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Description
The course describes the ICH’s Guideline for Good Clinical Practice E6(R3). E6(R3) includes several updates from E6(R2). This video-based course examines how the changes affect the responsibilities of investigators, sponsors, and Institutional Review Boards (IRBs). It details changes to the principles of GCP and key terminology used in Annex 1. The course concludes with an exploration of Annex 2 and its application to emerging technologies and clinical trial designs.
This course is an excellent overview for both organizations and experienced professionals who must understand the changes E6(R3) introduces.
Audience
Academic Medical Centers, Biomedical Product Companies, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Faculty, Principal Investigators, Regulatory Agencies, Sponsors, Students
Meet the Authors
Chinonso Singleton, MSc – LIBRE, LLC
Chinonso Singleton is a clinical research professional with 10+ years of experience. She has managed numerous clinical trials and is passionate about innovative, evidence-based research. Chinonso is dedicated to advancing research and shares insights through training, presentations, and mentorship. She is a Senior Clinical Operations Manager and Tulane alumna.
Cindy Gates, JD, RN, CIP – Independent Consultant
Cindy Gates obtained her JD from Seattle University School of Law. She served as Vice President at Western IRB and Director of IRB at UC Davis and the University of Miami. She has also worked for the human subject protection programs at Houston Methodist Medical Center and the George Washington University.
