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Title Assuring data quality and validity in clinical trials for regulatory decision making : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / Jonathan R. Davis [and others] editors.

Publication Info. Washington, DC : National Academy Press, [1999]
©1999

Item Status

Description 1 online resource (xii, 76 pages) : illustrations.
Physical Medium polychrome
Description text file
Series The compass series
Compass series (Washington, D.C.)
Bibliography Includes bibliographical references (pages 75-76).
Contents Executive summary -- Introduction -- Presubmission and submission -- FDA regulatory review -- Summary of issues -- Directions for the future -- Final comments -- Appendices.
Local Note eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America
Subject United States. Food and Drug Administration.
United States. Food and Drug Administration.
Clinical trials -- Quality control.
Clinical trials.
Quality control.
Clinical trials -- Data processing -- Congresses.
Clinical trials -- Data processing.
Clinical Trials as Topic -- standards.
Decision Making.
Quality Control.
Research Design.
Indexed Term Andre fag (naturvidenskab og teknik) Andre fag.
Genre/Form Congress.
Electronic books.
Conference papers and proceedings.
Conference papers and proceedings.
Added Author Davis, Jonathan R.
Institute of Medicine (U.S.). Roundtable on Research and Development of Drugs, Biologics, and Medical Devices.
Other Form: Print version: Assuring data quality and validity in clinical trials for regulatory decision making. Washington, DC : National Academy Press, ©1999 0309065941 (DLC) 00500867 (OCoLC)48761213
ISBN 0585142610 (electronic book)
9780585142616 (electronic book)
0309065941
9780309065948