Ensuring participant safety and trial integrity with clinical trials oversight.
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ABSTRACT:
SUBMITTER: Godfrey C
PROVIDER: S-EPMC3916962 | biostudies-other | 2014 Jan
REPOSITORIES: biostudies-other
Publications
Ensuring participant safety and trial integrity with clinical trials oversight.
Godfrey Catherine C Payton Manizhe M Tasker Sybil S Proestel Scott S Schouten Jeffrey T JT
Journal of acquired immune deficiency syndromes (1999) 20140101
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 clini ...[more]
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