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Concept information

Preferred term

Clinical Trials Data Monitoring Committees  

Type

  • Topical Descriptor

Entry terms

  • Board, Safety Monitoring
  • Boards, Safety Monitoring
  • Committee, Data Monitoring
  • Committees, Data Monitoring
  • Data and Safety Monitoring Boards
  • Data Monitoring Committee
  • Data Monitoring Committees
  • Monitoring Board, Safety
  • Monitoring Boards, Safety
  • Monitoring Committee, Data
  • Monitoring Committees, Data
  • Safety Monitoring Board
  • Safety Monitoring Boards

Scope note

  • 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.

History note

  • 2002

In other languages

URI

http://www.yso.fi/onto/mesh/D026661

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