Abstract
Background: A major goal of the National Institutes of Health’s Clinical and Translational Science Award program is to facilitate clinical research and enhance the transition of basic to clinical research. As such, a number of Clinical and Translational Science Award centers have developed services to facilitate the conduct of clinical research, including support with fulfilling regulatory requirements. Methods: The University of Kentucky sought to establish an institutional semi-independent monitoring committee to provide oversight for clinical research studies per National Institutes of Health requirements and recommendations. Our semi-independent monitoring committee was initiated in 2010. Results: Since the inception of our semi-independent monitoring committee we have restructured its operations and protocols to improve efficiency. This article discusses our experiences with semi-independent monitoring committee creation and growth. Conclusion: This article summarizes our experience in creating and maturing an institutional data monitoring committee.
Original language | English |
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Pages (from-to) | 523-530 |
Number of pages | 8 |
Journal | Clinical Trials |
Volume | 16 |
Issue number | 5 |
DOIs | |
State | Published - Oct 1 2019 |
Bibliographical note
Publisher Copyright:© The Author(s) 2019.
Keywords
- Data safety monitoring
- clinical trials
- institutional data monitoring committee
- leadership
- membership
ASJC Scopus subject areas
- Pharmacology