Subject data can now be unverified

Sponsor users can now unverify data at the visit, form, and question level that may have been verified in error. This removes the need to manually track verification errors, ensures verification is conducted on the required visits, forms, and questions, and ultimately improves overall data quality.

Details for all users

At the visit level, the UnverifiedUnverified icon is no longer displayed. Instead, the Verification Required Verification required icon easily identifies visits with data requiring verification.

All questions with the status of Unverified and the related action are still displayed in the Answer History and Visit History sidebars, along with the user who performed them.

Details for sponsor users

As a Clinical Research Associate (CRA), you can now unverify data directly on a subject's visit page. This can be done at the visit, form, and question level.

To use this feature, you must have the permissions associated with verifying data assigned to your role.

To unverify data at the form and visit levels, the newly introduced Unverify option, accessible by selecting Verify Visit Data at the top, is only available if at least one question within the form or visit you are working on is verified.
  • You can unverify visits whose data is partially verified.
  • A reason for change is required for all actions of unverification.
  • If you unverify a question in a visit that requires verification for that subject, the visit status is updated to Verification Required Verification required.
  • If you unverify questions that do not require verification in a visit with a status of Verified, the visit retains its Verified Verified status.
  • If a question has been verified, but a change in study settings makes the question ineligible for verification, you can still unverify that question. For example, you can unverify a question with the status of Verified if SDV is turned off.

Impact on reports

As is the case with any other action that causes a visit, form, or question to become unverified, the new unverify feature is reflected in the following reports with no further changes:

Parent topic: Data collection