Study Data Tabulation Model (SDTM) is a CDISC standard that specifies how clinical trial data are organized and formatted for regulatory submission.
SDTM structures data into standardized domains (such as adverse events, demographics, and lab results) so regulators can review and analyze datasets consistently across programs. SDTM implementation requires clear metadata, controlled terminology, and traceable derivations from raw data to submission-ready datasets. High-quality SDTM improves submission efficiency, reduces review cycles, and supports reproducibility of analyses. Adoption of SDTM strengthens interoperability and is a cornerstone of modern regulatory data standards.