An opinion and practice survey on the structure and management of data and safety monitoring boards.
Account Res
; 18(1): 1-30, 2011 Jan.
Article
en En
| MEDLINE
| ID: mdl-21287412
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.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Pautas de la Práctica en Medicina
/
Comités de Ética en Investigación
/
Comités de Monitoreo de Datos de Ensayos Clínicos
/
Testimonio de Experto
Tipo de estudio:
Evaluation_studies
/
Qualitative_research
Límite:
Female
/
Humans
/
Male
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Account Res
Asunto de la revista:
ETICA
Año:
2011
Tipo del documento:
Article
País de afiliación:
Estados Unidos
Pais de publicación:
Estados Unidos