Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making Workshop Report (1999) / Chapter Skim
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Pages 51-55
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51 APPENDIX A Workshop Agenda INSTITUTE OF MEDICINE NATIONAL ACADEMY OF SCIENCES ROUNDTABLE ON RESEARCH AND DEVELOPMENT OF DRUGS, BIOLOGICS, AND MEDICAL DEVICES Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision-Making April 14–15, 1998 National Academy of Sciences Auditorium 2101 Constitution Avenue, N.W., Washington, D.C.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS52 SESSION I: PRESUBMISSION 9:00 a.m. Data Collection John R
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APPENDIX A 53 Panelists: Robert Califf, M.D. Duke Clinical Research Institute Michaele Christian, M.D.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS54 WEDNESDAY, APRIL 15: DAY TWO SESSION III: FDA REGULATORY REVIEW 8:30 a.m. FDA Review: Paper Auditing Jay P
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APPENDIX A 55 Panelists: Susan Alpert, M.D., Ph.D. Center for Devices and Radiologica Health Food and Drug Administration William Fairweather, Ph.D.
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