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 medical research and healthcare. CDISC standards are widely used for study planning and data collection, tabulation, analysis, and submissions to the U.S. Food and Drug Administration (FDA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and other regulatory agencies internationally.

CDISC partners with NCI Enterprise Vocabulary Services (EVS) to develop and support controlled terminology for all CDISC foundational standards (Protocol, CDASH, SDTM, SEND, ADaM, Define-XML, and CDISC Glossary) and CDISC Therapeutic Area Standards. 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).

CDISC Terminology is freely available, without licensing restrictions, and versioned by date; all previous versions can be found in the archive subdirectories.

Study Data Tabulation Model (SDTM)

SDTM is an international standard for clinical research data and is approved by the FDA as a standard electronic submission format. CDISC Questionnaires, Ratings, and Scales terminology is included in the SDTM terminology publication. NCI EVS maintains and distributes SDTM controlled terminology as part of NCIt.

Clinical Data Acquisition Standards Harmonization (CDASH)

CDISC leads the CDASH project, which develops clinical research study collection standards in collaboration with sixteen 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 (ADaM)

CDISC leads the ADaM project, which supports 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

CDISC leads the Define-XML terminology project, which defines the 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 (SEND)

CDISC leads the SEND project, which guides the organization, structure, and format of standard nonclinical tabulation data sets for interchange between organizations such as sponsors and CROs and for submission to a regulatory authority such as the FDA. NCI EVS maintains and distributes SEND controlled terminology as part of NCIt.

Protocol Terminology

CDISC leads the Protocol Terminology project, which develops the semantics for commonly used research protocol entities. This project supports CDISC foundational standards for the Protocol Representation Model (PRM) and Clinical Trial Registry XML (CTR-XML). NCI EVS maintains and distributes Protocol Terminology as part of NCIt.

CDISC Glossary

CDISC leads the Glossary project, which harmonizes definitions (including acronyms, abbreviations, and initials) used in the various standards initiatives undertaken by CDISC in clinical research. Glossary also serves the community of clinical researchers by selecting and defining terms pertaining to clinical research sponsored by the pharmaceutical industry or a Federal agency. NCI EVS maintains and distributes CDISC Glossary 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 (TA)-specific data standards to support clinical trials, clinical care, research, and public health. TA 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.

CDISC's Therapeutic Area Standards provide 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, and other disease areas.

New Term Requests

CDISC New Term Request handles suggestions for both new terminology and changes to existing terminology. 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. Users who want to compare changes over different time spans for purposes of terminology analysis or mapping, for instance, can now use the Java program developed by NCI EVS to create such files using free source code.

 

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