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

Workshop Report

Institute of Medicine, Biologics Roundtable on Research and Development of Drugs and Medical Devices (Autoren)

Ronald W. Estabrook, Janet Woodcock, Vivian P. Nolan (Herausgeber)

Buch | Softcover

88 Seiten

1999
National Academies Press (Verlag)
978-0-309-08677-6 (ISBN)

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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.

Table of Contents

Front Matter
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

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

Erscheint lt. Verlag	27.7.1999
Verlagsort	Washington
Sprache	englisch
Maße	152 x 229 mm
Themenwelt	Medizin / Pharmazie
ISBN-10	0-309-08677-9 / 0309086779
ISBN-13	978-0-309-08677-6 / 9780309086776
Zustand	Neuware