Report an adverse event
Open the participant and click Add AE (or the + in the Casebook AE column). Enter the adverse event term, onset date, severity and whether it is serious, then click Submit. If it is serious, the form asks for more and the safety team is notified at once.
Where to find it
Participant page > Safety Events > Add AE
Before you start
- You are site staff with data-entry rights: Principal Investigator, Sub-Investigator or Study Coordinator.
Record the adverse event
Open the participant and click Add AE on the Safety Events card, or click + in the Casebook AE column.
Under Event description (verbatim), enter the Adverse event term as the participant described it, and any clinical detail.
Under Timing, enter the Onset date (partial dates allowed) and, when it has ended, the Resolution date, or mark it ongoing.
Choose the Severity: Mild, Moderate or Severe.
Answer Is this a Serious Adverse Event (SAE)?.
If Yes, the form asks for causality, the seriousness criteria and the SAE details (report a serious adverse event).
Click Submit, or Save and finish later.
A non-serious adverse event is recorded in the participant's AE log, counted in the Casebook and on the Safety page, and coded by the medical coder if the study uses MedDRA. No safety alert is sent.
Questions
What counts as an adverse event?
Any untoward medical occurrence in a participant, whether or not it is related to the study treatment. See our adverse event glossary entry and CTCAE grading.
Can I report an AE from a lab result?
Yes. When an out-of-range lab result is clinically significant, you can create an AE form straight from the lab row (assess lab results).
Was this guide helpful?
Related guides
Still need help?
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.