Clinical Trials Data Monitoring Committees [komise sledující výsledky klinických zkoušek]
- Terms
-
Data and Safety Monitoring Boards
Data Monitoring Committees
Safety Monitoring Boards
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.
- DUI
- D026661 MeSH Browser
- CUI
- M0378570
- Previous indexing
- Clinical Trials (1991-2001); Professional Staff Committees (1991-2001)
- History note
- 2002
- Public note
- 2002
Allowable subheadings
- CL
- classification
- EC
- economics
- ES
- ethics
- HI
- history
- LJ
- legislation & jurisprudence 2
- OG
- organization & administration 2
- ST
- standards 2
- SN
- statistics & numerical data
- TD
- trends 2