This example shows use of either an existing controlled term or a sponsor-defined term for each of the attributes associated with extensible enumerations:

Lines 2-14:Show the "Percent of subjects" operation of the "Summary by group of a categorical variable" analysis method, which 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 contains a controlledTerm with a permissible value from the OperationRoleEnum enumeration. 
Lines 19-24:

Show that, for the "Comparison of Subjects with TEAEs by Treatment - Placebo vs Low Dose" analysis:

  • Lines 21-22: 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).
  • Lines 23-24: The purpose attribute contains a controlledTerm with a permissible value from the AnalysisPurposeEnum enumeration.
Lines 27-37:

Show the "Summary of Demographics" output, which has two file specifications and the fileType attribute for:

  • Lines 32-33: The first file specification contains a controlledTerm with a permissible value from the OutputFileTypeEnum enumeration.
  • Lines 36-37: 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).
methods:
- id: Mth01_CatVar_Summ_ByGrp
  name: Summary by group of a categorical variable
  operations:
  - id: Mth01_CatVar_Summ_ByGrp_2_pct
    name: Percent of subjects
    referencedOperationRelationships:
    - id: Mth01_CatVar_Summ_ByGrp_2_pct_NUM
      referencedOperationRole:
        controlledTerm: NUMERATOR
      ...
    - id: Mth01_CatVar_Summ_ByGrp_2_pct_DEN
      referencedOperationRole:
        controlledTerm: DENOMINATOR
      ...
    ...
  ...
analyses:
- id: An07_01_TEAE_Comp_ByTrt_PlacLow
  name: Comparison of Subjects with TEAEs by Treatment - Placebo vs Low Dose
  reason:
    sponsorTermId: SPANREAS1
  purpose:
    controlledTerm: SECONDARY OUTCOME MEASURE
  ...
outputs:
- id: Out14-1-1
  name: Summary of Demographics
  version: 1
  fileSpecifications:
  - name: t14-1-1-demog
    fileType:
      controlledTerm: rtf
    ...
  - name: t14-1-1-demog
    fileType:
      sponsorTermId: SPFTYPE_ODT
    ...
  ...
...