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Preferred Label : Source;

NCIt definition : Where something is available or from where it originates.;

Alternative definition : CareLex: The originating point of the Content Item or record, including but not limited to archive import, Scan, fax, email, paper form.; CDISC-GLOSS: The specific permanent record(s) upon which a user will rely for the reconstruction and evaluation of a clinical investigation. NOTE: The term identifies records planned (designated by the protocol) or referenced as the ones that provide the information underlying the analyses and findings of a clinical investigation. Accuracy, suitability, and trustworthiness are not defining attributes of source. The term is also sometimes used as shorthand for source documents and/or source data. [After ICH E6, CSUICI] See also source document, source data, original data, certified copy.;

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09/05/2025


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