" /> Clinical Investigation - CISMeF





Preferred Label : Clinical Investigation;

NCIt definition : Any experiment that involves a test article and one or more human subjects, and must either meet the requirements for prior submission to the FDA or the results of which are to be submitted to or inspected by the FDA later as part of an application for a research or marketing permit.;

Alternative definition : CDISC-GLOSS: Any experiment that involves a test article and one or more human subjects, 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. Considered synonymous with clinical research by FDA. See clinical study, clinical trial. [FDA Science & Research];

NCI Metathesaurus CUI : CL540393;

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30/07/2025


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