the trial.


comment:
...whether this will impact the trial protocol.


comment:
This role is also responsible for responding to questions regarding the protocol.  vs. ?


comment:
I think we should say Procurement Representative vs. procurement.


comment:
I need written confirmation vs. I need a written confirmation


comment:
comma between 'weeks' and 'and' as well as 'timeline' and 'so'


comment:
Site activation activities can commence with a preliminary contract, but...


comment:
Contract negotiations can begin at this point.


comment:
Include the budget as an attachment into the agreed upon contract vs. merge the budget with the previously updated contract language.


comment:
That's right!  Ensure the approved budget is included as an attachment to the agreed upon contract.


comment:
The budget is officially approved and the budget has been included in the contract as an attachment.  Andrew only needs to complete a few remaining tasks for the contract to be considered executed.


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:
Would say documenting any trial-level enrollment and site activation mitigation and contingency plans.....


comment:
For determine budgeting organization activity, also include the agreed upon statement after the first sentence I suggested to add with a slight update: Move to the Obtain Budget activity and follow that path when non-HCP vendors are involved in a trial.


comment:
Take out site levels from last sentence as it is in the first sentence.


comment:
the volume on the woman's voice and the man's voice is not consistent.  I nearly fell out of my chair b/c the man's voice on this slide was so loud where I had to turn up the volume earlier for the woman.


comment:
The first sentence needs fixed.  It is complete when the activation plans and enrollment projections are developed and entered into internal systems as well as an defined mitigation and contingency plans for enrollment or site activation are documented


comment:
chnage to site activation plans and enrollment projections


comment:
I would say determining the planned enrollment ready date for each site


comment:
The red boxes don't show anything.  is that right?


comment:
i do not think that we need to go over the description of the three roles again since we just did on previous slide.  I think the fist part of the audio is fine but the pop up boxes are not needed, I think


comment:
for the site manager why should we put trial enrollment timing expectations?


comment:
Update Drop-down List pop-up verbiage. There is no arrow shown on the right-side of the drop-down list we are showing (I don't think there are any arrows for drop-down lists in the ISR application) so the sentence doesn't make sense. Maybe state "A list of values appears when a button with multiple options is selected."


comment:
As requested in Alpha, please reorder on-screen text to match previous slide.
- 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:
add "click continue" directions when audio stops


comment:
make sure that the audio only replays when I click the button again - when I used back to return, audio played on its own


comment:
I think per previous reviewer comments the last bullet should just be deleted.


comment:
make sure this page is in the left nav drop down


comment:
For the site manager, change study to trial


comment:
Under the site manager what, the last sentence.  I would say, Also, update site activation documentation....


comment:
In the why on study manager - add prior to the start of the trial enrolling


comment:
should putting it all together be flashing


comment:
I would change the site activation documentation to say, planned enrollment ready dates and site activation documentation


comment:
And then I would say:  Planned enrollment  ready dates for each site are entered into the internal system and when appropriate, the overall site activation plan for the trial is documented.


comment:
Need to say, site activation plans and enrollment projections,...

and Without these,


comment:
back arrows not working properly. When hit back arrow the screen that should come up when hitting the forward arrow comes up putting things out of order.


comment:
This is confusing and not very user friendly.


comment:
Can we move this to the front as discussed and put in a sample disclaimer that can be pulled from other MDT courses.


comment:
First paragraph. The develop Site Activation and Enrollment plans is critical in how well a trial proceeds. (I suggest to take out the "role" word)


comment:
First bullet:
Suggestion: 
Discussing with sites enrollment strategies (take out "their"), establishing enrollment projections (take out "solidifying enrollment numbers")and entering....


comment:
Bullet 2: At this moment plan and baseline are the same, I would put only baseline and forecast as example


comment:
Bullet 3, Why only trial level? sometimes are strategies only at country or site level


comment:
In enrollment manager I would suggest to put the same definition as in Recruitment participants course.


comment:
In site manager, I would suggest: If I don't do my job, enrollment will not start when is expected.


comment:
Red boxes disappear before you can click them.


comment:
I think this slide will be changed right? the red boxes won´t point specific roles correct?


comment:
Why we don´t use the same persons as for the Recruitment course... maybe would be easier make a connection.


comment:
Include site level enrollment projections is NOT a required activity, on ER dates at site level are required.


comment:
I need to look at the audio script a little bit more, but might discuss with Nancy and I more before changing the text on the screen.  I think her suggestions are a little too detailed for the written portion, feel like these should be a little more high level as written, with the appropriate explanation in the audio.


comment:
I think the first question should be more specific to requirements in answering questions - "How did the site staff answer my questions? Did their responses meet the basic Lilly and regulation requirements?"


comment:
Site Selection Guidebook will be one resource. Equipment Calibration & Maintenance Collab site another one (http://lillynetcollaboration.global.lilly.com/sites/EqCM/SitePages/Home.aspx) and probably you could use the CLO Collab site (http://lillynetcollaboration.global.lilly.com/sites/CDSWeb/Pages/default.aspx)


comment:
In the voice over, I would say "After completing this course vs. training".  Also, please define ICF in the voiceover.


comment:
We should spell out ICF before we use the abbreviation either on the course objectives slide or here.


comment:
I think it should say ICFs protect the interests of study participants, sites and Lilly vs. study participants, people who create the ICFs, and Lilly


comment:
I would revise the last sentence and use it as the first sentence in the 2nd paragraph: The ICF helps study participants decide whether or not participating in a trial is the right choice for them.  Prior to agreeing to participate in a trial....


comment:
This purpose of this course is to help those involved in the ICF process to recognize the importance of the ICF in the clinical trial.  The focus is on the importance of accuracy in preventing adverse impacts to study participants, sites and Lilly.


comment:
I need the ICF to provide this information because I work full-time.  I can't afford to take off work frequently as a result of bad side effects from participating in the clinical trial.


comment:
I need the ICF to clearly explain this to me.


comment:
Use 'consent' vs. 'informed consent' in the brown boxes.


comment:
in the answer: study participants' vs. patients'


comment:
Accurately describe the methods that will be used to address possible side effects during the trial in the ICF.


comment:
add a period at the end of the last sentence


comment:
childrens' parents vs. children's parents


comment:
voiceover....study participant, site and Lilly


comment:
ethics review board vs. institutional ethical review board.  ....had approved the trial vs. had given ethical approval for the trial


comment:
done without consent vs. done without informed consent


comment:
Action: On being informed of the need for study participant consent, the authors (is this right? should this be study team or Lilly or sites?) asked if they could correct the situation by obtaining consent retroactively.


comment:
in the response: study participants vs. patients


comment:
Study participants are informed of risks before the trial begins and provide their consent....


comment:
should it be as a result of this oversight?


comment:
please check entire course for use of patient...change to study participant


comment:
trial vs. study...please check throughout


comment:
That's right! Consenting study participants protects both Lilly and the study participant.  If the study participant or his mother feels they were not informed about the true risk of the trial...


comment:
Check your formatting of th equestion.....should the question be in the box or just answers in the box.  should the select all that are true be in the box or not.  Please pick a format and ensure consistency across all questions.


comment:
The study participant vs. This study participant


comment:
what is provided below isn't really an action, it seems like more information to describe the case.  The action should be that the study participant signed by didn't really understand that his participation was voluntary?


comment:
in front of all responses: The study participant may decide ....


comment:
Disregard my comments about study participant, Lilly and the person that created the ICF...ok as is now that I see the rest of the course content...but I would maybe use ICF writer vs. the person that created the ICF to align with the process map.


comment:
to the ICF: the form and the discussion between the study participant and site staff (instead of physician since a coordinator could technically do this I think)


comment:
this is the link to the current standard and it should remain the same when the doc is updated.
http://doculink.mosaicco.com/livelink/llisapi.dll?func=brava.bravaviewer&nodeid=5215388&vernum=0&OpenInNewWin=_blank&NewWinParam=resizable


comment:
The animation is a little distracting on this one. I get halfway through reading the first one and the second one pops up and I lose my place. Can both just be on the screen at the same time with no popup?


comment:
I'm pretty sure that the SAP manager/GM approve startup (sunup to 11) and AT SHIFT CHANGE.... not weekends.


comment:
This should be sulfuric shift supervisor. The other shift supervisors won't be doing this.


comment:
Need agreement that sulfuric area manager should say area manager. Procedure says just area manager.


comment:
I needed to come back to this slide to look at something. It forced me to redo all five options before letting me go forward even though I had already done them previously.


comment:
make the button and framing language as well as more information box use same terminology: physician vs. research staff


comment:
Check other ICF courses to see how we listed the ICF Library and ensure consistency


comment:
Why did we include the QualityDocs Landing/Home Page in the list?  We didn't include this in the other courses I don't think?


comment:
what do we typically include with regards to the operating system?  Do we refer to the process map?  This seems different than what we have done in the past.


comment:
The question "are different interlocks required" is answered by a reference to the high so2 procedure. This isn't really a different interlock. The question would read better as "What do you do in the event of a 2000PPM trip"


comment:
These two pages seem redundant. Let's review the bullets from both pages and make into one page.


comment:
Alarms add volume to 2nd bullet - Program Low Reservoir alarm "volume"


comment:
Agree with CSL's comments except the last statement - I think we had previously said that we wanted them to be able to come back to this screen in case they wanted to look at the tabs again?


comment:
On the STARTUP q/a, the minimum requirements sections needs to tie back to the all clear notification. You've not only had a successful startup, but can call the all clear.


comment:
Actually, it might make more sense to move that third question under startup to the suspension of work section and ask the question "when can an all clear be called"


comment:
Under announcement systems it says that not all interlocks, trips and sirens are the same due to differing requirements. I thought this standard required standardization. The most current version that I had from David didn't offer any allowances for plants to be different.


comment:
Clarification is needed on the definition of Code Blue.  This is a new term to LA operations.


comment:
The only railroad traffic we have in LA is the main railroad and it runs through our plant.  Are we expected to shut down the main rail system.  This isn't something we can do internally.


comment:
I don't know that this makes sense. in the procedure converter beds and so2 emissions are required for an all clear to be called. it doesn't actually say that they are required for startup itself.


comment:
SULFURIC OPS MANAGERS,
The following content is not contained in this overview module for everyone but will be contained in the approver/sulfuric module 2. I need to know if any of this needs to also be covered in this overview module. For everyone.
-Any reference to inversion or weather conditions.
-Any reference to required documentation.
-Any reference to how long a plant was down and what tools/procedures/etc are required to be used for startup
-All detail around the downfield observer tasks and tools, the prestart checklist and the logic diagrams.


comment:
For the GM/Area Manager I would say "approve any Sulfuric Plant start-up that occurs between sun rise to 11am or at shift exchange." Also "Shift Supervisor" has a new title it is "Production Supervisor"


comment:
Production Supervisor, I would use "Sun Rise" not "sunup" when referring to the morning start-up.
all other start-ups except the morning and shift exchange can be approved by Production Supervisor.


comment:
1. Keep the font consistent and black for the page title. 
2. The Menu should not be visible on this page.
3. Why did the start button change? Change it back.


comment:
Interlocks/Announcement Systems:
Everything is standard where possible, Riverview has in our permit for a 1000ppm trip that Polk and LA don't so we trip plant at 1000ppm. I think this should be noted in the interlock tab so there is no confusion when Riverview personnel are taking this course.


comment:
We need to take out the remarks about weekends for GM/Area Mangr and Production Supervisors.
The standard pertains to all sulfuric start-ups sun rise to 11am and shift exchange. 
The first box for the Production Supervisor should say obtain approval for morning and shift exchange start-ups after all requirements are met.


comment:
We mention in this slide that "you need to know what to do when different alarms and notifications sound" but we don't really explain anywhere on what that is. Should we say somewhere that other that the mentioned work stoppage all other work can continue but you need to be aware and in the case of a high SO2 trip event you must follow site protocol till an all clear is called?


comment:
Menu should not be visible on this page.


comment:
You should not be able to get to this page from the menu


comment:
Don't have the Click Next to continue "fly in". Why does the next button take a while before it shows up. It should be there when the page loads.


comment:
Don't automatically build the text boxes. It is distracting!!!!!! It should either require learner interaction to add additional text boxes (and only if meaningful) or should load all at once. I'm agreeing with ABB.


comment:
Menu should not appear on the Glossary page. This feedback box is loading from the wrong page.


comment:
Menu should not appear on the Resources, Notes, Glossary, or Help pages. This feedback box is loading from the wrong page.


comment:
If you have been to this screen and go back to it you should have to click each person to get the Next arrow. It should be there when you return to it.


comment:
Indicate once you slick on them. e.g., grey them out


comment:
Doing a screen build when someone is reading is distracting and useless. Stop it!


comment:
Why are "DIFFERENT notification and warning systems" in place? Clarify.


comment:
Previous button shouldn't keep changing positions.


comment:
Medical Terminology: Use of the term 'sugar-pill' in place of placebo. Although 'Sugar-pill' is also used in the Eli Lilly MED, is there a trend or preference towards referring to placebos as 'medication with no active ingredients'?


comment:
Navigation: Pressing the Back Arrow on e.g. 'Henrietta Lacks 3', takes the trainee back to 'The Story of Henrietta Lacks' instead of 'Henrietta Lacks 2'. In addition, would it be possible to allow trainees who have completed the slide to navigate to the previous slide and be given the option to move (back) to the next slide - rather than sitting through the entire audio again. For example: from 'Henrietta Lacks 3', to 'Henrietta Lacks 2', and option to move quickly back to 'Henrietta Lacks 3'.


comment:
Navigation: Is the Back button meant to take users back to 'The Story of Henrietta Lacks'? Or can it take users back to the Knowledge Check: Henrietta Lacks, from this page (to review their response).


comment:
Please amend the sentence 'the spouse of a research subject...' with 'the spouse of a 'study participant'. This is the correct term and allows consistency with remaining presentation.


comment:
Relevance: Questioning the use of 'one million pesos'. Is the purpose of this value to emphasise the negative impact? Converting this value to a familiar currency (such as USD) may provide a better idea of how much this fine represents. 'One millions pesos ($USD)'.


comment:
Definition: who are we referring to by 'authors'? Is this the same as ICF creators? In clinical trials is the role of the ICF creator/author to request informed consent, whether retroactively or initially?


comment:
Navigation: There is no 'Question #1' page. When the Back button is pressed the trainee is taken back to 'Lilly, the Study Participant, and You'. Pressing the Back button on Question #2 takes the trainee back to 'Case Study #1' instead of 'Question #1'. This occurs with all the case studies.


comment:
Accuracy: this is an intimidating slide (content-wise) and not accurate to the case-study in terms of responsibility. 

An ICF creator cannot be held responsible for a clinical trial site performing study procedures without consenting participants. On a similar note, ICFs are checked by an Ethics Review Board prior to approval to ensure the ICF is fit for use (at least in Australia and New Zealand). I do not see how an ICF creator can be penalised for this scenario and would be questioning the legality of being dismissed for errors in an ICF. Considering the bulk (or lack) of information in an ICF is provided via the PED (and PED writers), how can the ICF creator be liable? 

Who do we identify as an ICF creator? Is the expectation that the ICF creator is well-versed in the protocol and procedures so that they understand everything that needs to be included in a study ICF? 
This Q&A raises too many questions.


comment:
Acronym: Non-Alcoholic Hepatosteatosis vs. Non-Alcholic SteatoHepatitis (NASH).


comment:
Please see my comments in Module 4: Module 2: The Downstream Impact | Section 1: 1 | Page 14.

Risk statements are provided by the PED (by PED writers). How accurate is this in terms of ICF creator liability?


comment:
Please see my comments in Module 4: Module 2: The Downstream Impact | Section 1: 1 | Page 14.


comment:
Document Link: Broken link to eTrial Master File (eTMF) document - 'Finalise ad Manage Informed Consent Procedure'.


comment:
Question for the SMEs:
The 1st sentence "In this course we refer to commercial Clinical Research Units (CRUs) as "vendors"."
Is this correct, given that the term "vendor" is broader then just CRUs? Should the sentence be changed to for example:
"The term "vendors" used in this course includes, but is not limited to, commercial Clinical Research Units (CRUs."


comment:
In the GCBC representative box I think the term MSA is used for the 1st time. The abbreviation should be spelled out (Master Service Agreement)


comment:
We should talk about the page and how Qs & As are presented.


comment:
Stop the meaningless flying stuff in. It is just distracting the learning for reading. Pop up feedback text block covers up the other instructions. Click Next is in a new position - Keep it consistent  

Need to rework the interface.


comment:
I got stuck on this page when I clicked Previous and then came back to this.


comment:
if the request is outside of local parameters.


comment:
If the site submits a request that requires additional approval,....


comment:
I don't think you need to capitalize Fair Market Value in the first sentence.


comment:
I don't think you need to capitalize Fair Market Value in the question.


comment:
Change "Testing...Testing" to "LMS Test Course"


comment:
Change "Learn more about our company" to "Learn more about Bottom-Line Performance"

Change "See how our..." to "See how BLP helps you create the right learning solution."

Change "Learn more about BLP's work process." to "Learn more about the BLP Way."

Change "Learn More" to "Go" on all buttons. This is avoid saying "Learn More" in a description, then have the button say the same thing again.


comment:
Our philosophy is actually the four pillars on http://www.bottomlineperformance.com/about-blp/. The "BLP Leads, BLP Creates" stuff is just a way to communicate different aspects of what BLP does. You might add a section under "Our Philosophy" called "Who We Are" and then have these circles with all the descriptions, because it's good content and looks good on-screen.


comment:
Swap the "Analysis", "Learning Design", "Development" section with content from this page: http://www.bottomlineperformance.com/learning-technologies/


comment:
Change Step 2 to "Conduct design meeting. Create design document(s)" instead of "Conduct design documents"


comment:
Scratch that last edit. Change it to "Conduct design meeting"


comment:
Change Step 4 to "Develop learning solution(s)". We don't just make courses.


comment:
Verify with Nick that Info@bottomlineperformance.com is the best place to send feedback


comment:
The "skip" button has a weird hover issue, where if you hover over it, then the arrow part, the stuff flickers...nice to have if we can fix that.


comment:
I'd probably throw some sort of frame behind the video...the storyline player is ugly...like literally a white box around it all or something.


comment:
Maybe the selected state of the buttons should stay green? I'm fine if you disagree.


comment:
I feel like the answer options text is a little too big...maybe it should be the same size as the text on the video pages...I feel like it should be at least smaller than the "Submit".


comment:
We're also going to need a "reset results" somewhere...maybe when they click the quiz button on the main menu, I couldn't retake the quiz (see CAISO).


comment:
I don't like that you can stack these...maybe only allow 1 item in a drop spot.


comment:
I passed with 0%, but got "Uh Oh, you did not pass with 60%".


comment:
country target budget vs. country budget


comment:
you have already defined CPP....you can use CPP here.


comment:
primary investigator and study coordinator...if I would spell out here if you haven't already defined.


comment:
Same edit on this page as 12a for double right arrow and double left arrow.


comment:
Remove the following words "to change the resource's availability"


comment:
Change the bullet about the equipment field to say "The Equipment field is updated by using the equipment picker which we will fill out later.  Let's move on to the Start Date/Time."


comment:
Change "Operations Procedure to 32-10" to "ISO Operating Procedure 3210."


comment:
Change "Remember how we skipped the Equipment filed earlier?" to "Remember how we mentioned the Equipment field earlier?"


comment:
Change "Once that's done, we can pull the slider to the left and see that the equipment at the top is A/C line segment"  Change that to say "Once that's done we can pull the slider to the left and see the line that we selected in the equipment picker is now displayed at the top."


comment:
For the edit above, move the blue highlight from Type and ACLINESEGMENT to the Station and Nzme fields and their associated entries.


comment:
Remove "for conductor replacement" on the screen and in the narration.


comment:
In the first bullet on the script remove the word "approved" from before the words "outage number"


comment:
Please align the summary comment from the previous section.


comment:
FYI - The correct answer to the Equipment Picker question is False.


comment:
Change "close all" to "model".  
The correct answer is True.


comment:
Remove "to ensure the energy will be re-routed"


comment:
Change "transmission lines" to "transmission line".  Change "the lines" to "the line".


comment:
Please use the welcome screen layout from module 2, and make sure animation is inserted.


comment:
Edit intro text: Delete second sentence (We have learned...) AND sentence four (I want to...) Edit sentence 3: "This module is focused on testing methods and competitors, including how to:"


comment:
I think we need a previous button here.  We know they can't go forward with Next but they should at least be able to get back to the last page they visited.


comment:
I feel like when the learner clicks the PREV button here, it should take them to the grayed out map (since everything was completed) so that they can revisit locations if they want, but maintains their progress.  Leanne said that "one MUST have with Mosaic is that the course retains what you have already done, so if a screen makes you click everything before you can move forward, should you DO that and then decide to click previous to go back, and then you return to that screen, it shouldn't make you click everything again. DOes that makes sense?"


comment:
When I clicked PREV and came to this slide, my progress was gone.  Need to maintain the checkmarks but let learners click each box again if they want to.


comment:
To view other resources click the file cabinet icon above.


comment:
Audio stays: "I'm here to help you write accurate, complete TCEDs that study participants can understand".
Study participants don't see the TCED though.
Review with the SMEs, but I would propose something like "I'm here to help you write accurate, complete TCEDs in easy and understandable language."


comment:
Correct term is "Trial Consent Elements Document"


comment:
1st sentence "... they are asked to join". Is this language accurate?
replace with: ... the trials proposed to them?


comment:
1st paragraph:
... all trial, site, Ethics Review Board (ERB), and country requirements


comment:
Bolded text replace with Trial Consent Elements Document


comment:
"Country-specific" should be lower case: country-specific


comment:
Last sentence:
Because the content is intended to be ready by...


comment:
1st bullet:
"Inclusion/exclusion criteria"

2nd bullet:
Trial schedule?


comment:
the magnifying glass didn't work when clicked


comment:
Rather than the Risk Profile, should we show a screenshot of the isk section of the ICF?


comment:
Voice over: say ICH GCP instead of just ICH?


comment:
Under Protocol: replace study with trial.

Also, confim with SMEs if this is always obtained from Leo or also from eTMF?


comment:
write (PIL) next to Patient Information Leaflet


comment:
Let's be consistent throughout the document -- change "control unit" to "Control Unit" - first letters both uppercase.


comment:
Additional content (bad and good SOE examples) provided via email


comment:
Exemplary TCED in the most recent template v.6 is provided via email


comment:
After you have clicked each section and you need to click the white icons at the bottom of each section, I would be more clear. It took me FOREVER to figure this out and I never noticed the text change on the screen. Can you flash the first icon or put a red box around the new directions or something?


comment:
This entire scenario needs changed. Instead of Larry getting a friends request, how about Larry got a Facebook message from a friend who is also a competitive developer he's worked with in the past asking a question about MISO's process. 

Keep option #1 for response but chance #2 and #3. 

#2. Do not respond to any social media correspondence about this topic.

#3. (the correct answer) Tell him to contact Client Relations via email and they will answer his questions as appropriate.


comment:
The feedback provided when you click on the responses should be changed too. The correct answer should read: "Any communication regarding work-related processes, even via social media, should be handled with care. Remember, it's important not to share confidential or private information that is not publically available.


comment:
In the materials needed list for the software button activity, let's capitalize the first letter of each bullet for consistency.  "Eject" and "Global" are the only ones not capitalized.  Thanks!


comment:
For the Workflow Guide Review Activity materials needed - the hyphens are different in the bulleted list.  The top 2 and last one are one type of hyphen and the rest are different.  Can we make these consistent?  No preference on which.


comment:
The first bullet on this page has "cobas c 513 analyzer" duplicated at the end of the sentence.  Need to remove one.


comment:
In the 4th bullet down (Demonstrate how to activate Preventive action), capitalize the A in Action.


comment:
In the bullet "Demonstrate how to unload/load cobas c packs and explain" un-bold the word "and".


comment:
In the "Explain that if the reagent cassette contains..." bullet list, change the last two sub-bullets to include "the" -- Select the Registration button... and Select the Execute button.  This makes it consistent with the rest of the list.


comment:
In the "Demonstrate how to replace detergents..." bullet, add "the" to the last two sub-sub-bullets - Select the Execute button. and "Select the OK button"  Also need to add it for the sub-bullet "Select the Status button in the Reagent..."


comment:
In the Recommended Reinforcement Activities section, it's weird to have "Practice accumulating QC results" as the only bullet outside of the RDU box.  Is that because it's not a simulator task?  Just wondering.  I'll look again at other sections too.


comment:
The answer to the first question duplicates "cobas c 513 analyzer"  Need to eliminate one.


comment:
For the "Demonstrate how to check the pump pressure..." bullet, add "the" to the 3rd sub-bullet so it is "Verify the analyzer is in Stand By."


comment:
Under "Demonstrate how to check probes..." the first sub-bullet should be updated to "Verify the analyzer is in Stand By."


comment:
Update bullet "Demonstrate how to perform the Daily Pipe (wash rack)..."  (Added "the")


comment:
In the "Explain the calibration and QC run..." bullet change "form" to "from the Rack Monitor screen."


comment:
Can we add a comment somewhere to clarify that "Patient Reimbursement is not paid in observational studies"?


comment:
In the objectives, add a space on both sides of the ">" in the 2nd bullet.  Just makes it easier to read and consistent with what's below.


comment:
Under the "Demonstrate how to manually request calibrations" bullet, the 3rd sub-bullet refers the user to Step 6, but we haven't numbered them.  Is it possible to number these sub-bullets instead of keeping them bullets?  I'd prefer to number, but this (so far) would be the only section that is numbered, and if that's not the standard then keep as is.


comment:
Does the CDC need to request to see or check the thermometer or the temperature records?


comment:
1st sentence says "regarding equipment" - this course is about site qualifucations. Please change to "regarding site qualifications".


comment:
In the incorrect feedback (I selected the 2nd option) - "CDC" is mentioned twice in the feedback. Please correct.


comment:
The description of heart in the pop-up in upper right was correct.  The description of heart on the main page seemed more factual to me and more fitting to head/thinking.


comment:
add "Identify, Evaluate & Select Sites" before process map


comment:
Last sentence - end sentence with "do not draw conclusions"?  Adding "unless necessary" seems to open to door to non-value added text (CDC's opinion vs. facts)


comment:
Is it an issue to have the statement about "once we receive the official notice" we have been selected as a site...  That sounds like a written letter.  That isn't a requirement in the Select and Manage sites procedure, is it? I thought CDC could also inform site verbally they have been selected.  I know this is just an example but wanted to ask if implies formal, written approval since I thought was more flexible in the process. (best practice)


comment:
The rocket doesn't go all the way off the screen.


comment:
Add the word "is" to the last sentence of correct feedback.


comment:
Instead of saying "Your answers are helping create the rocket" let's say "Awesome job! Your careful communication skills are really showing! Keep up the great work!"


comment:
update text: Jill received an email from her boss about a known issue that included steps for fixing the issue......


comment:
Spacing in the email popup is odd. Not sure if it's my screen or not.


comment:
Instead of how too text say "Is this email okay to forward directly to her customer, or should Jill create a new email?"


comment:
Let's include the standards Cummins exit information. They can click next here and get the standard Cummins Certificate that you'll have to modify.


comment:
When they click Forward email, can you show the forwarded email on screen?


comment:
Let's add a graphic to this page to make it more visual.


comment:
update text: He is about to send a message to his co-worker Mark to see if he's ready to go to lunch. What message is the most appropriate to send?


comment:
Joe from Cummins had feedback that these messages didn't really seem like natural conversation. For the second one, he doubted that anyone would say a tough customer just called. Maybe we can say "Wow..I'm so ready for lunch! I just got off the phone with a frustrated customer. All is okay now, but man that was tough! Are you ready to go?


comment:
It's hard for me to realize that after I select a button, the scenario switches to what Mark is responding. Is there any other way to display this?


comment:
Suggest minor rewording:  ...information asked for in the ISEC...


comment:
Voice over was jumping in to give potential answers before I selected a possible option of conversation text.


comment:
Would there not be any other source information to use for completing this section? I'm not sure the Protocol Concomitant therapy section alone would alow the ICF writer to complete this section.


comment:
I think we say below 8th grade level earlier in the course


comment:
Add some instruction on what the 8th grade readining level corresponds with Flesh Reading Ease? E.g. should it be above 90?


comment:
Instructions ask for the total number of study participants, but 2nd exercise asks for duration of subjects participation.


comment:
The dropdown may get missed - maybe have it as a seperate screen?


comment:
Principle 3 needs additional content? There seem to be placeholders there?


comment:
I think it would help to have a print button on this course, or a way to see 2 screens next to each other.


comment:
I think there are 2 correct responses here:b and c


comment:
For clarity, can you rephrase the first answer choice (which is the incorrect answer) from "Ensure JTB Health is aware of the budgets previous vendors have been granted."  to  "Ensure JTB health is aware of the approved budgets from previous vendors." (still an incorrect answer).


comment:
When the correct answer is selected, the 'Correct' window pops up.  In that window, the wording should be "..., but study participant screening cannot occur until the contract is fully finalized."


comment:
Would a patient or study participant use the word ICF? Is there a layman term for ICF?


comment:
Question for the SMEs: is there a way to link the Thalidomide story more to ICFs? With this question it seems more related to safety reporting of adverse events and clinical trials in general?


comment:
We don't say it's Lilly in the case scenarion. Is it in fact Lilly? Or should way say "the sponsor"?


comment:
It's not only the ICF creator, but also the reviewer, approver...


comment:
I selected all 4 response option and got the feedback this was incorrect?


comment:
I don't think the 3rd bullet is correct as it talks about risks, but the scenario is about voluntary participation.


comment:
What is the correct answer? I got "incorrect" every time


comment:
Pop-up when clicking ICF Form:
Change study to trial


comment:
2nd bullet should change to the procedure title and link. I believe you have the list.


comment:
In general I think the course is too long. Should we look at shortening some of the case studies?


comment:
For last circle, it should say 'additional items of costs higher than the negotiator's limit are requested, if justifiable'


comment:
The system seems slow to move from the previous screen, thought the system had timed out.


comment:
I think the wording of the following sentence could be improved, but I don't have any great ideas, so if everyone else is ok with it, it doesn't have to change:
"Delayed site activation also delays enrollment, which means the site could have less or even no time to enroll study participants."


comment:
Confirm with SMEs that I didn't change the meaning, but I suggest changing the following:  "After reviewing the site-level budget, sites may need to request additional items to be included or higher costs than what are included."  to the following:  "After reviewing the site-level budget, sites may request to include additional items or to increase the cost of items already included."


comment:
Confirm with SMEs that I didn't change the meaning, but I suggest changing the following:  "If a site reviews the budget and decides they need to request additional items or higher costs, the budget negotiator evaluates these requests and negotiates where necessary." to the following:  If a site reviews the budget and decides they need to request either additional items or an increase in costs, the budget negotiator evaluates these requests and either grants the request or negotiates with the site."


comment:
Agree with Vance just remove weekend approval in verbiage


comment:
Need to add on this slid the comment about all work being suspended until all clear or upwind permit approval is obtained.


comment:
Should we "Upwind Work"- we know it is work that was previously defined as work to be suspended, but "Upwind Work" sounds like all work is expected to be suspended due to startups. Something like possible exceptions to prohibited work could be authorized by ........


comment:
All work is initially suspended however may continue in the upwind category after permit approval is obtained


comment:
Agree with Sophie.  Study participants don't receive the TCED, they receive the ICFs.  The audience is really the affiliates creating the ICF


comment:
the 'X' is over the title of the box Create Trial-level Consent Elements Document.  ALso, it should be Create Trial Consent Elements Document vs. Trial-level to match the map


comment:
Should be Create Trial-Level Assent vs. Trial-Level Assent.

I would remove: You will review the requirements of an assent form.


comment:
in the trial consent elements document information box, why are we including information about what we will learn?  This is supposed to describe the activity right vs. what the course will cover?


comment:
Create Trial-Level Addendum Informed Consent vs. Trial-Level Addendum


comment:
Please check other courses where we describe the purpose for addendums and include here.  Also, I don't think we want to include what we will review in the course here right?


comment:
To help study participants determine whether or not to participate in a clinical trial, we need to ensure that the Informed Consent Form (ICF) is accurate and easy to read, while still meeting all requirements.


comment:
suggested revision: The Trial Consent Elements Document (TCED) is an inputs into ICF creation at the country and site-level for multi-country trials.  Therefore, in order to meet the goal above for creating accurate, easy to read ICFs, we need to improve the quality of the TCEDs delivered to the affiliates.


comment:
again the TCED isn't a document read by study participants.  it is used to create the ICF that will be read by study participants.


comment:
the computer screened showed a screenshot of the Protocol Elements DOcument...Need to update


comment:
remove the comma between 'old' and 'and'


comment:
she has been asked to participate in a trial measuring the effectiveness of Ixekizumab in treating arthritis.  She is reading the ICF to determine if she wants to participate in the trial.  The ICF includes trial-specific information from the TCED...


comment:
I am not sure I even meet the criteria to participate in this trial....I think that's what you are trying to say?


comment:
Carole's husband, Tim, is more concerned about the long list of risks included in the ICF.


comment:
schedule for the trial vs. trial schedule


comment:
read and understand health literacy information included in the ICF.


comment:
why are some things bolded and others not?


comment:
This suspension of work is clear.  What about this example-  Contractors during tower work during turnaround, or on the vent stack.  This does not say that they need to come down from the stack or the tower, only that they get out of the confined space.


comment:
The TCED includes trial-specific information which is copied into the country-specific ICF templates.


comment:
The country-specific ICF templates are created by the affiliates using the Elements for Consent Content Guidance required tool and local requirements.  

In past courses, did we bold quality docs?  Please be consistent with approach.


comment:
example shows the PED vs. TCED.  Will need to update this.


comment:
instead of other required documents I would say other TCED sources


comment:
Source for Non-Lilly Drug/Device Risk (?) Language


comment:
trial vs. study when clicking on protocol


comment:
Document obtained from the study team (e.g. CLO provides approximate blood volumes per visit).


comment:
when you say TCED template or Country-specific ICF template...I don't think we need to capitalize template.


comment:
different trial designs or different designs vs. different study designs


comment:
Question for the SMEs:  Is the use of the term vendor in the course correct?  It think other areas of the company have switched from the term vendor to TPO.  There is a LQS definition for TPO, but not one for vendor. I think we should review the glossary during our meeting and discuss.


comment:
take a look at four key principles to help you...I would remove and related writing


comment:
reader-friendly or audience-friendly?  I like audience-friendly


comment:
The way the information is presented, such as formatting and layout, can greatly help or hinder understanding.


comment:
positive feedback on this type of formatting vs. organization


comment:
The ICF is pretty clear Tim.  The number of visits is reasonable.  I am sure I can fit the visits into my schedule.


comment:
Thanks to the improve content from the TCED, the ICF created was shorter and easier for the study participant to understand.


comment:
I am going to participate in the clinical trial Tim....


comment:
in addition to the main ICF.  In some cases, the addendum ICF may be combined with the main ICF....or should it say In some cases, content from the addendum ICF may be incorporated into the main ICF.?


comment:
The addendum ICFs include: 
Pre-screening addendum ICFs which occur prior to signing the main ICF
ICFs for optional procedures which occur after signing the main ICF.


comment:
Use language from the TCED created for the trial as appropriate


comment:
Do we normally include the process in the purple bubble below or the course name?


comment:
there isn't a specific WRiting an Accurate TCED process map in BWL.  It would be in Gather & Prepare Trial-specific Informed Consent Elements but I would only refer to the Finalize & Manage Informed Content process in BWL


comment:
Just confirming that "Study Work Order" is the correct term.  Use of Study vs. Trial


comment:
Is the "Action" needed to facilitate the story?


comment:
Could the "Action" part be incorporated into the scenario?


comment:
Same as before...  can the "Action" information be combined with the "Case"?


comment:
The voluntary participation language is off. Also, what does the CRA have to do with this?  As a note, for late stage Alzheimer, a legally authorized representative of the study participant would provide consent.  Maybe change language to say"
Once you begin this study as directed by your doctor, you are free to stop your participation at any time without penalty or loss of most benefits.  
The study doctor or study nurse may end your participation in the study at any time for any reason.  With approval from the study doctor, the sponsor may also end your participation in the study.  If you do withdraw from the study, you will be required to come back one more time for a final checkup.


comment:
What does "risks" in the 3rd answer have to do with voluntary participation language?


comment:
The answers need to be fixed in accordance with the scenario.


comment:
To the last line... maybe add language that the information needs to be presented in a way the typical study participant can understand...  manageable amounts of information, etc...


comment:
remove "loss of employment".  I would add in that audit/inspection findings.


comment:
Add "template" after country-specific ICF


comment:
Change "will have limited health literacy" to "may have"


comment:
Just because highly educated does not mean that they are health literate.  Additionally, research shows that even highly educated people find it difficult to comprehend information when there are "Stressors" such as receiving cancer diagnosis, dealing with a long term illness, etc...


comment:
Magnifying glass did not work.  Ask Maria for model.


comment:
Formatting notes and protocol section was removed.


comment:
Won't necessarily be grade level.  If using Flesch Reading Ease - it will just be a number.


comment:
Only the criteria that the person should be informed about before deciding to consent and go through testing... THe study doctor will review all criteria about study participation before the study participant would start the study drug.


comment:
As a note, Just because something is more readable...  also does not mean the information is relevant to making a decision about participation.


comment:
And the procedures that I will have to do are manageable.


comment:
Add "all" in front of detailed risk information


comment:
Could we also add another thought...  when the TCED is accurate, then it means that the ICF is accurate and does not delay the submission process?


comment:
In the intro sentence here, make "helps" lowercase.


comment:
This page is confusing. If I only pull over the bottom box because I am "part of the MTEP and Qualification stages in the process" it tells me I'm wrong. If that's what I do, how am I wrong?  Not sure what the intention of this activity is or how to fix it.


comment:
Should we label which row are roles and which are responsibilities? Also, I'm noticing for all knowledge checks, we are not requiring the learner to get it right. We just tell them they are wrong and move them along. Was this approved by Adriah? It surprises me.


comment:
I notice that all the character images are the same facial expression, including the learning agent. They all look scared. Can't we mix it up a bit and at least make them look happy or serious/important?


comment:
This Click Next to continue box is not in the right place


comment:
This activity is broken and confusing. For one, I didn't catch at first that there were multiple questions to click in a few of the pop ups. The directions aren't clear what to watch for. It took me forever to get the Next button to appear as a result, but when I did, I clicked next to advance to the next screen. When I returned to this screen, it didn't save what I already did, the Click Next to continue text appears but no Next button. So I'm literally stuck on this screen. I had to use the hidden menu to advance.


comment:
I didn't realize the Knowledge Check was an official scored post-test. We might want to make that clearer going into it.


comment:
In the Note, add "having" before "a general" -- ..., and having a general idea of their functions...


comment:
Should "Submit" look like an actual button? Not sure why it's not but everything else has a border around it.


comment:
Do we need to tell them how to exit the course? Print out their certificate?


comment:
At the beginning we call it a Knowledge Check but here and on the previous screen we call it a quiz. Which is it? If it's an official quiz, we should call it that and make sure learners know what they're getting into!


comment:
Okay, I see that Prev and Next are not really button images until you hover over them, but I'm wondering why Submit isn't on the screen (instead of underneath it). I couldn't find it at first.


comment:
On the first question, cobas c 513 analyzer is listed twice in a row.


comment:
In the answer for question 2, capitalize the G in "Green" (first word of the answer).


comment:
Content is provided via email (bad exanmple of exclusion criteria from the ICF)


comment:
I suggest to remove the study alias (or change to a made up one)


comment:
In the 4th sub bullet, say "Select Options, then select the calibration method."


comment:
In the 4th sub-bullet under "Demonstrate how to monitor calibration progress:" change the period at the end to a colon (Determine the status of each calibrator:)


comment:
In the Reviewing Calibration Reoprts/Alarms and Remedies activity, in item #2, make the first instance of "Calibration" lower case (Starting with the first calibration on the printout...)


comment:
Wondering if we need to say in the video the N'Vision programmer with Model 8870 Application card?


comment:
At 1:00 in the video the volume capacity of the pump is 40 mL as shown by the Pump Model Number field. Do not highlight "Volume 0.176 mL" as this is the volume of the catheter.


comment:
At 1:10 "The pump reservoir volume capacity is equal to, or greater than the planned refil volume..." is also referring the capacity of the pump which is 40 mL. The value you are highlighting is the current expected volume of the pump and is therefore incorrect.


comment:
Agree with Susan's comments. Video seems a bit off.


comment:
At 01:30-01:33 - the narration/voice is not consistent (sounds different). This should be corrected.


comment:
Seems like an abrupt start to the video, to make it more conversational perhaps we add "To enter the volume of Remodulin filled in the pump, select Infusion screen tab."
Since we don't say "Note, if the programmer has turned off" and it is only the written transcript the user would never see that text correct? If its important enough we hsould either say it or have a note on the screen.


comment:
Let's move the red star a little bit down since this is refill #3.


comment:
In #4 of the Revieiwng Calibration Reports activity, make "Calibrations" lower case.


comment:
In the last sub-bullet under "Demonstrate how to manually request.." change to "Select the Save button." (add "the")


comment:
Under the last sub-bullet of the 2nd bullet, change to "Select the Save button."  (add "the")


comment:
Under the 3rd bullet's 4th sub-bullet, replace the period at the end with a colon:  "Determine the status of each cup of quality control:"


comment:
In the second sub-bullet under "Explain that even as you monitor QC progress..." change "Operator Manual" to "Operator's Manual" for consistency.


comment:
In the instructions for the "Finding Key Information Activity" eliminate "Now" and change the sentence to "Practice this information with participants."


comment:
In the "Finding Key Information Activity" eliminate the extra space in the instructions before "Finding Key ..." (2nd sentence)


comment:
In the "Finding Key Information Activity" change "2" to "two" in the first Q.


comment:
In the RDU box, eliminate the 4th bullet (it's a duplicate of the third one) and add "the" in the last bullet  to say "Complete the Data Review Learning Checkpoints."


comment:
When I completed Basic Calibration and QC review, I did not get a checkmark for completion returning to this screen.  Ditto for Daily Checklist - Your Lab.


comment:
In 4th bullet, make "screen" lower case. (Start Conditions screen)


comment:
Under the Demonstrate how to manually program... bullet, the first sub-bullet should say "Select the global Test Selection button."


comment:
Under the Demonstrate how to manually program... bullet, the first sub-sub bullet in the next to last sub-bullet should say "Select the Barcode Read Error button."


comment:
In the "Programming Patient samples" activity, remove the extra "part" in the Note.


comment:
Under Recommended Reinforcement Activities, add "the" to the last bullet:  "Complete the Patient Sample Processing Exercise..."


comment:
In the Navigate Maintenance Software activity, change &/or to "and/or"


comment:
In the instructions for the Verifying PHotometer activity, spell out "four trainees" and "two groups"


comment:
When I got to this page from the training menu, all topics were already checked, as if I'd completed them (I haven't).


comment:
Ignore the last comment.  I lied.  What happened was that I did complete these, but the Maintenance item on the training topics was unchecked, so I came here again.


comment:
Maintenance topic not checked after completion.


comment:
ON the 4th bullet down, "Share" should be bold.


comment:
In the REsolving Data Alarms activity, eliminate the extra row space before the Operator's Manual bullet.


comment:
In the first bullet under Recommended REinforcement activities, change "Operator Manual" to "Operator's Manual" for consistency.


comment:
Under Share that when troubleshooting multiple samples bullet, 2nd sub bullet, remove the comma after "control set points"


comment:
Under Share that when troubleshooting multiple samples bullet, 3rd sub bullet, add a comma after "unaligned"


comment:
Under Share that when troubleshooting multiple samples bullet, last sub bullet, add a comma after "contaminated."


comment:
in the RDU activities, change to "Complete the Troubleshooting Learning Checkpoints." (added the)


comment:
Aesthetics - Is there any way to have the case study title wrap so that when it drops to the next line, it left aligns with the title above instead of dropping under the pdf image?


comment:
Change the first objective to "Identify" instead of "Know."


comment:
In the bullet "Refer to the Operator Notebook" change to "Operator's Notebook" for consistency.


comment:
In the bullet "Read the 'Finding Key Information..", remove the extra space before "Finding"


comment:
Remove "Now," in the Finding Information Activity instructions.  Should be "Practice this information with..."


comment:
In the instructions for the Finding Information Activity, remove the extra space before "Finding Key..."


comment:
In the Key it says that:
Required text is blue
and 
Requeired text is bold
This is confusing...


comment:
If you respond "No" twice you are allowed to continue further... Would be helpful if the correct answer "Yes" is required to proceed.


comment:
Answering incorrectly twice allows you to proceed further... Would be more useful to repeat until the correct answer is provided.


comment:
Again, answering incorrectly twice allowes you continue the course


comment:
There are no green text in the TCED template - update of the pop up window is needed


comment:
Flesch Reading Ease can be above 100 and below 0. Suggested language:
Flesch-Kincaid Grade Level which provides a US grade equivalency
Flesch Reading Ease score indicates how easy a language is to understand. Scores above 60 correlate with US grade redability level below 10th grade.


comment:
An explanation would be helpful - like screening period does not need to be included, double-blind placebo-controled treatment period can be combined with the Extension period when patients remain on ixe


comment:
please remove the periods from the items in the red boxes.


comment:
Per the updated file Matt sent, you need to add in the disclaimer pages immediately after this one. I'll create feedback release numbers


comment:
Safety info needs to be updated per file Matt sent.


comment:
remove the periods at the end of the bullets


comment:
reduce the needle size - it needs to be no larger than the vial.


comment:
Matt is sending a new screen. Please replace entire page with new interaction. MDT has changed how they want the sub-tabs to function.


comment:
only outline the box with the 80 in it, not the whole line across the programmer.


comment:
Also add on last line of white box:'The old vial is on the right'


comment:
Add 'on the left' after 'vial with insert' in Surepath copy


comment:
Add 'SurePathTM' after ThinPrep in Sample Loading copy. Superscript the 'TM'


comment:
Update transcript with language in attached document.


comment:
Matt providing updated video - missing vial of drug.


comment:
Take out the extra 'in' before currently in the answer section.


comment:
It may help to clarify that the GCBC Representative is a GCBC Contracting Representative (as there are others in that department who are not authorized to approve contract language changes).


comment:
Global for this section - update timeline in upper right to show complete red for step you're on. Matt to provide graphics


comment:
Change sentence two to: 'You can load a maximum of 4 tip racks in Bay D and 4 tip racks in Bay E (8 tip rack in total), for a total of 384 tests.

Change last sentence to: ...so load 4 tip racks in each of these bays.


comment:
Matt providing new video. Update transcript with language provided.


comment:
Change 768 to '384 tests(8 plates x 48 tests).'


comment:
My bad - I shouldn't have accepted an edit. Change Print back to Printing to be consistent with other bullets.


comment:
Delete black arrows in sample supply module area where we are loading samples.


comment:
add space between 4.0 and mL in last sentence of screen. Also move "was" down to that line.


comment:
the star is fine - I think we should remove the date.


comment:
Can the first sentence be shortened? It is very long!


comment:
Change last sentence to: 'We will add five tip racks, 4 to Bay D and 1 to Bay E to fill up the system.'

Please can you amend the drag drop to mimic this, currently shows five tips going to Bay D


comment:
Remove sentence after 'That is correct!' it makes it sound like you can add even more after we have just filled it up!


comment:
Directions say to click next to learn more about the participants in the process, which made me think I was going to see another process map.


comment:
We need to load 5 plates so same message as Tips from the previous page and loading pattern but loading Processing plates into bays F and G.'

Please can you amend the drag drop to mimic this, currently shows three plates but we need 4 going into F and 1 into G.


comment:
Box in upper right has an extra text box over the initial text.


comment:
If you have a country specific template, but no TCED, what .......


comment:
The try again feedback says "template". Do you mean TCED?


comment:
Check your white box header. I think you need a - vs. a =


comment:
Change 'two days' to 'three days' because ready access was Wednesday samples.


comment:
I feel like I missed three sections of the menu - starting with request for a change (also change details, explain your rationale) - unless these are sections I missed because the Done button didn't work?


comment:
Add 's' to offers and move the on-board box for alignment needs.The landing zone is off a bit!


comment:
Extra space after from in the sentence that starts with Phoebe.


comment:
Add an's' to test at end of first sentence


comment:
The incorrect answer should state what the correct three steps are as you can't go back and try and answer it again.


comment:
For this scenario and the last one, the retry button for the incorrect answer took me back here. Shouldn't it take me back to answer the question again, or do you want them to continue through the entire thing again?


comment:
Let's make the white box extend across the screen left to right. Then anchor the two images to the bottom of that box


comment:
Can we make the boxes fit better when you drag them so they aren't so big? They just look a little strange.


comment:
Matt sent the print video for this - please use file called printdemo.mp4 posted 1/24.


comment:
last bullet - change to Remodulin (treprostinil) Injection


comment:
I had to come back to this via the main menu as the one I selected first (I think participant negotiation?), didn't return here because the done button didn't work.


comment:
Ok - close! Let's make the buttons have the alarm icon that was on the screen before, with the label Critical Alarm and another with same icon that says Non-Critical Alarm. Should be red, with white text and icon.


comment:
in body of text, turn bolded critical and non-critical into rollovers. Should be blue text and underlined. Use exsiting popups, but just make them based on rollover state. Remove add'l blue terms that you added.


comment:
should make the "do-doop" telemetry noise, then start the fire alarm "wah-wah" about a second later.


comment:
final screen where you say "click >", change the current pump settings to have the 65 dose and 70 dosing weight. I provided it yesterday.


comment:
can you enlarge the programmer a little so it's easier to see they're on the alarms tab?


comment:
when alarm volume box open, update grey text to say "the current value of 4.0 mL." instead of "default value."


comment:
select yes screen - remove the "Demo mode" from the popup - can place white box over it.


comment:
telemetry complete screen - can we add the telemetry complete audio clip here?


comment:
last screen - can you add an outline around the low reservoir alarm date? Let's use blue instead of red so it calls attention but is clear it can't be clicked.


comment:
Position Programming head screen, please add text that says "Position the programming head over the pump and select OK."


comment:
Telemetry complete - add telemetry complete audio


comment:
last screen with pump status - add blue outline around critical and non critical alarm interval to call out what changed.


comment:
Does this contradict what we had earlier about antigen tests being not as sensitive as other methods?


comment:
update directions to say "... to troubleshoot another issue."


comment:
update directions "... to troubleshoot another issue."


comment:
change directions "... to troubleshoot another issue."


comment:
in popup, remove periods from all bullets


comment:
low res popup- move the () info up a line and add a period after ).


comment:
ERI popup - add period after (EOS). Also, move Service down to same line as EOS so it's not alone.


comment:
non-critical popup - remove - in programmed at the end of the first line of second paragraph


comment:
non-critical - move "are" down to line 2 in the first sentence so suspect is not by itself.


comment:
make the empty check boxes have check marks - just so they don't think it's something to click.


comment:
confirm prescription changes screen - put white box over Demo mode that's on the programmer screen


comment:
when Telemetry complete appears, can we have the Telemetry complete audio clip?


comment:
bold Note in last paragraph (just the word Note, not the whole sentence.)


comment:
change second "your patient" in line one to he/she - so "... he/she may be experiencing..."


comment:
I think "the cause of the symptoms" is a different grey


comment:
This graphic doesn't look smaller. Can you reduce? I would like to be able to see the last | to the right of never. Let Matt know if you need help or different files.


comment:
pocket fill - blue dot on Severity line needs to be all the way to right, even with the resolution dot


comment:
second box, update to say "with Remodulin (treprostinil) Injection" instead of Remodulin injection


comment:
Click next directions appear about 4 steps too soon


comment:
for items with yes/no answers, the yes/no line extends too far left and right after the words yes and no - should stop at the arrows, like it's one line that includes those arrows.


comment:
remove "(see reverse side)" from the Empty pump reservoir box


comment:
first sentence - add comma after symptoms


comment:
Instead of listing SAM, can you keep general and state site activation representative?


comment:
We need a new picture - they won't like someone in hospital ER - it needs to be someone in regular doctors office.


comment:
Use the updated image of this graphic that Matt provided that doesn't have the blue background


comment:
Ah-ha! I see what happened! Please remove disclosure statement here and put in the spot that mirrors it's location in the programming course. Sorry, I wasn't clear - they moved it to the start of the course.


comment:
study participant-partners vs. patient-partners.  Who is this?  Is this a caregiver instead?


comment:
disregard my CoLab vs. CoLAB comment...it should be CoLAB


comment:
Instructions around ensuring the blinding information is maintained appropriately at the site


comment:
Tools were created for the unblinded site staff....


comment:
I think we need to re-work the first sentence in RACT: RACT results for the trial indicate that there is a high risk that study participants may meet the criteria for discontinuing drug but may continue to remain in the trial?


comment:
combine 2 sentences: Risks to timelines and other operational challenges are regularly identified at these meetings as well as challenges....


comment:
PS Training Content Design required tool vs. PS Training Content Development tool.


comment:
Please ensure we use the same format when referring to the PS Training Content Design required tool....title in caps, required tool in lower case...


comment:
please check the slides where you tell people to review the tool...in some instances you can advance without reviewing and in othe rcases you have to review the tool in order to advance.  I would make consistent.


comment:
Review the Effective PS Training screen...Screen should be capitalized in the text and on the button


comment:
the site understand the key complexities for the trial and can manage.....


comment:
Instead of Use other ways to present information, Use other methods to present.


comment:
Contact your Training Owner assigned to the trial for questions vs. Just Training Owner


comment:
Is the Activate Sites procedure link correct?


comment:
Directional text (blue): per DP edit, "Click A day in the life of EIM to get started."


comment:
Why this new 1st screen? Should we not stick to the "ESSP" screen?


comment:
The pre-market, market and post-market boxes are not centered when they first appear in the animation.


comment:
I would remove the Storyline character when AIM is onscreen and put a silhouette character into the AIM box. This would make the entire animation consistent. Otherwise, it's strange that she's there.


comment:
I don't think we need the "Continue" button at all here. The segments are super short, and the stopping points don't make 100% sense to me (it breaks in the middle of the market and post-market sections currently). If we leave these in, I recommend removing the breaks that happens in the middle of the market and post-market sections AND include onscreen directional text that says "Click Continue to see application function in the next phase of the market."


comment:
There is no right arrow at the end of the animation. Need arrow to appear and directional text "Click the right arrow to continue." to show up at the end.


comment:
Last sentence of the voiceover "this course focuses on the equipment that you should inspect....".
This course also focusses on the facilities and diagnostic services. Should that not be added?


comment:
Intro text: says that you can verify which environment you're in by looking at the URL. Do we know the URL differences between the 3 environments? I think it would be helpful to include in each environment's popup box what they should expect to see in the URL that differentiates them, since we call that out. (e.g. The Production environment URL always ends with /production/ [may or may not be true...that's just a guess])


comment:
Given that this is the 3rd module in the series, I wonder if this is the right module to have this content in? Would it not be better in the 1st module of the series? Or the "preparing for site visit" module?


comment:
When this screen zooms in, the transcript zooms with it (making it unreadable). I don't think the audio needs to include "Click the right arrow to continue." That should just be directional text that appears above the monitor graphic once the audio finishes and the right arrow appears.


comment:
BSAP popup: 2nd sentence ends with a comma instead of a period. I think that there are more roles to include in this list. Based on the character list, plant operators and system operators should be added.


comment:
Overall, it seems like these popups should have sub-headers. "What does this application do?" and "Who uses this application?" That provides some consistency, and easier reading.


comment:
CIDI popup: Looks like there's an extra space at the beginning of the 1st sentence.


comment:
MRI-S popup: 2nd sentence says ADS, not MRI-S.


comment:
OMS popup: Need to include who uses OMS (outage submitters).


comment:
Ignore my OMS comment about not calling out the role using the application. However, dividing the popups into What does this application do? and Who uses this application? sections would restructure the existing sentence.


comment:
RDT popup: Does not contain info on who uses the RDT (per character list: bid schedule submitters, plant operators, RDT submitters, and system operators).


comment:
SIBR popup: same edit as OMS, dividing the screen up restructures the existing sentence.


comment:
Directional text: Currently the right arrow stays active at all times, and once I click all applications nothing changes in terms of directions. Change to "Click the desired application(s) to learn more. Advance to the next screen by clicking the right arrow at any time."


comment:
Last question on this screen - Is this really how it is formulated on the SPI? It seems like there is a word missing: .... meets the IATA (International Air Transport Association) REQUIREMENTS. The word requirements is missing I think. 
This is the actual question from the Transcelerate form:
Does the study staff that prepares or transports dangerous goods have training that meets the IATA International Air Transport Association (US) or other countries hazardous training requirements for shipping dangerous goods?


comment:
3rd button, Deeper dive: if you click this button, it changes to a visited state and says "You try it"


comment:
pop-up box for the last bullet;
Is is a GCP requirements that staff is IATA trained? To verify with Quality


comment:
Slight modification to my directional text edit. Currently, the right arrow only appears once all applications are visited. Since we talked about this being an exploration and not requiring learners to look at all of the applications, I would make the right arrow appear at the beginning, and stick with my edited directional text.


comment:
3rd answer option, and elsewhere: "Submit a question to the ISO"


comment:
The MPP was covered in the 1st module, no longer the 3rd module. Intro text and rollover module text should be updated accordingly.


comment:
Once a role is selected (I chose manager to start), every time you use the menu to navigate to an application in module 2, the same character shows up. In this case, I see "Shay" appear on all of them. She is the only character I see regardless which application I select. This indicates that testing must be done in a specific way and won't be open-ended. I think we need to talk before I send this out tomorrow.


comment:
Intro text: "Knowing which application to use for a task is an important step in learning how to work in EIM." (change "what" to "which", add "an", and "how")


comment:
I selected the 1st answer "Submit a question to ISO"; it says I'm correct, but the feedback says "You would view open cases in CIDI." This needs to be reconciled, so that the correct answer and its feedback match.


comment:
Culture based methods for Cdiff do not lack specificity. You can say are not as sensitive to molecular methods but when a culture is positive it is a True Positive (e.g., 100% specific)


comment:
Scenario 2: Remove the question mark at the end of the 2nd sentence. (A co-worker remarks that a similar question came up previously.)


comment:
Please correct the Competitors "box". For example, you list Xpert MRSA and Nasal Complete under Cdiff


comment:
Are we talking Cdiff or MRSA here? I thought this was all about Cdiff.


comment:
Need to change question box. It says MRSA and should be Cdiff.


comment:
Transcript and audio: 5th paragraph, 1st sentence: per #18 edit, "As this happens, OASIS and CMRI pull real-time data from the ISO transmission system and the market into reports." (change "its" to "the")


comment:
Transcript and audio: 2nd paragraph: "Market Participant Portal" (change "Participation" to "Participant")


comment:
Intro text: "As a settlement analyst, you will primarily use the following applications:" (lowercase "s", correct spelling for analyst, add comma after analyst, change period to a semi-colon). Apply the capitalization and grammar convention to all module 2 intro screens per role.


comment:
Intro text: Says and shows "Elyse", but in the 2nd sentence says "He". Confirmed gender match for all of the "Here's what I've learned" screens.


comment:
Title: I get that we have this as a copy/paste throughout the course, but it feels like each application should have its "own" title ("Here's what I've learned using MRI-S", as an example.) This makes it clearer about what the screen covers.


comment:
MRI-S or MRIS? I think it should be MRI-S globally. Ctrl+F MRIS and replace with MRI-S.


comment:
4th bubble: per style guide, MWh should be MWH.


comment:
1st bubble (bottom left): "scheduling coordinator" (lowercase s)


comment:
BD Max MRSA is NOT, again NOT, a screening competitor for Cdiff. It is a MRSA test for God's sake. Honestly, isn't anybody checking this?

Also, please note this whole discussion on antigen testing only applies to GDH and Cdiff screening. Only because GDH is an enzyme produced by Cdiff irrespective of toxin production so it detects all Cdiff but the Cdiff may not causing disease - hence the confirmatory test for toxin.

Thus, in general, antigen tests are less sensitive than culture which are less sensitive than molecular methods. I fear that this example will be extrapolated by our team to other discussions regarding strengths and weaknesses of antigen tests.


comment:
Is it possible to add a bookmark feature or allow going back one slide?


comment:
Some inconsistency around ERB/IEC. A slide early on spells each out and then later, sometimes ERB is used and sometimes ERB/IEC.


comment:
The text on these buttons looks larger than usual


comment:
directional text calls first module "Validation basics and timelines" and button just has timeline... make consistent whichever it is.


comment:
The player size is off, particular the bottom bar. The width of the bottom should be as wide as the sides. Checkout any of the links here https://123.writeboard.com/ejp8b10nqgffa9ikmmf0vg5d as reference.


comment:
The buttons move around on rollover. Movement of those below the one you're rolling over is right (when first one expands, other 2 have to move down), but they are all moving. When i rollover any, all are moving down. The first one should stay in the exact same place always. If I rollover the 3rd, nothing should move. If I rollover the 2nd, only the 3rd should move down as text on #2 expands, etc.


comment:
Remove the video that's currently here on meter data


comment:
I'm not sure I understand the animation.  Might need to add words.


comment:
5th bubble (bottom right): change "What" to "When" (When I'm looking for...)


comment:
Transcript (not audio): 1st paragraph, 2nd sentence: break up into 2 sentences - "...transmission information. For example, settlement analysts..."


comment:
Scenario 2 text, 2nd sentence: change to "What application do you use to communicate the error to the ISO?"


comment:
2nd bubble (top left): "matters" is spelled incorrectly.


comment:
Audio vs transcript, 2nd sentence: audio says "setting" while transcript says "settling" - update audio to say "settling"


comment:
4th bubble (bottom right): change "time" to "timely"


comment:
Transcript and audio, 1st sentence: "OMS supplies critical outage information to the real-time market." (change capitalization and remove "application")


comment:
Ctrl+F "master file"/"Master file" and make it "Master File"


comment:
Transcript, 1st paragraph, last sentence: "The RDT is used on a continuous basis every day." (we're talking about the RDT here, not Master File)


comment:
Question 4 of 4 text: "...to the Master File?" (remove application)


comment:
Deeper dive scenarios rollover text: It looks like the alpha script calls for this to be "Check your knowledge on the applications used in your role." Globally replace with this text.


comment:
Question 4 of 6 text: "resource-specific" (add a hyphen)


comment:
Question 5 of 6 text: "Which of these applications provides..." (that way they match the location of the answer options and the answer options)


comment:
"Wrapping it up" is not listed on the Menu drop-down, but Conclusion is. So, I can't hop to "Wrapping it up", and when I click Conclusion, nothing happens. I would change the Conclusion in the menu to Wrapping it up, and make sure that it's linked when I click the Menu.


comment:
Transcript and audio, 2nd sentence: per DP edits, change to "The RDT is a template used to capture resource operating characteristics that are stored in the Master File. The Master File provides this information to..."


comment:
Menu says "Entering bids in SIBR splash screen"


comment:
BAAOP popup text: per DP edit, change to "An operator user interface to the real-time market, to validate commitments and make data corrections, as needed."


comment:
BSAP popup text: per DP edit, change to "A system used to enter, submit and balance base schedules."


comment:
On my screen the already completed session does not grey out - is there a way to indicate for the learner which session was already completed?


comment:
For me Training owner and Study team are not linked


comment:
Suggest to say for the SC " daily protocol-specific processes...otherwise it sounds a bit contradictory that these roles need standard processes.


comment:
Put some numbers next to the items to help someone understand that they are different.  I was looking for another word for Resource-intensive


comment:
it sounds like the study team is developing the training on their own, I would see the GSTM being involved here at least highlevel?


comment:
the voice over did not make sense when talking about face to face meeting and online training "to decide what they prefer" pls can you check , maybe it is just me...


comment:
Change first sentence to "Hello again!"

Also can we change the size of the dialogue box so we don't have "hanging" single words at the end of each bullet?


comment:
Also, take out the word "crazy" from last sentence.


comment:
Need consistency in titles.  "Methods" is capitalized in some words but not others.


comment:
I don't think the bullets next to the logos are necessary and clutters the page


comment:
Change conversation bubble to something like, "In addition, there are many companies that are offering chromagenic agar tests that make the workflow simple for technicians."


comment:
Ignore above change.  Keep original sentence and change to ... "but take a look at some of the top companies offering culture-based tests that I've found"


comment:
Agree with Steven.  We need different graphic to show that these are two different things rather than a description of each other


comment:
We need better visual separation between the competitive products.  Bullets make it look more cluttered.  And also, again, no single words on its own line please.


comment:
These pictures are so harsh for "That's not what I heard her say."  Please soften language and picture


comment:
I believe there is no antigen competitor to MRSA?  If this is true, please put "none" under first bucket.


comment:
What is the second step in the 2 step algorithm?


comment:
What is EIA?  And didn't we say earlier than antigen tests are very sensitive?


comment:
Sorry Mike, we ran out of time at content review, and this is the first time we're checking content on this section.  This was probably a typo that got carried on throughout the module.


comment:
On the 3rd bullet can we move 'prescribed' to the next line?   
On the 4th bullet can we change to: Average refill intervals are between 4-16 weeks


comment:
Also the syringe looks very small compared to the vial of Remo.  Can the scale be adjusted or is it this way on purpose?  (Same on next slide)


comment:
When I click on the Pump and catheter screen the tab at the top still says Patient Information.  Does this not change when you click on different tabs?


comment:
Should the pump be positioned in the 3:00 or 9:00 position?  Not 12:00 position?


comment:
The video goes dark around 00:50 and then just stays dark until it stops at 01:14


comment:
The video does not start until close to 4 sec.  
At 00:16 it states we need 2 syringes.  Can we specify 2-20ml syringes?
At 00:21 the video talks about attaching the filter to the syringe but it is still talking about purging air from the filter when the video shows the syringe being connected to the tubing (00:26)
At 01:08 The video states to confirm expected appearance (such as evidence of blood).  This would not be the expected appearance


comment:
At 00:56 before they hit the ok button and close the screen can the video remind them to scroll down and check all settings?  It shows it but does not actually say it.


comment:
Can we put this warning (or something along this line) on the bottom of the page: Decreasing a reservoir alarm volume too aggressively can lead to actual reservoir volumes of less than 1 mL, which can result in underinfusion and the return of symptoms, including a drug underdose for the patient


comment:
Oopsie, delete my comment on the previous screen.  I see it is right here.


comment:
Does the learner have to return to this page?  Can they just go to the recap page?


comment:
Not certain if we can suggest to consider starting an external infusion of Remodulin here.


comment:
I like the Part of the Science of selling family. I wonder if this should be called "Distribution Sales Analytics Curriculum" vs. BI?


comment:
When I click on This checklist, nothing happens.  That may just be my computer but I expected to be taken to an actual checklist.  Can you verify this link is working?


comment:
1.  What does saving a tissue slide if the wrong staining protocol was used have to do with performing a recovery protocol?  We state that you would implement a recovery procedure under 3 separate conditions but none of these conditions is because you used the wrong staining protocol.


comment:
We use the term "recovery protocol", recovery procedure", and "recover protocol".  Should we be consistent with the term that we use?


comment:
Under Objective(s), the second bullet says to Define what is considered excess fluid in the "train" after staining.  Should this be "tray"?


comment:
In the first document, change "templates" to "documents"


comment:
The Trial-level ICF writer does not distribute anything to the site managers.


comment:
The site manager should reach out to the study manager or CRP/CRS.  Not the trial-level writer.


comment:
The negotiation guidance document does not provide guidance on whether to verbally inform or revise the ICF.  The NGD provides guidance on negotiating certain elements as well as what changes are allowed and if additional approvals are needed.


comment:
The risk profile is useful only if there is no TCED.  It is not needed if there is no CS-ICF template.


comment:
THe non-lilly risk information is only needed if there is no TCED.


comment:
The Content Elements document is only needed when there is no CS-ICF template.  It provides the general information that needs to be included in a template.


comment:
storyline menu - remove the module name at the beginning of each screen title (ex. so this screen would just say Settlements overview)


comment:
The storyline player has a big extra chunk of green at the bottom that isn't usually there.


comment:
Also remove transcript text for meter data video


comment:
Text under "The basics of charge codes": This should change since they are no longer "working" the problem. Instead, Javier is walking them through it. Change to something like "Learn about the market conditions that trigger charge codes by seeing a simple scenario in action."


comment:
Remove metering video that is currently here.


comment:
Seems like we shouldn't have a next button on this screen until all is complete - each piece on the slider, buttons below the timeline of slider, videos played, etc.


comment:
FB tool appears to be pulling from the previous screen here as well.


comment:
I think the wording here is a little awkward.  Can we change the "Soo" sentence to something more like "Leading a dig is a lot like managing a customer account. You have to be organized and you have to have a plan." Then go to the next screen.


comment:
Same applies to the K50 powered range, need to work on the text re fuel economy as well


comment:
Do not create TCED template. Use TCED template.


comment:
You do not modify TCED template and get CRP/CRS approval.  You get approval on country-level ICF.


comment:
Need to provide what the language should look like when properly modified.


comment:
For these language modifications requested, I would not say "Yes, Yes with minor edits, or No".  It's really Yes OR Only with edits".  The changes aren't really "minor".


comment:
Change "sponsor negotiation" to data privacy or something?


comment:
I do not see how this language should result in any other...  it would just require an edit to make the language acceptable just as the previous examples.  Please see prior comments.


comment:
ANy changes to risk language require documented approval.  Email is not acceptable.  Additionally, the CRS could also approve the change as well as the local CRP/CRS


comment:
Negotiations with sites, ERBs, and RAs do not occur in person.  They occur via phone or email.


comment:
SAM would typically involve CRP/CRS into risk language discussion to obtain/provide information about rationale behind risk language changes.  The SAM would use this information to respond to the site/ERB/RA.


comment:
Instead of saying that the blood draw risks are too much...  say instead that the risks are standard of care and that most people know what those risks are.


comment:
It is as soon as possible...  but no later than the deadline provided in the cover letter.


comment:
ERB and IRB mean the same thing.  As a note, some countries submit the ICF to the ERB on behalf of the sites.


comment:
Most of the ICF revision scenarios are about risk language.  That's great...  but much difficulty does arise in negotiating data privacy, esp with the site.  There was little reference to actually using the NGD to see if the changes were acceptable...


comment:
Crop the image down to remove the last 3 or 4 rows, and put a box around the screenshot to make it cleaner. Then, once the script indicates the URL, provide the link in its box in the white space below so it is easy to read.


comment:
Transcript: General comment, make sure that there is one, single space after a period. I saw more than 1 spot where there was no space after a period.


comment:
The settlements process has 3 parts. When the animation/script break those down, we show on screen the name of the step and describe it. The first step says "Settlements process" (0:53) but the audio/transcript refer to billing. It seems like the audio/transcript are incorrect for this and need to be updated. Then the animation moves onto billing (1:01), and this section is fine. Last is the invoicing step (~1:10) is covered. I would recommend all 3 steps are consistent (leave settlements process text onscreen at the top, show which step you're on with onscreen text on the left, describe the step using animation and script).


comment:
The calendar image looks pretty crappy (low res, busy) - can we replace it with either a cropped, zoomed-in version; or create a simple graphic that shows what information goes into each column?


comment:
2nd to last paragraph, last sentence: "This settlement cycle follows a specific timeline for invoicing and payment dates. It is known as the payment calendar. I'll show you more on that later." Include onscreen text "Payment Calendar" so they know what they are looking at when it comes onscreen.


comment:
Intro text, 2nd sentence: "Its" should be "It's"


comment:
Can we include a blank line between intro text and directional text? Otherwise it looks too busy.


comment:
Box titles: These are inconsistent in capitalization. Recommend making all sentence case (1st letter capitalized, rest uncapitalized). Do this for the popup windows as well.


comment:
Have the boxes go into a visited state once the learner clicks them, that way they can keep track of what they've clicked and what remains.


comment:
Ignore visited state comment. For whatever reason, the check marks weren't obvious to me. Leave as is, and we'll get feedback from CAISO.


comment:
Popup boxes: Add directional text to all "Click X to close the window."


comment:
Feedback isn't working for the next screen that shows the LMP graphics. Edits here are for the next screen.

General, global comment: All transcripts should have a space between paragraphs. Otherwise, the text is too busy to read.

Graphics: Why not leave the #1 image on-screen as the images are shown to connect all 3 together? Otherwise, it looks weird that at the end it just shows #2 and #3.


comment:
One more comment for next screen: 1st sentence only, change "LMP" to "LMPs"


comment:
This interaction can be improved. The first text that appears in the first box is pretty wordy, and the 2nd text that appears doesn't really answer for both the BPM and the configuration guides. Recommend turning this into a table like we saw in #14 Interchange and e-tags comparing resource and transaction IDs. Modify the  text to have the characteristics/questions on the left side, and summarize the info that goes under the BPM and configuration guide columns (basically split the right hand side into 2 columns and add a header for each). Ping me with questions on this and we can talk through it.


comment:
No interaction? Can we add a few rollover buttons and include some descriptions of different sections of this spreadsheet?


comment:
Tab text capitalization consistency: I see both "Meter data deadline" and "Settlement Statement" - recommend all are in sentence case.


comment:
Directional text: Have this change to "Click the right arrow to continue." once the final tab has been clicked.


comment:
Base schedules popup text: Is it "...the forward energy schedules generated in a..." That sentence doesn't click for me, please confirm.


comment:
Transcript/audio: 2x it says "settlements statement" - the first word should be singular.


comment:
Transcript: 2nd sentence: change the comma after CMRI to a colon. 

2nd sentence: Highlight the 3 reports onscreen as they are mentioned in the audio. 

3rd sentence: End the transcript with a period.


comment:
Intro text: add a space after the bolded question (1st sentence). 2nd sentence: lowercase "report" in "Expected Energy Report". 3rd sentence: "Break down" is one word. 4th sentence: "megawatt" should be "MW".


comment:
Popup text: Capitalization consistency: recommend all popup headers are sentence case.


comment:
Same edit as previous slide: add a space after the bolded question sentence.


comment:
"Expected Energy report", lowercase report


comment:
Terms buttons: Let's move these to the center so that they are symmetrical with the screen - right now they are too far to the left.


comment:
For incorrect options, I'd have the terms return to the shelf rather than stay in the "drop zone" - this is like the monitor activity we did in other courses; they don't "stick" if they are incorrect.


comment:
To illustrate my other comment, I can drag all 8 of the items into the "drop zone" and they all appear there and I get correct feedback. Definitely promotes confusion.


comment:
Is there another way to describe the term "Transmission access charge rates"? The wording goes over the inside lines of the flour bag icon. We could just remove all of the interior lines for all flour bags, and that way all text fits inside each of them.


comment:
That's right! feedback: add a colon after "such as"


comment:
Capitalization consistency: make "Expected Energy" and "Flexible Ramp" sentence case.


comment:
Capitalization consistency: Make sure all terms are sentence case in this activity.


comment:
Flashcard functionality: Once I select my rating, the card "flips" to show me the definition. That's good, but if I click the star rating again, it disappears. Should it?


comment:
Incorrect feedback text: include directional text "Click Try Again to select a new answer."


comment:
2nd question text: "An intertie is missing an e-Tag."


comment:
Intro directional text: Change "Person" to "Joe"


comment:
Question text: "A scheduling coordinator does not submit a greenhouse gas bid curve. What will happen because he didn't?"


comment:
1st answer option: lowercase "Default Greenhouse Gas Bid Curve"


comment:
Add spaces between paragraphs in the transcript.


comment:
"Payments Calendar" is "Payment Calendar"


comment:
Intro directional text: per DP edit, line 52: I think this needs to be reworded since there's no penalty that Joe is avoiding. Suggest adding intro text that says something like "Joe missed a payment due date last week. This was not good, and he needs to figure out how to read the invoice and know when it's due." Keep the same directional text. Change the question intro text to "Joe receives an invoice on Wednesday, January 18th. What information will he find located on this invoice, and what date is his payment due?"


comment:
Certificate printed 2 pages. Page 1 was the certificate but page 2 was blank. Can page 2 be deleted?


comment:
when all customers complete, need to change directions to say click next.


comment:
remove the "(example)" from the header in the green box.


comment:
Could we have the Citizen's building here that you illustrated? just as something fun to see.


comment:
I don't love the big green bullets - I would imagine they would be normal text.


comment:
change title to "History's Impact on Today"


comment:
On the main menu it is called Daily Checklist but on this page (once selected) it is Daily Checklist Basics. Recommend to use the same title in both areas.


comment:
Check sub-bullet spacing for the first bullet in the content area.


comment:
change "bid process" to "Competitive Transmission Project"

Use the word "proposal" instead of bid


comment:
Sue's role is unclear to me

"she is a cross functional member of Evaluation Team for Competitive Transmission Projects"


comment:
Change 1st bullet to:

Share information or conversations regarding the MISO Competitive Transmission Process


comment:
Align instructional and directional text onscreen.


comment:
Recommended Reinforcement Activities:  Demonstrate to the customer by placing a thumb drive into the USB to download a PDF of the inventory


comment:
I would make a statement here about random access and what that truly means so that everyone is on the same page for the comparison


comment:
Safety info - the bottom of the popup is getting cut off - the last line of text isn't readable.


comment:
next two screens - disclosure and safety info - the wrong course title is in teh top navigation. Says Get Ready and it needs to say Implant in Practice


comment:
All screens in this section - Change module title (grey text) to say Get Started. Right now it flips between Get Started and Welcome


comment:
the red boxes are not timed to the audio at all.


comment:
transcript - italicize Implant in Practice in the first line.


comment:
Update the image on this screen with the female version - get from Matt or Leo


comment:
popup 1 (CAP) remove CAP from start of bullet 2 and just start it with "Is a.."


comment:
popup 1 - make the "Do not...." it's own sentence (not a bullet) at the bottom of the box. Bold the warning to make it stand out. And add a period since it's not a bullet. :)


comment:
ignore my first edit about bullet 2 - remove bullet 2 entirely since you added the disclaimer at the bottom


comment:
popup 4 Suture loops - go to Implant Overview screen and adjust this version to show the same circles on the larger image. Remove the small thumbnail in the popup.


comment:
make images not to scale disclaimer the same font size as disclaimer on starting  page of this section.


comment:
tip popup - there are orphans on the first and last bullet - any way to fix?


comment:
take both (R) symbols and superscript them please


comment:
Change last sentence to the following:
Let's explore the lab!

(to shorten it)


comment:
Update directions to match Implant Overview - move the Click > to continue. to the bottom of the screen


comment:
make sure the transcript matches the audio


comment:
This needs to say "Welcome to the Implant in Practice course. This courses review the implant procedure for the Implantable System for Remodulin, the first FDA approved implantable pump for intravenous treatment of Pulmonary Arterial Hypertension (PAH)." You'll have to have Matt re-record and update the transcript


comment:
list 2, bullet 4, make implantable system on same line so system not alone


comment:
Sweet sassy molassy they had some conflicts here - ignore my edit that said to ignore my edit.


comment:
last popup - remove the comma after code on line 2


comment:
line 2 of non critical - needs to say single-tone (add hyphen)


comment:
tip popup - needs comma after valve in third bullet


comment:
need to update page title to include Clinician before Programmer


comment:
main body text, need capitalize programmer (full name) as it is in the title


comment:
body text - add comma after procedure, drop the "and" so it says "...procedure, then dig..."


comment:
Second bullet point on page under "Objective(s)" should state "Define what is considered excess fluid in the tray after staining."  Incorrect use of the word "train" here, please replace with "tray."


comment:
try again feedback - remove "and scarring" from second sentence


comment:
they want the reference numbers outside of the period - please fix in both paragraphs


comment:
globally - check that the references have the journal articles with only the initial caps on the first word; all others in title should be lowercase


comment:
References popup - remove last line with "INSERT LINK" stuff


comment:
move "any" down a line so reason isn't alone


comment:
need to update videos and transcripts when recieved


comment:
Globally - I'll provide a red-lined transcript so you can update all videos while we wait for video segments to arrive.


comment:
correct feedback - need comma after set in sentence 2


comment:
Globally - make sure directions update when you close the video popup to say "Click > to continue." They didn't on this page and may not have on some of the others


comment:
Begin by explaining the setting - Roche rep will talk to 3 lab staff.

rewrite: 

There's a Roche rep in the lab today who will be meeting with 3 lab staff members.

Today, Roche focuses on screening and diagnostic products for the Microbiology lab. I am eager to learn what she has to say about the competitive technologies including the companies that offer them along with their strengths and weaknesses.


comment:
pump - remove comma after delays in line 3 of paragraph 1 and remove comma after oriented in line 2 of paragraph 2


comment:
change four to 4 in line 4 of paragraph 1


comment:
not clear that this is a dialogue between the lab director and rep. Can you have both the director and staff on the same screen? Perhaps grey out the rep.


comment:
Add instructions to choose an item below.


comment:
stretch text box of popup 4 so that procedure isn't bumped down a line by itself


comment:
when all popups clicked, trigger directions to say Click > to continue.


comment:
redo the page so easier to follow. It's very busy.


comment:
text in underdose box is a line lower than other box - and now the directions wind up under the button. Fix


comment:
symptoms popup - bold Click Safety Information


comment:
Capitalize r in resources to begin paragraph


comment:
First sentence doesn't read well, the word "actually" and "in terms of" feel weird. And it isn't a complete sentence, either.


comment:
Do we want to include instructions here to click the tabs and review the new information and where it came from?  Maybe the new info appears in red?  Just thinking that we could show them where it fits (as one of their objectives on performing an account plan update).


comment:
Global on these popups: If description of charge code takes up more than the line the # is on, suggest having description text indented to be aligned with beginning of description text. This will help it read easier.


comment:
Weirdness -- I saw that the pointer changed to a clickable finger just outside of the tabs, so I clicked it and all of the tabs turned gray.  They turn red again if I rollover them and onto the journal  The Journal is clickable too, just to the inside of the tabs.


comment:
Bump up the Note to Cummins - It's partially off the page at the bottom.


comment:
When I click button "The basics of charge codes" it just takes me to the next version of this menu screen where it is time to click module 3


comment:
T+37.5 popup: Change "Fifteen-Minute Market" to "fifteen-minute market (FMM)". Use FMM throughout the remainder of the course.


comment:
I think we need to build out his statement a little more.  What did he learn and how can we translate that for our learner and into the journal?


comment:
timing off by about 1 second when you get to the last two red boxes


comment:
Per our call, can you apply a different treatment. Perhaps have the sheet fly in and turn over (e.g., animation from powerpoint) as it is not clear that the  index card on the front is actually its back side.


comment:
remove the "additional resources" and everything under it.


comment:
Perhaps number the answer choices. It wasn't clear that there are 2 limitations as one looks different in the red box.


comment:
ortega - don't break the 18-23 across the lines; move the 18- down


comment:
update capitalization here, as well as in references per earlier edit


comment:
italicize Implant in Practice on main screen and in transcript


comment:
back button on safety/disclaimer screens didnt' appear to work


comment:
I would suggest "adequate documentation and and inadequate documentation" as the how to answer intent, rather than "how to answer and how not to answer"....a lot of these are yes/no and they will just be answered, what the focus will be on is documentation type when really speaking about the answers.


comment:
As this is a very "study specific" example on the sample ISEC, can there be a text box put over the listed equipment saying something like "Critical Equipment appropriate for the trial will be identified here"? Specifically for the "See the form" box, I think we need to ID it as a "will be variable" type question.


comment:
Please crop out the PK question in the SPI sample. It should end after the IATA question comment box.


comment:
Think this page needs to highlight that these are all SPI questions. Perhaps the header on the screen reading "Explore the SPI" for this page, then "Explore the ISEC" for the next?


comment:
To SV comments - yes, that is how the question currently reads. It is poor, agreed, but apparently that is the way SIP is planning to word it since it is a SIP question and we can't change those. And Nancy was the one who said it was a GCP requirement that staff is IATA trained, but with some quick googling, I do think we need quality to weigh in on that as it may not be fully accurate.


comment:
2nd question pop-up - add "interventional" after All. (Observational trials may not have any requirements on equipment/procedures.)


comment:
Obviously go with reworking the screenshot to make it more readable. Goal is to keep the basic question and answer formatting match the system, but if it needs to be altered on basic viewing layout that is fine.


comment:
voice over: "about the site's equipment, facilities and diagnostic processes" (last sentence) is a better path than just saying "Equipment" since that is not the sole focus of this module.


comment:
Critical equipment is not "equipment required for the trial." It is equipment required for procedures that support our main trial objectives."


comment:
First pop-up after No answer previously. "The site is still responsible..." answer. Has a quotation mark at the end that needs to be removed.


comment:
Just verifying we want what is spoken not to be what is on the slide?  I like that it isn't reading word for word but wonder if because there is a speaker folks won't read the slide thinking the speaker is addressing everything on the slide?


comment:
I made comments earlier on the conversation page about the critical/non-critical designation. Once that is updated, the first option here will officially be wrong.


comment:
Voice over for 4th box...again, this is not just about equipment. I would say equipment and processes here at minimum.


comment:
The items in the first screen would really fall under the "SOC equipment question". Might be smart to pull that question screenshot up and run through these items (you can just create a running list as you go) and then on after they have all been looked at, say something like "the site appears to have the reasonable SOC equipment for conducting research." or something of the like.


comment:
BP Machines - calibration stickers are only ONE method of proving functioning equipment. Change the pop-up to say that "Calibration evidence is often found directly on equipment, such as a dated calibration sticker" or something of the like. We cannot say that any equipment HAS To have a sticker...it has to have documentation of some method.


comment:
So...not to be picky, but what you have pictured and called out as a thermometer is not a thermometer. It is an otoscope and opthalmoscope....while I love this overall room image much more than before, this will be noticed by anyone with a medical background and needs to be changed. If this is the ONLY picture option, then maybe call this out as basic diagnostic type equipment and ensure thermometer is called out in the wording, but that the image isn't CALLED a thermometer.


comment:
As per Carol Tipton which had previously been verified by quality:  The investigator site is responsible for ensuring their staff is properly trained per their national regulations.  Biological Substance, Category B are specimens being transported for investigational purposes. Effective 01
January 2005, training requirements for persons responsible for packing and shipping Biological Substance,
Category B, UN3373, has been redefined in the International Civil Aviation Organization (ICAO) Technical Instructions as well as the International Air Transport Association (IATA) dangerous goods regulations.


comment:
Thermometer - I would recommend saying "Sites are required to track temperatures in the lab refrigerators and freezers - there are various temperature monitoring devices, but Min/Max temperature tracking is a key aspect that should be documented." Just because there are multiple methods that may track this, not JUST a traditional thermometer as pictured.


comment:
Lab Room - there is a nice storage area here and we are evaluating the facilities overall, include the space available. Why not call out one of the cabinets as well as an example of available storage for trial related supplies?


comment:
Infusion Room - Why no temp log on the wall like there was in the lab fridge space?


comment:
I would revise to reflect the following:  The investigator site is responsible for ensuring their staff is properly trained per their national regulations.  It is necessary for all individuals involved in the preparation or transport of dangerous goods to be properly
trained.  Biological Substance, Category B are specimens being transported for investigational purposes. Training requirements for persons responsible for packing and shipping Biological Substance,
Category B, UN3373, has been redefined in the International Civil Aviation Organization (ICAO) Technical
Instructions as well as the International Air Transport Association (IATA) dangerous goods regulations.


comment:
Yes...we have additional... Take "trial" out of that sentence. It should just read "additional lab staff".


comment:
The definition of critical equipment as defined today in the process is:  Critical Equipment  Equipment used in determining primary and/or secondary objectives (including safety objectives), in addition to equipment used in IP and/or samples temperature control or preparation (e.g. centrifuges).  Because it is critical the CDC is required to verify that the site has the associated documentation for that critical equipments periodic calibration and/or maintenance as per manufacturers instructions. This documentation needs to reamin at site level and available upon request.


comment:
Per feedback, let's update this a little to make it clearer that they really need to explore their own options. Left hand choices - "Tell her that a rental or purchase option must be evaluated thoroughly. If they are not able/willing to obtain the equipment, there may not be a path for them continuing in the trial, especially if there are plenty of potential sites who have the necessary equipment. You can let her know that you evaluate any potential other options after they have done everything possible to secure the necessary equipment on their own." Can we then have a pop-up or something that says(others may hate this language and we don't do the money thing as CDCs, but realistically, budge has to be a consideration) "Note to CDC: Sometimes sites can think about this up front and determine what they may need in budget negotiations to make this a financial possibility for their site and/or in rare instances, Lilly may be able to coordinate provision of loaner equipment."


comment:
I don't know that this slide is clear- the answer is acceptable but more information is needed to better understand how they work with their TPO- when I hit yes and the next screen comes up neither answer seems right


comment:
Alternatively, if the CLO folks still hate that overall, I might recommend changing the equipment type to "the trial requires a fixed angle centrifuge to perform the specific PK samples - looking at your centrifuge it does not appear to meet that requirement. Would you be able to get a fixed angle?" and then walk through the "Can you provide me the specific brand? I can try..." and then CDC can say "let me take feedback to the study team and see what if anything can be done about this." and then move it forward with a CDC thought process of "team probably needs to have these available to provide since it is so specific and there isn't a reason for sites to have this outside of the trial..."


comment:
2nd box. "are there any ANSWERS that are a cause..."


comment:
Pretty sure I already provided a list of resources, please look back through initial documentation for those, but the site selection guidebook will be a resource for EVERY module.


comment:
maybe both are meant to be wrong since No apparently is the wrong answer- if someone was looking for more detail - like myself they would think the answer isn't sufficient- suggest adding to the answer otherwise this question could be right or wrong depending on who is reading it


comment:
I think it is important to mention that though we don't monitor the site's maintance & calibration for standard equipment they are still required to maintain that equipment as per manufac. guidelines and can be asked during an inspection for that documentation- the first bullet only speaks to critical and while that is what we "look" for we ask about the maintenance of all equipment


comment:
Concern if we use scale as a piece of standard equipment- maybe we should say A scale, depending on your TA could be considered standard equipment- I mention because a scale isn't standard in all TAs so I want it to be clear that standard will be defined for each TA


comment:
Like the verbiage associated with the Bp cuff maybe something similar for the scale?


comment:
hazardous waste containers is one I think many will miss since we haven't really ever listed them as critical or even standard under equipment.  Just highlighting this may be a miss for many as all sites are required by law to have this in place across the globe.  It's a great reminder just highlighting a concern


comment:
-Change colon to a period after 'popular'. 
-rewrite: Compared to culture, real-time PCR technology is:
-Add instructions at the top (eg., Choose the best answer to complete the sentence)


comment:
Is there any way we can incorporate how the CDC is to then document the specifics of the conersation??  I think this would be very helpful- had the conversation--> now here is one way you would capture this discussion in the ISEC


comment:
Same comment- we could follow this with an example of how to document this example which is straight forward


comment:
Can we name the rep? This way we can say Click Dana's tablet to swipe to the next screen.


comment:
There was a delay when I clicked on the correct answer for this example for the next options to come up- a long delay


comment:
I know we mention documenation on the front end of this training- if we don't re-introduce with the prior examples and we don't mention anything else about documenation I think we need to add something


comment:
Can you either bold or use another font color for the header so it's easily distinguishable.


comment:
revise:

....creating a table to summarize...


comment:
I would suggest not adding anything about budget


comment:
maybe we add- if you decide you want to use this site remember to ensure your documentation within the ISEC provides the information to support that choice and any follow up items that need resolution prior to SIV.  Or something along those lines


comment:
1. Can you limit the number of answers? There's too many to read through. Can we organize them per row (i.e., both potential answers in one row next to the fill in the blank section?
2. Not clear that the answers in red on the right are all possible answers for each category. Can we add a numbering system or any other system to show they are answers.


comment:
rewrite:

It looks like you have a good understanding of culture-based testing.


comment:
I would take the "process" piece out of this course. It is covered in the Overview course and as process maps change ferquently may require a lot of maintenance.


comment:
VO: "Proper treatment" of our study particoants - replace with well being of the study participants?


comment:
1st pop-up
Instead of "sample list" say "example of a list of..."


comment:
Explore slides are very wordy.
Is there a way to "lighten" these, or make more easy to read?


comment:
Example 2 free text:
..." She confirmed..." Should that be the Site confirmed? Who is "she"?


comment:
For these examples, should we show what good looks like? What would an acceptable "comments" entry be?


comment:
The start of the conversation doesn't start right:
- SC: Can you give me the list of critical equipment for the study?
I think that should be
- SC: Can you give me the list of equipment for this trial? (remove the word critical, as the CDC then says "First is our critical equipment")


comment:
I know this isn't the final audio, but the CDC soulds very cheerfull, not sure final audio should be like that?


comment:
I didn't think the pictogram used for the hazardous waste container was easy to see/find :-)


comment:
Since this is a global course, should we start with saying what an infusion room is and why it may be required?


comment:
1st sentence in instruction seems weird
"site's processing collection, processing, ..."
Can this be reworded?


comment:
No voiceover or audio?
Delay for me as well


comment:
1st sentence, instruction.
It's more than just expectations on equipment. Add lab samples?


comment:
disclosure and safety info screens have the wrong course title (Get REady) - should be New System Implant Programming on both


comment:
Slide header says "Introduction", which made me think we went back to the beginning of the training :-)
Change the header to "Making Decisions" or Determining Next Steps?


comment:
have forward arrow only come up with audio stops


comment:
Slide Header "Is it qualified?" Change to Is the Site Qualified?


comment:
toolkit screen - I have no way of going back to see the other sub-tabs. Can we have 3 buttons (one for each) come up when you click back into that popup?


comment:
all of the text for the sub screens needs to be replaced with what sonja had in line. so Alarms test is fine. Pump off should say "The Pump Off sub-screen tab is used to stop the pump permanently. Use of this feature is not recommended with this system." Events should say " Use the Event Log sub-tab screen to review events, or pump conditions, including the date and time the event occurred."


comment:
oddly enough, the > button didn't come up with I had prime bolus open. It used to. Now I have to close the field and then it appears. But that conflicts with directions. Can we trigger it along with prime bolus popup?


comment:
remove the "you're wrong, try again" feedback from the screen


comment:
I think that we should still be showing the pump over the box before the "telemetry complete" message displays. Wasn't that clip in the video twice?


comment:
We have new video of the sterile field, I'll download and send. We need to get that back in there before we send back.


comment:
I still don't see you select ok to dismiss the warning.


comment:
The text for See in action is too long - it ends behind the You try it button. Either shorten text or raise the button higher when the user rolls over it.


comment:
See it in action button - per DP edit (row 3), remove "including daily and hourly bid components."


comment:
use same video clip I send of it in sterile field - place just before telemetry complete screen


comment:
very first screen of drug, change to say "To enter the drug information, select Remodulin..." as a single line of directions. So everything in blue


comment:
need new starting screen shot that shows 0 in the low res alarm volume


comment:
screen where you're entering 4, the red boxes are off around the initial 0 and the 4


comment:
current pump settings for all of the alarms screens needs to match the previous drug info interaction. Not sure what I did when I took these...


comment:
Intro text, 2nd sentence: add a comma before "SIBR" (..have been submitted, SIBR performs...)


comment:
on telemetry complete screen, add telemetry complete noise


comment:
When incorrect feedback box comes onscreen, its white background blocks part of the directional text, but not all. Recommend either that white space behind the feedback box blocks the entire directional text or that the directional text disappears when the feedback is onscreen.


comment:
when scroll bar shows up, the telemetry complete text needs to go away.


comment:
very last screen with click > directions, remove the grey onscreen text


comment:
FYI, the See it in action button rollover text works fine here.


comment:
video popup - the close button didn't work. I couldn't get back to this screen unless I used the drop down menu


comment:
capitalize Infusion in line 1 of transcript


comment:
Real Time Bids text: I would call it the "Real Time Bids tab" in the text to match the screenshot.


comment:
#4 and #5 rollovers: Was it requested that we show these 2x? The same information appears under the Real Time Bids tab rollover as well.


comment:
telemetry complete screen - add telemetry complete audio and remove the text from the red box; have the text just onscreen like all of the other directions.


comment:
Data grid rollover text: The content needs document only says page 34, but the course text says 34-35; was that clarified during a content gathering session?


comment:
GHG bid adder popup text: "Self Schedule" should be "self-schedule"


comment:
the image of the new pump settings looks all wonky - it has borders on some sides but not others. Can we take a new screen shot? Or clean it up?


comment:
Economic bids popup box text: EDP edit, row 25 says remove "and demand offers monotonically decreasing bids." I see very similar text in the course now; it seems like it should be removed.


comment:
Sonja also wanted "Prime Bolus ends at 16 minutes" to appear onscreen in the video


comment:
Title should be "See it in action: Create a self-schedule. Intro text, last sentence: "You'll need to create a self-schedule in SIBR."


comment:
and again, close doesn't work. What has happened to those???


comment:
Transcript, 4th bullet: "Self Schedule - Standard" per onscreen text. 8th bullet: "Ctrl + Down" to match onscreen text. 10th bullet: the hyphen between Schedule and Standard is off-center. Last bullet: since we aren't referring to the title of something, shouldn't it be "You've created a standard self-schedule in SIBR."?


comment:
summary tab - the programmer should be in simple continuous with a dose and weight visible in the current settings section. So you will likely have to actually scroll on the image. See the PPT


comment:
move "You can" down to be on the same line as "now"


comment:
can we add an image of the programmer, maybe with the print screen up? just for something to see


comment:
have > come up when directions to click > come up


comment:
Transcript: 5th/6th bullets - recommend combining them into one fluid sentence since the "pause" isn't really reflected in the audio or onscreen tasks.


comment:
Screen 18/21: I realize that was Wendell or Cindy accidentally entering $22 before adjusting to $2 - is there a way to remove that error or have you already tried?


comment:
Repeat, made global: "Real Time Bids tab" and "self-schedule"


comment:
For this scenario and the one in You try it - it's likely that Cindy will ask that we provide some direction onscreen as to why the learner MUST enter data entirely in the 1st column before moving to the next column. I think we can leave it for now rather than put in the effort up front.


comment:
Why are learners required to click the Bid Summary tab to complete the interactions? Was this something pointed out by Cindy/Wendell?


comment:
Are we asking this for Cummins Learning Center? Is CLC where this will be hosted? This would give us the ability to track completions, but are we wanting to do that?


comment:
make the training content relevant to identified site personnel in the trial vs. specified?


comment:
in the response, ....and in some cases, they may result in the addition of another protocol-specific training topic...


comment:
no study participants were kept on the drug after...vs. trial drug


comment:
should the button be Developing & Delivering Effective PS Training?


comment:
Is this meant to be done for DP or are we planning to add more before alpha? It think we need to have a little more happening on screen to support the audio


comment:
Change "Five-Minute Market" to "five-minute market (RTD". Use RTD for the remainder of the course.


comment:
Make "Real-Time Dispatch" lowercase when you need to use it. In this case, change it to RTD based on the other comment I added.


comment:
I LOVE what you did with this activity. Do we need to give them a scenario in order to know who to choose though? Maybe it's in the note to Cummins to ask or Digs has his account plan/journal open and says something like "Here's what we know about our account so far." Then the text you currently have on the screen.  Thoughts?


comment:
Can we make sure that only the Initiatives tab is red since that's the only one we're referring to here?  I'd make the others grey.


comment:
suggest adding T+40 before the icon and 6045/6046 come on screen


comment:
study manager/consulting agreements - change getting to obtaining


comment:
study manager/meetings - remove comma after activity


comment:
study manager/financial disclosure - add comma after Disclosure


comment:
Same comments re range, fuel economy etc as first half of warehouse tour


comment:
medical director/financial disclosure - "...to determine if financial disclosure needs collected..." change to: "...to determine whether financial disclosure needs to be collected..."


comment:
C250 unit has text from the 500kVA also the image has a dealers branding on it and I believe they may no longer be a dealer


comment:
statistician/financial disclosure - remove comma after assessment


comment:
This is wordy - can it be paired down for the message


comment:
There are other chrom agars out there ie Remel, Biorad etc 
need to confirm TAT for the chrom agars - many are read at 18-24 hours.


comment:
IT is not practical for most labs to perform C diff culture as well


comment:
What two- Step algorithm are you referring to here? Antigen to EIA is still cheaper than PCR. For C diff TAT is the bigger factor. It is very expensive to go straight to PCR for Cdiff.


comment:
This statement depends on what exactly we are referring to in terms of application. I am unclear the drive home message for this slide.


comment:
This competiors list is not complete - 
for C diff do you go into the algorithms? 
the list could get long


comment:
Can you  use some of the time motion or mixed batch studies that were done to support these claims


comment:
Guidelines are a moving target. which guideline are you referring to here? I would only say that there are algorithms and ask about the GDH. and which algorithm are you referring to GDH to EIA to PCR? GDH to PCR? 
one of the advantages of GDH is that is has a high NPV so you can r/o your negatives very quickly.


comment:
This is confusing. 
What antigen you are referring to here? 
you have toxin tests listed here not GDH tests. 
TechLab makes alot of the GDH products - they make a 96 well GDH product and as Antigen-EIA cartridge that has GDH & Toxin on it.


comment:
need to understand what objective is to this slide


comment:
Cdiff testing can be two- step or three step.


comment:
Toxin EIAs do not have low specificity.

This is also a moving target with the guidelines with the debate with over calling of  c diff with PCR. we need to be careful about the messaging


comment:
This is not a good card - more than one right answer. not sure the user with understand the difference between GDH antigen and Toxin EIA


comment:
Culture is highly specific. not always as sensitive.


comment:
MRSA & Cdiff are mixed alot here and creating confusion


comment:
Do we need to spell out the first time in this course is used ISEC and SPI? I do not know how this is managed for other courses


comment:
I do not see the difference on what it is assessed for a local lab vs a central lab. There are different things a CDC should assess when a trial has a central lab, for example we will need to ensure staff has IATA training. For a local lab, it is more than just verifying the accreditation, it should also considered the local regulatory accreditation


comment:
I do not see the difference between questions that are study specific or general for this topic, maybe we can include what standard questions are part of SPI vs. ISEC


comment:
there are some countries that have specific regulations for local labs, we can add a reference in item 3 or pop-up that local regulation requirements should also be assessed as applicable


comment:
Screen 1: the example is illegible, please add a screenshot that we are able to read


comment:
How are we handling thermometers for the IP? are those assessed in this section? if yes, I would recommend to add an example. It is a key devide for monitor CT Material


comment:
I would recommend to provide guidance on how frequently temperature for  refrigerated/frozen samples should be taken, how to handle out of the office hours, back-up plans


comment:
"programmer automatically calculates the refill interval (days) from the..." "Click X to continue"
(not a fan of click X to see another option)


comment:
Low res alarm date 
"The programmer also automatically detrmines the low reservoir alarm date. The patient should be..."


comment:
Same comment as Susan. I know we're going to swap out the video animation with the new version once it's available, so I don't think this is an issue.


comment:
seems like bullets 3 and 4 are essentially the same?
Add Need to call if they hear an alarm?


comment:
Seems to repeat previous screen. Delete last bullet?


comment:
Fix formatting for the non-critical alarm pop-up


comment:
They don't need to review the alarms sub-tab change to "The Alarms test sub-tab automatically opens."


comment:
Moving the magnifying glass around is cumbersome. Its not obvious where to place it and I was frustrated in the last screen because I couldn't find all 6 easily. And when you click the glass, it doesn't pop up the info window automatically so you could just not read it and go to next instrument and it would count as being read.


comment:
Agree with comments, but realize that the updates (except for Susan's narration comments) are being made in the new animation. Can we make note of the updates, so the reviewers are aware of the modifications that will be coming?
I will make updates to the narration script and will send the updated version to you for recording. Will update verbiage to "We need two 20 mL syringes to complete Emmas 40 mL fill." and "Periodically withdraw and observe a portion of the Remodulin as it is injected to confirm the expected appearance. If the withdrawn fluid has an unexpected appearance (for example, evidence of blood), the needle may not be properly inserted into the pump. After confirming the needle is properly seated in the reservoir, resume injecting the Remodulin."


comment:
They will not get a tone indicating telemetry complete - it will just sound immediately sound either the critical or noncritical alarm along with the telemetry complete message.


comment:
In the first para change sentence slightly to: "Changing the low reservoir alarm volume changes the refill interval days and low reservoir alarm date"


comment:
If you hit 'Back' to go back to the previous 'page' to refer to something, should you have to go through and complete each of the boxes again on the previous page?


comment:
Consider also stating "Decreasing the low reservoir alarm volume would increase the number of refill interval days; Increasing the low reservoir alarm volume will decrease the number of refill interval days."

Keep 2nd para, and I like the addition of Susan's warning which is directly from the manual. 

I'm leaning towards deleting 3rd paragraph?


comment:
Now that I review this again, I'm wondering of the value of this interaction. Certainly it does tell them how to change the interval if they want to. Not sure how often that was done in the clinical trial and if it is important enough to show them how to do it?  That being said, if it is important then we should show them a change. Right now we are showing them 4, telling them to keep 4, but then telling them to update the pump which wouldn't be necessary because no changes were made.


comment:
I don't think we should be showing them how to increase the critical alarm interval - if we are going to change anything let's show them how to reduce the non-critical alarm interval.


comment:
Agree with Sonja, re: the note. Perhaps we could use similar verbiage to New System Implant Programming course and start the video with "If the programmer was shut off or if it timed out, turn the programmer back on and re-interrogate the pump. To enter the volume of Remodulin placed in the pump, select the Infusion screen tab."
Re: Susan's narration updated at 00:56, maybe we should add "Review the new Pump Settings and select OK to close the Pump Status screen."
Let's discuss so I can make appropriate updates to the narration script for you and Tim.


comment:
Not sure that we should be showing "Pump is in safe state", that is not listed in the tech manual? 
Also, for the 5th error label should say "Tube set interval" and I din't think we can say "If desired, restart pump and verify flow rate." Need to ask Marty what is appropriate to include here - I don't think pump would even let you restart it.


comment:
As requested in Alpha review, please updated the verbiage in the Actual removed volume to "The actual removed volume is..."


comment:
No mention of freezer for storage of lab samples and temp monitoring.


comment:
I think we need to add something to this page to tell them what we are doing. Don't want to imply that you can only change dose from 65 to 67. "To illustrate this, let's change the dose for this patient from 65 ng/kg/min to 67 ng/kg/min.


comment:
I know that we went back and forth on this. But the alarm troubleshooting section feels a bit out of place as the other troubleshooting steps are all about tactical steps. Are we sure this is the right place for the alarm troubleshooting?


comment:
For consistency, in the first paragraph we should either use 'accuracy ratio' or 'Accuracy Ratio'. The 2 sentences do not have consistent capitalization.
Also, the star should be moved to the right a bit since we're at refill #3.


comment:
Would signs and symptoms of a catheter puncture be immediate or could they be delayed? Might be one slight difference from a site reaction to catheter puncture?


comment:
Correct the orphan in the first sentence.


comment:
Why are rheumatology trials singled out?  There may be other types of imaging that would be critical for oncology, etc. or other types of trials.


comment:
Need a little more to introduce this. If you suspect a possible site reaction, pocket fill or overdose, perform the following actions as necessary:
I think this flow chart needs some work but I'll wait to see if others have comments.


comment:
General system issue - I got 'stuck' in a room when all items were selected (if four items, four items were checked) and it wouldn't let me go forward.  If I selected 'Back', it went back and was as if I hadn't been in that room before (i.e. no check box for 'Lab', etc.)


comment:
What happened to the firste few seconds of the video that showed the box with programmer wand on top of the box?


comment:
Ignore previous comment, I should have watched the whole video first. Delete the 2nd sentence "Turn the box over and place..." Adjust the 4th bullet to say "Once the Interrogate dialog box appears, position the progrmaming head over the target symbol of the unopened box and select the Ok button."


comment:
We need to adjust this video. only show from 00:23-00:36 of the original file I sent you. This should match up fine with your audio.


comment:
In the "Rollover..." sentence, "each" is used twice. Rewrite the sentence to read "Rollover each module to find out what you'll learn in this course." This will be consistent with other modules.


comment:
This video has unnecssary downtime. The captivate should show entering of 4 (at 00:10)while the audio is talking about that step. (then 00:22-00:33 can be deleted)


comment:
Delete "Note: the default value automatically populated in the Reservoir Volume field is 40 mililiters." This is not correct. Should just say "Select the Reservoir Volume button and enter the volume of Remodulin placed in the pump. Select OK to continue. Verify the infusion mode..." Sonja verifying with engineering on this.


comment:
Under the T+12B tab, the last sentence under "What is it?" and the sentence under "Impact" are exactly the same. I believe the decision was made to remove the "Impact" header and place the information under "What is it" (please check notes to verify). Remove the word "Impact" under "What is it?".


comment:
Sonja also to verify that new system implant will indeed see message at 00:12 "Drug information has been changed but Reservoir volume has not been updated..." need to verify that this isn't just a function of the emulator.


comment:
At 00:19 is there anyway to have a dual screen with the programmer and the head over the device, like a split screen? Seems clunky the way it is going back and forth. I liked video being shown at 00:32 better than 00:28-30( with the pump on a big empty table)


comment:
Delete "Note that the nominal setting to stop...external line will change." This is on previous video and doesn't need to be repeated.


comment:
Transcript - remove space between + and 40 at the beginning


comment:
Same feedback as previous with the journal -- it appears clickable just along the outer edges and shouldn't be.  check them all.


comment:
Transcript - add quotes and a question mark: ....so I have to as myself, "Are Over and Under Scheduling charges triggered or not triggered?"


comment:
I don't understand the statement "If a resource is selected for flexible ramping instead of dispatched,..." Isn't flexible ramping one method of dispatching? I think it should just be "If a resource is selected for flexible ramping to meet the demand forecast, it triggers..."


comment:
Flexible Ramping or flexible ramping? lowercase in transcript, uppercase on green box in on screen graphic


comment:
Add (FRP) after "Flexible Ramping Product". Then change directional text to "Click Play to learn more about FRP charge codes."


comment:
Maybe we have them click the red tabs to update the information so they can see where it goes based on those two conversations.  All other tabs should be gray.


comment:
Just a thought for before we get audio recorded - let's clarify with them how they want these numbers spoken - T+ a number - does 7.5 minute market= seven point 5 or seven and a half? and charge codes - 64600 = six four six zero zero, sixty four six hundred, etc.?


comment:
we should prob use some different checkmarks/boxes that are just images and not actually selectable and deselectable


comment:
Move scenario details box down a little so it meets up with the teal/green pattern footer


comment:
I think we should consider switching the order of these slides. Show this video first, then show the previous slide with the graphs. Team - thoughts?


comment:
The menu drop down says "Entering bis in SIBR splash screen".  Please correct this.


comment:
Need to fix the low res alarm date on the summary screen tab. Right now it is saying 2033. should be same as previous screen. This screen snap shows pump in min rate which is why the refill date is in 2033. Please fix.


comment:
when I answered correctly, I got the popup box...and then I wasn't sure what to do. then I saw the instructions at the bottom of the pop up but by putting them there, the popup has to stay on the screen.  Can you make the pop up disappear (after answering correctly) and then add the instructions either at the bottom in bold (or red?) or as a separate popup?


comment:
reword first sentence in CoLab risks to something like (trying to give the why)--Need instructions to ensure that the blinding information is maintained appropriately while at the site to guard the integrity of the data.   The drug will be unblinded when shipped to the site so it needs to be clear that the there is specific unblinded staff who are responsible for preparing the drug.


comment:
Manager explanation should say "I'm responsible for ensuring that there are..."


comment:
The text looks out of alignment on the phone


comment:
Change first sentence to read, "Based on your selection, you are an RDT submitter."


comment:
The image is of the plant operator not the system operator.


comment:
I think this should be the system operator image, not the plant operator.


comment:
Change the spelled-out name of the CIDI acronym to "Customer Inquiry Dispute and Information"


comment:
It's very hard to tell, but I want to make sure that there is no proprietary information on the BSAP screen shot - particularly the BSC ID


comment:
Can you find a screenshot for BAAOP that does not have blurred information?


comment:
In the script, change "scheduling coordinators" to "base schedule coordinators" in the 3rd sentence.


comment:
Under "What does this application do?" change the description to:

CIDI is used to submit questions or settlement disputes to the ISO. CIDI also contains a knowledge base of articles on various topics.


comment:
For OMS - change the description under "What does this application do?" to: OMS is used to submit and manage generation and transmission outages.


comment:
I will provide you with a screenshot to use for the AIM application. I'd rather that they see an example of an outage being submitted than the outage summary screen.


comment:
For ADS - change the sentence under "What does this application do?" to:

ADS is a messaging system that replaces the manual, telephone-based method of dispatching energy in the real-time market.


comment:
For ADS - change the sentence under "Who uses this application?" to:

ADS is used by system operators, plant operators, bid and base schedule submitters, RDT submitters, and settlement analysts.


comment:
For RDT, change the sentence under "What does this application do?" to: 

The RDT is a template used to capture resource operating characteristics that are stored in the Master File. These characteristics determine how resources are dispatched to balance the market.


comment:
For RDT, change the sentence under "Who uses this application?" to: 

The template is used by RDT submitters, plant operators, bid and base schedule submitters, and system operators.


comment:
Note that my earlier comment about giving you a new screenshot is for the OMS application, not AIM. :)


comment:
This title seems redundant, "A closer look at your applications: Your applications"

Please change it to: "A closer look at your applications"


comment:
Change the first sentence to read, "As an RDT submitter, you will primarily use the following applications:"


comment:
The text in the third thought bubble needs to be centered better. (I now have a new, automated means of receiving dispatch instructions.)


comment:
Change title to: "A closer look: Here's what I've learned using the RDT"


comment:
Change first sentence to, "Patrick has learned a lot about the value of using the RDT while participating in EIM."


comment:
Words in the middle thought bubble need to be centered. (The thought bubble that starts with, "Entering the correct data into the RDT"...)


comment:
Change MW's to MWs in the information on the right.


comment:
Change question to read, "Which of these tasks is done using the RDT?"


comment:
Change question to read: "Which application would you use to query historical dispatch instructions?"


comment:
Change question to read: "Which of these items is used to upload resource characteristics to the Master File?"


comment:
Please add the following words "The content check is the first set of rules check the data relevant to the resource type that was selected.  The validation check ensures that bids are within specified Master File parameters.


comment:
Change scenario wording to: "A new resource is coming online in your balancing area. What item do you use to enter the resource's characteristics?"


comment:
Change Daily Components screen to say "This screen is where  start up costs, minimum load costs, ramping and transition costs for MSGs are updated if necessary."


comment:
In the introduction add the word "toolbar" after "in the..."


comment:
Change the wording on the second sentence in the self schedule box to read "There is no price curve associated with this product type - you intend to run your resource regardless of the price."


comment:
I believe we talk about the 10 bid segments later on in the CBT, so let's remove that sentence from the Economic bids box.


comment:
In the GHG bid adder box start the first sentence off with "The greenhouse gas bid adder is an optional component..."


comment:
In the intro change the second sentence to read "You want to run your generator regardless of the market price."


comment:
In the box with the Begin button put a hyphen between self and schedule.  It does not need to be capitalized.


comment:
Change the first sentence of the narration to say, "CIDI is used by market participants to manage their business interactions with the ISO and track inquiries or issues."


comment:
First thought bubble should read, "I use OMS to submit a generation outage when a resource trips offline."


comment:
On the first bullet of the script change the last sentence to read " First we'll make sure we enter the SCID for the Scheduling Coordinator which is EIMZ in this example."


comment:
Second thought bubble should read, "I use OMS to update the planned end time when I learn an ongoing generation outage is going to be extended."


comment:
One exception to the self-schedule rule above is when we refer to the selection in the drop down box that says "Self Schedule - Standard"


comment:
Please make startup one word throughout.


comment:
Insert the word "may" before "require" in the first bullet, second sentence.


comment:
Change "thunder storm" to "thunderstorm"


comment:
Add to the bullet that reads "You can see that our Startup components have been added to the Daily Bid Components grid because a reference ID is visible."


comment:
Change the self-schedule verbiage in the script to read "Create a self-schedule when you want to generate energy regardless of the market price."


comment:
For the roles that only have one primary application, change the first sentence to read, "As a _____, you will primarily use the following application:"


comment:
Change first sentence to read, "Based on your selection, you are an outage submitter."


comment:
Change to the beginning of the first sentence. It should start like this: "As an outage submitter, you will primarily use..."


comment:
In the box with the Begin button for the real-time daily bid components, change it to read "In this activity, you'll practice creating real-time daily bid components in SIBR..."


comment:
Change scenario to read: "A transmission line in your balancing area will be de-energized for maintenance work. Which application do you use to report this event?"


comment:
Change question to read, "What task do you perform in OMS to report the outage for the de-energized line?"


comment:
Change correct answer to say: "Make sure to submit a transmission outage for all line maintenance work."


comment:
Change the first answer to say "When the prices in the last two bid segments are duplicated."  This is the correct answer.


comment:
Outage submitter explanation should say, "I'm responsible for reporting changes in availability for transmission lines or generating resources."


comment:
Make sure photo of system operator shows up on the "your role" screen when that role is selected.


comment:
For the correct answer, change the wording as follows: "That is the correct item."


comment:
Change third sentence to read, "AIM is used on an as needed basis."


comment:
Change third bullet on the summary screen to read: "Submit a question to the ISO"


comment:
It looks like the branching takes the user access administrator role to "a closer look at CMRI" as well. This role should only branch to AIM and CIDI.


comment:
Enter base schedules and Submit base schedules are nearly the same thing.  Change one of them to "View base schedule information."  
Add to the script that Base schedule coordinators also use BSAP to view base schedule and flex ramp information.


comment:
On the MRIS - Here's what I've learned - change the bottom right bubble to say "All of my settlement statements..."


comment:
In the script, take out the word MRI-S from the second sentence and replace it with "it".


comment:
Please replace the CMRI screenshot with one that does not have blurred information.


comment:
Remove the "and transmission information" from the script.


comment:
Remove the sentence "CMRI is used on a daily basis."


comment:
In scenario 2 we don't know if the resource is a generator or transmission.  Suggest changing it to say that a generating resource has tripped off line to be more precise.


comment:
Now that I know the right answer, change resource to transmission line.


comment:
BAAOP - Under "what does this application do?" "It is a user interface to the real-time market.  It is used to validate commitments and make data corrections, as needed."


comment:
BSAP - Under "What does this application do?" "A system to submit, balance and review base schedule information."


comment:
Components such as AVM's are not optional


comment:
timeline overview - change "have been assigned" and "has been committed" to "are assigned" and "is committed"


comment:
Didn't notice this until now: Please make all process steps all uppercase. Match 1st box to 2nd box, i.e. change "SET-UP" to "SET UP"


comment:
Under CMRI - "What does this application do?" - "It provides resource specific information related to market results and settlements."


comment:
I think we confirmed that Plant Operators do not need to know about MRI-S.


comment:
MRI-S - Update the MRI-S screenshot to include the metering tab


comment:
Change the SIBR thought bubble to read "I can also use SIBR to let the ISO know that I want to run my generator regardless of the market price."


comment:
Change the last box from "Check on a bid" to "Submit daily and miscellaneous bid components."


comment:
Please remove the sentence "OASIS is used on a daily basis."


comment:
The comment above was for BAAOP not BSAP.


comment:
I clicked on CMRI and received the response "That task is not done in CIDI."


comment:
Change this question to read "You are responsible for entering energy bids for your participating resource scheduling coordinator.  What application do you use to submit energy bids to market?"


comment:
Scenario 1 - Change this to read "You need to submit a base schedule to ensure that your portfolio is balanced.  What application would you use to find the information you need?"


comment:
Change the follow up question to say "Which of the following would you do in BSAP to ensure that your BA is balanced for the hour?


comment:
When the follow up question comes up and the first question gets lighter, it also lightens some of the words above (given task)


comment:
Please check all the bubbles to make sure the words are centered.


comment:
Is this proper English "may damage a trial's data integrity"? suggestion: "may compromise a trial's..." or "may jeopardize..."


comment:
3rd bullet point: remove site (PS training also needs to be specific for CRA who is no site role, so suggest to keep generic to fit both site and other roles)


comment:
Can Tera confirm that there is no requirement to DOCUMENT training requirements - in the early phase comment it says that discussions take place but implies that these discussions are not documented. Just to verify.


comment:
wording in audio implies that there is always a training meeting. There often is, but not necessarily. suggest to add "if applicable" or other wording to clarify that a training meeting does not necessarily need to take place and there are other training delivery methods that might be utilized (web meeting, online training)


comment:
If there is a explanation for the abbreviation RACT, I suggest to add (maybe there isn't)


comment:
"Finalizing the Plan for Training document, are you referrig to the Study training plan (the one that used to be required?) if so is this the new name ? if not can we refer to the real name of the document?  if you are not referring to the study training plan, maybe better to say, "if one is being used" instead of "if it's being used"?


comment:
from the 3 boxes on the slide the first two are highlighted, it looks like I took both of them although I only took the first one "the value of effective training"


comment:
When you click on print topic - in the print preview the table is separated from the table


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:
Remove "From the main menu you can select Simulator Tasks to see the list of tasks that are available in the Interactive Simulator."


comment:
Replace analyzer with instrument or system - leave it up to developwer


comment:
Printing function & certificate needs to have product name updated from cobas to "VENTANA HE 600 system" and replace 5114-010416 with "6078-02-0217". Change Green on certificate with the Blue used in the VENTANA guide, please.


comment:
.   The only thing that I saw that I think we should think about before this is launched is the definition of Key roles.   With the role out of task based training this definition is going to change.  I just wonder if we should come up with a more generic definition that will still be valid after we move to task based training.


comment:
Clarifying the roles a bit more:
Under the "role" table - with the Super User, Recommended Topics, Next to these two: 
Settings and Reporting (additional subtopics covered) Troubleshooting (additional subtopics covered)


comment:
Agree with CB - change "analyzer" but use "system" - also, make this a NOTE since it's important.


comment:
Sorry, Nick. I messed this one up.
Edit phone number to "1-800-227-2155" formatting.
Replace COBAS entire line with:
VENTANA, VENTANA HE, VENTANA CONNECT, CAREGIVER, and VANTAGE are trademarks of Roche.


comment:
Print function missing document number. 
6078-02-0217


comment:
Forgot to trim this image - I don't want the Footer in the image. I can give you a trimmed image.


comment:
Under "Ask learners to demonstrate how they know the instrument is at "ready." Edit the 4th sub-bullet to:
"If unsure what the status symbols mean, tap [i button] to pull up the status key."


comment:
I'm going to try & edit this image by Monday. It needs to have the sections labelled for the facilitator.


comment:
Under "Tell each learner to navigate to the Operator Manual and then return to the Settings tab."
Edit 1st sub-bullet "To return to the Settings tab, tap the Settings button in the upper left corner of the menu." 
Nick, I will need to edit the screen to add a red box around the Settings button on this screen.


comment:
Photo needs to indicate where the "Add New Protocol" button is b/c it's a blue + and doesn't have those words. Can you draw a red box around it?


comment:
Edit "Demonstrate how to edit an existing staining protocol that is not in use:"


comment:
Add second sentence to second sub-bullet "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." Add 
"Customers should follow guidelines in package inserts regarding post processing slide treatment."
Add note from Op Manual:
"Note: rinsing specials stains in any solution after processing may result in lighter staining results."
Then pick up with 3rd sub-bullet.


comment:
under the second bullet on the note, rephrase "Another option to back up the VENTANA HE 600 system is to connect a USB to the VENTANA HE 600 computer to continuously backup data."


comment:
Forgot an objective & new setting regarding Alerts. Writing it now...


comment:
This dialogue doesn't make sense to me. First, I wasn't clear that I was supposed to choose one of the statements and secondly, I don't understand the message that is being conveyed.


comment:
I am missing something. The screen says that he likes what was said about the cobas 4800 but I didn't see anything about the 4800?


comment:
I think we should emphasize isolation rather than starting antimicrobial therapy because I believe the only actions for CRE will isolation.


comment:
Insert 1st sub-bullet under "Demonstrate how to check the VENTANA connectivity settings set by a Roche Representative:"
From the Setting screen tap Connectivity.
(place existing 2 sub-bullets under this new one)


comment:
New section at the end, just before reinforcement activities:
Demonstrate how to check Alerts Settings on the instrument.
From the Setting screen tap Alerts.

Explain that audio for Alerts are optional and can be set for the following conditions:
System Error
Waste Full
Insufficient Inventory
Tray Complete

Explain that volume can be adjusted by moving the sliders:
For the entire system.
Each Alert it is selected in the drop down box.


comment:
Sorry - under my first comment should say "USB drive".


comment:
4th objective:

Check the Alerts Settings on the instrument.


comment:
Replace 3rd bullet under reinforcement activities:
Check the Alerts settings on the instrument.


comment:
Add questions & answers:

How can an operator exit sleep mode on the instrument?
o Insert a new tray into a portal 
o Remove a processed tray from a portal. 
o Tap the Eject tray button on the computer touchscreen.

What is one method in which your lab may back up the VENTANA HE 600 system database?

o Having the lab IT department to save it to a local network.
o Connect a USB drive to the VENTANA HE 600 computer.

How do you check Alerts Settings on the instrument?
Tap Settings tab, Tap Alerts


comment:
At the bottom of the page the "Go to the next subtopic, Daily shutdown" needs to say "Go to the next subtopic, As-Needed Maintenance"


comment:
Not sure if this is possible:
I really like the Note sections but they are closer to the section following than the section before - is there any way to move all of these up a little?


comment:
Check & change all CareGiver to CAREGIVER.


comment:
Edit sub-bullet to "Tap Shutdown (a cleaning cycle will be performed taking ~1 hour to complete)."


comment:
Edit 2nd objective to "Recognize when to implement tray recovery procedures." and move it to be the 3rd objective to follow the flow of the section.
Also, edit "Explain when to implement tray recovery procedures:"


comment:
Edit bullet point "For more complex cases, describe Manual Tray Recovery Procedure:"


comment:
Edit bullet "Review automatic tray recovery procedures:"


comment:
Edit first sub-sub-bullet
"If a tray is seen, it must be removed manually, so proceed to describing Manual Tray Recovery Procedure."


comment:
I was able to tap & pull up certificates, however, I didn't get a print dialog box. Is this a feature that works in iPad & not PC? I was able to print with ctrl + p


comment:
Let's make their edits in the transcripts they see here, along with the ones you will have in a document. (Need to say after completing this course, and define ICF)


comment:
You have ICFs twice in the second sentence.


comment:
Tera's edit was "of the ICF in the clinical trial" you have"to the clinical trial".


comment:
It might just be me, but I didn't hear audio when I first got here until I selected pause and play.


comment:
The incorrect feedback for the 2nd answer reads strange. Are we missing the words "Any side effects" or something like this?


comment:
If you haven't already, update the PF so that module headers match what is in the file now.


comment:
Review the correct and incorrect feedback. The correct feedback only said that it was right, and didn't give any other information.


comment:
I think you should record audio here with the correction. Otherwise they may get confused and think we missed the edit. I see that it is in the transcript.


comment:
Update this to say Trial instead of Study. Check all feedback, etc.


comment:
The hover over for this option adds a layer to the title bar. Please check the other questions as well. Also update this hover to say trial instead of study.


comment:
Next didn't appear after I finished all 3 case studies.


comment:
buttons still say "ICF Form". Should just be ICF.


comment:
(it happens when you click the 2nd red button on the page)


comment:
Not all of the purple circles are linked correctly.


comment:
Update the links in the Resources doc too (the purple circles aren't all linked correctly)


comment:
budget overview - put commas around "as needed"


comment:
Notify Personnel of Approved... - "...has been approved and is available..." - change to "is approved and available..."


comment:
I don't think the yellow boxes for the transcript are needed. Let's update these throughout - especially if we update the audio correctly. This was fine for Alpha, but now should just be standard.


comment:
The Demand forecast graph and supply forecast graph don't really represent this correctly.  I will send you a sample picture.


comment:
Change the script to read "The settlements process includes settlement statements, billing and invoicing.
Settlements calculates the charges and payments..."


comment:
Change the introduction to say "The locational marginal price is the market clearing price used to pay or charge for energy produced or consumed. It is determined for each node taking into account energy, congestion, loss and greenhouse gas cost."


comment:
In the introduction after "locational marginal price" add ", or LMP,"


comment:
In the box for Marginal cost of congestion, add the word "the" before "LMP" and remove "at a PNode".  Add to the end of the sentence "at a particular node."


comment:
Change the second sentence of the Marginal cost of congestion to say "Congestion is a situation that occurs when available least-cost energy must be replaced with higher cost energy due to transmission constraints."


comment:
In the wording for the Greenhouse gas component, do not capitalize Greenhouse in the first sentence.


comment:
Change the wording for the Greenhouse gas component to say "The greenhouse gas component is the marginal cost of providing the next MW of energy to serve ISO load from an EIM balancing authority area outside of California."


comment:
The graphic for the load is incorrect - see the slide deck that this came from for additional graphics.  There is also a graphic for interties as well.  If you do not see it, I can find it for you.


comment:
Change the introduction to read "In order to correctly validate settlement statements, users will need to review several important documents. This includes the Business Practice Manuals for EIM, Settlements and the associated configuration guides. For this course we will focus on the main body of the Settlements BPM which provides..."


comment:
Configuration Guides - What information is in it?  "Configurations guides provide a description of each charge code, the business rules, formulas, bill determinants and charge types."


comment:
BPM - Why is it important? "The BPM is where to find the most up-to-date information on the settlements process and timelines."


comment:
For Where is it located?  Instead of this link (which is not correct) add a resource tab at the top of the page with a link to the BPM page.


comment:
Change the note to say "For more information about metering timelines, review the Metering: Foundational Concepts course."


comment:
T+3B - add "the" in front of ISO.  Remove the word "when"


comment:
There is a lot of white space on all of these tabs.  Can you spread the verbiage out.


comment:
Also remove the sentences below Impact on T+48B.


comment:
Change the script starting at "Let's look at an example.  On the calendar date of January 18th you will receive a T+3B settlement statement for January 9th and a T+12B recalculation statement for December 29th.  Also the calendar shows that weekly invoice will be published. In this example due to a holiday an invoice will be publish on the same calendar date."


comment:
Change the fourth sentence to read "Participants can refer to the payment calendar to find relevant meter submission dates, settlement statement publication dates, dispute deadlines and invoice publication and due dates for any calendar date."


comment:
Move the link to the payment calendar to the resources tab.


comment:
On Commitment costs change the word "initial" to "operating"


comment:
This is the energy reserved to account for load forecast error.


comment:
Change the second sentence to say "In the settlements process, the data from various applications are mixed together and baked in the settlements system to produce a settlement statement."


comment:
Let's talk about how to reword the next sentence that starts with "To finish the cake"


comment:
In the intro change "energy component" to "one".


comment:
In Base schedule change "running" to "opimization


comment:
Spell out TEE - which is Total Expected Energy.


comment:
Remove "bid price" from the Expected Energy report.  It is on the Expected Energy Allocation Report.


comment:
The manual dispatch energy box should say "Energy dispatched by the EIM BAA Operator to resolve emergency dispatch conditions."


comment:
Change the intro to read "The expected energy allocation details report is another important report..."


comment:
Actually the intro needs to be rewritten to say "The expected energy allocation details report is another important report used to validate settlement statements.  It further breaks down the expected energy into components and their relative bid segments."


comment:
On Expected energy add "An example is optimal energy or OE."


comment:
Change the market service type to read "This identifies in which market the energy was procured.


comment:
Change bid price to read "The price at which the energy was procured relative to the resource's bid curve."


comment:
Change "Energy" to "Total expected energy" and change the description to read "The energy expected..."


comment:
I provided you with incorrect answers - where will these be used?


comment:
On the Settlements BPM definition remove "and charge codes"


comment:
On the Intertie question - answer 1 and 3 are exactly the same. Please change the 3rd answer from Operational Adjustment to  Uninstructed Imbalance Energy.


comment:
Spacing/balance of graphics seems awkward on this slide. Since 2 & 3 are pop-outs of 1, perhaps they can be more offset, or else move 2 & 3 over to the right to not cover 1.


comment:
On "Settlement basics: Business practice manual" page, when you move the "Where is it located" information to the reference, please fill in the space by expanding the remaining boxes.


comment:
I know that "where it is located?" will be removed, but I wanted to note that, when you click on that box, the paragraph under the title reverts back to language from a previous course where we discussed transaction/resource IDs. It would be great if we could keep an eye on this to make sure this doesn't occur in the gold master.


comment:
Please enlarge the wording and spread out the text box to leave less empty white space (see metering CBT for example).


comment:
To confirm for T+12B. Under "What is it?", remove the bolded word "Impact." The sentence can stay under "What is it?" and remove the "Impact" header and sentence under it. Please enlarge the wording and spread out the text box to leave less empty white space (see metering CBT for example).


comment:
In the initial screen, please center payment calendar graphic.


comment:
In the first sentence, replace the word "but" with "and"


comment:
Will need to change the words on the bowl. To discuss.


comment:
Same note about the bowl -- need to revisit the words on it. This applies to anywhere the bowl is located.


comment:
Instead of the bowl moving into the over, could there just be an arrow that points from the bowl to the oven & have the bowl disappear?


comment:
For the 3 report pages, each shows the information in a different manner. Would it be better to have them all be formatted the same way for consistency? Perhaps we could discuss.


comment:
When all the ingredient bags get moved to the "drop zone", the bottom bag covers the edge of the bowl. Could we balance those?


comment:
On the flashcards, please center the terms.


comment:
Is there a way to have the payment calendar and the scenario show up on the same screen? This will eliminate excessive clicking for the learner.


comment:
As soon as the narration stops, the actor disappears (before clicking to next screen).


comment:
On the indication page under warnings first bullet, separate into two bullets.  Refill and implant warnings should not be in the same bullet.  The warnings are not related.  For whatever reason I could not enter a comment on that page


comment:
Add volume to program low reservoir alarm bullet


comment:
Update pump does more than save setting.  It downloads the settings to the pump with RF communication.  Without successful update nothing changes in the pump settings.  This is crucial to understand


comment:
Get better example of event log from Michael Riley.  We are telling centers to check this at every refill for motor with recovery


comment:
Make the date of the refill about 7 weeks even with the 7.9 refill interval.  I think the low reservoir alarm is likely to be sounding in your example


comment:
I think we can say chilling reduces frequency and severity of refill reactions.  This will need to be changed in the manual.  Can we put this on the list for potential changes for both manual and training


comment:
Refrigerator is obvious method.  Add picture of vial in a styrofoam coffe cup with ice.  That is the easy way.  Add is good for transporting refrigerated drug


comment:
We just sent our letter to check and download logs


comment:
At start need that the dosing weight is still the same . I think 70. Kg


comment:
Have video show bubbles in tubing sucked into pump and plunger moving without force applied.  These are critical steps to confirm needle in septum.


comment:
Depends on what information is needed...  If she needs information due to local regulations, she may need to consult with ICF Template Owner as well.


comment:
How is this 3rd scenario different from the first scenario?  Both have a CS-ICF template but no TCED. Should this one be a TCED but no template?


comment:
The suggested text on the previous slide indicated that only "regulatory authorities" would send data outside of the US...  This does not align here with the "corrected text".


comment:
bullet 1 should we say what accurate and complete site evaluation documentation looks like?  We have been trying to stay away from saying specific forms to accommodate for any future revisions


comment:
We also are making sure the PI meets the trial requirements- think we should add to the first bullet see what you think about the following:  ....conduct the trial and meets all the necessary trial specific requirements or and meets the trial specific requirements.


comment:
Depending on the groups decision re: my comment on the site qualifications for bullet #1 this can either stay as is or keep as ISEC


comment:
Shift Supervisor title has changed to Production supervisor.  I saw this comment previously, but the prototype hasn't changed yet.


comment:
use "Sales Analytics Curriculum" in place of "Business Intelligence Curriculum"


comment:
Globally we call each continent (basically) a Region and that is how the term is used in DSA and in Global conversations --- unfortunately in North America they think of having 8 Regions in North America but in the Global nomenclature what they call a Region in North America is called a Territory everywhere else -- we may want to make a note on this?


comment:
This moves a little fast for non-English speakers (and for me!) might want to slow it down.


comment:
This is the first instance of the acronym TCED in this training. As this is an introductory course for the creation of ICFs, it would be helpful to expand this to it's full form.


comment:
Question 3 is a duplication of Question 1 but re-worded. Is this intentional?


comment:
The 'Rate Yourself' bar would be more intuitive for users if it allowed users to click on their rating as opposed to dragging it across. This was not obvious at first.


comment:
The 'Close Feedback' button no longer functions on this page after progressing to the 'Expert Version' section.


comment:
Ryan: This should no longer be Operation: REVEAL. (Pretty sure that was tied to Hologic?) We need a new operation name.


comment:
Missing a space between Liat and system in question and fdbk


comment:
Please do global search for BD Max to make sure it is branded with TM


comment:
Add space btw cobas and ctng in question and fdbk


comment:
Do a global search to make sure there's always a space inserted after a brand name with an R-ball


comment:
Edit second answer option: "highest-risk forms of HPV"...ALSO, in third answer option, add space btw HPV and 18


comment:
Edit question: "What's one feature...you could point out" (add "you")


comment:
Ryan - is it okay to refer to "the 8800" as the fdbk does here?


comment:
I clicked the correct answer (BD) and it marked it as wrong, even though I responded correctly.


comment:
Please gray out the icon once it has been clicked so they can see which are remaining


comment:
Agent should disappear once I've found all the hot spots


comment:
RYAN: Should we define the word gantry in that popup?  How does Cepheid describe its fx?


comment:
All of the instructions on this screen don't disappear/appear when they should - take a look.


comment:
In cartridge door popup, edit: "The cartridge door on all Xpert instruments..."


comment:
Integrated scanner popup points to the wrong icon


comment:
Is there an image that should/can go in the Smart Waste Disposal popup?


comment:
The text on the draggers is too small. Can we expand the table across the screen further, so each answer box can be bigger? Agent could provide instruction/fdbk on top of the table, then go away.


comment:
All answer options and feedback need the word "at" inserted - "AT a time"


comment:
edit question - random access should not be capitalized


comment:
RYAN: What is meant to be in the fdbk that we can't write it yet? Isn't it sort of generic, or no?


comment:
Change the agent's feedback, "Good work. Looks like you're ready to explore some of the shortcomings of these competitor systems. Click continue."


comment:
In question, delete the word "it" btw "but" and "only"


comment:
Replace "I totally forgot..." sentence with "I know this place can be easy to get lost in."


comment:
Edit "It really adds up... Batching at higher volumes enables true efficiency gains..."


comment:
Edit the customer stmt: "Whoa! Let me do some math. Cepheid said it took less than two minutes per sample, but 1 minute of processing for 2074 samples... that's 34.5 hours! How can that be?"


comment:
In customer stmt, replace comma with a period after "microbiology." Then start new sentence, "Since we run a lot of LDTs,..."


comment:
Delete the word "is" in customer's first sentence


comment:
Molly says "when you're ready to start stay on target" but the next module in the map says "use your clues." Not sure which is right without moving on, just make sure it's consistent.


comment:
Assuming we won't receive the content before wednesday, let's copy/paste the Hologic and Beckman target statements with a big yellow note to Roche that says: "Content to be replaced with Cepheid/BD target statements"


comment:
Re: Previous comment - I think that's what you've done, but for some reason this first one got messed up. Let's just make sure this section is navigable, and call it a day...


comment:
Scoot up the speech bubble so Molly's hand doesn't overlap it


comment:
Please disable the link to REVEAL guru here and on the top-of-screen menu on the next page. That's the old version, and I don't want to confuse them. Let's even put a yellow Note to Roche on this screen: "First draft of Cepheid/BD guru game questions will be delivered for review on 2/16/17."


comment:
As said we wouldn't add the process map here


comment:
Change title to "Is the site qualified"?


comment:
Throughout the course we should use Ethics Review Board (ERB), not the IEC wording.


comment:
We should define TCED somewhere in the course.  either on this slide or in the course overview.


comment:
The title of the slide says The Country and Site-Level ICF Process, but the process that is being reviewed is the Finalize & Manage Informed Consent Content process.  Please make sure the title matches what is being reviewed.  Or the title could just say Process Overview.


comment:
the voice over says site managers handle site-level changes....they also handle changes to the master (or country) ICFs...


comment:
Regarding the title of this page, I think it should be process overview cont.


comment:
In the Develop Master Informed Consent activity, it discusses that addendum ICFs and assents some times need to be developed and as a result site managers do the following....they do the following regardless if assent or addendum ICF is needed.  I think you need to get rid of the first sentence and say site managers complete the following or something like that.


comment:
Identify Informed Consent Forms information: you don't need to define ICF again.


comment:
Develop Site INformed Consent - same comment as was mentioned for master informed consent form.


comment:
The first sentence seems like it needs to be broken out into 2 sentences.  Country-level ICFs are created to ensure local requirements are included in the ICF (or something like that).  Country-level ICFs are updated when requirements change, protocol amendments and/or risk profile updates occur and when changes occur at the local level.


comment:
I wouldn't say local site managers.  I would say Site Managers


comment:
She's about to meet a new Site Manager who has questions vs. who may have questions


comment:
country-level ICF in the response vs. country level...please ensure consistency throughout the course


comment:
Think about what could happen if you copy and paste the wrong information into the ICF.


comment:
CRP/CRS/CP - please check throughout course


comment:
They can ensure the TCED is revised if needed.


comment:
Who is your site team?  I think we may need a different role to include here


comment:
If the Study Manager is unsure of where to find the missing information, they can reach out to members of the study team as needed.  The Study Manager can also reach out to the Trial-Level ICF Writer if updates need to be made to the TCED.


comment:
I think I will be better prepared going forward.


comment:
For more information on the TCED Template, it seems like some language is missing....use this document to help guide you when pulling language from the protocol to create your ICF?...


comment:
check the font for the more information - I think Risk Profile is different


comment:
Under Risk Profile - Describes the risks for the Lilly drug/device.  The risk profile is useful if a TCED was not created for the trial.

Not sure how this sentence fits here: It is not needed if there is no CS-ICF template.  I think this should be removed, please ask SMEs.


comment:
Non-Lilly Risk Information - Check Font

This information contains the risks for non-Lilly drugs/devices used in the trial.  The non-Lilly risk information is only needed if a TCED was not created for the trial.


comment:
Is Content Elements Document supposed to be the Elements for Consent Content Guidance required tool?  if yes, please include the full name in the icon as well as in the information box that pops up.

This required tool is needed when a Country-specific ICF (CS-ICF) template does not exist for a country.  This required tool provides information that needs to be included in a template.


comment:
Should be country-specific ICF template or CS-ICF template.  please check throughout course and ensure consistency


comment:
Change Content Elements Document to Elements for Consent Content Guidance required tool.  please change throughout course


comment:
Response re-wording: That's right!  If a country-specific ICF template is available, use the protocol, protocol amendment, quality review checklist, negotiation guidance document and risk profile as needed to create the ICF.  You should not need the Elements for Consent Content Guidance required tool in this scenario.


comment:
In the title for this slide, it should be: Which Documents Do I Need: No TCED or CS-ICF Template


comment:
If a TCED and country-specific ICF template are not available for use, what are some of the documents you may need to create a country-level ICF?


comment:
the cover letter should be listed as Cover Letter to Distribute Trial-Level Documents required tool in the answers and response.


comment:
That's right!  You'll need the TCED template, risk profile, non-Lilly risk information and the Elements for Consent Content Guidance required tool if a TCED and country-specific ICF template is not available for creating the country-level ICF.  The Cover Letter to Distribute Trial-Level Documents required tool will not be helpful in this scenario.


comment:
Update slide title: Which Documents Do I Need: No Country-Specific ICF Template


comment:
Actually for this scenario, the title of the slide should say No TCED vs. No Template


comment:
If a TCED was not created for the trial but a country-specific ICF template does exist, which documents are needed when creating the ICF?


comment:
This scenario is the same as the first one...I think you want to change it to no CS-ICF exists but TCED does....if yes, change the question and response.


comment:
Creating Country-Level ICFs with a TCED in the title vs. Country Level ICFs


comment:
CRP/CRS/CP vs. Trial CRP above the avatar


comment:
Do you remember Phoebe from earlier in the course?  She has received several requests for edits to her ICF.


comment:
I just received a request for a change to my site-level ICF from an Ethics Review Board (ERB).


comment:
I think we should be using the full name of the Negotiation Guidance Document here since it's a quality document: Informed Consent Negotiation Guidance Document required tool.  Maybe you can spell out first and then shorten throughout course after defined.


comment:
Be clear about why you are suggesting an edit to the suggested change.


comment:
....around local privacy laws to ensure this is understood....

...about my edit to your suggested change.


comment:
not sure you need to capitalize regulatory authorities here?


comment:
in the response, the site was identified as able to stop the study participant's participation in the trial...not stop the trial...


comment:
I just received feedback on withdraw of consent and samples from an ERB.


comment:
If you withdraw your consent, your samples will be destroyed.


comment:
I am fairly certain that our requirements around withdrawing consent and samples is different from the language that the ERB is requesting.


comment:
taken prior to the study participant withdrawing may still be used by Lilly unless the revoke their consent.  The suggested language must be further negotiated.


comment:
If you are a good communicator, regulatory authorities, ERBs and/or sites who request changes to ICFs will be much more likely to work with you on the requested changes.


comment:
Requests from Stakeholders....I am not sure I would call these people stakeholders.  Maybe just title this section Requests for ICF Changes: Introduction?


comment:
When creating the ICF, you may need to negotiate with different people involved in the process.  Sometimes changes may be approved without any questions or concerns, but at other times, you may need to negotiate when changes cannot be fully approved.  Phoebe just received an email from an ERB who wants to make changes to her ICF, and Phoebe may need some help.


comment:
Can you explain why you refused to negotiate the change?


comment:
The CRS for the trial mentioned that you contacted him to discuss a change requested to the ICF.  I also heard that you involved the local CRP.  I want to thank you for being absolutely clear on whether or not the change could be made.  Way to go!


comment:
I have a call scheduled in a few minutes with the regulatory authority to discuss a potential change to the ICF.  Let's see what change they would like to make.


comment:
Regulatory Authority Request vs. A Regulatory Authority Request


comment:
Regulatory Authority Request: Meet Rodrigo


comment:
if a study participant suffered these symptoms, this could result in serious risk to the study participant and legal action towards Lilly if this risk was not included in the ICF.


comment:
I have a call scheduled with the study coordinator at a site that would like to make a change to their ICF.


comment:
in some of these instances we would receive the changes via email....


comment:
Thank you for letting me know your site has a change they would like to request to the ICF.


comment:
Thanks, Phoebe.  The language we are concerned about is in regards to blood draw risks.  We want to remove reference to the risks altogether as they are standard of care and most study participants are aware of these risks anyway.


comment:
I heard from Matt, your study coordinator.  He said that you refused to work with him to make adjustments to the blood draw risks included in the ICF.  We need to negotiate this language, so we can obtain approval for this ICF quickly and avoid delays.


comment:
The CRP for the trial reached out to me because he found out that blood draw risks were removed from the ICF.  He understands that these risks are not serious but believes Lilly could be at risk if something goes wrong during the trial.  You should have discussed this request with your CRP.


comment:
In the examples, I would just say CRP or CRS and not have The CRP or THe CRS


comment:
I am reaching out to let you know that I am impressed with how you handled the blood draw risk situation with the site.  I heard that you worked with the CRP to adjust the language.  Both the CRP and site are happy with the language in the ICF, and the site is glad that you are willing to take their suggestions seriously.  Way to go!


comment:
Instead of stakeholders, I would say All of the parties involved in the ICF process are pleased with how Phoebe negotiated with them.  Way to go!  

Remember to keep these tips in mind when negotiating:


comment:
cover letter should be lower case in the responses


comment:
That's right.  The cover letter is not shared externally.  Phoebe should pull the appropriate information from the cover letter and provide to the site in an email.


comment:
After she drafts an email and obtains approval from the Study Manager.


comment:
Not quite.  Phoebe should reach out to the site as soon as possible, but no later than the deadline provided in the cover letter to ensure they have plenty of time to obtain approval from regulatory authorities and/or ERBs.  This could take some time, so the sooner the site receives the information, the better it will be for all involved.


comment:
use the full name for cover letter....Cover Letter to Distribute Trial-Level Documents


comment:
So there is no option to move regulatory authority into the email...but the response says that this is needed?


comment:
Hi, Phoebe.  I wanted to reach out and let you know that the site was impressed with how quickly you communicated the changes to them and that you included all of the information they needed.  Good work!


comment:
Should it be Maintaining the Site-Level ICF: Conclusion.  Please check your titles.


comment:
You should now have a better idea of what is needed to maintain your ICF.


comment:
Per the other courses, the process map names should be included in the purple box vs. the name of the course.


comment:
In addition, Lilly and the study participant's safety could be at risk if the ICF does not include correct information as well as information is not included in the ICF as the study participant would not be fully aware of what to expect during the trial.


comment:
Do we want to include the high-level process of Finalize and Manage Informed Consent Content or do you want to include the lower level processes where country and site ICFs are described? Develop Master Informed Consent and Develop Site Consent.


comment:
Prior to agreeing to participate in a trial, the study participants need to be informed about the possible risks as well as the possible benefits of participating in the trial.


comment:
The focus of this course is on the importance of ICF accuracy to prevent adverse impacts to study participants, sites and Lilly.


comment:
I want to know if I am going to receive real medicine in the trial.


comment:
I don't know if I want to sign up to participate in the trial if I will potentially receive placebo.


comment:
Where there are pauses in the narrative, can we re-do those?


comment:
May want to do a global find replace on Cdiff. We can confirm this later, but I believe we go with C.diff for consistency.


comment:
However, the negative publicity from the inadequate ICFs can sway public opinion against GSK.


comment:
May need to do a global find replace on Liat too. I believe it gets an R-ball every time.


comment:
May want to do a global find replace to put a space after the rball. This copied from excel weird.


comment:
The response needs rewording: If the trial is enrolling pediatric patients, a consent is obtained from a literate guardian of legal age.


comment:
I would change title of this slide to Case Studies


comment:
Regarding the statement in this slide around proper ICFs used....I think we should use the statement that study participants don't have all of the information they need to make an informed decision about participating in the trial vs. approval of the trial.


comment:
Upon being informed of the missing procedure in the ICF, the ICF was updated and study participants were re-consented.  If the ICF had not been updated, what could have happened?


comment:
Study participants are informed of risk before the trial begins as well as consent...


comment:
Case Study #1: Question #1...Case Study #1: Question #2...etc...


comment:
Not quite.  The ICF protects both study participants and the sponsor.


comment:
Move the : If you need to review the scenario....underneath Select all statements that are true....

Check for similar format on other screens for consistency.


comment:
I think it should say: This will have no impact on the study participant vs. this trial.


comment:
The study participant is unaware of the risks, and is therefore, not prepared for possible side effects.


comment:
The study participant may decide not to participate because they can't walk away from the trial and still need to come to the site for more procedures.


comment:
the correct answer should also mention that there participation is completely voluntary as this was one of the answers to select.


comment:
Potential slight re-wording to responses: 
Deviation must be filed internally.
Poor performance report for the individual that created the ICF.
Corrective actions assigned as needed.


comment:
Would we audit their other work?  is that what this is saying?  If yes, I would say:...audit performed of other ICFs, poor performance report, dismissal or other corrective actions pu tinto place.  If not, I would remove audit.


comment:
There are two key elements to the ICF process: the form and the discussion between the study participant and the site personnel.


comment:
Lilly can only control the information included in the ICF about the trial and drug.


comment:
For the pop up of the ipad, I want to confirm DSA can be leveraged via an ipad?


comment:
physician or site personnel or site staff?  we should be consistent.


comment:
...more effective than any other intervention in improving study participant comprehension during the ICF process.


comment:
to hear from a Lilly employee about the potential impact of ...


comment:
don't we include the process in the purple box vs. the course name as a practice?  please check the other courses and be consistent.


comment:
Errors or incorrect information in an ICF


comment:
8800 can't be alone. It must be cobas(r) 8800 System


comment:
Gantry is used in their literature a lot. I think techies know what it is. The smart waste disposal is a tiny rectangular door and not very visual. Let's just make the pop up box smaller.


comment:
Cepheid has 1-hour tests should be the right answer here. When I clicked it I got the negative feedback.


comment:
The feedback is generic, but I really need to see all the assay information before I write it.


comment:
Please add a yellow note to Roche here that we need the rest of the assay information to complete the table. Do the same on the next one.


comment:
Put a yellow note to Roche here that this section is where we will put the completed target statements for each competitor. For now it is programmed with placeholder text.


comment:
Need a yellow note here that we will need to decide what reference materials to use here.


comment:
please remove the guru link here, but leave the button. The link goes to the old game and will change.


comment:
on final menu view, need to change the clue cards at the bottom to the new Budapest clues.


comment:
Information Management needs to have a simpler definition.  This is very IT and most will not understand this. Needs to be in words we will understand.


comment:
Governance is another word people are not familiar with


comment:
Instructions say click Device. Which device? I see 3 (laptop is third)


comment:
Make sure the chat boxes don't cover up the text on the device


comment:
I'm not loving our definition of information management still.  It feels heavy and text-booky.  I found this definition for enterprise data management that was simple enough for me to understand.  Enterprise-wide management of data is understanding
the current and future data needs of an
enterprise and making that data effective and efficient in supporting business activities."  What if we tweaked it to information management and still included the three bullets in the definition on this page?


comment:
When I see True or False, I feel like I need to respond with one of those options.


comment:
Could the text on the phone read 'IT is responsible for information management' or 'IT is responsible for managing our company's information'?  It reads better to me and an added benefit is it might fit better and not look like it's under water!


comment:
I think I read somewhere that the devices would be highlighted somehow.  I think that would help.  I'm not against or opposed to the graphic.  I like the graphs in the background


comment:
Some people have had trouble with the hover working. Could be an issue with their laptop, but should we keep the hover or should we present this differently to avoid frustrations?


comment:
There is a typo on best practice #1....IF not OF


comment:
Prepare for the hand-off. We need to be more clear here on whether I'm moving into a role or preparing for someone filling the role I'm moving from


comment:
Instructions should explain that you have to click on each best practice to advance, since that is the logic


comment:
I think there is an assumption I'm supposed to get with moving to another role


comment:
Keep the best practice on the header of the example and definition or one way to know the value your information delivers ....blah blah


comment:
Make the story clear that you moved to a new role


comment:
It's difficult to read the table at that angle.


comment:
Kerning on phone is strange. Needs to be more legible.


comment:
T/F is confusing, because you don't have opportunity to respond


comment:
The numbers are difficult to read with the shadow on the font


comment:
Sensitivity of the hover doesn't work well in FF


comment:
Best practice #1, remove the comma after journey


comment:
Remove extra space on best practice #1 example


comment:
Best Practice #3 extra space after defined


comment:
Change "This will help the transition into their new role." to "This will help the new person transition into the new role"


comment:
Best practice #4 should definition say record? Should we word this differently?


comment:
Best Practice #4 is the example accurate to state each function has a central location? This is what we want, but we aren't there yet.


comment:
I feel like there are parts missing to this story.  For instance, why should I care about IM if I'm moving on?  What's the benefit?  After reading through a second time, I felt like it might even work better to say you're new on the job and the person who held your position previously left the job before you were hired.  Here are things you can do starting Day 1 to manage your information effectively or something like that.   It would also perhaps be more consistent with an empty desk!


comment:
'Here's an example of switching it to starting a new job..  just a thought. 
'Get to know a process from end to end, not just the part that you execute (or are involved in).  Understand the value of your information and how it is used in decision making for your function and the company.'   
For best Practice #1 -  
 I also don't think much needs to change with each statement.  There's a typo somewhere in one of the numbers but if we modify these statements I didn't think we needed to document.  I can if you need me to


comment:
Instead of 'Welcome' could we say something like Let's see how well you know the best practices!  It feels like it jumps into the game without explaining the purpose of the game.  Also, it says to click on Help as a reminder of game instructions but we never saw them to begin with.  Should the 'got it' button be enabled?

I wonder if they could make the windshield on the car less round to look more like a truck

I'm  not loving the computer's face... but I can live with it :)


comment:
HELP SCREEN - Kerning is terrible on this screen


comment:
HELP - We should add definitions and examples and questions so this serves as a reference for the answers to the game


comment:
HELP - 
Here are the instructions that I think need to be included before they start playing.   We should remove the comma between analyzer and 'and' in the first sentence.  The last sentence could read 'Complete a round of three questions to service the vehicle' .  And I think we should say something about there being three rounds to set expectations.

How do we feel about contractions?  I have mixed feelings.  It makes it less formal, more gamey but thought I would ask your opinion.


comment:
Should all the bottles have something on them?


comment:
Pouring action should be faster or something to speed up game play. I feel like I'm just waiting to be able to click


comment:
I need to know how many choices I need to pick on each question


comment:
How can I unselect something after I've poured it in?


comment:
Why doesn't the analyzer automatically analyze after i've selected the right # of answers?


comment:
There isn't an explanation at the beginning of the round which says what I"m getting ready to do. We need an explanation of each round.


comment:
WRONG ANSWER - "Text" needs to be removed from the chat.


comment:
WRONG ANSWER - It would be nice to know if it's partially correct or what is correct/wrong


comment:
WRONG ANSWER - We need to be coaching them and not focus on the exercise of clicking and dragging the right things to the truck


comment:
Since we only have 5 best practices does it make sense to only have 2 right answers per question in Round 1?


comment:
Can we take 10W40 off the oil because that's not the correct engine oil?


comment:
Shouldn't the "don't use the data if you can't verify the source" be a best practice?


comment:
Will non native English understand "purring like a kitten"?


comment:
There's too much space after the text on the banners


comment:
The options in this round were a bit difficult for me because they were a mix of the 5 best practices we landed on plus the best practices we had gathered from other places.  We wouldn't want someone to NOT do one of these things so by saying they are wrong, I feel like we are giving the wrong impression.  One example of this is on question 2 when one of the options was treat information as an asset or in question 3 one of the options is adhere to retention policies.  We absolutely want people to do these.  Could we make our wrong options less right?!  Maybe something like 'Standardize all of your data'.  We need to them to standardize only that which is the most critical.  Trying to do everything is overkill and none value add.  We can brainstorm these if you agree.


comment:
You are asking me the same question to many times because I'm picking from the 5 same things. Can we have 2 questions and only ask for each best practice once?


comment:
Having an explanation what I need to do at the beginning of the round would be helpful.


comment:
Can we specify how many options we need to choose at the very least?  Possibly remind them to click the little machine too?


comment:
I agree with Laura, this round seems hard to connect the dots between the scenario and the best practice.  I missed three questions right off the bat!  I'm wondering if we make it easier by saying pick the best practices that best applies?


comment:
If a question is answered correctly, we need a response of "You are a good steward"


comment:
This is the first time we see all 5 best practices to choose from. maybe a nice transition from Round 1 would have been ending on all 5 best practices


comment:
Without the details of all 5 best practices in front of me, I cant answer.


comment:
We need to do more at the desk to help teach, based on seeing the best practice that one time, I cant recall the best practices.
It feels like it goes straight into quiz mode


comment:
We need to explain why these best practices are correct.


comment:
Why do I have to redo the same questions that I got right? Why not redo what I got wrong?


comment:
We need to explain the 3 xs and the reset


comment:
Why doesnt it tell me that Im wrong as soon as I put the wrong answer in?


comment:
Click me to continue on the analyzer should include the text bubble


comment:
When I put the answer in it doesnt tell me why its right
When I put the wrong response in it doesnt tell my what the right answer is


comment:
We need to be teaching more&I feel like this is typical CLC content


comment:
Beef up the training part so I can learn something, I havent yet found the game


comment:
The car coming in/out and the analyzer smiley isnt exciting enough.  The car sits in the garage the whole time


comment:
Its a hard topic to quickly grasp, if you dont make it fun enough or make it mandatory people wont take it


comment:
If I knew my wrong answers were damaging the truck, I would take more care to get the right answer.


comment:
WRONG ANSWER - The fire puts itself out immediately


comment:
It would help if the featured best practice was on the screen somewhere


comment:
I think selecting two right answers out of the five is good and would work for all questions, all rounds if we needed it to.


comment:
ROUND 3 - The tenses used for the scenario are different than the options.  Could we modify one to be consistent?


comment:
ROUND 3 TYPOS - Scenario has misspellings.  Should read 'As a material planner, you are reviewing lead times for each supplier. '

Misspelling in option 3 of the answers.  Should read 'Find out the monetary implications of a longer lead time'


comment:
PLAY AGAIN - Play again is intuitive, but exit isn't


comment:
PLAY AGAIN - This is just a training game, we want them to have fun and know the answer. This isn't compliance training.


comment:
What options are available if I don't want to play again?  I missed this screenshot but there were no other options!  Could I print the certificate even if I missed some or do I have to acheive a certain level?  What are those levels?  I got 7 wrong overall (don't laugh I was purposeful for at least 1 of those!).  I like how I got a 'rusty under the hood' or something like that.  Can we tie this back to the begining maybe in the instructions to say the goal of the game is to acheive super mechanic (or something) status and here are the levels?


comment:
Other example to consider&you are creating the part data (you are responsible for creation of data) how are you failsafing your processes?   How do you keep up with workflow changes as they are updated? Are you periodically verifying?


comment:
We shouldn't have the concept of if you miss 3 you have to go back.  Why not if I miss it explain the correct answer and go on?


comment:
Same comments as Refill course (Beta).
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:
2nd bullet under Alarms "Program Low Reservoir Alarm Volume"


comment:
Same comments as Refill Course (Beta).
Update Drop-down List pop-up verbiage. There is no arrow shown on the right-side of the drop-down list we are showing (I don't think there are any arrows for drop-down lists in the ISR application) so the sentence doesn't make sense. Maybe state "A list of values appears when a button with multiple options is selected."


comment:
Agree with Sonja - timing is off (entry of 4.0 mL should start at 00:10). At 00:07, it states "...and set to the desired value." Since we just stated that, at 00:10, should we say "In this example, we set the reservoir alarm volume to 4.0 mL."? Otherwise, it seems as though we're restating the same information.


comment:
Agree with Sonja, either show a split screen or cut to the programming head footage at 00:17/00:18 and then back to the programming screen at 00:22. Delete 00:28-00:34, the footage isn't necessary.


comment:
Steps 6 and 7 sound almost identical to me, except for the word "examination".  Is this verbatim what was in the book?

Also change "testing to test susceptibility" to "Testing for susceptibility"


comment:
Clinician "interprets" the report - subject verb agreement.
Question for MSA:  For step 11, can we change this to "Clinical implements the appropriate therapy or triage of the patient"?


comment:
What if we have a special box for the references to the case study.  This one could say something like, "In the case of Juanita, hospital protocol dictates that she should be tested for MRSA colonization."


comment:
Another special box for the case study, where it says that they took a nasal swab from Juanita's nose.


comment:
I like the way this screen is phrased.  It separates the case study from the generalities


comment:
Is the first bulletpoint correct?  The main goal is to minimze the time between collection?  Or is there something missing here... between collection and ______
Second bulletpoint is not a sentence


comment:
Can we make sure that the language here matches the language changes we made earlier in the module?  For example, I think we changed clerical staff to healthcare professional, among other changes


comment:
I don't think we ever explicitly mention that specimen size is an important characteristic.  We should either take it out of the list here or put it in earlier in the module.


comment:
The case study should be in its own box.  And for Chromogenic agar plates, I don't think the goal is to isolate a colony.  Maybe in the special box say something like, "In Juanita's case, the sample is streaked onto a chromogenic agar plate.  While typical conventional culture methods would require isolation of a colony for identification, the chromogenic agar plate will allow shortcutting of that process with its selective of differential agar that will indicate the presence or absence of MRSA without need for further analysis."  Please check this with MSA


comment:
Should we have this be a MRSA colonization example and have it go to the surveillance bench, to be consistent with our case study?  
If so, this example should come first (before the two others), and language should say something like, "Where should Juanita's sample be sent to?"  Followed by "Other samples are coming into the lab.  Which benches should they be sent to?"
Also, if we make this change, we should change wording of "Suspected Infection" to "Suspected Infection or Colonization"


comment:
I don't think MRSA would be collected on sputum sample or go to the respiratory bench.


comment:
Special box that says, "In the case of Juanita, the chromogenic agar plate is the only analysis that was needed."


comment:
Special box - Juanita was found to be positive for MRSA colonization.


comment:
Special box - "Juanita is only colonized with MRSA, not infected, so she does not necessarily need to take antibiotics."


comment:
Special box - "Though Juanita does not require therapy, she will undergo decolonization procedures to reduce the bacterial load on her body and prevent the spread of MRSA in the hospital."


comment:
Change "infection" to "colonization"
1.  The microbiologist wrote the final report, which indicated that Juanita is colonized with MRSA.
2.  Fine the way it is
3.  Delete
4.  Juanita was isolated and decolonized for MRSA


comment:
Or instead of deleting Number 3 say something like "No antibiotic susceptibility test was performed because Juanita is not infected, only colonized with MRSA"


comment:
This case study is a little confusing because I'm not sure whether we're about to see a surveillance example or a sepsis example.  Can we just take out all the words after "ICU"?


comment:
Audio: Pronunciation of 'Kefauver' - Harris Amendment act.


comment:
Navigation: hyperlink in the 'folder' button takes users to http://www.bottomlineperformance.com/clients/Lilly/NGD/SeeTheImpactICFs/Beta/ManageSiteInformation.pdf

Exists only in the border of the icon.


comment:
The first time ICFs is used, please write it out in full with the abbreviation in brackets.


comment:
If you define ICF in full in the previous slide, you do not need to repeat Informed Consent Forms here


comment:
Carlos:  Would suggest to move the bit about consent to the end of the first paragraph, i.e. 'Is there a penalty for leaving the trial?  I need the consent form to provide this information'.   Then the second paragraph would be:
I work full-time and can't afford to take time off work as a result of bad side effects from taking part in the clinical trial.


comment:
Sherry: Would suggest to use 'consent form' instead of just 'consent'


comment:
This is the first time I have seen this course and I struggle with the relevancy of the Thalidomide scenario to ICFs in trials, as the issue stemmed from off-label prescribing of a marketed drug.


comment:
Not sure why we call out the individuals creating the ICFs here....would use the same language as previously, i.e. Lilly, sites and the study participants.


comment:
In the pop-up answer, patients = study participants


comment:
Suggested re-wording of first part of the case:

The trial proposed a new wound healing technique and involved needle puncture.

Forty study participants from two medical centers participated in the trial.


comment:
The sponsor could also face action from the ICH GCP - what does this mean? The sponsor could face action from the regulators.....


comment:
Correct answer needs re-wording - the sponsor would not face violations from the ICH GCP, they would be in violation of ICH GCP.


comment:
I'm not sure I understand the rationale for including the second paragraph - the site owns the IC process and how they conduct that.


comment:
The male figure covers some of the text.


comment:
Again, would be consistent with who is impacted, i.e. study participants, sites and Lilly.


comment:
I would remove dismissal from the response. There are many steps in the ICF process before it gets to the study participant, e.g. quality review, approval, review & approval by the ERB...so I don't think dismissal of the ICF writer would be appropriate outcome here...


comment:
Since we are eliminating the video on the next screen, change the last sentence here to:  We all have a responsibility to make sure out plant is the safest around, because if we don't, we risk hurting ourselves and others.


comment:
Delete this slide.  They will not be putting in a video.


comment:
Can we change the expression on the startup approver on the right to the "happy neutral"?  This one looks scared.


comment:
Change the last sentence here to:  ...select your role below for the information you need to ensure safe startups.


comment:
Just so you know - I am going to check with Adriah to see if there is a picture and quote we can put in here to replace the video.  We added one to Jackie's course and I think it would be good reinforcement.  Instead of deleting - add a yellow note to mosaic that says:  Note to Mosaic: This is a placeholder slide for a photo and quote from an area or company leader stressing the importance of following the standard.


comment:
Also eliminate the play button and the learning agent's text bubble.


comment:
When I pressed the PREV button to come back to this slide, the field observer character was gone and in his place was the grayed out placeholder we used for the DP.  Need to have the characters grayed if they've been selected.


comment:
The photo used as the background on this slide seems to have a thick white frame at the top, and the top of the learning agent's head goes in that area.  Can we use the whole photo in the space for the background?


comment:
The Granulation guy's head is not lined up with his body.  Can you shift it a smidge to the left?  LOVE LOVE LOVE his look!


comment:
Change first paragraph first sentece to:  Leadership in other areas of the plant ensure their people are safe so startup can occur.


comment:
The character image has some shadow on her neck that looks odd.  Can you fix?


comment:
Change the sentence (1st paragraph) to:  The Sulfuric Operator completes the site pre-startup checklist and make sure proper approvals are obtained before starting up the plant.


comment:
I think I'd like to see some indication of which answers are correct, too.  Can we add a green checkmark to the correct answers when the feedback pops up?  I'd like that for all of these types of questions.


comment:
Why does the PREV and NEXT buttons appear here?  They are not on other screens.  Other screens have the continue button.  Need to be consistent for this section.  The NEXT button should not be active at all.


comment:
Change 1st sentence in first paragraph to:  The Field Observer records and communicates stack and plant conditions to the Sulfuric Operator during startups. This includes SO2 levels downwind of the plant (including zero readings) and the time of his observations.


comment:
Nit picky - the white feedback box doesn't quite cover the green box underneath it. Can you please fix?


comment:
I notice that some feedback is so long that we don't show the original MC options.  For consistency throughout this activity -- IGNORE my previous feedback about the checkmarks on the right answers, and just ensure that the MC options are NOT shown when the feedback appears.  Feedback screens should look like this one.


comment:
No PREV and NEXT buttons should appear here.


comment:
Change first paragraph to:  The General Manager and Sulfuric Area Manager ensure that the Sulfuric Startup Standard is applied at their location, and uphold the requirements set forth in the Standard itself. They approve sulfuric plant startups when the plant has been down for longer than 30 minutes and occurring between sunrise and 11:00am or at shift change.


comment:
Now that I noticed it once, I see it on others.  Do a quick check of the feedback boxes to make sure they completely cover the green button underneath.


comment:
After I viewed the GM/Sulfuric Area Manager and come back to this screen, the character should be gray.


comment:
Can we have the underlined "inversion" link to the term in the glossary?  If not, can we create a rollover instead and pop up the definition?


comment:
When we refer to the Standard, should be an uppercase S.  Do a global search and replace to fix.


comment:
Remove the extra space after the end of each sentence (should only be one space).


comment:
Change 3rd sentence to "...traffic into the plant"


comment:
On the popup that appears for "Is Stack SO2>2000ppm" change "reached" in the first sentence to "reaches."


comment:
ON the popup that appears for "Is Stack SO2>2000ppm" change 2nd sentence in 1st paragraph to:  At that point, startup can continue following the normal startup checklist and SOP.


comment:
The Learning AGent is saying this, so the text should appear in one of the speech bubbles.


comment:
When I got to this screen after clicking PREV, my progress was not maintained and I had to do the activity over again.  If I return to this screen after completing it, the NEXT button should be active.


comment:
The first time on this screen, I should not see "Click Next to continue".  The NEXT button should also be grayed out and inactive until after the activity is complete.


comment:
On the popup for "Has the plant been down for >30 minutes" change the 2nd sentence to "...why the trip occurred and get the plant set up for startup again."


comment:
Are we planning on changing the net sales to include the $10,000 correction?


comment:
On the popup for "Use checklist and observer", change the 1st paragraph, 2nd sentence to: "The pre-startup checklist is developed by each plant and includes the minimum requirements.


comment:
On the popup for Use the Standard Start-up Procedure, capitalize "Standard Start-up Procedure" in the explanation and make sure Start-up is hyphenated.


comment:
Changing continent to region in the paragraph would be good so that there is no confusion in the future of what we are talking about when referring to region. Puts them in the right mindset from the start


comment:
When I clicked the PREV button to get here, my progress was lost.  Should maintain the checkboxes indicating completion.


comment:
On the incorrect feedback for "How can you tell?" Let's not make them try again.  Instead, let's provide the following feedback:  Actually, time of day, stack dispersion, and changing weather can all indicate a risk of inversion.


comment:
For the Who Do you ask? question, incorrect feedback should have learners try again.  Add "Please try again." as the last sentence.


comment:
The feedback that should appear when I click the "use standard Start up Procedure" is "This is not the correct decision point. Please try again."


comment:
I noticed that the feedback for all of the decision points after the "You find out from Jack that yes, unfortunately..." question goes to the same (previous screen's) incorrect feedback.  Make sure they all point to "This is not the correct decision point. Please try again."


comment:
Learning agent's speech should be in a speech bubble.


comment:
Change 3rd bullet on this screen to "...click the file cabinet icon above."


comment:
IGNORE my last comment and change the 3rd bullet to:  To view your other resources, including the Sulfuric Startup Standard, click the file cabinet icon above. Eliminate the last bullet.


comment:
Text in the first set of bullets under question 1 doesn't line up.  Granulation needs to move to the right.


comment:
Fix placement of Granulation guy's head.  Needs to move to the left.


comment:
Course title doesn't render when I click PREV to come back to this screen.


comment:
Add a final instructional bullet that says, "When you are ready to decide if it is ok to startup the plant, click the "I'm ready" button in the lower right corner of the map."


comment:
Sub title should say, "Put it all together"


comment:
I want the ability to go back into the map to review roles and responsibilities, but I can't get past the "Now you know a little more about the roles and responsibilities..." screen.  PREV button here should take you back into the map.


comment:
ON all maps - we don't label any of the other workers/positions, so please eliminate the "field observer" label from all maps.  Keep the dude and the truck.


comment:
I have already completed this activity, I should be able to click NEXT.


comment:
I already completed this activity.  I should be able to click NEXT.


comment:
If I've already completed this entire activity, I should be able to click NEXT to continue.  Also don't see the PREV button.


comment:
Change the first sentence to:  As the Production Supervisor on a weekend, you need approval from the GM or Sulfuric Area Manager to startup.


comment:
We don't have an end of course assessment. Eliminate this wording.


comment:
The previous comment was from clicking the pencil icon.


comment:
Change the 2nd sentence 1st paragraph to: If you need to review the questions and answers, click the paper icon below.


comment:
We need to have this open a page that shows all the questions and answers from each person on the map. Is this something you can easily create?


comment:
The text in the large white box on this screen should be a speech bubble.


comment:
For this scenario, the correct answer to "Can you start up the plant?" is NO.  Feedback for Yes should be "Actually, you can NOT start up the plant."  Feedback for NO should be "Good job!"


comment:
I selected the three correct answers here, but received the Incorrect feedback.  I think they are switched.


comment:
Eliminate the "Pass the course assessment" unless this is the standard?  We can add instructions to the Put it all together scenario at the end if needed to make this an assessment.


comment:
Add to the text, "But what is an inversion exactly? Click the Play button to find out more."


comment:
Learning agent text should be in speech bubble.


comment:
In the 2nd paragraph 2nd sentence, say "You'll have the same resources to help you make your decisions."


comment:
On instructions, change "share with them" to "share with him"


comment:
Global change for this activity:  Change instructions to:  "....Share information button to identify information to share."


comment:
Shadow bugs me on character.  Looks like it cuts off part of her chin.


comment:
Change the first option in the MC to :There's likely going to be a startup.


comment:
Eliminate the extra period after 1000ppm.


comment:
Change first MC option to "There's likely going to be a startup."


comment:
Course title didn't render on this screen.


comment:
Change the first MC option to "There's likely going to be a startup."


comment:
Need to link to a page with all questions and answers here.


comment:
This screen should be the same as the last instruction screen for the previous scenario.


comment:
Course title not rendering on this slide.


comment:
All buildings on the map are gray. When I click them, it is the information from the previous scenario. Needs to be updated with info from the final scenario in the PPT.


comment:
Feedback is reversed.  In this final scenario, the plant cannot be started up.


