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 ... [et al.] editors.

Format:

Book

Contributor:

Davis, Jonathan R.

Institute of Medicine (U.S.). Roundtable on Research and Development of Drugs, Biologics, and Medical Devices.

Series:

Compass series (Washington, D.C.)

The compass series

Language:

English

Subjects (All):

United States. Food and Drug Administration.

United States.

Clinical trials--Quality control.

Clinical trials.

Physical Description:

1 online resource (88 p.)

Edition:

1st ed.

Place of Publication:

Washington, DC : National Academy Press, c1999.

Language Note:

English

Summary:

In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.

Contents:

Front Matter; Preface; Acknowledgments; Contents; Executive Summary; Introduction; Presubmission and Submission; FDA Regulatory Review; Summary of Issues; Directions for the Future; Final Comments; APPENDIX A Workshop Agenda; APPENDIX B Speakers and Panelists; APPENDIX C Workshop Registrants; APPENDIX D Glossary and Acronyms

Notes:

Description based upon print version of record.

Includes bibliographical references (p. 75-76).

ISBN:

0-309-17280-2

0-309-52024-X

0-585-14261-0

OCLC:

830028287