Data & Quality
CDISC (SDTM and ADaM)
CDISC (Clinical Data Interchange Standards Consortium) is the global non-profit that develops the data standards required by FDA and PMDA for regulatory submission, including SDTM (Study Data Tabulation Model) for raw observed data and ADaM (Analysis Data Model) for analysis-ready datasets.
CDISC standards make submission datasets reviewable, reproducible, and traceable. SDTM organizes raw data into domain tables (DM, AE, LB, EX, etc.); ADaM derives analysis variables traceable back to SDTM and the SAP. Define-XML documents the metadata.
FDA has required CDISC-conformant submissions for studies starting after December 2016 (NDA/BLA) and December 2017 (IND).
References
Related terms
Electronic Data Capture (EDC)
Electronic Data Capture (EDC) is the system used to collect, manage, and store clinical trial data electronically via electronic case report forms (eCRFs), replacing paper-based data collection.
Statistical Analysis Plan (SAP)
A Statistical Analysis Plan (SAP) is a detailed technical document that specifies, before database lock, every statistical analysis to be performed on a clinical trial's data, including primary and secondary endpoint analyses, handling of missing data, multiplicity adjustments, and sensitivity analyses.
Clinical Study Report (CSR)
A Clinical Study Report (CSR) is the comprehensive scientific document, structured per ICH E3, that describes the conduct, methods, and results of a completed clinical trial and is submitted to regulatory authorities to support marketing applications.
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