SDTM
Also written as: SDTM — Study Data Tabulation Model
Study Data Tabulation Model, a CDISC standard that defines the structure and content requirements for clinical trial datasets submitted to regulatory authorities.
Full Definition
SDTM (Study Data Tabulation Model) is a foundational CDISC standard that establishes a consistent format for organizing and presenting clinical trial data to regulatory agencies. The standard defines specific domain structures, variable naming conventions, and controlled terminology for different types of clinical data including demographics, adverse events, medications, and laboratory results. In oncology informatics, SDTM is particularly important for structuring complex cancer trial data including tumor assessments, biomarker results, and treatment histories. The model ensures that clinical trial data can be reviewed efficiently by regulatory authorities and enables consistent analysis across studies and sponsors.
Usage
Usage note: Spell out on first use in documents intended for non-specialist audiences.
In Context
- "The biostatistician mapped the oncology endpoints to the appropriate SDTM domains before database lock." — Regulatory submission preparation
- "All tumor response data must conform to SDTM standards for the FDA submission." — Data management specification