...
In situations where a sponsor needs to use a sponsor-defined term instead of one of the defined set of controlled terms, a terminology extension is created. A terminology extension is a set of one or more sponsor-defined terms created to be used instead of the controlled terms defined for one of the "extensible" enumerations.
| Excerpt Include | ||||
|---|---|---|---|---|
|
...
| Tip |
|---|
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. |
| Example | ||||||
|---|---|---|---|---|---|---|
|
Sponsor terms that have been defined in a terminology extension are referenced through use of an enumeration-specific specialization of the ExtensibleTerminologyTerm class.
...