keyword
- Guideline or reference source
- HL7eCTD RPS terminology map
- Definition
- A Keyword is a piece of metadata or identifying information associated with a File through a reference in a Context of Use. The Keyword Definition element belongs to the Application (Dossier). Keywords may be elements of controlled lists (such as Species, Route of Administration), or free-form text (such as Study ID). For example, a New Drug Approval Dossier may include many study report Documents with the same Context of Use code for each Study Report Body File. The Keywords may identify the Study ID, the Indication, etc. The choice of Keywords associated with each Context of Use is determined by the regulatory authority's requirements for each Regulatory Activity.
- Broader Term
- metadata
- Related Term
- context of use
- natural language
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