CDISC Terminology
The Clinical Data Interchange Standards Consortium (CDISC) 1 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 2 on an NCI File Transfer Protocol (FTP) site in Excel 3, text 4, odm.xml 5 and pdf 6 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 7. CDASH terminology is a subset of SDTM terminology and is available for direct download from the CDISC CDASH directory 2 on an NCI File Transfer Protocol (FTP) site in Excel 8, text 9, odm.xml 10 and pdf 11 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 12 on an NCI File Transfer Protocol (FTP) site in Excel 13, text 14, odm.xml 15 and pdf 16 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 17 on an NCI File Transfer Protocol (FTP) site in Excel 18, text 19, odm.xml 20 and pdf 21 formats.
The CDISC New Term Request 22 web page handles suggestions for both new terminology and changes to existing terminology. The CDISC Term Request Tracking 23 Excel spreadsheet helps members of the CDISC community review and comment on all submitted requests.