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:
Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah
Kelly Cairns, MA BASc, APMR, CCRA, FACRP, Head, Quality Medicine, Boehringer Ingelheim Canada
Suzanne Kincaid, CCRA, ACRP-PM, FACRP, Owner, Independent Consultant, Responsibility Research
Jerry Stein, PhD, FACRP, ACRP-MDP, ACRP-CP, President, Summer Creek Consulting, LLC , Independent Clinical Research Professional, Medical Writer, Consultant
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