Protocol Violation Report
A Protocol Violation is any divergence or departure of a serious nature from study conduct as described in the current version of the research protocol. The “Protocol Violation Report” is used to notify the REB of the non-compliance and to provide details of the situation according to MUHC policy. The REB will evaluate the corrective action taken by the Investigator and may require additional remedial action. Notification of the incident and its resolution to the Sponsor is mandatory.