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Entreprise · 20/11/20011 min de lecture
Draft “Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees;” Availability
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Résumé
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 The draft guidance document, when finalized, will assist sponsors of clinical trials in determining when a data monitoring committee (DMC) is needed for optimal study monitoring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.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →