What is CDISC SDTM?

CDISC SDTM (Study Data Tabulation Model) is a standard for organizing and formatting clinical trial data. It defines a consistent structure and content for datasets submitted to regulatory authorities like the FDA. SDTM is used to streamline the review process, facilitate data sharing, and enable efficient data analysis across studies. It involves mapping clinical trial data into a set of predefined domains (e.g., Demographics, Adverse Events, Medications) and variables, following specific naming conventions and data formats.