| Terminology
Background
The CDISC Terminology Initiative was formalized in 2005 with the primary objective to define and support the terminology needs of the CDISC models across the clinical trial continuum. Work to date (and continuing throughout 2007) encompasses development of controlled terminology for the SDTM (Study Data Tabulation Model). This work is intended to further the CDISC mission for the development of data standards “…that enable information system interoperability to improve medical research and related areas of healthcare.”
Throughout the development process CDISC controlled terminology is developed and moved into production under the following guiding principles:
- Evaluate and/or utilize available terminology first
- Expand existing terminology where incomplete, working with vocabulary developer and owner
- Develop terminology recommendations for all appropriate fields in the CDISC models, beginning with the SDTM
- Harmonize across CDISC models and with pre-existing vocabulary initiatives
- Ensure terminology recommendations suit international needs for global organizations and projects
- Ensure a sustainable “open source” environment for production terminology supporting terminology evolution
For further overview of the CDISC Terminology Initiative, please refer to the following documents:
To date, terminology development has been distributed across 4 Terminology Projects Teams with work at various stages of development and production. Project Teams include: (1) SDTM Package-1; (2) Labtest Team; (3) SDTM Package-2A; and (4) SDTM Package-2B. The new Terminology Implementation Team is currently being formed.
Recent Progress
The CDISC Terminology Team has finalized the production release of SDTM Package 2A. This set of controlled terminology is comprised of approximately 600 terms across the following SDTM domains – ECG Test Results (EG), Concomitant Medications (CM), Exposure (EX) and Substance Use (SU). This terminology set has been combined with prior production releases of SDTM Package 1 and Labtest Package 1, bringing the total number of SDTM production terms to nearly 1600 across some 40 SDTM codelists. SDTM terminology is maintained and distributed as part of NCI Thesaurus and is available for direct download at the following web-link or you can download it below.
CDISC SDTM Production Terminology Spreadsheet
NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6
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