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. In lieu of an original signature, the submission email can be sent by the PI or by a research team member with the PI cc’d.
- Step 2: Submit an electronic copy of the complete submission to email@example.com, with the subject line “REB <REB Number> – Safety Information”. Incomplete submissions will be returned to the submitter.
- Step 3: The submission will be reviewed by the REB.
- Step 4: A copy of the form signed by the Chair or designee will be sent to the study team via email.