Committees established to review interim data and efficacy outcomes in clinical trials. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings
Research Design -- Congresses -- United States : Redesigning the clinical effectiveness research paradigm : innovation and practice-based approaches : workshop summary / LeighAnne Olsen and J. Michael McGinnis, editors ; Institute of Medicine of the National Academies
The form and structure of analytic studies in epidemiologic research
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Research Design -- legislation & jurisprudence : Access to research data in the 21st century : an ongoing dialogue among interested parties : report of a workshop / Science, Technology, and Law Panel, Policy and Global Affairs, National Research Council
Research Design -- United States -- Congresses : Transforming clinical research in the United States : challenges and opportunities : workshop summary / Rebecca A. English, Yeanwoo Lebovitz, and Robert B. Giffin, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly
