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  • A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [after ICH E6 [R2], EU CTR 2014] See also clinical study, clinical investigation.
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