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

Davis, Jonathan R. (Editor)/ Nolan, Vivian P. (Editor)/ Woodcock, Janet (Editor)/ Estabrook, Ronald W. (Editor)/ Institute of Medicine (U. S.) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices (Corporate Author)

ISBN 10: 0309065941 / ISBN 13: 9780309065948

Published by Natl Academy Pr, 1999

About this Item

76 pages. 8.75x6.00x0.25 inches. In Stock.

Seller Inventory # x-0309065941

Bibliographic Details

• Title: Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making: Workshop Report
• Publisher: Natl Academy Pr
• Publication Date: 1999
• Language: English
• ISBN 10: 0309065941
• ISBN 13: 9780309065948
• Binding: Paperback
• Condition: Brand New
• Weight: 0.07 kilograms

About this title

Synopsis

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.

About the Author

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