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Data Safety Monitoring Boards

  • Rachael A. CallcutEmail author
Chapter
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Part of the Success in Academic Surgery book series (SIAS)

Abstract

The overall purpose of the Data Safety Monitoring Board, or Data Monitoring Committee, is to insure the integrity and safety of clinical trial research. Federal guidelines have been established by the Food and Drug Administration and the National Institutes of Health regarding when a board or committee is required for federally funded research. These boards or committees serve to advise the sponsor and/or researchers of the study on the safety of the trial, the continuing validity of the trial, and the scientific merit of the trial. A data safety monitoring board charter is typically created prior to initiation of a clinical trial to explicitly address the mission and operating procedures for the committee. Committees can terminate trials early for either futility or reaching an early conclusion from interim analysis showing clear benefit. Even if a Data Safety Monitoring Board is not required, most clinical research trials should have a data safety monitoring plan.

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Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  1. 1.Department of SurgeryUniversity of California San FranciscoSan FranciscoUSA

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