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.
The CDISC Glossary version 10.0 contains four additional groups of new terms – Milestones, eSource, Transparency, and Clinical Trial & Clinical Study. The NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, which contains FDA-NIH harmonized terms used in translational science, is included the Glossary’s Reference Citations section; specific terms from that will be included in a future update.
The CDISC Glossary is NOT comprehensive for all words bearing on human health, medicine, or laboratory methods.
Please note: Acronyms, Abbreviations & Initials list was not updated during the Glossary update cycle for version 10.0.