Research Adverse Event Report Template
A research team form for recording study participant adverse events, including timing, description, severity, study relationship, and actions taken.
When to use it
- A study team needs to document a newly reported adverse event.
- A coordinator is collecting details for an event follow-up.
- Researchers need a consistent record of severity and actions taken.
- A team wants to gather reports without putting participant details in ordinary email.
What it asks
- Your name
- Your email address
- Your phone number
- Participant ID
- When did the event occur?
- Describe the event
- What was the event's severity?
- What is the event's relationship to the study?
- What actions were taken?
Why it should be encrypted
Event descriptions and participant IDs may reveal sensitive health or study information, and reporter contact details are personal. Only authorized study staff should be able to read these answers.
Tips
- Use participant IDs rather than names, and avoid requesting extra identifying details.
- Clarify how reporters should describe severity and the event's relationship to the study.
- Tell reporters who can access submissions and how to report urgent events.