Therapeutic Area Liaison(s)
The CDISC Controlled Terminology program consists of more than 15 active terminology teams responsible for developing terminology to support 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).
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.
The CDISC Terminology Teams support the terminology needs of all CDISC foundational standards and disease/therapeutic area standards. Depending on the scope and complexity of the new/modified terms to be developed, each 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 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.
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.