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2014 MeSH

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Clinical Trials Data Monitoring Committees
MeSH HeadingClinical Trials Data Monitoring Committees
Tree NumberN05.700.685.149
Scope NoteCommittees 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 TermData and Safety Monitoring Boards
Entry TermData Monitoring Committees
Entry TermSafety Monitoring Boards
See AlsoClinical Trials as Topic
See AlsoEthics Committees, Research
See AlsoResearch Design
Allowable QualifiersCL EC ES HI LJ OG SN ST TD UT
Previous IndexingClinical Trials (1991-2001)
Previous Indexing Professional Staff Committees (1991-2001)
History Note2002
Date of Entry20010725
Unique IDD026661

MeSH Tree Structures

Health Care Quality, Access, and Evaluation [N05]
   Quality Assurance, Health Care [N05.700]
      Professional Staff Committees [N05.700.685]
Arrow pointing to current tree nodeClinical Trials Data Monitoring Committees [N05.700.685.149]
Ethics Committees [N05.700.685.300]  +
Pharmacy and Therapeutics Committee [N05.700.685.625]

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