Document Detail


An opinion and practice survey on the structure and management of data and safety monitoring boards.
MedLine Citation:
PMID:  21287412     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
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.
Authors:
Patti M Tereskerz; Thomas M Guterbock; Deborah A Kermer; Jonathan D Moreno
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Accountability in research     Volume:  18     ISSN:  1545-5815     ISO Abbreviation:  Account Res     Publication Date:  2011 Jan 
Date Detail:
Created Date:  2011-02-02     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9100813     Medline TA:  Account Res     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1-30     Citation Subset:  E; IM    
Affiliation:
Program in Ethics and Policy, Center for Biomedical Ethics and Humanities, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
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