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Concept information

Health Care Quality, Access, and Evaluation > Quality of Health Care > Quality Assurance, Health Care > Professional Staff Committees > Clinical Trials Data Monitoring Committees
... > Health Occupations > Health Services Administration > Quality of Health Care > Quality Assurance, Health Care > Professional Staff Committees > Clinical Trials Data Monitoring Committees
... > Health Occupations > Health Services Administration > Organization and Administration > Professional Practice > Professional Staff Committees > Clinical Trials Data Monitoring Committees

Terme préférentiel

Clinical Trials Data Monitoring Committees  

Type

  • mesh:Descriptor

Définition

  • Committees established to review interim data and efficacy outcomes in clinical trials. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.

Concept générique

Concepts associés

Synonyme(s)

  • Data and Safety Monitoring Boards
  • Data Monitoring Committees
  • Safety Monitoring Boards

Qualificatif(s) autorisé(s)

Traductions

URI

http://data.loterre.fr/ark:/67375/JVR-C1BMK0MV-5

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RDF/XML TURTLE JSON-LD Date de création 25/07/2001, dernière modification le 15/07/2009