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DeCS
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Descriptor English:
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Clinical Trials Data Monitoring Committees
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Descriptor Spanish:
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Comités de Monitoreo de Datos de Ensayos Clínicos
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Descriptor Portuguese:
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Comitês de Monitoramento de Dados de Ensaios Clínicos
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Synonyms English:
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Board, Safety Monitoring
Boards, Safety Monitoring
Committee, Data Monitoring
Committees, Data Monitoring
Data Monitoring Committee
Data Monitoring Committees
Data and Safety Monitoring Boards
Monitoring Board, Safety
Monitoring Boards, Safety
Monitoring Committee, Data
Monitoring Committees, Data
Safety Monitoring Board
Safety Monitoring Boards
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Tree Number:
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N05.700.685.149
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Definition English:
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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. |
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See Related English:
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Clinical Trials as Topic
Ethics Committees, Research
Research Design
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History Note English:
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2002
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Allowable Qualifiers English:
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Record Number:
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36380
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Unique Identifier:
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D026661
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Occurrence in VHL:
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Similar:
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DeCS
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