Changes to Timeline for Post-Approval Reporting Requirements

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.

HRPP Guidelines

The Adverse Event Guidelines and Post-Approval Reporting Requirements have been updated and provide detailed information on which events must be reported.

Compliance Requirement

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.

Please contact us at 415-476-1814 or [email protected] with questions about post-approval event reporting requirements. Visit our website for more info.