Local Serious Adverse Event / Unanticipated Problem

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 St. Michael’s Hospital Research Ethics Board (REB) jurisdiction.

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 Research Ethics Board within 7 days of the St. Michael’s Hospital study team’s awareness of the event/report or within 3 days if fatal or life threatening.

  • Step 1: Complete the local SAE reporting form
  • Step 2: Submit three (3) hard copies to the research ethics office, located at 250 Yonge St., 6th floorIncomplete 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.