The Clinical Data Interchange Standards Consortium (CDISC) is an international non-profit organization that develops data standards for medical research and other healthcare areas. CDISC produces the CDISC Terminology to aid their efforts.
The goal of CDISC is to develop platform independent standards that aid interoperability of healthcare information systems.
The CDISC Terminology includes these subsets as part of the NCI Thesaurus:
- Study Data Tabulation Model (STDM) is a FDA-approved controlled vocabulary standard for electronic submission of clinical research data.
- Questionnaire (QS) and Functional Test (FT) Terminology is a controlled terminology for questionnaires and functional tests to aid biomedical and therapeutic research.
- Clinical Data Acquisition Standards Harmonization (CDASH) is a project which develops a controlled terminology standard for clinical research study content.
- Analysis Data model (ADaM) controlled terminology supports the production, review and submission of clinical trial data.
- Standard for the Exchange of Nonclinical Data (SEND) project is a guide for the structure and format of standard nonclinical data sets exchanged betwen sponsors and facilitates the transmission to regulatory organizations such as the FDA.
- Clinical Data Element Glossary is a controlled terminology to support the therapeutic area standards of CDISC. The terminology is disease-specific and supports the structure and format of clinical trial data transmitted to regulatory organization such as the FDA.
Metathesaurus Update Frequency
The CDISC Terminology is updated annually as part of the NCI Thesaurus in the Metathesaurus.
- National Cancer Institute [Internet]. Bethesda (MD): National Cancer Institute (US); [cited 2014 Dec 02]. CDISC Terminology; [cited 2014 Dec 02]. Available from: http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/CDISC
- CDISC [Internet]. Austin (TX): Clinical Data Interchange Standards Consortium; c2014 [cited 2014 Dec 02]. Available from: http://www.cdisc.org/