Lisa R Tannock1,2,3, Marietta Barton-Baxter3, William W Stoops3,4. 1. Department of Internal Medicine, University of Kentucky, Lexington, KY, USA. 2. Barnstable Brown Diabetes Center, University of Kentucky, Lexington, KY, USA. 3. Center for Clinical and Translational Science, University of Kentucky, Lexington, KY, USA. 4. Department of Behavioral Science, University of Kentucky, Lexington, KY, USA.
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.
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.
Entities:
Keywords:
Data safety monitoring; clinical trials; institutional data monitoring committee; leadership; membership
Authors: A M Grant; D G Altman; A B Babiker; M K Campbell; F J Clemens; J H Darbyshire; D R Elbourne; S K McLeer; M K B Parmar; S J Pocock; D J Spiegelhalter; M R Sydes; A E Walker; S A Wallace Journal: Health Technol Assess Date: 2005-03 Impact factor: 4.014
Authors: David L DeMets; Thomas R Fleming; Frank Rockhold; Barry Massie; Thomas Merchant; Alan Meisel; Barbara Mishkin; Janet Wittes; David Stump; Robert Califf Journal: Clin Trials Date: 2004 Impact factor: 2.486
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