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 REB within 15 days of the study team’s awareness of the event/report.
- Step 1: Complete the updated safety information reporting form, with an original signature of the Unity Health Lead Applicant.
- Step 2: Submit two (2) hard copies of the completed from to the research ethics office, located at 250 Yonge St., 6th floor. One copy of the form will be date stamped and given back to you for your records. Incomplete submissions will be returned to the submitter.
- Step 3: The submission will be reviewed by the REB.