MeSH Browser

MeSH Heading: Clinical Trials Data Monitoring Committees
Tree Number(s): N05.700.685.149
Unique ID: D026661
RDF Unique Identifier: http://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.
Entry Version: CLIN TRIALS DATA MONITORING COMMITTEES
Entry Term(s): Data Monitoring Committees; Data and Safety Monitoring Boards; Safety Monitoring Boards
Previous Indexing: Clinical Trials (1991-2001); Professional Staff Committees (1991-2001)
See Also: Clinical Trials as Topic; Ethics Committees, Research; Research Design
Public MeSH Note: 2002
History Note: 2002
Date Established: 2002/01/01
Date of Entry: 2001/07/25
Revision Date: 2009/07/15

Allowable Qualifiers: classification (CL)

economics (EC)

ethics (ES)

history (HI)

legislation & jurisprudence (LJ)

organization & administration (OG)

standards (ST)

statistics & numerical data (SN)

trends (TD)

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.
Terms: Clinical Trials Data Monitoring Committees Preferred Term
Term UI T436068
Date02/13/2001
LexicalTag NON
ThesaurusID; Data and Safety Monitoring Boards
Term UI T436069
Date02/13/2001
LexicalTag NON
ThesaurusID NLM (2002); Data Monitoring Committees
Term UI T449952
Date06/11/2001
LexicalTag NON
ThesaurusID BIOETHICS (2000); Safety Monitoring Boards
Term UI T449976
Date06/11/2001
LexicalTag NON
ThesaurusID BIOETHICS (2000)

Clinical Trials Data Monitoring Committees MeSH Descriptor Data 2024