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.
As of 21 December 2018 the CDISC Glossary is coded in NCI Thesaurus and the output available through the NCI-EVS Ftp site. The date of the new file is 2018-12-21 and is available on the NCI-EVS website in Excel, text, odm.xml, pdf, html and OWL/RDF formats. This glossary update contains 58 new terms and around 47 changes to existing content.
The CDISC Glossary version 12.0 contains four additional “clusters” of related terms which, when their definitions are read together, help sharpen their semantic distinctions and optimize effective communication - investigator, monitoring, exposure, study participant/subject, and data integrity. Additional authoritative sources are referenced within glossary definitions.
The CDISC Glossary is NOT comprehensive for all words bearing on human health, medicine, or laboratory methods.
Acronyms, Abbreviations & Initials list was updated during the Glossary update cycle for version 12.0. This update included 7 new additions and 45 minor edits to existing terms.