Responding to sponsor audits is one of the most stressful—and most misunderstood—tasks in clinical research. Site teams often prepare in isolation, without ever truly understanding what an auditor is looking for, how findings are interpreted, or what a response actually needs to accomplish. Meanwhile, auditors regularly receive responses that miss the point entirely.
This session flips the script. Using a dynamic role-play format, attendees experience the audit process from both sides of the process simultaneously—hearing directly from an experienced auditor while a site leader responds in real time as the principal investigator, clinical research coordinator, regulatory coordinator, and site administrator. The result is a candid, practical, and unexpectedly engaging look at what makes audit responses succeed or fail. Attendees will leave with concrete strategies to prepare their teams, craft effective responses, and approach the audit process with confidence rather than dread.
CEU: 1.0 ACRP
Speakers:
Leslie Pimentel-Byatt, MSML, MBA, CCRC, PMP, FACRP, Director, Clinical Trials Operations, University of New Mexico Hospital
Suheila Abdul-Karrim, CCRA, FACRP, MICR CSci, RQAP-GCP, Independent Clinical Research Consultant, Auditor & Trainer