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.
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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