Clinical Trials Data Monitoring Committees [komise sledující výsledky klinických zkoušek]

topical
27
Terms

Data and Safety Monitoring Boards
Data Monitoring Committees
Safety Monitoring Boards

Persistent link   https://www.medvik.cz/link/D026661
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.

DUI
D026661 MeSH Browser
CUI
M0378570
Previous indexing
Clinical Trials (1991-2001); Professional Staff Committees (1991-2001)
History note
2002
Public note
2002