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

Parent Collection
The National Academies Press: Consensus Study Reports
Authoring Institution
Institute of Medicine
Publisher
National Academies Press
Rights
Use of Materials on the OEC
Discipline(s)
Life and Environmental Sciences
Research Ethics
Topics
Fabrication
Falsification
Governance
Human Rights
Human Subjects Research
Law and Public Policy
Privacy and Surveillance
Research Misconduct
Responsible Innovation
Safety
Expert Reports
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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Citation
. . Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making: Workshop Report. Online Ethics Center. DOI:. https://onlineethics.org/cases/national-academies-press-consensus-study-reports/assuring-data-quality-and-validity-clinical.