" /> Electronic Case Report Tabulation - CISMeF





Preferred Label : Electronic Case Report Tabulation;

NCIt synonyms : eCRT;

NCIt related terms : eCRT (electronic case report tabulation);

NCIt definition : The collection of digital data and documentation for a clinical study that is submitted for regulatory review.;

Alternative definition : CDISC-GLOSS: Case report tabulation (CRT) provided in electronic format for eSubmissions (electronic regulatory submissions). NOTE: according to FDA guidance, eCRTs are datasets provided as SAS Transport files with accompanying documentation in electronic submissions. They enable reviewers to analyze each dataset for each study. Each CRF domain should be provided as a single dataset; however, additional datasets suitable for reproducing and confirming analyses may also be needed. SDTM is the preferred format.;

NCI Metathesaurus CUI : CL540521;

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12/05/2025


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