Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 88 |
Release | : 1999-07-27 |
ISBN-10 | : 9780309172806 |
ISBN-13 | : 0309172802 |
Rating | : 4/5 (802 Downloads) |
Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.