Creation of an institutional semi-independent data monitoring committee

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

Research output: Contribution to journalArticlepeer-review

2 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 languageEnglish
Pages (from-to)523-530
Number of pages8
JournalClinical Trials
Volume16
Issue number5
DOIs
StatePublished - 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

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