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Geschäft · 20.11.20011 Min. Lesezeit
Draft “Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees;” Availability
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Zusammenfassung
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees" dated November 2001. The draft guidance document, when finalized, will assist sponsors of clinical trials in determining when a data monitoring committee (DMC) is needed for optimal study monitoring and how such committees should operate.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →