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

Description

Link to the National Academies Report, Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making: Workshop Report

Body

Product of a workshop hosted by the IOM 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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