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When needed, a single terminology extension may be created for any of the 4 extensible enumerations, and each terminology extension may contain one or more sponsor terms. The enumeration attribute of the terminology extension indicates the name of the enumeration for which the terminology extension is being created, an identifier value for the terminology extension is specified in the id attribute and one or more sponsor terms are defined in the sponsorTerms attribute, each as an instance of the SponsorTerm class. Each sponsor term has the value to be used when represented for representation in a submission (in the submissionValue attribute), corresponding descriptive text (in the description attribute) and an assigned identifier value (in the id attribute).
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The enumerations defined in the ARS model are considered to be CDISC controlled terminology so existing guidance should be followed when assigning sponsor terms for extensible enumerations. This includes, for example, guidance indicating that sponsor terms should not be synonyms for existing controlled terms. |
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Sponsor terms that have been defined in a terminology extension are referenced through use of an enumeration-specific specialization of the ExtensibleTerminologyTerm class.
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