Terminology Update and Call for Terminology Review
The online Terminology Request Page has been in operation since January 2009. The CDISC New Term Request webpage is the mechanism for both new terminology requests and changes to existing terminology. The CDISC Term Request Tracking webpage provides review and accepts comments on previously submitted requests.
Between October 1 and December 31, 2009 (Q4), 11 terminology requests were submitted through the Terminology Request page. The requests have been assessed, addressed and answered as appropriate. The requests are assigned a Level I, II, or III based on the change requested. Level I=spelling fixes, duplication of terms, or minor changes to the definition (none in Q4), Level II= synonyms added, significant additions or changes in the meaning of definition (2 terms), Level III= new terms added to an existing codelist and suggestions for new codelists (9 terms). Q3 terms were incorporated into the Package 4 terminology review cycle. The terms from both Q3 and Package 4 have been reviewed by the terminology group and are in final quality control at NCI. These terms will be available for use in NCI EVS in mid to late February 2010.
The Q4 Level II and III changes requested via the CDISC New Term Request page are available for public review and will be posted for public review for a period of approximately 4 weeks. The document with the changes and the comment spreadsheet are available below:
Public Review Comment Form
Q4 Type II, III Change Requests
Please return all comments to Chris Tolk. The review period closes on 26 February 2010.
Recent Progress
CDISC Terminology Package 4 is in the final quality control process. We expect these terms to be published on NCI EVS by themiddle of February 2010.
SDTM 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 3.1.1. With few exceptions, the terminology also meets the requirements for CDASH (Clinical Data Acquisition Standards Harmonization) Version 1.0.
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
To ensure effective ongoing development, terminology activities have been distributed and staggered across numerous Terminology Projects Teams. Project Teams have included: (1) SDTM Package-1; (2) Labtest Team; (3) SDTM Package-2A; (4) SDTM Package-2B; and now (5) SDTM Pacakge 3. From initial project scope, each team is responsible for draft terminology set development, addressing public comments and moving new terminology into production.
Package 4 Terminology Review Comments (zip)
The above zip file contains the comments received during the public review cycle and the team responses.
