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 22 December 2017 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 2017-12-22 and is available on the NCI-EVS website in Excel, text, odm.xml, pdf, html and OWL/RDF formats. This glossary update contains 56 new terms and around 100 changes to existing content.
The CDISC Glossary version 11.0 contains six additional groups of new terms - Outcomes Assessment (including eCOA), Endpoints, International Organization for Standardization (ISO) for the identification of medicinal products (IDMP), the ICH E6 update, the NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, and elements from the Common Protocol Template. 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.
Please note: Acronyms, Abbreviations & Initials list was updated during the Glossary update cycle for version 11.0. This updated included around 30 new additions and minor edits to existing terms, including the capitalization of proper nouns in the long name.
|CDISC Glossary v11.pdf||302.07 KB|
|CDISC Glossary v11.xls||390 KB|
|CDISC Glossary Acronyms, Abbreviations, Initials v10.xlsx||32.68 KB|