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 ARSP-14 - Getting issue details... STATUS to indicate the value used for an attribute ARSP-15 - Getting issue details... STATUS 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.
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.
| Specialization | Attribute | Used To Specify: |
|---|---|---|
| controlledTerm | A permissible value from the OperationRoleEnum enumeration. | |
| sponsorTermId | The identifier of a sponsor term in the terminology extension for the OperationRoleEnum enumeration. | |
| controlledTerm | A permissible value from the AnalysisReasonEnum enumeration. | |
| sponsorTermId | The identifier of a sponsor term in the terminology extension for the AnalysisReasonEnum enumeration. | |
| controlledTerm | A permissible value from the AnalysisPurposeEnum enumeration. | |
| sponsorTermId | The identifier of a sponsor term in the terminology extension for the AnalysisPurposeEnum enumeration. | |
| controlledTerm | A permissible value from the OutputFileTypeEnum enumeration. | |
| sponsorTermId | The 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
| 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 27-37: | Show the "Summary of Demographics" output, which has two file specifications and the fileType attribute for:
|
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
...
...
...