Terminology Home on the CDISC Website
- Terminology Home on the CDISC Wiki (Access may be restricted to Controlled Terminology Team Members)
Leadership Team
Team Leaders
NCI-EVS Contact(s)
GGG Liaisons Anna Pron-Zwick, Erin Muhlbradt, Jordan Li Therapeutic Area Liaison(s) | ||
Team Characteristics The CDISC Controlled Terminology program consists of more than 10 active 15 active terminology teams responsible for developing terminology to support Foundational Standards and Therapeutic AreasCDISC foundational standards and therapeutic areas. These teams consist of terminology and subject matter experts, data and standards personnel from pharmaceutical, biologics and device companies, CROs, academic researchers, and personnel from regulatory authorities. | The US National Cancer Institute's Enterprise Vocabulary Services (NCI-EVS) provides | services including team leadership and management, adherence to terminology best practices, definition writing, subject matter expertise, terminology publication, and maintenance. CDISC terminology is incorporated as part of the NCI Thesaurus (ncit.nci.nih.gov). |
Team Mission Primary Objectives
Adopt…Adapt…Develop Philosophy Terminology Development Cycle The CDISC terminology teams follow a quarterly process for CDISC terminology updates. The CDISC Glossary team follows a yearly update cycle. New term requests and requests for changes come in through the CDISC new term request system (powered by EVS) and the CDISC terminology teams develop each request in the order received. Therapeutic area requests have priority over general user requests. At a pre-determined timepoint, the package is closed and sent out for a four-week open, public review. Public review comments are addressed by CDISC CT teams and EVS does final QA/QC on the content before loading into Protégé/NCIt. EVS generates the final, updated CDISC terminology files and posts the files on the NCI Ftp site. EVS also produces a diff file that programmatically lists all changes from last quarter’s release to the current quarter’s release; this file is also posted to the NCI Ftp. CDISC updates codetable mapping files on the CT webpage on CDISC.org. CDISC communicates the update to their user community via list-serv and website updates. Create new terminology sets if need be – DEVELOP |
Scope The CDISC Terminology Team supports Teams support the terminology needs of all CDISC foundational standards (SDTM, CDASH, ADaM, SEND) and all CFAST disease/therapeutic area standards. Depending on the scope and complexity of the new/modified terms to be developed, each team has about term undergoes a 3-month development cycle. The team evaluates the requests received, incorporating as much as possible into the package for each quarterly release. Each quarter has a public review comment period followed by a publication release. All approved controlled terminology is stored on the NCI EVS CDISC staff coordinate the teams and maintain the membership through careful selection of volunteer experts who can contribute to its various sub-teams with their technical or therapeutic-based subject matter expertise. Volunteers can contribute by contacting the leadership team or any team lead. |
Education
The controlled terminology training team works cooperatively with CDISC Education to develop course materials, identify and qualify new instructors, and deliver authoritative training on the CDASH standard through classroom and online courses. Training subteam: Erin Muhlbradt. Chris Gemma, Kit Howard.
Deliverables
- CDISC terminology teams develop quarterly updates to the CDISC terminology standards: SDTM, SEND, ADaM, CDASH, and Protocol. The CDISC Glossary team develops yearly updates to the Glossary terminology standard. These terminology sets are published in 6 formats: .xls, .txt, .html, OWL/RDF, .pdf, and odm.xml.
- The terminology teams develop and maintain codetable mapping files. These are publicly reviewed and posted to the CDISC website.
- The terminology teams develop and maintain rule sets that outline
- Development and maintenance of the CT Implementation Guide.
Stakeholders/Constituency
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Collaborations NCI-EVS, SDS and subteams, MDIGMedical Devices team, PGxIGPGx team, SEND and subteams, CDASH team, ADaM team, SHARE team, Therapeutic Area teams, XML-Tech, GGG,Data Exchange Standards team, Global Governance Group, goRENI and Regenstrief Institute. |
Operating Model & Meetings
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