Any event that meets the following criteria:
- Protocol Deviation
- Adverse Event
- Other Unanticipated Event
Unanticipated Event: Any incident, experience, or outcome that meets all of the following criteria
- Unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol‐related documents (e.g. – the REB‐approved research protocol and informed consent document[s], Investigator Brochure, Product Monograph, Device Manual, etc.); and the characteristics of the research participant population being studied
- Related suggests that the research places research participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
- Possibly related: there is a reasonable possibility that the incident, experience, or outcome may have been caused by the investigational product(s) or procedures involved in the research
REB Review Process
- REB receives Unanticipated Problem Report (includes proposed corrective and preventive actions )
- REB reviews report, and either:
- Accepts the report (proceed to Step 3)
- Proposes modifications or clarifications about the report (once modifications/clarifications are approved, proceed to Step 3)
- Research team may now carry out the activities proposed in the report
Periodic Safety Update Reports require reporting only if the event(s) meet all 3 of the criteria to constitute an Unanticipated Problem and are accompanied by the required information from the Sponsor as outlined in the REB guidance document.
Updated Investigational Product Documentation (IPD) such as Investigator Brochures (IBs), Product Monographs (PM) and Device Manuals need only be submitted to the REB if the new information requires a change to the study conduct, or reflects a change to the risks to study participants.
For example, if the new information contained in the updated IPD requires an Amendment to the study (as defined in the REB’s Amendment Submission Guidelines), only then must the updated IPD be submitted to the REB, as a component of the Amendment submission.