Write and approve monitoring visit reports

1. 1

   Open CTMS > Monitoring and click New Visit Report.

2. 2

   Fill Site, Visit Type, Visit Mode and Visit Date, and optionally the times and the next planned visit.

3. 3

   Enter the metrics: participants and consent forms reviewed, queries raised and resolved, and the SDV target and actual percentages.

4. 4

   Add findings with a category, severity, description and recommendation.

5. 5

   Write the Report Summary and the Summary for the site, then click Create Draft.

6. 6

   Open the draft and click Sign and Submit, then sign with your password.

   The meaning is "I am the author of this monitoring visit report and confirm that it is accurate and complete."

Study Owners, Study Managers, Trial Managers and Administrators review submitted reports, but never their own. Click Approve and Sign to approve, or Return to CRA and say what must change. On approval, a follow-up letter is issued under Follow-up Letters (with Print) and action items are created for the site.

Statuses are Draft, Pending Review, Returned, Approved and Cancelled. A report counts as overdue after 10 business days without submission. Site staff see the follow-up letters for their own site.