Re-verify a subject's data

If a response to a question is updated on a form or visit that is already verified, that form or visit becomes unverified. In order to perform source data verification, you have to re-verify that form or visit.

Consider the following before re-verifying a subject's data:

• If verifying subjects' data is required in your study protocol and data is updated after you've already verified it, then you need to re-verify subjects' data at some point during the study conduct period, to validate the latest information. You can verify questions and forms that are associated with incomplete visits, irrespective of a visit's status in a system (whether it's in progress, incomplete, just started, or completed).
• If a site user removes a completed and verified repeating form instance, that visit and repeating form table become unverified and you must verify the entire repeating form again.
• A visit may have two consecutive Verified and Unverifiedrecords in the Visit History due to changes such as:
  • A subject is selected for SDV after the visit has been verified.
  • A new dynamic question or form requiring verification is added to the visit, after the visit has been verified.
  • A trigger question which does not require verification is answered, which prevents triggering a child form. The response to the trigger question is eventually changed, which triggers a child form with at least on question that requires verification.

Want to see how to perform this task? Watch the video below.

1. On the Home page, determine where to work:
   • To work with real data in Production mode, click the title of the study.
   • To work with mock data in Training mode, click the Training Mode button ( ) on the study.
2. From the View drop-down, select Ready to Verify to filter your search for subjects who need to be verified.
   The filter displays all visits that have at least one question requiring verification, which has not yet been verified. However, you can also verify data associated with incomplete visits.

   Note:

   If SDV is not turned on in the study settings, the filter will not be available.

   Note:

   In order for the filter to display results correctly for an existing study, a user must first open a visit.
3. If you have access to multiple sites for the study, select a site from the Site drop-down.
4. Locate a subject in the table, and click a visit in the Previous Visit column that contains the unverified icon ().
5. Along the top of the page, click Verify Visit Data.
6. There are two ways for you to re-verify data:
   • If you want to re-verify an entire form, select the checkbox next to that form, on the left.
   • If you want to re-verify a certain question, select the checkbox next to that question.
7. Depending on how the study's targeted source data verification strategy is configured, you may see two types of check boxes for questions that need to be verified.
   • Questions with an outlined check box: it is mandatory for you to verify these questions
   • Questions with a simple check box: it is up to you whether you want to verify these questions or not
8. In the lower-right corner, click Verify or Verify & Close.

All verified forms and questions appear with the verified icon () next to them. The same icon appears next to each subject if all of their data has been verified, as well as in the Answer & Visit History.

Figure 5-3 How a Clinical Research Associate sees a visit that they need to reverify

Need more help with verifying data?

What does each icon mean for signing, verifying, or freezing data?