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CDISC Terminology
The 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 in several areas, notably CDISC's 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 SDTM and other terminology goes through an extensive process of definition, development, and review before it is declared ready for release. Terminology that has completed this process is tagged as "Production," and now includes some 50 SDTM codelists with about 2,200 terms covering demographics, interventions, findings, events, trial design, units, frequency, and ECG terminology. This terminology is maintained and distributed as part of NCI Thesaurus, and is available for direct download from the CDISC SDTM directory on an NCI File Transfer Protocol (FTP) site in both Excel and text 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 both Excel and text 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 both Excel and text formats.
The CDISC New Term Request web page handles suggestions for both new terminology and changes to existing terminology. The CDISC Term Request Tracking web page helps members of the CDISC community review and comment on all submitted requests.
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