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.
Institute of Medicine. 1999. Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making: Workshop Report. Washington, DC: The National Academies Press. https://doi.org/10.17226/9623.
|Presubmission and Submission||13-25|
|FDA Regulatory Review||26-41|
|Summary of Issues||42-42|
|Directions for the Future||43-44|
|Appendix A: Workshop Agenda||51-55|
|Appendix B: Speakers and Panelists||56-58|
|Appendix C: Workshop Registrants||59-67|
|Appendix D: Glossary and Acronyms||68-76|
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