This example shows use of either an existing controlled term or a sponsor-defined term for each of the attributes associated with extensible enumerations:
- The "Percent of subjects" operation of the "Summary by group of a categorical variable" analysis method has 2 referenced operation relationships, which identify the operations whose results are used as the numerator and denominator in the calculation of the percentage. For both referenced operation relationships in this example, the referencedOperationRole attribute of the ReferencedOperationRelationship class contain a controlledTerm with a permissible value from the OperationRoleEnum enumeration.
- For the "Comparison of Subjects with TEAEs by Treatment - Placebo vs Low Dose" analysis:
- The reason attribute contains a sponsorTermId with the identifier value of a sponsor term defined in the terminology extension for the AnalysisReasonEnum enumerator (as shown in the example in the TerminologyExtension section).
- The purpose attribute contain controlledTerm with a permissible value from the AnalysisPurposeEnum enumeration.
- The "Summary of Demographics" output has two file specifications and the fileType attribute for:
- The first file specification contains a controlledTerm with a permissible value from the OutputFileTypeEnum enumeration.
- The second file specification contains a sponsorTermId with the identifier value of a sponsor term defined in the terminology extension for the OutputFileTypeEnum enumerator (as shown in the example in the TerminologyExtension section).
YAML Example