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

By Institute of Medicine, Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, Ronald W. Estabrook (Editor), Janet Woodcock (Editor), Vivian P. Nolan (Editor), Jonathan R. Davis (Editor)
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$147.00
By Institute of Medicine, Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, Ronald W. Estabrook (Editor), Janet Woodcock (Editor), Vivian P. Nolan (Editor), Jonathan R. Davis (Editor)
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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 s...

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