CDISC — Clinical Data Interchange Standards Consortium

Overview

CDISC is the global standards body for clinical research data, developing and maintaining the data standards required for regulatory submissions to the FDA and EMA. Its standards ensure that clinical trial data is structured, traceable, and reusable across studies and regulatory jurisdictions.

Key Standards

• SDTM (Study Data Tabulation Model) defines the standard structure for submitting tabulated clinical trial data to regulators.
• ADaM (Analysis Data Model) defines the standard for analysis-ready datasets and documentation of analysis decisions.
• CDASH (Clinical Data Acquisition Standards Harmonisation) defines the standard for data collection and CRF design.
• Define-XML is a machine-readable metadata specification linking datasets to their definitions.
• COSMOS (Controlled Terminology) provides a shared controlled vocabulary for clinical concepts.

Connections

• Maps to: OMOP CDM (SDTM↔OMOP mapping), HL7 FHIR (ResearchStudy alignment), SNOMED CT (controlled terminology)

Resources

• https://www.cdisc.org
• https://www.cdisc.org/standards (full standards catalogue)