Preferred Label : clinical trials data monitoring committees;
MeSH definition : 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.;
MeSH synonym : data and safety monitoring boards; safety monitoring boards; monitoring committees, data; boards, safety monitoring; monitoring committee, data; monitoring board, safety; data monitoring committees; committee, data monitoring; committees, data monitoring; data monitoring committee; board, safety monitoring; monitoring boards, safety; safety monitoring board;
Origin ID : D026661;
UMLS CUI : C0949757;
Allowable qualifiers
- Automatic exact mappings (from CISMeF team)
- Record concept(s)
- See also
- See also inter- (CISMeF)
- Semantic type(s)
- UMLS correspondences (same concept)
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.
