Page History

• Lab           Phil Pochon
• PK            Lacey Wallace
• General    Bernice Yost
• QRS         Roberta Rosenberg
• SEND       Craig Zwickl
• ECG         Bernice Yost
• Oncology  Barrie Nelson
• Device      Bernice Yost
• Virology    Anna Pron-Zwick
• CV            Bernice Yost
• PGx          Joyce Hernandez

NCI/EVS Team Lead

                  Erin Muhlbradt

Team Characteristics

The CDISC Controlled Terminology consists of multiple teams program consists of more than 10 active terminology teams responsible for developing terminology for different areas to support Foundational Standards and Therapeutic Areas.   Each sub-team of subject matter experts meets weekly while there is a need for new terminology.

The number of active project team members is estimated at 50 – 60 at any one time depending on the number of active teams.

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)

NCI EVS

NCI EVS colleagues participate on all teams. They have access to 75 + different vocabularies. NCI EVS provides starting definitions for all terms.

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:  LABLab, PK, General, QRS, SEND, ECG, Oncology, DeviceDevices, VirologyMicrobiology, CV, and PGxPGx, 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, all disease standards development teamsTherapeutic Area teams, XML-Tech, GGG, Regenstrief Institute, others?

Operating Model & Meetings

• There are is an ongoing needs need to adopt, add or modify terminology for existing codelists to support CDISC user community requests as well as foundational and to define terminologies for new foundational/ therapeutic area standards. 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 The requests for these new/modified terms come in through the New Term Request Page that can be accessed via the CDISC Controlled Terminology website.
• The Lab, General, QRS, and PK sub-teams meet continually to address requests that come in from the New Term Request Page.
• 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 Other teams are convened as needed based on the type of requests receivedneeds of new CDISC standards. Individual CT teams may be dissolved if they are no longer needed.