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 |
|---|---|
| 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
Funding Information:The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the National Institutes of Health (NIH) National Center for Advancing Translational Sciences through grant numbers UL1TR000117 and UL1TR001998. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the US Government.
Publisher Copyright:
© The Author(s) 2019.
Keywords
- Data safety monitoring
- clinical trials
- institutional data monitoring committee
- leadership
- membership
ASJC Scopus subject areas
- Pharmacology