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komisie pre monitorovanie údajov z klinického skúšania

Subject h.	komisie pre monitorovanie údajov z klinického skúšania
Subject h.	Clinical Trials Data Monitoring Committees
Entry terms	komisie pre monitorovanie údajov z klinických štúdií komisie pre monitorovanie dát z klinického skúšania výbory pre monitorovanie údajov a bezpečnosti rady pre monitorovanie údajov a bezpečnosti výbory pre monitorovanie bezpečnosti rady pre monitorovanie bezpečnosti komisie pre monitorovanie dát z klinických štúdií komisie pre monitorovanie údajov z klinických skúšok
English X references	Data and Safety Monitoring Boards Safety Monitoring Boards
Scope note in English	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.
See also reference (FX) in Slovak	skúšanie klinické ako téma komisie etické pre výskum projekt výskumný
See also reference (FX) in English	Clinical Trials as Topic Ethics Committees, Research Research Design
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