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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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Data and Safety Monitoring Boards
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 CID-10 SciELO LILACS LIS
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