Sign off a participant's casebook as investigator

1. 1

   Open the Casebook and click Sign in the participant's Signature column.

   Hover over the button first to see how many forms are complete and how many queries are open.

2. 2

   In Investigator Sign-Off, check Outstanding items at time of signing: incomplete forms, open queries or unresolved adverse events.

3. 3

   Read the meaning: "I confirm that the data for this scope has been reviewed and is accurate to the best of my knowledge."

4. 4

   Tick the confirmation. If there are outstanding items, also tick the acknowledgment and write a justification of at least 10 characters.

5. 5

   Type your full name exactly as shown, enter your password and click Sign Off.

   You see "Sign-off recorded" and a green Signed off shield appears.

If someone changes the data after you signed, the shield turns amber with Signature broken: "Data changed after this signature." Click Re-sign, review the changes and sign again with the re-sign meaning. All sign-offs are listed on the participant's Sign-Offs tab, with current and superseded signatures.

• "Typed name must match your full name exactly": type your name exactly as shown in the dialog, including capitals.
• "A justification of at least 10 characters is required...": explain why you sign while items are still open.
• "Signing is locked after repeated wrong passwords": wait for the time shown (signing locked).