Verify a subject's data at a form and question level

If source data verification is required in your study, then you must perform this task to make sure the data collected during a study is accurate.

Note:

When you apply the Ready to Verify filter for subjects and you check the visit-level verification box, only the questions that are visible to the user will be verified. If the study is set up with to allow SDV overrides, the questions that do not require verification will not be verified since they will not be visible in this case.

Consider the following before performing this task:

  • Remember that you can verify forms and questions that are incomplete or that are associated with incomplete visits in the study.
  • A visit may have two consecutive Verified and Unverified records 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 ( graduation cap button ) on the study.
  2. If you have access to multiple sites for the study, select a site from the Site drop-down.
  3. From the View drop-down, select Ready to Verify to filter your search for subjects who need to be verified.
    The filter only displays subjects with visits that have been started and include at least one question requiring verification (which also does not have a status of Verified).

    Note:

    If SDV is not turned on in the study settings, the filter will not be available.
  4. Locate a subject in the table, and click a visit in the Previous Visit column.
  5. Review data entered for the visit by scrolling down the forms. To learn more about how to review data, 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 an entire form, select the checkbox next to that form, on the left.
    • If you want to verify a certain question, select the checkbox next to that question.
    • If you want to verify all forms and questions from a visit, select the checkbox next to the word Forms, on the left.
  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.
    • 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
    • Questions with a Targeted SDV icon(A target pierced by an arrow, meaning Targeted SDV.): if SDV Override is turned on in the study settings, you can verify these questions if you wish.
  9. In the lower-right corner, click Verify or Verify & Close.

All verified questions, forms, and visits appear with the verified icon (Verified icon is a green check mark) 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.