External Serious Adverse Event / Unanticipated Problem

A serious, unexpected and related or possibly related adverse event (SAE) is an event experienced by a research participant enrolled by the investigator(s) at other centres outside the jurisdiction of the St. Michael’s Hospital  Research Ethics Board (REB) (e.g. the research participant is enrolled at an external site in a multi-centre trial in which St. Michael’s Hospital is also a participating site). 

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 problems 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 external SAE reporting form
  • Step 2: Submit two (2) hard copies to the research ethics office, located at 250 Yonge St., 6th floor. Incomplete submissions will be returned to the submitter.

Not sure if you need to submit a report to the REB? Use the quick reference tool for reporting SAEs / UPs

For more details, read the Guidelines for reporting serious adverse events / unanticipated problems.