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Updated: May 5, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Ensuring participant safety and trial integrity with clinical trials oversight
Catherine Godfrey1, Manizhe Payton, Sybil Tasker
1*HIV Research Branch and the Office of Clinical Site Oversight at the Division of AIDS, National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD; †PRA International, Raleigh, NC; and ‡Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Research Center, Seattle, WA.
Abstract:
Clinical trial oversight is a critical element that ensures the protection of research participants and integrity of the data collected. The trial sponsor, a local Institutional Review Board, and independent monitoring committees all contribute with complementary but overlapping responsibilities. Consistency among these groups is essential for the smooth conduct of a clinical trial but may be challenging in resource-limited settings (RLS). Capacity building and training for RLS may improve clinical trials oversight and ultimately medical management. In this article, we review the components necessary for optimal clinical trial oversight and the issues that arise in the RLS, with some suggested strategies for improvement.
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