Unsign CRF version
A CRF stands for case report form, a document used in clinical trials to collect and record study data. As the trial evolves, new insights or challenges may emerge, requiring changes to the CRF. These modifications, especially after data collection has commenced in the EDC system, lead to what is known as versioning. This process involves adapting the CRF to new protocol requirements or data collection processes during the clinical trial.
When maintaining CRF versions, you can sign them in any lifecycle. Signatures are often required to formally approve the CRF design and verify its suitability for the upcoming data collection phase. However, the signature you provide on the previously signed CRF version may no longer be required due to protocol amendments or other study-specific reasons. In such a case, you can unsign this CRF version.
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In the Study Designer application header, select the VERSIONING tab.
Figure 1. Accessing CRF versions
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From the workspace toolbar of the Version Information table that appears, select the needed lifecycle and role.
Figure 2. Selecting lifecycle and role
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In the Version Information table, next to the CRF version you have previously signed, select
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Figure 3. Selecting to remove signature from CRF version
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In the UnSign dialog that appears, enter the comment explaining the reason for unsigning this CRF version, and then select
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Figure 4. Unsigning CRF version
Once saved, the CRF version is unsigned.