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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

Preferred term

Clinical Trials Data Monitoring Committees  

Type

  • mesh:Descriptor

Definition

  • 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.

Broader concept

Related concepts

Entry terms

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

Allowable Qualifier(s)

In other languages

URI

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

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RDF/XML TURTLE JSON-LD Created 7/25/01, last modified 7/15/09