Concept information
Health Care Quality, Access, and Evaluation
Quality of Health Care
Quality Assurance, Health Care
Professional Staff Committees
Preferred term
Clinical Trials Data Monitoring Committees
Type
-
Topical Descriptor
Broader concept
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
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Finnish
-
kliinisten tutkimusten seurantatoimikunta
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kliinisten tutkimusten valvontatoimikunnat
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kliinisten tutkimusten valvontatoimikunta
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Swedish
URI
http://www.yso.fi/onto/mesh/D026661
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