Download Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making: Workshop Report eBook
by Institute of Medicine,Biologics and Medical Devices Roundtable on Research and Development of Drugs,Ronald W. Estabrook,Janet Woodcock,Vivian P. Nolan,Jonathan R. Davis
Washington (DC): National Academies Press (US); 1999.
The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. Dr. Kenneth I. Shine is president of the Institute of Medicine.
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Washington, DC: The Institutes of Medicine, National Academies Press; 1999.
Other Authors: Nolan, Vivian . Woodcock, Janet. Staff, Institute of Medicine. by: Cherubini, Antonio.
Institute of Medicine Workshop report. Washington, DC: National Academy Press; 1999. php?record id 9623&page R1.
The Institutes of Medicine. National Academies Press, Washington, DC, 1999.
Washington DC: National Academy Press, 1999.
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.