| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule(s) |
|---|
| OID | oid | Required | Unique identifier for StudyParameter. Note a StudyParameter can be referenced from other elements. | - Must be unique within the Protocol.
|
| Term | name | Required | Longer name. Provides the full name of the parameter.
| - For the CDISC end-to-end use case, when the study parameter will be included in the SDTM Trial Summary (TS) domain dataset, the Term will be taken from the CDISC Controlled Terminology "TSPARM" (C67152) codelist
Note the term may include white space. |
| ShortName | name | Required | Short name or code for the parameter. | - Must not include white space.
- For the CDISC end-to-end use case, when the study parameter will be included in the SDTM TS domain dataset, the ShortName will be taken from the CDISC Controlled Terminology "TSPARMCD" (C66738) codelist and the value of ShortName will be limited to 8 characters.
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