This is a REd Synchronous (live) class.
Unanticipated problems in research involving risk to human subjects or others must
be reported to the Institutional Review Board (IRB). An "Unanticipated Problem" includes
some types of adverse events, protocol deviations, non-compliance, and other incidents
that place individuals at risk of harm.
This presentation will include advanced case studies involving IRB reporting policies
for unanticipated problems. The criteria for reporting an unanticipated problem, including
various definitions and guidance contributing to the interpretation of the criteria,
will be discussed.
Participants will learn how to apply the criteria for an unanticipated problem in
different scenarios and will better understand how to provide complete and accurate
information in the IRB Report Form for complex unanticipated problems.
REd Synchronous classes are taught by subject matter experts and provide both fundamental and advanced
skills training in flipped classroom format. To register for upcoming trainings, click here to view our calendar.