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 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.
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2 terminology extensions, with 1 sponsor term defined for the AnalysisReasonEnum enumeration and 2 sponsor terms defined for the OutputFileTypeEnum enumeration:
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| id | enumeration | sponsorTerms |
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| id | submissionValue | description |
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| SPANREAS | AnalysisReasonEnum | SPANREAS1 | DEMONSTRATION | The analysis was included in the set as an additional example to demonstrate both a different type of analysis and sponsor terminology for analysis reason. | | SPFTYPE | OutputFileTypeEnum | SPFTYPE_DOCX | docx | Office Open XML Document Format (DOCX) | | SPFTYPE_ODT | odt | OpenDocument Text Format (ODT) |
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```
methodsterminologyExtensions:
- id: Mth01_CatVar_Summ_ByGrp
name: Summary by group of a categorical variable
operationsSPANREAS
enumeration: AnalysisReasonEnum
sponsorTerms:
- id: Mth01_CatVar_Summ_ByGrp_2_pctSPANREAS1
namesubmissionValue: PercentDEMONSTRATION
of subjects
referencedOperationRelationshipsdescription:
The analysis was -included id: Mth01_CatVar_Summ_ByGrp_2_pct_NUM
referencedOperationRole:in the set as an additional example to
demonstrate both controlledTerm:a NUMERATOR
different type of analysis and sponsor ...
terminology - id: Mth01_CatVar_Summ_ByGrp_2_pct_DENfor analysis
referencedOperationRole:reason.
controlledTerm- id: DENOMINATORSPFTYPE
...
...enumeration: OutputFileTypeEnum
sponsorTerms:
...
analyses:
- id: An07_01_TEAE_Comp_ByTrt_PlacLowSPFTYPE_DOCX
name: Comparison of Subjects with TEAEs by Treatment - Placebo vs Low DosesubmissionValue: docx
reason:
sponsorTermIddescription: SPREAS1
Office Open purpose:
XML Document controlledTerm: SECONDARY OUTCOME MEASUREFormat (DOCX)
...
outputs:
- id: Out14-1-1SPFTYPE_ODT
name: Summary of Demographics
versionsubmissionValue: 1odt
fileSpecifications:
- namedescription: t14-1-1-demog
fileType:
controlledTerm: rtf
OpenDocument Text Format (ODT)
...
- name: t14-1-1-demog
fileType:
sponsorTermId: SPFTYPE_ODT
...
...
...
`````` |
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