View CRF version history for study
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 comprehensive history of the CRF version changes per each subject at all your study sites in one comprehensive report.
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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 History.
Figure 1. Accessing CRF version history
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In the Version History table that opens, study the comprehensive history of all the CRF version changes as explained in the following table.
Figure 2. Analyzing CRF version history per study
Column
Details
Site Code
Represent the code of the site to which belongs the subject whose CRF version history is shown.
Subject ID
Represents the ID of the subject whose CRF version history is shown.
CRF Version
Represents the CRF version that has once been effective for a subject and is now a part of the CRF versioning history.
Version Backup Date
Represents the date and time when the backup data has been saved for that particular CRF version.
You have studied the history of CRF versioning for our study.