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 20 December 2019, 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 2019-12-20 and is available on the NCI-EVS website in Excel, text, odm.xml, pdf, html and OWL/RDF formats. This glossary update contains 35 new terms and around 41 changes to existing content.
The CDISC Glossary version 13.0 contains 10 new or changes to “clusters” of related terms which, when their definitions are read together, help sharpen their semantic distinctions and optimize effective communication – Master Protocol, Study Participant, Real World Evidence, Investigator, Clinical Trial Results, Virtual and Remote Trials, Standards, Data Monitoring Committee, Comparator/Control/Placebo, IDMP and Combination Products. Additional authoritative sources 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 updated during the Glossary update cycle for version 13.0. This update included 12 new additions and 51 minor edits to existing AAIs.