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Terminology Home on the CDISC Website

  1. Terminology Home on the CDISC Wiki (Access may be restricted to Controlled Terminology Team Members)

Leadership Team

 Team Leaders

NCI-EVS Contact(s)

                  Erin Muhlbradt, Jordan Li

Therapeutic Area Liaison(s)

           Erin Muhlbradt, Jordan Li

Team Characteristics

The CDISC Controlled Terminology program consists of more than 10 active terminology teams responsible for developing terminology to support Foundational Standards and Therapeutic Areas. These teams consist of terminology and subject matter experts, data and standards personnel from pharmaceutical companies and CROs, academic researchers, and personnel from regulatory authorities.

NCI EVS

The US National Cancer Institute's Enterprise Vocabulary Services 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

  • Define and support the terminology needs of CDISC foundational standards and therapeutic area standards across the clinical study lifecycle
  • Focus on “standards” terminology codelist management and publication
  • Harmonize across CDISC Models and with pre-existing vocabulary initiatives (for example:  NCI Toxicity Scales for Adverse Events)
  • Improve the Terminology process to keep pace with the development of CFAST Therapeutic Area Standards and other CDISC projects

 Adopt…Adapt…Develop Philosophy

  • Identify, evaluate and/or utilize existing terminology first - ADOPT
  • Expand existing vocabularies for evolving needs or where incomplete, working with vocabulary developer / owner – ADAPT
  • Develop new terminology sets if we cannot adopt or adapt

Scope

The CDISC Terminology Team supports the terminology needs of all CDISC foundational standards (SDTM, CDASH, ADaM, SEND) and all CFAST disease/therapeutic area standards. Based on the new/modified terms that need to be developed each team has about a 3-month development cycle.  The teams evaluate the requests received, incorporating as much as possible for each quarterly release.  Each quarter has a public review comment period followed by a publication release.  All approved controlled terminology is stored on NCI EVS and can be accessed via the CDISC website.

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.  The following terminology teams currently exist:  Lab, PK, General, QRS, SEND, ECG, Oncology, Devices, Microbiology, CV, PGx, Glossary, Protocol Entities, and SDTM Domain Abbreviations.

Stakeholders/Constituency 

  • Regulatory Authorities
  • Standards Development Organizations
  • Pharmaceutical Sponsors
  • Organizations specializing in Medical Devices and Diagnostics
  • Contract Research Organizations & Consultants
  • Academic Researchers
  • Laboratories
  • CDISC Therapeutic Area Teams
  • CDISC Foundational Teams
  • Others?

Collaborations

NCI-EVS, SDS and subteams, SEND and subteams, CDASH, ADaM, Therapeutic Area teams, XML-Tech, GGG, Regenstrief Institute, others?

Operating Model & Meetings

  • There is an ongoing need to add or modify terminology for existing codelists to support CDISC user community requests as well as foundational and therapeutic area standards.
  • Most all terminology sub-teams meet weekly for 1-2 hours to address requests that come in from the New Term Request Page. Meetings are canceled if there is nothing to discuss. Meeting date/times are stored on this page: https://wiki.cdisc.org/x/UIJX. 
  • All requests for new terms or modifications to existing terms are made through the New Term Request webpage here: https://ncitermform.nci.nih.gov/ncitermform/?version=cdisc, which can also be accessed via the CDISC Controlled Terminology website.
  • CT Meeting quorum is defined as at least 1 team lead plus 3 additional team members, not including NCI-EVS or CDISC personnel.
  • New CT teams may be created as needed based on the needs of new CDISC standards. Individual CT teams may be dissolved if they are no longer needed.

 

 

 

 

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