The Glossary effort was launched in 2002 to support other CDISC standards by clarifying and disambiguating key concepts in clinical research. Over time, the volunteers who serve on the Glossary team have enhanced its scope and utility by:
- Handling and dispositioning new term requests from the CDISC user community by following the CDISC change control process
- When filling out the new term request form, please choose ‘CDISC-Glossary’ from the Codelist drop-down list
- Improving integration with terminology teams: Controlled Terminology Guiding Principles include expectation that the Glossary is an essential reference
- Harmonizing with terms developed by the CDISC Protocol Entities group
- Reviewing terms for accurate NCI C-codes and unique definitions
- Adding “clusters” to link groups of related terms and to highlight distinctions and similarities
- Proposing definitions of terms used in CDISC Standards, but not defined, like exposure, General Observation Classes.
The Glossary now includes more than 750 terms and is published in the National Cancer Institute’s Enterprise Vocabulary Services (NCI-EVS) on an NCI File Transfer Protocol (FTP) site in six formats: Excel, text, odm.xml, pdf, html, and OWL/RDF.
The Glossary team has worked with NCI-EVS to link Glossary terms with Controlled Terminology concepts. Each year, the team updates 50 - 100 existing terms, reviews new guidances and current topics for terms, and updates acronyms/abbreviations/initials, if needed. In addition, authoritative sources for definitions are provided as a tab in the Excel file for ease of use.