Panel Study & Site Management track
Cautionary Tales from the Front Lines of Clinical Trials
Fri, Apr 25, 2025 · 4:30–5:30 PM CDT Hyatt Regency New Orleans
About this session
Numerous clinical trial failures are traced by the U.S. Food and Drug Administration back to inadequate oversight by principal investigators (PIs). This session delves into real-world examples of such failures, highlighting the threats posed to participant safety and trial integrity. We will explore key focus areas, including the qualifications of delegated individuals, adequacy of training, requirements for continuous supervision, and provisions for third-party oversight. Attendees will learn how to avoid common pitfalls and enhance PIs' knowledge to ensure trial success. Additionally, we will discuss the practical application of risk-based quality management, the ongoing debate on the necessity of monitoring, and the impact of training deficits. This session is essential for clinical research professionals aiming to support PIs and uphold the integrity of clinical trials.
CEU: 1.00 ACRP
Speakers
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Program Director · University of Utah
Panelist
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Owner, Independent Consultant · Responsibility Research
Panelist
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President, Summer Creek Consulting, LLC, Independent Clinical Research Professional, Medical Writer · Consultant
Panelist