View CRF version history per site
In eClinical, CRFs are designed and maintained in the Study Designer (SD) application and then populated to EDC for data entry. Each time there is a need to implement changes to the CRF, a new CRF version is created in SD. Then, in EDC, you can upgrade the CRF version for sites or subjects to keep the system up-to-date.
Keeping track of all the CRF versions throughout a trial is vital for compliance reasons. Thus, in EDC, you can view the history of the CRF version changes per each site, who performed them, and when.
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In the EDC application header, select the STUDY INFO tab.
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On the page that opens, in the left pane, select CRF Version > Version Upgrade.
Figure 1. Accessing CRF version upgrade
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In the Version List table that appears, locate the site for which you want to see the CRF version history. Then in the Action column next to it, select History
.
Figure 2. Accessing CRF version change history
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In the Change History dialog that appears, view the CRF version change history as explained in the following table.
Figure 3. Viewing CRF version change history
Column
Details
Modified By
Represents the name of the user who has performed the CRF version change.
Modified Time
Represents the date and time when the CRF version change has taken place.
Last Version
Represents the CRF version of the site before the change has taken place.
Current Version
Represents the CRF version of the site after the change has taken place.
OK
Select
to close the dialog.
Once the change history has been studied, the dialog is closed and you return to the Version List table.