If you’re looking for standards for study planning and data collection, tabulation, analysis, and submissions to regulatory agencies (like the U.S. Food and Drug Administration [FDA], Japanese Pharmaceuticals and Medical Devices Agency [PMDA], and others), you can use resources from an organization with which NCI partners. This organization, the Clinical Data Interchange Standards Consortium (CDISC) is an open, non-profit organization that develops and supports global data standards to improve the quality and interoperability of data in medical research and healthcare.

CDISC partners with NCI Enterprise Vocabulary Services (EVS) to develop and support controlled terminology for all CDISC standards initiatives, including:

CDISC Terminology goes through an extensive process of content development and public review, with wide participation from the research and healthcare community. EVS maintains and distributes CDISC Controlled Terminology as part of NCI Thesaurus (NCIt).

You can use CDISC Terminology for free, without licensing restrictions. You will see terminology versioned by date and find all previous versions in the archive subdirectories.

Study Data Tabulation Model

Use this foundational, international standard for your clinical research data. The FDA approved SDTM as a standard electronic submission format. The SDTM terminology publication includes CDISC questionnaires, ratings, and scales terminology. NCI EVS maintains and distributes SDTM controlled terminology as part of NCIt.

Clinical Data Acquisition Standards Harmonization

Use this foundational standard for collecting data consistently across research studies. CDISC leads the CDASH project, which develops clinical research study collection standards in collaboration with 16 partner organizations, including NCI. NCI EVS maintains and distributes CDASH controlled terminology as part of NCIt. CDASH terminology is a subset of SDTM terminology.

Analysis Data Model

Use ADaM for efficient generation, replication, review, and submission of analysis results from clinical trial data. NCI EVS maintains and distributes ADaM controlled terminology as part of NCIt.

Define-XML Terminology

Use this for defining enumeration values found within the CDISC Define-XML data exchange standard. NCI EVS maintains and distributes Define-XML controlled terminology as part of NCIt.

Standard for the Exchange of Nonclinical Data

Use SEND for data set interchange between organizations (such as sponsors and Contract Research Organizations) and for submission to a regulatory authority (such as the FDA). SEND guides the organization, structure, and format of standard nonclinical tabulation data sets for this type of interchange. NCI EVS maintains and distributes SEND controlled terminology as part of NCIt.

Protocol Terminology

The CDISC-lead Protocol Terminology project develops the semantics for commonly used words and phrases in clinical research protocols, including oncology protocols. This project supports CDISC foundational standards for the Protocol Representation Model (PRM), which provides you with a standard for planning and designing a research protocol with focus on study design, eligibility criteria, and various requirements. This project also supports CDISC foundational standards for Clinical Trial Registry XML (CTR-XML), which lets you implement tools that enable a “write once, use many times” solution for generating submissions for multiple clinical trials. NCI EVS maintains and distributes Protocol Terminology as part of NCIt.

Digital Data Flow

CDISC has partnered with TransCelerate, Microsoft, and Accenture on the DDF project. DDF is a study definition reference architecture designed to serve as a standard model for the development of a study definitions repository, which will ultimately increase your access to standardized study definitions. NCI EVS develops, maintains, and distributes DDF-controlled terminology as part of NCIt.

CDISC Glossary

CDISC leads the Glossary project, which harmonizes definitions (including acronyms, abbreviations, and initials) that are in the various CDISC-managed standards initiatives in clinical research. If you’re a clinical researcher, you can use the CDISC Glossary to select and define terms related to clinical research that the pharmaceutical industry or a federal agency sponsors. NCI EVS maintains and distributes CDISC Glossary controlled terminology as part of NCIt.

Multi-Regional Clinical Trials Center Clinical Research Glossary

The MRCT Center of Brigham and Women's Hospital and Harvard, in collaboration with CDISC, built a Clinical Research Glossary containing plain language definitions and other semantic artifacts for commonly-used concepts in clinical research. If you’re a clinical researcher, patient, trial participant, caregiver, or patient advocate, you can use this glossary to enhance health literacy and create empowering participant research communications. NCI EVS maintains and distributes the MRCT Center controlled terminology as part of NCIt.

CDISC Therapeutic Area Standards

NCI EVS has partnered with CDISC, the Critical Path Institute (C-Path), the FDA, TransCelerate BioPharma (TCB), and other national and international organizations to create CDISC Therapeutic Area-specific data standards. These standards support clinical trials, clinical care, research, and public health by providing you with disease-specific CDISC standards implementation practices and terminology for regulatory data submissions. Therapeutic Area standards contain specialized extensions to CDISC foundational models, including the data collection standard CDASH, the data submission standard SDTM, and the data analysis standard ADaM. They also include CDISC controlled terminology managed as a subset of NCIt.

You can get downloads of published CDISC Therapeutic Area Standards for:

  • autoimmune disorders.
  • cardiovascular diseases.
  • endocrine diseases.
  • gastrointestinal diseases.
  • infectious diseases.
  • mental health disorders.
  • neurology disorders.
  • oncology.
  • rare diseases.
  • respiratory disorders.
  • treatments.
  • other disease areas not previously mentioned.

New Term Requests

If you have a suggestion for new terminology or changes to existing terminology, submit it through CDISC New Term Request. You can also use this request system for terminology related inquiries. The CDISC Term Request Tracking sheet helps members of the CDISC community review and comment on all submitted requests.

CDISC Changes Files Program

Each terminology data release includes files listing changes from the previous quarter’s release. If you want to compare changes over different time spans for purposes of terminology analysis or mapping, for instance, you can now use the Java program developed by NCI EVS to create such files using free source code.

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