Talk Regulatory & Compliance track
Principal Investigator Qualifications: Are Micro-Credentials Enough?
Sat, Apr 26, 2025 · 11:30 AM–12:30 PM CDT Hyatt Regency New Orleans
About this session
In a post-pandemic landscape, learning, conducting, and implementing clinical trials significantly changed with the adoption of globally accepted decentralized methods. Variability across educational offerings may not assess learner competency to perform clinical research operational activities. In this panel, clinical investigators, a U.S. Food and Drug Administration representative, and educators will explore varied modalities for training investigators and consider avenues for comprehension in terms of learning on the job, through structured courses, by attending sponsor/contract research organization-conducted trainings, or by completing online modules--none of which may be sufficient in isolation. Fundamentals of online teaching and learning, coupled with adult learning methods and the industry's continued reliance on a "decentralized method of training," are pivotal to assess learner capability. In the absence of documented analysis and evaluation of the effectiveness of micro-credentials, presenters will discuss strengths/weaknesses, gaps, and challenges of the biopharmaceutical industry's reliance on the current modes of training and education of clinical research professionals.
CEU: 1.00 ACRP
Speakers
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Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research · U.S. Food and Drug Administration
Panelist
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Assistant Professor, School of Health Profession, Rutgers · The State University of New Jersey
Panelist
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Professor, Academic Vice Chair and Director of Clinical Research, Department of Psychiatry and Behavioral Medicine, Virginia Tech Carilion School of Medicine · Virginia Tech Faculty of Health Sciences
Panelist
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Director, Research Experience · Rutgers
Panelist