All updated safety information must be reported to the Research Ethics Board (REB).
Safety information includes:
- Data Safety Monitoring Board (DSMB) summaries,
- Periodic safety update reports,
- Revised investigator’s brochures (IBs),
- Product safety information (e.g. updated product monograph, prescribing information, instructions for use),
- Safety alerts (e.g. black box warning, drug recalls, etc.),
- Any other relevant safety information.
All updated safety information must be reported to the Research Ethics Board within 15 days of the St. Michael’s Hospital study team’s awareness of the event/report.
- Step 1: Complete the updated safety information reporting form
- Step 2: Submit two (2) complete packages to the research ethics office, located at 250 Yonge St., 6th floor. Incomplete submissions will be returned to the submitter.
For more details, read the guidelines for reporting serious adverse events / unanticipated problems.