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Clinical Trials Data Monitoring Committees
Hierarchy: | ∟ ∟ ∟ ∟ Clinical Trials Data Monitoring Committees 2 coordinate concepts∟ ∟ ∟ ∟ ∟ Clinical Trials Data Monitoring Committees 2 coordinate concepts∟ ∟ ∟ ∟ ∟ Clinical Trials Data Monitoring Committees 2 coordinate concepts∟ ∟ ∟ ∟ ∟ Clinical Trials Data Monitoring Committees 2 coordinate conceptsX |
Broader terms: | ∟ ∟ ∟ ∟ Clinical Trials Data Monitoring Committees ∟ ∟ ∟ ∟ ∟ Clinical Trials Data Monitoring Committees ∟ ∟ ∟ ∟ ∟ Clinical Trials Data Monitoring Committees ∟ ∟ ∟ ∟ ∟ Clinical Trials Data Monitoring Committees |
History note: | |
historyNote*: | 2002
X |
publicMeSHNote*: | 2002
X |
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.
X |
activeMeSHYear*: | |
dateCreated*: | 2001-07-25X |
dateEstablished*: | 2002-01-01X |
dateRevised*: | 2004-07-13X |
recordAuthorizer*: | sjnX |
recordMaintainer*: | sjnX |
recordOriginator*: | hjnX |
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Labels and equivalent concepts: | Kliinisten tutkimusten seurantatoimikunnat (fi) XKliinisten tutkimusten valvontatoimikunnat (fi, replaced) Kliinisten tutkimusten valvontatoimikunta (fi, replaced) Kliinisten tutkimusten seurantatoimikunta (fi, replaced) Safety Monitoring Boards (en, replaced) Data Monitoring Committees (en, replaced) Data and Safety Monitoring Boards (en, replaced) |
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