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  • 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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