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.

It includes references and links to other glossaries, such as regulatory dictionaries and health-related controlled terminologies useful in conducting clinical research, including the CDISC Terminology Project. Glossary terms are organized alphabetically, by first word, according to the opinion of the Glossary Project Team concerning most common usage in clinical research. For example, “source document verification” would appear under “source,” not “verification.” The Glossary follows the practice of preceding certain terms with the letter “e” to denote that they pertain to electronic or Web implementation.

Glossary v14.0

Release Date: 8 May 2020

The CDISC Glossary is coded in NCI Thesaurus and the date of the new file is 2020-05-08. These files are available on the NCI-EVS website in Excel, text, odm.xml, pdf, html and OWL/RDF formats. This glossary update contains eight new terms and no changes to existing content.

Glossary v14.0 contains eight new terms to support the CDISC Interim User Guide for COVID-19 and the CDISC Guidance for Ongoing Studies Disrupted by COVID-19 Pandemic. Additional authoritative sources for all Glossary terminology are referenced within glossary definitions and on the references tab.

The CDISC Glossary is NOT comprehensive for all words bearing on human health, medicine, or laboratory methods.

Acronyms, Abbreviations & Initials (AAI) list was not updated during the Glossary update cycle for v14.0.