Term
| What center milestone needs to be updated since you are no longer able to manually change the center status from "active" to "concluded"? |
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Definition
| LSLV (also called Study End or SE in eTrack) |
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Term
| Where can you find information about the IP app? In what situations would you most likely find this app to be helpful? |
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Definition
| Link to IP app: AMTS --> other monitoring materials; bulk return |
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Term
| eTrack MVR Question 01.00 = No - what should be discussed in the comments section? |
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Definition
| Is Principal Investigator (PI) oversight of site activities in this trial adequate? Describe any changes and applicable action plans |
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Term
| Which of the following eTrack roles gets pulled into the MUL and therefore gives them access to myLesson? Primary Coordinator or Coordinator or Coordinator/Sub-I |
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Definition
| All three - Primary Coordinator, Coordinator, Coordinator/Sub-I |
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Term
| CDs of the standard training modules are no longer available for free - what should you do? |
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Definition
| 1) myLesson, 2) download the files and send by e-mail |
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Term
| Where do I find the URL that will take me to the Study Portal? |
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Definition
| eNavigator – Quick Links – System Links |
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Term
| Is the Study Portal “live” for our sites? |
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Definition
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Term
| I need to locate my study in the Study Portal, what identifier do I use? |
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Definition
| It is only the 6 digit numeric portion of the study ID e.g., “100601” |
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Term
| There appears to be an error with some data in the Study Portal, how do I fix it? |
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Definition
| Go to the “source system” and make your correction there |
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Term
| Where can I find the eDX User Guide? |
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Definition
| The eDX Information Page – Essential Tools |
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Term
| eDX requires that all users be trained before access is granted – how do my sites receive their training? |
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Definition
| The minimum training that is required is to view the 14 minute video |
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Term
| You need to know if your site is using our electronic regulatory document repository. What is the name given to this repository, and where would you look to determine whether it is being used for this site? |
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Definition
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Term
| How do I name reports in eTrack? |
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Definition
| By using auto-population feature (need to pick activity type and report #, then click save). Since all of the words in auto-populated visit name are without spaces, the monitor is expected to put spaces between them, however, if report is submitted without added spaces, it is not expected to be returned for that correction. |
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Term
| Where do I find the list of master agreements with us? |
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Definition
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Term
| What are the two main reasons why users at not being pulled into the MULs? |
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Definition
| Phone # or email or both are missing |
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Term
| My LCRA/CSA hasn't provided me with the latest MUL. Where do I get it? How do I check whether my user pulled over into the latest MUL? |
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Definition
| Go under InForm community --> InForm Links (on the bottom of the web page) --> MUL library |
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Term
| If the site is asking for external auditor access to InForm, what options are available? |
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Definition
| For auditor to view InForm data over site staff shoulder or if the date of the audit is known several weeks in advance, site can request a copy of a CD with all of the subject data pulled from InForm. |
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Term
| I cannot see a user in the eDX permissions app. Why? |
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Definition
| Check both provisioned and non-provisioned users before checking eTrack; 2) If the user is not in either category, check if user has email address listed and whether it's correct in eTrack. If unlisted or wrong, that might be the reason the user did not pull up into eDX permissions app. If present and correct, check if user is associated with a needed center. |
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