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Descriptor English: Clinical Trials Data Monitoring Committees
Descriptor Spanish: Comités de Monitoreo de Datos de Ensayos Clínicos
Descriptor comités de monitorización de los datos de ensayos clínicos
Entry term(s) comités de monitorización de ensayos clínicos
consejos de monitorización de la seguridad
consejos de monitorización de seguridad
consejos de monitorización de seguridad y datos
Scope note: Comités creados para revisar los datos provisionales y los resultados de la eficacia en los ensayos clínicos. Se utilizan los hallazgos de estos comités para decidir si se debe mantener un ensayo tal como se ha diseñado o si es preciso modificarlo o concluirlo. Las normas gubernamentales estadounidenses respecto a las investigaciones financiadas con fondos federales con participación de sujetos humanos (la "Regla Común") exige (45 CFR 46.111) a los comités de ética que examinan los ensayos clínicos a gran escala que vigilen los datos obtenidos con empleo de un mecanismo como un comité de monitorización de datos. Las normas de la FDA (21 CFR 50.24) requieren que se creen tales comités para controlar los estudios realizados en el ámbito de las emergencias.
Descriptor Portuguese: Comitês de Monitoramento de Dados de Ensaios Clínicos
Descriptor French: Comités de surveillance et de suivi des essais cliniques
Entry term(s): 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
Tree number(s): N05.700.685.149
RDF Unique Identifier: https://id.nlm.nih.gov/mesh/D026661
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.
Allowable Qualifiers: CL classification
EC economics
ES ethics
HI history
LJ legislation & jurisprudence
OG organization & administration
SN statistics & numerical data
ST standards
TD trends
Previous Indexing: Clinical Trials (1991-2001)
Professional Staff Committees (1991-2001)
Public MeSH Note: 2002
History Note: 2002
Entry Version: CLIN TRIALS DATA MONITORING COMMITTEES
Related: Clinical Trials as Topic MeSH
Ethics Committees, Research MeSH
Research Design MeSH
DeCS ID: 36380
Unique ID: D026661
Documents indexed in the Virtual Health Library (VHL): Click here to access the VHL documents
Date Established: 2002/01/01
Date of Entry: 2001/07/25
Revision Date: 2009/07/15
Clinical Trials Data Monitoring Committees - Preferred
Concept UI M0378570
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.
Preferred term Clinical Trials Data Monitoring Committees
Entry term(s) 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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