Timeline and Definition Changes for Internal (on-site) adverse events
- Must be submitted within 5-working days of UCSF PI awareness
- Includes death
These changes are being implemented to meet federal guidelines of reporting to the IRB.
External (off-site) adverse events and protocol violations and incidents timeline has not changed and will remain at 10-working days of the UCSF PI’s awareness of the event.
If you are at the SF VAMC, you must continue to submit the event within 5 days and adhere to VA definitions and requirements for reporting post-approval events.
The Adverse Event Guidelines and Summary Sheet for Post-Approval Reporting Requirements have been updated and provide detailed information on which events must be reported.
Failure to report these events not only puts you out of compliance, but may also jeopardize the safety of study participants or integrity of the study. You must review adverse events, protocol violations and incidents, study conduct and safety information on a regular basis to ensure adherence to post-approval event reporting requirements.