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The role of the Data and Safety Monitoring Board in a clinical trial: The CRISIS Study

OBJECTIVE: Randomized clinical trials are commonly overseen by a data and safety monitoring board (DSMB) comprised of experts in medicine, ethics, and biostatistics. DSMB responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. D...

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Detalhes bibliográficos
Main Authors: Holubkov, Richard, Casper, T. Charles, Dean, J. Michael, Anand, K. J. S., Zimmerman, Jerry, Meert, Kathleen L., Newth, Christopher J. L., Berger, John, Harrison, Rick, Willson, Douglas F., Nicholson, Carol
Formato: Artigo
Idioma:Inglês
Publicado em: 2013
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3648617/
https://ncbi.nlm.nih.gov/pubmed/23392377
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1097/PCC.0b013e318274568c
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