Sign off an adverse event as investigator
Open the submitted adverse event and click Complete AE Sign-off. Read the meaning statement, type your full name and password, tick the confirmation and click Sign & Authorize. Principal Investigators can delegate AE sign-off to Sub-Investigators.
Where to find it
AE form > AE Sign-off Status > Complete AE Sign-off
Before you start
- You are the Principal Investigator or a Sub-Investigator at the event's site (or the Study Owner).
Sign off the event
Open the submitted adverse event, for example from the PI request email or the Safety page.
In AE Sign-off Status, click Complete AE Sign-off.
Read the meaning: "I have reviewed this adverse event report and confirm the clinical assessment is accurate and complete. I authorize AE Sign-off for this report."
Type your full name exactly as shown and enter your password.
Tick the confirmation that your electronic signature is the legal equivalent of your handwritten signature, and click Sign & Authorize.
You see "AE Sign-off completed successfully". The card shows who signed and when.
Delegate AE sign-off
Study managers set delegation in Settings > Team > AE Sign-off Delegation > New Delegation: choose the site, the Sub-Investigator, the start date and an optional end date and reason. The sign-off then shows "Signing under delegation from" the PI.
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Email support@capture.study or use the contact form. Tell us the study name, what you were trying to do and the exact message on screen; a screenshot helps.
Please never send participant names, contact details or health information to support.