Follow up or close an adverse event
Open the adverse event, click Edit, add the new information and save with a reason. To close it, enter the Resolution date and Outcome. For an SAE, every saved change sends a follow-up notice to the safety team.
Update the event
Open the event from the Casebook AE column, the participant page, or the Safety page (Open CRF).
Click Edit and add the follow-up information.
To close the event, enter the Resolution date and the Outcome.
An ongoing event cannot have a resolution date; entering one sets it to not ongoing.
Save, choose the reason for change and, in a live study, sign (correct submitted data).
If an SAE is later changed to not serious, the SAE report and its deadlines stay in place for the safety team to review. Investigators may need to sign off again after significant changes.
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