Long before a problem surfaces in an inspection, it usually surfaces at the IRB. Reportable events — protocol deviations, unanticipated problems, consent process failures, confidentiality breaches — arrive in volume, and the patterns within them are a leading indicator of where research programs are struggling.

In this session, WCG's compliance and quality assurance leadership draws on reportable event experience across WCG's IRBs to show what noncompliance actually looks like in practice: which categories dominate, which recur at the same sites, what separates an isolated lapse from serious or continuing noncompliance, and how IRBs evaluate the corrective action plans institutions submit in response. Attendees will leave understanding how their submissions are read on the receiving end and what a credible corrective action plan includes.

Learning objectives — following this session, participants will be able to:

1. Describe the categories of reportable events most frequently submitted to IRBs and the patterns that distinguish isolated events from serious or continuing noncompliance.
2. Explain the criteria an IRB applies in determining serious or continuing noncompliance and the regulatory reporting obligations triggered by that determination.
3. Evaluate a corrective action plan against the elements IRBs assess when judging whether a response adequately addresses the underlying cause.