Assuring data quality and validity in clinical trials for regulatory decision making : workshop report

Main Author: Davis, Jonathan R.
Corporate Author: Institute of Medicine (U.S.) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Format: eBook
Published: Washington, DC National Academy Press 1999, c1999
Online Access:
Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
Table of Contents:
  • Executive summary
  • Introduction
  • Presubmission and submission
  • FDA regulatory review
  • Summary of issues
  • Directions for the future
  • Final comments
  • Appendices
  • Includes bibliographical references