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Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making:

Workshop Report

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Status: Available Now

Size: 88 pages, 6 x 9

Publication Year:1999

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Authors:
Jonathan R. Davis, Vivian P. Nolan, Janet Woodcock, and Ronald W. Estabrook, Editors; Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, Institute of Medicine
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Table of Contents
Select a link below to start reading online free!
Front Matter	i-xii
Executive Summary	1-6	(skim)
Introduction	7-12	(skim)
Presubmission and Submission	13-25	(skim)
FDA Regulatory Review	26-41	(skim)
Summary of Issues	42-42	(skim)
Directions for the Future	43-44	(skim)
Final Comments	45-50	(skim)
Appendix A: Workshop Agenda	51-55	(skim)
Appendix B: Speakers and Panelists	56-58	(skim)
Appendix C: Workshop Registrants	59-67	(skim)
Appendix D: Glossary and Acronyms	68-76	(skim)

Authoring Organizations

Institute of Medicine (IOM)

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