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.
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.