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Preferred Label : Source Document;

NCIt related terms : source documents;

NCIt definition : The original information in a variety of media, which may substantiate information contained in an electronic record of the study.;

Alternative definition : CDISC-GLOSS: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medicotechnical departments involved in the clinical trial). See also eSource document, source, original data, certified copy. [ICH; CSUICI];

NCI Metathesaurus CUI : CL540585;

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30/07/2025


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