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

Therapeutic Area Liaison

Team Characteristics

The CDISC Controlled Terminology consists of multiple teams program consists of more than 15 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.

NCI EVS

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

CDISC 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 regulatory authorities. The US National Cancer Institute's Enterprise Vocabulary Services (NCI-EVS) provides 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

CDISC, in collaboration with the National Cancer Institute's Enterprise Vocabulary Services (EVS), supports the controlled terminology needs of CDISC Foundational and Therapeutic Area Standards. CDISC Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to regulators in CDISC-compliant datasets. CDISC Glossary seeks to harmonize definitions (including acronyms, abbreviations, and initials) used in the various standards initiatives undertaken by CDISC in clinical research. Glossary also serves the community of clinical researchers by selecting and defining terms pertaining to clinical research, particularly eClinical investigations, sponsored by the pharmaceutical industry or a federal agency.

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 NCI-EVS) and the CDISC terminology teams develop each request in the order received. Therapeutic area requests have priority over 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 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.

Scope

The CDISC Terminology Teams support

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 Depending on the scope and complexity of the new/modified terms that need to be developed, each team has about term undergoes a 3-month development cycle.   The teams 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 Ftp site 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, Device, Virology, CV, and PGx

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. All terminology sets are published in 6 formats: .xls, .txt, .html, OWL/RDF, .pdf, and odm.xml. 
• Development and maintenance of codetable mapping files, which are publicly reviewed and posted to the CDISC website.
• Development and maintenance of rule sets that outline terminology norms across all CDISC codelists and within individual codelists.
• Development and maintenance of the CT Implementation Guide.

Stakeholders/Constituency 

• Regulatory Authorities
• Standards Development Organizations
• Pharmaceutical Sponsors
• Organizations specializing in Medical Devices , and Diagnostics
• Contract Research Organizations & Consultants
• Academic ResearchersResearch Labs and Organizations
  
• Laboratories
• CDISC Therapeutic Area Teams
• CDISC Foundational Teams
• CDISC SHARE
• IT Vendors
  

Collaborations

NCI-EVS, SDS and subteams, Medical Devices team, PGx team, SEND and subteams, CDASH team, ADaM

team, SHARE team, Therapeutic Area teams, Data Exchange Standards team, Global Governance Group, goRENI and Regenstrief Institute.

Operating Model & Meetings

• There are is an ongoing needs need to adopt, add or modify terminology for existing codelists and to define terminologies for new foundational/ therapeutic to support CDISC user community requests as well as foundational and therapeutic area standards. 
• The requests All requests for these new/modified terms come in through new terms or modifications to existing terms are made through the New Term Request Page that can webpage here: https://ncitermform.nci.nih.gov/ncitermform/?version=cdisc, which can also be accessed via the CDISC Controlled Terminology website.
• The Lab, General, QRS, and PK sub-teams meet continually Most terminology sub-teams meet weekly for 1-2 hours weekly 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. 
• 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 received.

• needs of CDISC standards. Individual CT teams may be dissolved if they are no longer needed.
• CT teams adhere to the CT Guiding Principles: Guiding Principles