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

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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.

88 pages, Paperback

First published July 1, 1999

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Institute of Medicine

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The National Academy of Medicine (NAM, formerly the Institute of Medicine-IOM) is an American nonprofit, non-governmental organization. The National Academy of Medicine is a part of the National Academies of Sciences, Engineering, and Medicine, along with the National Academy of Sciences (NAS), National Academy of Engineering (NAE), and the National Research Council (NRC).

The National Academy of Medicine provides national advice on issues relating to biomedical science, medicine, and health, and serves as an adviser to the nation to improve health aims to provide unbiased, evidence-based, and authoritative information and advice concerning health and science policy to policy-makers, professionals, leaders in every sector of society, and the public at large.

Operating outside the framework of the U.S. federal government, it relies on a volunteer workforce of scientists and other experts, operating under a formal peer-review system. As a national academy, new members of the organization are elected annually by current members, based on their distinguished and continuing achievements in a relevant field as well as for their willingness to participate actively.

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