Study Data Tabulation Model (SDTM)

The Study Data Tabulation Model (SDTM) is a CDISC standard that defines how clinical trial data collected on subjects should be organised and formatted for submission to regulatory authorities. Data is arranged in standard domains, each a dataset with predefined variables: Demographics (DM), Adverse Events (AE), Concomitant Medications (CM), Exposure (EX), Laboratory Results (LB), Vital Signs (VS), Medical History (MH), Disposition (DS) and many others, grouped into interventions, events, findings and special-purpose classes. The SDTM Implementation Guide specifies variable names, controlled terminology and rules for each domain.

SDTM datasets are created by mapping the data collected in the eCRF (ideally already structured according to CDISC's CDASH collection standard) and external data from laboratories, imaging and eCOA vendors into the standard domains. They form the basis for the ADaM analysis datasets. Submission in SDTM format has been mandatory for NDA and BLA submissions to the FDA since 2016 and to Japan's PMDA since 2020, and is accepted by the EMA; conformance is checked with validation tools such as Pinnacle 21.

SDTM datasets contain subject-level health data, including dates, demographics and detailed medical history, which makes them pseudonymised personal data rather than anonymous, particularly for rare diseases or small trials. Their submission to non-EU regulators is an international data transfer that must be disclosed in the informed consent form, and their sharing with data-sharing platforms or partners requires a compatibility assessment and appropriate contractual and technical safeguards. Programmers and statisticians at CROs handling SDTM data act as processors.