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FDA DRAFT GUIDANCE ON CLINICAL TRIAL DATA MONTORING COMMITTEES

FDA DRAFT GUIDANCE ON CLINICAL TRIAL DATA MONTORING COMMITTEES. Susan S. Ellenberg, Ph.D. Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research, FDA Medical Research Summit Washington, D.C. March 25, 2002. DATA MONITORING COMMITTEE (DMC).

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479 views • 24 slides

C. Michael Gibson, MS, MD on behalf of the ATLAS ACS 2 TIMI 51 Investigators

A nti- Xa T herapy to L ower Cardiovascular Events in A ddition to Standard Therapy in S ubjects with A cute C oronary S yndrome - Thrombolysis in Myocardial Infarction 51 Trial (ATLAS ACS 2 - TIMI 51):

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403 views • 18 slides

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Trial leadership - PowerPoint PPT Presentation

FDA DRAFT GUIDANCE ON CLINICAL TRIAL DATA MONTORING COMMITTEES

C. Michael Gibson, MS, MD on behalf of the ATLAS ACS 2 TIMI 51 Investigators