Enhancements to Source Data Verification (SDV)

Sponsor users can now perform Source Data Verification (SDV) more efficiently on questions, forms, and visits using an enhanced status filter, a new status icon, as well as other changes to the behavior of the SDV functionality.

Adjustments to the SDV filter

The SDV status filter has been adjusted to make it easier for you to spot visits with outstanding SDV:

• Visits which have a status of Not Started are not included in the results when filtering for the status Ready to Verify.
• Existing subjects continue to function as they did prior to the upgrade: visits which have not been verified will not have a status icon, regardless of whether the subject has been selected for SDV. The status icons associated with all visits for a subject will be refreshed once one of the following actions is performed:
  • A user accesses a visit.
  • At least one question is unverified due to data change.
  • A subject previously with a status of No SDV Required is selected for inclusion in the SDV pool. For more information, see How do the source data verification settings work together in a strategy?.

New icons in the Subjects panel

Two new icons have been added, making it easy for you to identify items that require SDV:

• A new Verification Required icon (
  
  
  
  ) has been added to help identify visits with outstanding SDV.
• A new Targeted SDV icon (
  
  
  
  ) has been added to help identify questions which have been marked as Critical Variables, for subjects which have not been selected for the SDV pool. For more information about how subjects are selected for targeted SDV, see How are subjects randomly selected for targeted source data verification?.

Already working in a live study?

As soon as the upgrade is complete, if your study uses SDV strategies, you can start making use of these new enhancements. You can find additional information in the Sponsor and CRO User Guide after the Release Assessment Environment (RAE) upgrade.