Add significant changes record to CRF version history
In SD, under the Version History subtab, you can manually add records of significant changes made to each CRF version. This comprehensive log helps with traceability and enhances control over the CRF design changes.
Important
You can add changes for each version only once. If needed, edit the existing record for the version or delete it to add new one from scratch.
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In the Study Designer application header, select the CONFIGURATION tab.
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From the left pane, select the Version History subtab.
Figure 1. Accessing CRF version history
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On the Version History page, from the workspace toolbar of the Version History Details block, select New Item
.
Figure 2. Selecting to add new version history record
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In the New Version History panel that appears on the right, complete the details as explained in the following table.
Figure 3. Adding new version history record
Tip
In the following table, mandatory elements are marked with an asterisk (*).
Element
Details
Version*
Select the unique identifier of the CRF version in the eClinical system for which you want to add the record of significant changes.
Only one record can exist for every CRF version.Version Name*
Enter the custom name of the CRF version.
This name has no system logic and only exists in the Version History Details table for user convenience in distinguishing between versions.Version Date*
Enter the custom date to outline when the significant changes were introduced to the CRF version.
This date has no system logic and only exists in the Version History Details table for user convenience in distinguishing between versions.Significant Changes*
Enter the summary of significant changes made to the CRF design that initiated the creation of the new version.
SAVE
Select
to implement the changes.CANCEL
Select
to discard the changes, close the dialog, and return to the Version History page.
Once saved, the new record is added to Version History Details.