Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making : Workshop Report
Davis, Jonathan R. (EDT); Nolan, Vivian P. (EDT); Woodcock, Janet (EDT); Estabrook, Ronald W. (EDT); Institute of Medicine (U. S.) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices (COR)
Language: English
Published by National Academies Press, 1999
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- Title
- Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making : Workshop Report
- Author
- Davis, Jonathan R. (EDT); Nolan, Vivian P. (EDT); Woodcock, Janet (EDT); Estabrook, Ronald W. (EDT); Institute of Medicine (U. S.) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices (COR)
- Publisher
- National Academies Press
- Publication year
- 1999
- Condition
- As New
- Binding
- Soft cover
- Language
- English
- ISBN 10
- 0309065941
- ISBN 13
- 9780309065948
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.
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