What is a Major (reportable) Incident?
A major study-related incident is any problematic or unanticipated event involving the conduct of the study or participant participation that may occur during the course of the research project. Major Incidents are reportable to the HRPP. One type of particularly significant reportable incident involves the situation when changes to the protocol are necessary to eliminate or reduce an apparent immediate hazard to the safety of research participants or others. Such changes must be reported to the CHR within 10 working days of initiating the changes in the study procedures. Important note: With one exception, regulations require prior CHR approval for proposed changes in the ongoing conduct of research studies, even though the changes may be sponsor-initiated or sponsor-approved modifications. The one exception is when changes to the protocol are necessary to eliminate or reduce an apparent immediate hazard to the safety of research participants. Under this one exception, regulations all
