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The November topic of the Clinical Trials Community of Practice is “What Actually Happens When You Report Something? Demystifying Reportable Events, Noncompliance Reviews, and CAPAs.”
Reportable events are an expected part of conducting research, yet many investigators and study teams remain uncertain about what needs to be reported, what happens after a report is submitted, and how events are evaluated by institutional oversight bodies. Concerns about reporting can create unnecessary anxiety and may obscure the important role that reporting plays in protecting participants, maintaining study integrity, and improving research processes.
Join Catherine Rogers from the UW IRB and Jake Rome from the FDA Regulated Research Oversight Program for a practical discussion of the reportable event lifecycle, from identification and submission through review, corrective actions, and resolution. Attendees will gain insight into what reviewers look for in submissions, common trends observed across studies, practical approaches to root cause analysis and CAPA development, and how information from reported events can be used to strengthen research oversight and drive continuous improvement across the research enterprise. Case-based discussion and audience Q&A will be included.
To receive a calendar invitation for this virtual event (Zoom), please contact Theresa Lins at tlins@wisc.edu.