FHIR IG analytics| Package | hl7.fhir.uv.clinical-study-protocol |
| Resource Type | Bundle |
| Id | validation-oo.json |
| FHIR Version | R6 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
"resourceType": "Bundle",
"type": "collection",
"timestamp": "2026-02-10T16:53:05.241+00:00",
"entry": [
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/ImplementationGuide-hl7.fhir.uv.clinical-study-protocol",
"resource": {
"resourceType": "OperationOutcome",
"id": "ImplementationGuide-hl7.fhir.uv.clinical-study-protocol",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 1
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 2099
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "InstanceValidator"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "IG_DEPENDENCY_VERSION_ERROR"
}
],
"severity": "error",
"code": "business-rule",
"details": {
"text": "The ImplementationGuide is based on FHIR version 6.0.0-ballot3 but package hl7.fhir.uv.extensions#dev is based on FHIR version 5.0.0. Use the package hl7.fhir.uv.extensions.r6 instead"
},
"expression": [
"ImplementationGuide/hl7.fhir.uv.clinical-study-protocol: ImplementationGuide.dependsOn[0]"
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},
{
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{
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "InstanceValidator"
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "IG_DEPENDENCY_VERSION_ERROR"
}
],
"severity": "error",
"code": "business-rule",
"details": {
"text": "The ImplementationGuide is based on FHIR version 6.0.0-ballot3 but package hl7.terminology#7.0.1 is based on FHIR version 5.0.0. Use the package hl7.terminology.r6 instead"
},
"expression": [
"ImplementationGuide/hl7.fhir.uv.clinical-study-protocol: ImplementationGuide.dependsOn[1]"
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{
"extension": [
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"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
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{
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "InstanceValidator"
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "IG_DEPENDENCY_VERSION_WARNING"
}
],
"severity": "warning",
"code": "business-rule",
"details": {
"text": "The ImplementationGuide is based on FHIR version 6.0.0-ballot3 but package hl7.fhir.uv.ebm#1.0.0-ballot2 is based on FHIR version 6.0.0-ballot2. In general, this version mismatch should be avoided - some tools will try to make this work with variable degrees of success, but others will not even try"
},
"expression": [
"ImplementationGuide/hl7.fhir.uv.clinical-study-protocol: ImplementationGuide.dependsOn[2]"
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}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/CodeSystem-narrative-elements-cs",
"resource": {
"resourceType": "OperationOutcome",
"id": "CodeSystem-narrative-elements-cs"
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/Composition-IGBJ-Narrative-1.3",
"resource": {
"resourceType": "OperationOutcome",
"id": "Composition-IGBJ-Narrative-1.3",
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{
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 8
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C218519' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
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}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/Composition-IGBJ-Narrative-2.1",
"resource": {
"resourceType": "OperationOutcome",
"id": "Composition-IGBJ-Narrative-2.1",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 26
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 8
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C218521' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"Composition/IGBJ-Narrative-2.1: Composition.section[0].code.coding[0].code"
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]
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{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/Composition-IGBJ-Narrative-5.1",
"resource": {
"resourceType": "OperationOutcome",
"id": "Composition-IGBJ-Narrative-5.1",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 26
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 8
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C218548' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"Composition/IGBJ-Narrative-5.1: Composition.section[0].code.coding[0].code"
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}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/Composition-IGBJ-Narrative-9",
"resource": {
"resourceType": "OperationOutcome",
"id": "Composition-IGBJ-Narrative-9",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 26
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 8
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C218608' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"Composition/IGBJ-Narrative-9: Composition.section[0].code.coding[0].code"
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/Composition-IGBJ-Narrative",
"resource": {
"resourceType": "OperationOutcome",
"id": "Composition-IGBJ-Narrative",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 26
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 8
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C218519' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"Composition/IGBJ-Narrative: Composition.section[0].code.coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 41
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 8
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C218548' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"Composition/IGBJ-Narrative: Composition.section[1].code.coding[0].code"
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/Composition-JPMA0001-Section5-jpn",
"resource": {
"resourceType": "OperationOutcome",
"id": "Composition-JPMA0001-Section5-jpn",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 26
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{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 8
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C218549' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"Composition/JPMA0001-Section5-jpn: Composition.section[0].code.coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 41
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 8
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C218550' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"Composition/JPMA0001-Section5-jpn: Composition.section[1].code.coding[0].code"
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/Group-DIBASY-Eligibility",
"resource": {
"resourceType": "OperationOutcome",
"id": "Group-DIBASY-Eligibility",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 1
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 2
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "InstanceValidator"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "http://hl7.org/fhir/StructureDefinition/Group#cnl-2"
}
],
"severity": "error",
"code": "invariant",
"details": {
"text": "Constraint failed: cnl-2: 'Group.type SHALL be defined if Group.membership is either 'definitional' or 'enumerated' (Group.type.exists() or (Group.membership = 'conceptual'))' (defined in http://hl7.org/fhir/StructureDefinition/Group)"
},
"expression": [
"Group/DIBASY-Eligibility: Group"
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/Group-IGBJ-Eligibility",
"resource": {
"resourceType": "OperationOutcome",
"id": "Group-IGBJ-Eligibility",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 1
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 2
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "InstanceValidator"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "http://hl7.org/fhir/StructureDefinition/Group#cnl-2"
}
],
"severity": "error",
"code": "invariant",
"details": {
"text": "Constraint failed: cnl-2: 'Group.type SHALL be defined if Group.membership is either 'definitional' or 'enumerated' (Group.type.exists() or (Group.membership = 'conceptual'))' (defined in http://hl7.org/fhir/StructureDefinition/Group)"
},
"expression": [
"Group/IGBJ-Eligibility: Group"
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/Group-JPMA0001-Criteria-JPN",
"resource": {
"resourceType": "OperationOutcome",
"id": "Group-JPMA0001-Criteria-JPN",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 23
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 12
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C16735' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"Group/JPMA0001-Criteria-JPN: Group.characteristic[0].timing[0].contextCode.coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 81
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 8
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "Display_Name_for__should_be_one_of__instead_of"
}
],
"severity": "error",
"code": "invalid",
"details": {
"text": "Wrong Display Name 'Hemoglobin A1c/Hemoglobin.total in Blood' for http://loinc.org#59261-8. Valid display is one of 4 choices: 'Hemoglobin A1c/Hemoglobin.total standardized per IFCC-RMP for CDT in Blood' (en-US), 'Hemoglobin A1c/Hemoglobin.total standardized per IFCC-RMP for CDT in Blood' (en-US), 'HbA1c per IFCC-RMP for CDT SFr Bld' (en-US) or 'HbA1c/Total Hgb Standardized per IFCC-RMP for CDT, Blood' (en-US) (for the language(s) 'en')"
},
"expression": [
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]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 112
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 12
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C16735' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"Group/JPMA0001-Criteria-JPN: Group.characteristic[3].timing[0].contextCode.coding[0].code"
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/MedicinalProductDefinition-IGBJ-MedicinalProduct",
"resource": {
"resourceType": "OperationOutcome",
"id": "MedicinalProductDefinition-IGBJ-MedicinalProduct",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 6
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 8
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C218675' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"MedicinalProductDefinition/IGBJ-MedicinalProduct: MedicinalProductDefinition.identifier[0].type.coding[0].code"
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/Organization-IGBJ-Organization",
"resource": {
"resourceType": "OperationOutcome",
"id": "Organization-IGBJ-Organization"
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/Organization-JPMA-Organization",
"resource": {
"resourceType": "OperationOutcome",
"id": "Organization-JPMA-Organization"
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/ResearchStudy-IGBJ-ResearchStudy",
"resource": {
"resourceType": "OperationOutcome",
"id": "ResearchStudy-IGBJ-ResearchStudy",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 90
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 12
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C217026' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[0].value.ofType(CodeableConcept).coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 126
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 12
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "Unknown_Code_in_Version"
}
],
"severity": "error",
"code": "code-invalid",
"details": {
"text": "Unknown code 'AU-NSW' in the CodeSystem 'urn:iso:std:iso:3166' version '2018'"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[3].value.ofType(CodeableConcept).coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 155
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 45
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "InstanceValidator"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "Type_Specific_Checks_DT_URL_Resolve"
}
],
"severity": "warning",
"code": "invalid",
"details": {
"text": "No definition could be found for URL value 'https://somelocation'"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[7].value.ofType(url)"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 165
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 16
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C41065' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[9].extension[0].value.ofType(CodeableConcept).coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 165
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 16
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "Terminology_TX_NoValid_1_CC"
}
],
"severity": "error",
"code": "code-invalid",
"details": {
"text": "None of the codings provided are in the value set 'Study Amendment Scope Enrollment Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.1-ballot2), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41065)"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[9].extension[0].value.ofType(CodeableConcept)"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 186
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 16
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C68846' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[10].extension[0].value.ofType(CodeableConcept).coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 186
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 16
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "Terminology_TX_NoValid_1_CC"
}
],
"severity": "error",
"code": "code-invalid",
"details": {
"text": "None of the codings provided are in the value set 'Study Amendment Scope Enrollment Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.1-ballot2), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C68846)"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[10].extension[0].value.ofType(CodeableConcept)"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 205
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 12
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C218490' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[11].value.ofType(CodeableConcept).coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 217
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 12
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C218494' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[12].value.ofType(CodeableConcept).coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 233
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 12
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C49488' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[14].value.ofType(CodeableConcept).coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 233
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 12
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "Terminology_TX_NoValid_1_CC"
}
],
"severity": "error",
"code": "code-invalid",
"details": {
"text": "None of the codings provided are in the value set 'CDISC Yes No Unknown Not Applicable Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/cdisc-yes-no-vs|1.0.1-ballot2), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C49488)"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[14].value.ofType(CodeableConcept)"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 275
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 16
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C218515' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[18].extension[2].value.ofType(CodeableConcept).coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 275
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 16
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "Terminology_TX_NoValid_1_CC"
}
],
"severity": "error",
"code": "code-invalid",
"details": {
"text": "None of the codings provided are in the value set 'M11 Section Codes Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-section-codes-vs|1.0.1-ballot2), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218515)"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[18].extension[2].value.ofType(CodeableConcept)"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 300
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 16
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C218550' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[19].extension[2].value.ofType(CodeableConcept).coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 300
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 16
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "Terminology_TX_NoValid_1_CC"
}
],
"severity": "error",
"code": "code-invalid",
"details": {
"text": "None of the codings provided are in the value set 'M11 Section Codes Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-section-codes-vs|1.0.1-ballot2), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218550)"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.extension[3].extension[19].extension[2].value.ofType(CodeableConcept)"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 333
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 4
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C15602' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.phase.coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 333
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 4
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "Terminology_TX_NoValid_1_CC"
}
],
"severity": "error",
"code": "code-invalid",
"details": {
"text": "None of the codings provided are in the value set 'M11 Phase Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-phase-vs|1.0.1-ballot2), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15602)"
},
"expression": [
"ResearchStudy/IGBJ-ResearchStudy: ResearchStudy.phase"
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/ResearchStudy-JPMA0001-eng",
"resource": {
"resourceType": "OperationOutcome",
"id": "ResearchStudy-JPMA0001-eng",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 34
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 270
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "InstanceValidator"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "Type_Specific_Checks_DT_String_WS"
}
],
"severity": "warning",
"code": "invalid",
"details": {
"text": "value should not start or finish with whitespace '\\tA Multicenter, 52-week, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of Co-administration of JPMA001 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control Treated With Oral Hypoglycemic Drugs as a Single Agent'"
},
"expression": [
"ResearchStudy/JPMA0001-eng: ResearchStudy.title"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 37
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 4
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C15602' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"ResearchStudy/JPMA0001-eng: ResearchStudy.phase.coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 37
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 4
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "Terminology_TX_NoValid_1_CC"
}
],
"severity": "error",
"code": "code-invalid",
"details": {
"text": "None of the codings provided are in the value set 'M11 Phase Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-phase-vs|1.0.1-ballot2), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15602)"
},
"expression": [
"ResearchStudy/JPMA0001-eng: ResearchStudy.phase"
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/ResearchStudy-JPMA0001-jpn",
"resource": {
"resourceType": "OperationOutcome",
"id": "ResearchStudy-JPMA0001-jpn",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 47
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 111
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "InstanceValidator"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "Type_Specific_Checks_DT_String_WS"
}
],
"severity": "warning",
"code": "invalid",
"details": {
"text": "value should not start or finish with whitespace '\\t経口血糖降下薬単剤による治療では血糖コントロール不十分な2型糖尿病患者を対象として，JPMA001を併用投与した時の安全性および有効性を検討する多施設共同，52週間，ランダム化，並行群間試験'"
},
"expression": [
"ResearchStudy/JPMA0001-jpn: ResearchStudy.title"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 50
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 4
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "UNKNOWN_CODE_IN_FRAGMENT"
}
],
"severity": "warning",
"code": "code-invalid",
"details": {
"text": "Unknown Code 'C15602' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment"
},
"expression": [
"ResearchStudy/JPMA0001-jpn: ResearchStudy.phase.coding[0].code"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-line",
"valueInteger": 50
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-col",
"valueInteger": 4
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "TerminologyEngine"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "Terminology_TX_NoValid_1_CC"
}
],
"severity": "error",
"code": "code-invalid",
"details": {
"text": "None of the codings provided are in the value set 'M11 Phase Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-phase-vs|1.0.1-ballot2), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15602)"
},
"expression": [
"ResearchStudy/JPMA0001-jpn: ResearchStudy.phase"
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/StructureDefinition-m11-amendment-detail",
"resource": {
"resourceType": "OperationOutcome",
"id": "StructureDefinition-m11-amendment-detail",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "InstanceValidator"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "SD_CONTEXT_SHOULD_NOT_BE_ELEMENT"
}
],
"severity": "warning",
"code": "business-rule",
"details": {
"text": "Review the extension type for m11-amendment-detail: extensions should not have a context of Element unless it's really intended that they can be used anywhere"
},
"expression": [
"StructureDefinition/m11-amendment-detail: StructureDefinition.context[0]"
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/StructureDefinition-m11-amendment-scope-impact",
"resource": {
"resourceType": "OperationOutcome",
"id": "StructureDefinition-m11-amendment-scope-impact",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "InstanceValidator"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-message-id",
"valueCode": "SD_CONTEXT_SHOULD_NOT_BE_ELEMENT"
}
],
"severity": "warning",
"code": "business-rule",
"details": {
"text": "Review the extension type for m11-amendment-scope-impact: extensions should not have a context of Element unless it's really intended that they can be used anywhere"
},
"expression": [
"StructureDefinition/m11-amendment-scope-impact: StructureDefinition.context[0]"
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/StructureDefinition-m11-confidentiality-statement",
"resource": {
"resourceType": "OperationOutcome",
"id": "StructureDefinition-m11-confidentiality-statement",
"issue": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/operationoutcome-issue-source",
"valueString": "Publisher"
}
],
"severity": "warning",
"code": "business-rule",
"details": {
"text": "The Implementation Guide contains no examples for this extension"
},
"expression": [
"StructureDefinition.where(url = 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement')"
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/StructureDefinition-m11-protocol-amendment",
"resource": {
"resourceType": "OperationOutcome",
"id": "StructureDefinition-m11-protocol-amendment"
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/clinical-study-protocol/OperationOutcome/StructureDefinition-m11-research-study-narratives",
"resource": {
"resourceType": "OperationOutcome",
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