Model Documentation

Class: ExtensibleTerminologyTerm

The abstract ExtensibleTerminologyTerm class acts as a template that defines 2 attributes, either (but not both) of which may be used to indicate the value assigned to an attribute associated with an extensible enumeration. The controlledTerm attribute is used to specify 1 of the permissible values from the enumeration or the sponsorTermId attribute is used to indicate which sponsor term is used in the terminology extension for the enumeration. 

Class Diagram: ExtensibleTerminologyTerm

There are 8 specializations of the ExtensibleTerminologyTerm class: There is a pair of specializations for each of the 4 extensible enumerations, with 1 of the pair specifying use of only the controlledTerm attribute and the other specifying use of only the sponsorTermId attribute.

SpecializationAttributeUsed To Specify:

OperationRole

controlledTermA permissible value from the OperationRoleEnum enumeration.

SponsorOperationRole

sponsorTermIdThe identifier of a sponsor term in the terminology extension for the OperationRoleEnum enumeration.

AnalysisReason

controlledTermA permissible value from the AnalysisReasonEnum enumeration.

SponsorAnalysisReason

sponsorTermIdThe identifier of a sponsor term in the terminology extension for the AnalysisReasonEnum enumeration.

AnalysisPurpose

controlledTermA permissible value from the AnalysisPurposeEnum enumeration.

SponsorAnalysisPurpose

sponsorTermIdThe identifier of a sponsor term in the terminology extension for the AnalysisPurposeEnum enumeration.

OutputFileType

controlledTermA permissible value from the OutputFileTypeEnum enumeration.

SponsorOutputFileType

sponsorTermIdThe identifier of a sponsor term in the terminology extension for the OutputFileTypeEnum enumeration.

These specializations are designed to constrain the use of attributes and enumerations for attributes associated with extensible enumerations. In practice, sponsors simply populate any attribute associated with an extensible enumeration with either:

  • A controlledTerm attribute containing one of the permissible values from the associated enumeration, or
  • A sponsorTermId attribute containing the identifier of a sponsor term defined in the terminology extension for the associated enumeration. 

Example

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).

YAML Example
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
    ...
  ...
...

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