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Clinical investigation

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Considered synonymous with clinical research by the Food and Drug Administration (FDA), any experiment that involves a test article and one or more human subjects (human subject), and that either must meet the requirements for prior submission to the FDA or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. FDA 21 CFR 50.3, Definitions; CDISC Glossary

Clinical investigation (FDA IND): Any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug during medical practice. FDA: 21 CFR 312.3, Definitions and Interpretations

Investigation (FDA IDE): A clinical investigation or research involving one or more subjects (subject) to determine the safety or effectiveness of a device. FDA: 21 CFR 812.3, Definitions

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