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 Unity Health Toronto Research Ethics Board (REB) (e.g. the research participant is enrolled at an external site in a multi-centre trial in which a Unity Health site 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 REB within 15 days of the study team’s awareness of the event/report.
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.