Staff Services / Research Ethics / Research Ethics Board / Updated Safety Information

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.

A serious, unexpected and related or possibly related adverse event (SAE) is an event that has occurred to a research participant in a study under the jurisdiction of the Unity Health Toronto Research Ethics Board (REB) .

An unanticipated problem (UP) is any incident, experience, outcome that meets all the following criteria: unexpected in relation to the research and/or patient population and related or possibly related to participation in the research and points to increased risk/harm to the research participant.

All external serious adverse events or unanticipated problem must be reported to the REB within 7 days of the study team’s awareness of the event/report or within 3 days if fatal or life threatening.

1. Step 1: Log into the Unity Health eREB to complete and submit a Safety Reporting form. For information on creating an account and logging in, please see the eREB page. Guides on completing post-approval submissions can be found in the eREB.
2. Step 2: The submission will be reviewed by the REB.
3. Step 3: An acknowledgement letter signed by the Chair or designee will be sent to the study team via email.