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 Prohlížeč

CUI

M0378570

Předchozí užití

Clinical Trials (1991-2001); Professional Staff Committees (1991-2001)

Historická pozn.

2002

Veřejná pozn.

2002