Source Data Verification status can be reset from verified to unverified either manually by user with appropriate permissions, or automatically by the OpenClinica software under certain conditions. Once marked as unverified, the CRF can be verified again at any time. The Study Audit Log tracks any change in Source Data Verification status for a CRF.
- Manually: To manually change the Source Data Verification status for any CRF, in the Source Data Verification page, click the SDV Complete icon in the SDV Status column:
- In the Source Data Verification By Event View, you click the icon for a CRF. After you click the icon, it becomes a checkbox, and the CRF is no longer reported as verfied.
- In the By Subject View, you click the icon for a Subject to reset the SDV Status for all CRFs for that Subject. After you click the icon, it becomes a checkbox, and all CRFs for that Subject are no longer reported as verfied.
- Automatically: The OpenClinica software automatically resets the Source Data Verification status for a CRF from verified to unverified in these cases:
- When the CRF data changes
- When an Annotation Discrepancy Note is added to the CRF