Terminology

New Term Requests

The online Terminology Request Page has been in operation since January 2009. In March 2010 the CDISC New Term Request web page was updated to be more user friendly. This page is the mechanism for both new terminology requests and changes to existing terminology. The CDISC Term Request Tracking web page provides a list of previously submitted requests.

Approved terminology is maintained and distributed as part of NCI Thesaurus and is available for direct download at the following web-link:

NCI EVS Terminology Resources (access to CDISC, FDA and other terminology)

Overview

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 has primarily encompassed development of controlled terminology for the SDTM (Study Data Tabulation Model) Implementation Guide Version 3.1.2. With few exceptions, the terminology also meets the requirements for CDASH (Clinical Data Acquisition Standards Harmonization) Version 1.0. Some terminology sets have also been developed for ADaM. There are currently about 4200 terms across 65 code lists.

Throughout the development process CDISC controlled terminology is developed and moved into production with these guiding principles in mind:

• 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

If you are interested in learning more about the CDISC Terminology Program and/or contributing to core terminology development, harmonization and production activities, please contact Chris Tolk.