Verify a subject's data

If Source Data Verification (SDV) is required in your study, then you must perform this task to make sure the data collected during a study is accurate.

You can verify forms and questions in any started or skipped visit, irrespective of the visit's status in the system, whether it's complete, in progress or incomplete.

WARNING:

If a response to a question is updated on a form or visit that is already verified, that question becomes Unverified, as well as the form and visit. In order to complete SDV and return the question, form and visit to a Verified status, you have to re-verify that question to validate the latest information.

To understand how the SDV status can change for a form, visit or question, see About Source Data Verification statuses.

Before working in this task, be aware that if SDV is turned off in the study settings, you will not be able to perform SDV. The Ready to Verify filter and the button to Verify Visit Data won't be available even if you have the appropriate permissions.

For more information about SDV settings and use cases see Understand source data verification.

Also, consider that hidden questions with data classifications may also require verification. Only the users with the appropriate permissions to see the classified data will be able to verify it.

Note:

For users that are not allowed to view classified data, it may happen that a form or visit has a Verification Required or Unverified status even when they see all data within as verified. This would indicate that the data that is pending verification is classified and another user with the appropriate permissions must do it.

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

  1. From the Home page, Access your study in a specific mode.
  2. If you have access to multiple sites for the study, select a site from the Site drop-down.
  3. From the All reviews drop-down, select Ready to Verify to filter your search for subjects who need to be verified.
    The filter results only display visits that have been started and include at least one question requiring verification (that is not under a status of Verified).
  4. Locate a subject in the table, and click to open the visit to be verified.
  5. Review data entered for the visit by scrolling down the forms. See Review the data collected for a subject.
  6. Along the top of the page, click Verify Visit Data.
  7. There are two ways for you to verify data:
    • If you want to verify a certain question, select the checkbox next to that question.
    • If you want to verify an entire form, select the checkbox next to that form, on the left.
    • If you want to verify all forms and questions from a visit, select the checkbox next to the word Forms, on the left.

      Note:

      When you check the form-level or visit-level verification box:
      • Only the questions that are visible to the user will be verified. Hidden questions will not be verified.
      • If overrides are not allowed, only the questions that require verification will get verified.
      • Read-only questions are never verified.
  8. Depending on how the study's targeted source data verification strategy is configured, you may see three types of indicators for questions that need to be verified.
    • Bold check box: Verification is required for this question.
    • Simple check box: This is only available if study allows SDV overrides and means verification is optional.
    • Simple check box with a Targeted SDV icon(A target pierced by an arrow, meaning Targeted SDV.): This only displays if study allows SDV overrides and means this is a critical variable question but SDV is optional because the subject is not part of the targeted SDV subject pool.

      Critical variables are only required for subjects selected for the targeted SDV subject pool as per the SDV strategy. You can verify this question if you wish knowing it is a critical variable, even though it is not required for this particular subject.

  9. In the lower-right corner, click Verify or Verify & Close.

All verified questions display with the verified icon (Verified icon is a green check mark) next to them. The same icon appears on the visit tile for a verified visit, in the Answer & Visit History and next to each subject if all of their data has been verified. All verification records in the Visit History are attributed to the user who performed the SDV.

Need more help with icons? See What does each icon mean for signing, verifying, or freezing data?

Related Topics

Parent topic: Monitor subjects and sites