CDISC — Clinical Data Interchange Standards Consortium
Overview
CDISC is the global standards body for clinical research data. Its standards are required by the FDA (Food and Drug Administration) for regulatory submissions: new drug, biologics, and abbreviated new drug applications since 2016. The European Medicines Agency has not mandated CDISC, though it accepts and encourages its use. CDISC standards ensure that clinical trial data is structured, traceable, and reusable across studies and institutions.
Key Standards
- SDTM (Study Data Tabulation Model) defines the standard structure for submitting tabulated clinical trial data to regulators, coding adverse events using MedDRA terms.
- 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
- relatedTo: OMOP CDM (active SDTM-to-OMOP mapping work via OHDSI and the HL7 Vulcan Accelerator)
- relatedTo: HL7 FHIR (ResearchStudy resource alignment for clinical trial data exchange)
- relatedTo: SNOMED CT (cross-mapping for clinical concept controlled terminology)
- relatedTo: MedDRA (SDTM’s Adverse Events domain codes events using MedDRA terms)
Resources
- https://www.cdisc.org
- https://www.cdisc.org/standards (full standards catalogue)
- https://www.cdisc.org/standards/foundational/sdtm (SDTM specification, including MedDRA-coded Adverse Events domain)