STATISTICAL ANALYSIS PLANS (SAP) PRINCIPLES AND PRACTICE by johanpetro

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									28th Annual Meeting                                  Pre-Conference Workshop
Society for Clinical Trials                          May 20, 2007
Montreal, Canada


 STATISTICAL ANALYSIS PLANS (SAP):
    PRINCIPLES AND PRACTICE

            Henry S. Hsu, Ph.D. MPH
       Director, Division of Biostatistics
  Center for Biologics Evaluation and Research
         Food and Drug Administration


       The views expressed in this presentation are those of the speaker and
   do not necessarily reflect policies of the U.S. Food and Drug Administration.
Food and Drug Administration (FDA)
   Center for Biologics Evaluation and Research (CBER)
   Center for Devices and Radiological Health (CDRH)
   Center for Drug Evaluation and Research (CDER)
   Center for Food Safety and Applied Nutrition (CFSAN)
   Center for Veterinary Medicine (CVM)
   National Center for Toxicological Research (NCTR)
   Review of SAP in Study Protocol

   Pre/post submission contacts with FDA
   Amendments to protocol
   Changes in SAP
   Reply to information request (IR) / complete
    response (CR) letters
   Protocol violation
   Post hoc analysis
Q & A’s

								
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