Unsubmit 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 unsubmit the latest one that has been previously submitted. This feature is used when some changes still need to be introduced to the CRF before it is published to EDC for data collection purposes.
Important
The CRF version can be unsubmitted only if it has not yet been published to EDC or pushed to UAT.
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In the Study Designer application header, select the VERSIONING tab.
Figure 1. Accessing CRF versions
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In the Version Information table that appears, next to the submitted CRF version, select
.
Figure 2. Selecting to unsubmit CRF version
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In the UnSubmit dialog that appears, enter a comment for unsubmitting the CRF version, and then select
.
Figure 3. Unsubmitting CRF version
Once saved, the CRF version is unsubmitted.