# 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 (the US and European medicines regulators). It is widely adopted in pharmaceutical clinical trials and increasingly in academic clinical neuroscience, including studies conducted through [[ECRIN]] and at academic hospital centres such as [[AP-HP]]. 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. ## Neuroscience Relevance CDISC standards are required for regulatory submissions in neurological disease trials and are used in studies conducted through [[ECRIN]] and at [[NeurATRIS]] clinical platforms. The CDISC Therapeutic Area Data Standards for Alzheimer's Disease and Parkinson's Disease provide domain-specific extensions. ## Connections - Maps to: [[OMOP CDM]], [[HL7 FHIR]], [[SNOMED CT]] - CDISC↔OMOP: the [[OHDSI Clinical Trials Working Group]] has published conventions for converting CDISC SDTM to OMOP CDM v5.4, though SDTM-to-OMOP conversions remain uncommon in practice — see https://www.ohdsi.org/web/wiki/doku.php?id=projects:workgroups:clinicalstudy - Adopted by: [[ECRIN]], [[VIVLI]], [[YODA Project]], [[TransCelerate]] - Regulatory context: FDA, EMA submission requirements ## Resources - https://www.cdisc.org - https://www.cdisc.org/standards (full standards catalogue)