Creation of an institutional semi-independent data monitoring committee

Lisa R. Tannock; Marietta Barton-Baxter; William W. Stoops

doi:10.1177/1740774519859876

Creation of an institutional semi-independent data monitoring committee

Lisa R. Tannock, Marietta Barton-Baxter, William W. Stoops

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

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	https://doi.org/10.1177/1740774519859876
State	Published - Oct 1 2019

Bibliographical note

Publisher Copyright:
© The Author(s) 2019.

Funding

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.

Funders	Funder number
US Government Accountability Office
National Institutes of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)	UL1TR001998, UL1TR000117

Keywords

Data safety monitoring
clinical trials
institutional data monitoring committee
leadership
membership

ASJC Scopus subject areas

Pharmacology

Access to Document

10.1177/1740774519859876

Cite this

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AU - Stoops, William W.

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Creation of an institutional semi-independent data monitoring committee

Abstract

Bibliographical note

Funding

Keywords

ASJC Scopus subject areas

Access to Document

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