CDISC Glossary v15.0 contains 23 new terms, 53 changes to existing content and many new, or changes to, existing “clusters” of related terms that, when their definitions are read together, help sharpen the semantic distinctions and optimize effective communication. New clusters include Pre-approval Access, Plain Language Writing, Virtual or Remote Clinical Trials, Observational Studies, Artificial Intelligence, Reports, and COVID-19 related terms listed below.
Glossary v15.0 can also be found in Excel, text, odm.xml, pdf, html, and OWL/RDF formats, along with CDISC Terminology Changes files on the NCI-EVS website with file date 2020-12-18. that list these new terms and changes to existing terms can be found here:
Glossary v15.0 contains the eight COVID-19 terms (epidemic, pandemic, endemic disease, immediately life-threatening disease or condition, medical countermeasure, morbidity rate, mortality rate, and pre-approval access) that were published in Glossary v14.0 to support the CDISC COVID-19 Package of Resources.
New authoritative sources are referenced within glossary definitions and on the References tab, numbering 26 this year. The Acronyms, Abbreviations & Initials (AAI) list for Glossary 15.0 includes four new additions.
The CDISC Glossary is NOT comprehensive for all words bearing on human health, medicine, or laboratory methods. Please refer to the CDISC SDTM Terminology and CDISC Protocol Terminology for other specific technical terms.