Creation of an institutional semi-independent data monitoring committee

被引:1
|
作者
Tannock, Lisa R. [1 ,2 ,3 ]
Barton-Baxter, Marietta [3 ]
Stoops, William W. [3 ,4 ]
机构
[1] Univ Kentucky, Dept Internal Med, MN 145,800 Rose St, Lexington, KY 40536 USA
[2] Univ Kentucky, Barnstable Brown Diabet Ctr, Lexington, KY 40536 USA
[3] Univ Kentucky, Ctr Clin & Translat Sci, Lexington, KY 40536 USA
[4] Univ Kentucky, Dept Behav Sci, Lexington, KY 40536 USA
基金
美国国家卫生研究院;
关键词
Data safety monitoring; institutional data monitoring committee; leadership; membership; clinical trials; BOARDS;
D O I
10.1177/1740774519859876
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
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.
引用
收藏
页码:523 / 530
页数:8
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