| Element Name | StudyParameter |
|---|---|
| Parent Elements | StudySummary |
| Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/StudySummary/StudyParameter |
| Element Textual Value | None |
| Attributes | OID, Term, ShortName |
| Child Elements | (ParameterValue, Coding*) |
| Usage/Business Rules |
| 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. |
|
| Term | name | Required | Longer name. Provides the full name of the parameter. |
Note the term may include white space. |
| ShortName | name | Required | Short name or code for the parameter. |
|
A StudyParameter defines a study design parameter for which the value or values are delivered in the ParameterValue child element or elements.
The OID is a unique identifier that can be referenced from other elements.
The Term attribute 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 domain dataset, the Term will be taken from the CDISC Controlled Terminology "TSPARM" (C67152) codelist.
The ShortName provides the short name or code of the parameter. For the CDISC End-to-End use case, when the Study Parameter will be included in the SDTM Trial Summary 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.