Open AccessEnsuring Participant Safety and Trial Integrity With Clinical Trials Oversight
Author(s) -
Catherine Godfrey,
Manizhe Payton,
Sybil A. Tasker,
Scott Proestel,
Jeffrey T. Schouten
Publication year - 2014
Publication title -
journal of acquired immune deficiency syndromes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.162
H-Index - 157
eISSN - 1944-7884
pISSN - 1525-4135
DOI - 10.1097/qai.0000000000000041
Subject(s) - clinical trial , institutional review board , consistency (knowledge bases) , data monitoring committee , clinical research , medicine , resource (disambiguation) , business , computer science , pathology , surgery , computer network , artificial intelligence
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.