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.

For eREB studies and migrated pre-eREB studies:

  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.

For studies that are not yet migrated:

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 researchethics@unityhealth.to, 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.