cdiscvocab

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CDISC Controlled Terminology provides standardized codelists and valid values for clinical research data collection, tabulation, analysis, and submission to regulatory agencies including FDA and PMDA. Maintained as part of NCI Thesaurus and distributed by NCI EVS in multiple formats.

Domains

clinical, biomedical, health, information technology

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cdiscvocab

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Product Summary

Products

From this Resource
ID Name URL Category Format Description
cdiscvocab.sdtm SDTM Controlled Terminology SDTM Product mixed Study Data Tabulation Model controlle...
cdiscvocab.cdash CDASH Controlled Terminology SDTM Product mixed Clinical Data Acquisition Standards H...
cdiscvocab.adam ADaM Controlled Terminology ADaM Product mixed Analysis Data Model controlled termin...
cdiscvocab.send SEND Controlled Terminology SEND Product mixed Standard for Exchange of Nonclinical ...
cdiscvocab.definexml Define-XML Controlled Terminology Define-XML Product mixed Define-XML controlled terminology pro...
cdiscvocab.protocol Protocol Controlled Terminology Protocol Product mixed Protocol Representation Model control...
cdiscvocab.glossary CDISC Glossary Terminology Glossary Product mixed CDISC Glossary controlled terminology...
cdiscvocab.ddf DDF Controlled Terminology DDF Product mixed Digital Data Flow controlled terminol...
cdiscvocab.tmf TMF Controlled Terminology TMF Product mixed Trial Master File controlled terminol...
cdiscvocab.mrct MRCT Glossary Terminology MRCT%20Center%20Clinical%20Research%20Glossary Product mixed MRCT Center Clinical Research Glossar...
cdiscvocab.browser NCI EVS CDISC Terminology Browser evsexplore.semantics.cancer.gov GraphicalInterface http NCI Enterprise Vocabulary Services br...
From other Resources
ID Name URL Category Format Description
athena.mappings Athena Concept Mappings start MappingProduct csv Concept mappings between different te...
athena.vocabularies Athena Vocabulary Downloads list Product csv Downloadable standardized vocabulary ...

Details

Overview

CDISC Controlled Terminology is developed and maintained through a collaboration between the Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute’s Enterprise Vocabulary Services (EVS). The terminology provides the standardized codelists and valid values required for CDISC-compliant datasets used in submissions to regulatory agencies such as the FDA and PMDA.

Controlled Terminology does not define what data to collect, but rather specifies how to represent and submit collected data in electronic datasets. The terminology undergoes extensive content development and public review with broad participation from the research and healthcare community.

Key Features

  • Comprehensive Coverage: Supports multiple CDISC foundational standards including SDTM, CDASH, ADaM, SEND, Define-XML, Protocol, and therapeutic area standards
  • Multiple Formats: Available in Excel, text, ODM XML, PDF, HTML, and OWL/RDF formats
  • Regular Updates: Quarterly releases with detailed change tracking and version control
  • Integrated with NCI Thesaurus: Maintained as part of NCIt, ensuring semantic consistency and interoperability
  • Free Access: Available without licensing restrictions from NCI EVS FTP site
  • Community-Driven: New term requests and changes can be submitted through the CDISC Term Request system
  • Regulatory Acceptance: Required for FDA and PMDA submissions in CDISC-compliant formats

Terminology Components

Foundational Standards

  • SDTM: Study Data Tabulation Model terminology for clinical research data tabulation
  • CDASH: Clinical Data Acquisition Standards Harmonization for data collection
  • ADaM: Analysis Data Model for efficient generation and submission of analysis results
  • SEND: Standard for Exchange of Nonclinical Data for preclinical studies
  • Define-XML: Enumeration values for the Define-XML data exchange standard

Supporting Standards

  • Protocol Terminology: Semantics for protocol representation and clinical trial registry
  • CDISC Glossary: Harmonized definitions across CDISC standards initiatives
  • DDF: Digital Data Flow for study definition repositories
  • TMF: Trial Master File for electronic trial documentation
  • MRCT: Multi-Regional Clinical Trials plain language glossary for health literacy

Therapeutic Area Standards

Specialized extensions for disease-specific implementations including oncology, cardiovascular, neurology, infectious diseases, rare diseases, and other therapeutic areas.

Update Frequency

CDISC Controlled Terminology is updated quarterly with comprehensive release packages. Each release includes:

  • New and modified terms across all terminology components
  • Updated codetable mapping files
  • Terminology development rules documents
  • Change tracking files comparing to previous releases
  • Updated publication schedules

The most recent update (September 26, 2025) included approximately 662 new QRS terms and 648 new terms across all terminology files.

Access and Distribution

All CDISC Controlled Terminology products are freely available from the NCI EVS FTP site without licensing restrictions. Users can download individual components in their preferred format or access terminology through the CDISC Library browser interface. Historical versions are maintained in archive subdirectories for version control and reproducibility.

Community Participation

The CDISC community can submit new term requests or suggest changes to existing terminology through the CDISC New Term Request system. The Term Request Tracking system enables community review and comment on all submitted requests, ensuring transparency and broad input in terminology development.

Is this information incorrect or incomplete? Request an update.

Created: November 05, 2025 | Last modified: April 10, 2026