Verification is a tool that allows monitors, sponsors, or data managers to mark data as verified. The verification tool can be given any meaning desired by the study, as it can be named when setting up the study. Could for instance be: Monitored, Source Data Verification (SDV), or reviewed. Depending on what is needed in the study. 

When creating a study or editing an already existing study, you can add up to two verification types. These work exactly the same way, but make it possible to distinguish between the two verification groups. This can be useful when study personnel with different roles in the study has to verify the data independent of each other.

Any user with the appropriate permission (Verification) can verify and unverify data points in the study.

Currently, it is possible to verify and unverify the following:

  • Individual questions (regular events and unscheduled)
  • Entire forms (regular events and unscheduled)
  • AE reports
  • Medication
  • Medication Accounting

Verifying anything will either put a logo with a tooltip or a banner, containing information on who verified it and when. Depending on the granted verification permission, the banner will show either a green or blue logo.

Verification cascade:

Verifying a single question in a form, will mark the form as partially verified, which in turn will mark the data event as partially verified.

If all questions in a form are marked as verified, the form will become fully verified.

All forms must be fully verified in a data event, before the data event is marked as fully verified.

Editing a question will remove the verification from the question.

If a question in a fully verified data event is edited, both the data event and the form containing the question will go from fully verified to partially verified until the question are verified once again.

Verification status is visible on data events in the site overviews and on the ‘form tab’ inside each data event. On the image below, V1 is partially verified and V2 is fully verified. Indicating that all forms/questions in the particular data event have been answered.

In the overview of a data event, the top bar shows the forms included in the data event and which of these forms are partially or fully verified. 

Above it is showed how the verification will appear for partial and full verification, respectively.

How to verify:

  • AE reports can be verified when viewing the full report. (Can only be fully verified)
  • Questions + forms can be verified when viewing form answers
  • Medication + medication accounting can be verified from the list view (Can only be fully verified)
  • Verification of individual questions can be found in the action buttons, the same place where queries are raised.
  • Verify and unverify button is visible in AE reports and on whole forms.

Clicking on a data event where a question has been verified will show verification statistics for the given data event:

Verification percentage is calculated based upon how verified each form is within the data event, no matter the number of questions in each form.

Meaning that in a data event with two forms both with 50% verification, the verification percentage would be 50%. Additionally, it will show the last person to have verified a question or form in the data event, along with when clicking on the bar with the percentage.