An Opinion and Practice Survey on the Structure and Management of Data and Safety Monitoring Boards

Authors: Tereskerz, Patti1; Guterbock, Thomas2; Kermer, Deborah2; Moreno, Jonathan3

Source: Accountability in Research: Policies and Quality Assurance, Volume 18, Number 1, January 2011 , pp. 1-30(30)

Publisher: Taylor and Francis Ltd

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Abstract:

There is little to no empirical data available on how data and safety monitoring boards (DSMBs) are structured and how they operate. The purpose of this study was to provide data on this. To accomplish this goal, we administered a random survey on current structure and management practices and opinions as reported by principal investigators (PIs) and biostatisticians. We also surveyed Institutional Review Board (IRB) community members, as proxies for the public, as to their opinions on how DSMBs should be structured and managed. A final purpose was to compare opinions about what should be taking place to what is actually happening.

Keywords: data safety monitoring boards

Document Type: Research Article

DOI: http://dx.doi.org/10.1080/08989621.2011.542680

Affiliations: 1: Program in Ethics and Policy, Center for Biomedical Ethics and Humanities, University of Virginia School of Medicine, Charlottesville, Virginia, USA 2: Center for Survey Research, University of Virginia, Charlottesville, Virginia, USA 3: Center for Bioethics, University of Pennsylvania, Philadelphia, Pennsylvania, USA

Publication date: January 1, 2011

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