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CDISC Terminology

Clinical Data Interchange Standards Consortium (CDISC) is an international, non-profit organization that develops and supports global data standards for medical research. CDISC is working actively with EVS to develop and support controlled terminology for a wide spectrum of clinical and nonclinical studies. CDISC terminology goes through an extensive process of content development and public review before it is declared ready for release. CDISC controlled terminology is versioned by date. All previous versions of CDISC controlled terminology can be found by clicking on the directory links below and going into the Archive subdirectory.

CDISC's Study Data Tabulation Model (SDTM) is an international standard for clinical research data, and is approved by the FDA as a standard electronic submission format. NCI EVS maintains and distributes SDTM controlled terminology as part of NCI Thesaurus. More information is available at CDISC's SDTM Web page. SDTM terminology is available for direct download from the CDISC SDTM directory on an NCI File Transfer Protocol (FTP) site in Excel, text, odm.xml, pdf, html and OWL/RDF formats.

CDISC Clinical Outcome Assessment (COA) Terminology contains standardized, controlled terminology for commonly used questionnaires, functional tests and clinical classifications in biomedical and therapeutic area research. This terminology was previously referred to as QS-FT, and older versions of this terminology can be found in this Archive. NCI EVS maintains and distributes COA controlled terminology as part of NCI Thesaurus. More information is available at CDISC's Questionnaire Web page. COA terminology can be used for both collection (CDASH) and submission (SDTM) data sets, and is available for direct download from the CDISC COA directory on an NCI File Transfer Protocol (FTP) site in Excel, text, odm.xml, pdf, html and OWL/RDF formats.

CDISC also leads the Clinical Data Acquisition Standards Harmonization (CDASH) project, which develops clinical research study content standards in collaboration with sixteen partner organizations including NCI. NCI EVS maintains and distributes CDASH controlled terminology as part of NCI Thesaurus. More information is available at CDISC's CDASH Web page. CDASH terminology is a subset of SDTM terminology and is available for direct download from the CDISC CDASH directory on an NCI File Transfer Protocol (FTP) site in Excel, text, odm.xml, pdf, html and OWL/RDF formats.

CDISC also leads the Analysis Data Model (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 NCI Thesaurus. ADaM terminology is available for direct download from the CDISC ADaM directory on an NCI File Transfer Protocol (FTP) site in Excel, text, odm.xml, pdf, html and OWL/RDF formats.

CDISC also leads the Standard for the Exchange of Nonclinical Data (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 NCI Thesaurus. SEND terminology is available for direct download from the CDISC SEND directory on an NCI File Transfer Protocol (FTP) site in Excel, text, odm.xml, pdf, html and OWL/RDF formats.

CDISC's Clinical Data Element Glossary contains controlled terminology to support CDISC therapeutic area standards. These are disease-specific implementations of CDISC data standards, intended to guide the organization, structure, and format of standard clinical trial tabulation datasets for exchange, analysis, or submission to regulatory authorities; for more information, see CDISC's Therapeutic Area Standards Web page. NCI EVS maintains and distributes this terminology as part of NCI Thesaurus, and makes it available for direct download from the CDISC Clinical_Data_Element_Glossary directory on an NCI File Transfer Protocol (FTP) site in Excel, text, odm.xml, pdf, html and OWL/RDF formats.

The CDISC New Term Request web page handles suggestions for both new terminology and changes to existing terminology. The CDISC Term Request Tracking Excel spreadsheet helps members of the CDISC community review and comment on all submitted requests.