@prefix fhir: . @prefix owl: . @prefix rdf: . @prefix rdfs: . @prefix xsd: . # - resource ------------------------------------------------------------------- a fhir:StructureDefinition ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "research-study-m11-protocol-amendment"] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div [ fhir:v "

Generated Narrative: StructureDefinition research-study-m11-protocol-amendment

#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n#xD;\n
NameFlagsCard.TypeDescription & Constraints\"doco\"
\".\"\".\" Extension 0..*ExtensionAn amendment to a study protocol
\".\"\".\"\".\" extension 2..*ExtensionExtension
\".\"\".\"\".\" Slices for extension Content/Rules for all slices
\".\"\".\"\".\"\".\" extension:identifier 1..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"identifier\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1IdentifierAmendment identifier
\".\"\".\"\".\"\".\" extension:previous 0..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"previous\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1CodeableConceptStatement regarding prior amendments
Binding: ICH M11 Amendment Details Statement Value Set (required)
\".\"\".\"\".\"\".\" extension:scope 1..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"scope\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1CodeableConceptGlobal or Not Global
Binding: ICH M11 Amendment Scope Value Set (required)
\".\"\".\"\".\"\".\" extension:country 0..*ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"country\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1CodeableConceptCountry
\".\"\".\"\".\"\".\" extension:region 0..*ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"region\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1CodeableConceptRegion
\".\"\".\"\".\"\".\" extension:site 0..*ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"site\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1Site
\".\"\".\"\".\"\".\"\".\"\".\" valueIdentifierIdentifier
\".\"\".\"\".\"\".\"\".\"\".\" valueReferenceReference(Any)
\".\"\".\"\".\"\".\" extension:approvalDate 0..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"approvalDate\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1dateApproval date
\".\"\".\"\".\"\".\" extension:signature 0..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"signature\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1SignatureSignature
\".\"\".\"\".\"\".\" extension:signatureUrl 0..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"signatureUrl\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1Signature URL
\".\"\".\"\".\"\".\"\".\"\".\" valueStringstring
\".\"\".\"\".\"\".\"\".\"\".\" valueUrlurl
\".\"\".\"\".\"\".\" extension:signatureMethod 0..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"signatureMethod\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1stringSignature Method
\".\"\".\"\".\"\".\" extension:scopeImpact 0..3(Complex)Provides number or percentage of each group affected by a single amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-scope-impact
\".\"\".\"\".\"\".\" extension:primaryReason 0..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"primaryReason\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1CodeableConceptReason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
\".\"\".\"\".\"\".\" extension:secondaryReason 0..*ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"secondaryReason\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1CodeableConceptReason for amendment, e.g. Safety
Binding: ICH M11 Reason for Amendment Value Set (extensible)
\".\"\".\"\".\"\".\" extension:summary 0..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"summary\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1stringSummary of changes
\".\"\".\"\".\"\".\" extension:substantialImpactSafety 0..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"substantialImpactSafety\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1CodeableConceptSubstantial impact on safety
Binding: ICH M11 Yes No Value Set (required)
\".\"\".\"\".\"\".\" extension:substantialImpactSafetyComment 0..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"substantialImpactSafetyComment\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1stringComment on substantial impact on safety
\".\"\".\"\".\"\".\" extension:substantialImpactReliability 0..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"substantialImpactReliability\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1CodeableConceptSubstantial impact on reliability
Binding: ICH M11 Yes No Value Set (required)
\".\"\".\"\".\"\".\" extension:substantialImpactReliabilityComment 0..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"substantialImpactReliabilityComment\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1stringComment on substantial impact on reliability
\".\"\".\"\".\"\".\" extension:details 0..*(Complex)Provides detail of a single change within an amendment
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-detail
\".\"\".\"\".\"\".\" extension:rationale 0..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"rationale\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1stringRationale
\".\"\".\"\".\"\".\" extension:description 0..1ExtensionExtension
\".\"\".\"\".\"\".\"\".\" extension 0..0Extension
\".\"\".\"\".\"\".\"\".\" url 1..1uri\"description\"
\".\"\".\"\".\"\".\"\".\" value[x] 0..1Description
\".\"\".\"\".\"\".\"\".\"\".\" valueMarkdownmarkdown
\".\"\".\"\".\"\".\"\".\"\".\" valueStringstring
\".\"\".\"\".\" url 1..1uri\"http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment\"
\".\"\".\"\".\" value[x] 0..0Value of extension

\"doco\" Documentation for this format
"^^rdf:XMLLiteral ] ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Code ; fhir:v "can-bind" ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Integer ; fhir:v 1 ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Code ; fhir:v "cds" ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Code ; fhir:v "trial-use" ] ] ) ; # fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"^^xsd:anyURI ; fhir:l ] ; # fhir:identifier ( [ fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ; fhir:l ] ; fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.44.42.163" ] ] ) ; # fhir:version [ fhir:v "1.0.0-ballot3"] ; # fhir:name [ fhir:v "ResearchStudyM11ProtocolAmendment"] ; # fhir:status [ fhir:v "active"] ; # fhir:date [ fhir:v "2026-10-02T12:47:35+00:00"^^xsd:dateTime] ; # fhir:publisher [ fhir:v "HL7 International / Clinical Decision Support"] ; # fhir:contact ( [ fhir:name [ fhir:v "HL7 International / Clinical Decision Support" ] ; fhir:telecom ( [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "http://www.hl7.org/Special/committees/dss" ] ] ) ] ) ; # fhir:description [ fhir:v "An amendment to a study protocol matching M11 template."] ; # fhir:jurisdiction ( [ fhir:coding ( [ fhir:system [ fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "001" ] ; fhir:display [ fhir:v "World" ] ] ) ] ) ; # fhir:fhirVersion [ fhir:v "6.0.0-ballot5"] ; # fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:uri [ fhir:v "http://hl7.org/v3"^^xsd:anyURI ; fhir:l ] ; fhir:name [ fhir:v "RIM Mapping" ] ] ) ; # fhir:kind [ fhir:v "complex-type"] ; # fhir:abstract [ fhir:v false] ; # fhir:context ( [ fhir:type [ fhir:v "element" ] ; fhir:expression [ fhir:v "ResearchStudy" ] ] ) ; # fhir:type [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ; # fhir:baseDefinition [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:l ] ; # fhir:derivation [ fhir:v "constraint"] ; # fhir:snapshot [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:String ; fhir:v "6.0.0-ballot5" ] ] ) ; fhir:element ( [ fhir:id [ fhir:v "Extension" ] ; fhir:path [ fhir:v "Extension" ] ; fhir:short [ fhir:v "An amendment to a study protocol" ] ; fhir:definition [ fhir:v "An amendment to a study protocol." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] [ fhir:key [ fhir:v "ext-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "Must have either extensions or value[x], not both" ] ; fhir:expression [ fhir:v "extension.exists() != value.exists()" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.id" ] ; fhir:path [ fhir:v "Extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "2"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:identifier" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "identifier" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:identifier.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:identifier.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:identifier.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "identifier"^^xsd:anyURI ; fhir:l fhir:identifier ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:identifier.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Amendment identifier" ] ; fhir:definition [ fhir:v "Amendment identifier." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Identifier"^^xsd:anyURI ; fhir:l fhir:Identifier ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:previous" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "previous" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:previous.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:previous.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:previous.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "previous"^^xsd:anyURI ; fhir:l fhir:previous ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:previous.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Statement regarding prior amendments" ] ; fhir:definition [ fhir:v "Statement regarding prior amendments." ] ; fhir:comment [ fhir:v "State {Not applicable. This protocol has not been amended.} or state {This protocol has been amended previously. Details of prior amendments are presented in Prior Protocol Amendment(s).} or include Current Amendment details as appropriate (See instructions)." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:binding [ fhir:strength [ fhir:v "required" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-details-statement"^^xsd:anyURI ; fhir:l ] ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:scope" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "scope" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:scope.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:scope.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:scope.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "scope"^^xsd:anyURI ; fhir:l fhir:scope ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:scope.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Global or Not Global" ] ; fhir:definition [ fhir:v "Global or Not Global (Country, Region, or Site)." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:binding [ fhir:strength [ fhir:v "required" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope"^^xsd:anyURI ; fhir:l ] ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:country" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "country" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:country.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:country.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:country.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "country"^^xsd:anyURI ; fhir:l fhir:country ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:country.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Country" ] ; fhir:definition [ fhir:v "Country." ] ; fhir:comment [ fhir:v "Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; country/region codes. ICH M11 Study Amendment Country Value Set posted at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-country-region-vs.html." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:region" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "region" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:region.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:region.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:region.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "region"^^xsd:anyURI ; fhir:l fhir:region ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:region.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Region" ] ; fhir:definition [ fhir:v "Region." ] ; fhir:comment [ fhir:v "Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; country/region codes. ICH M11 Study Amendment Country Value Set posted at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-country-region-vs.html." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:site" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "site" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:site.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:site.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:site.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "site"^^xsd:anyURI ; fhir:l fhir:site ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:site.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Site" ] ; fhir:definition [ fhir:v "Site." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Identifier"^^xsd:anyURI ; fhir:l fhir:Identifier ] ] [ fhir:code [ fhir:v "Reference"^^xsd:anyURI ; fhir:l fhir:Reference ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:approvalDate" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "approvalDate" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:approvalDate.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:approvalDate.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:approvalDate.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "approvalDate"^^xsd:anyURI ; fhir:l fhir:approvalDate ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:approvalDate.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Approval date" ] ; fhir:definition [ fhir:v "Approval date." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "date"^^xsd:anyURI ; fhir:l fhir:date ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:signature" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "signature" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:signature.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:signature.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:signature.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "signature"^^xsd:anyURI ; fhir:l fhir:signature ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:signature.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Signature" ] ; fhir:definition [ fhir:v "Signature." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Signature"^^xsd:anyURI ; fhir:l fhir:Signature ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:signatureUrl" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "signatureUrl" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:signatureUrl.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:signatureUrl.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:signatureUrl.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "signatureUrl"^^xsd:anyURI ; fhir:l fhir:signatureUrl ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:signatureUrl.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Signature URL" ] ; fhir:definition [ fhir:v "Signature URL." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] [ fhir:code [ fhir:v "url"^^xsd:anyURI ; fhir:l fhir:url ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:signatureMethod" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "signatureMethod" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:signatureMethod.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:signatureMethod.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:signatureMethod.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "signatureMethod"^^xsd:anyURI ; fhir:l fhir:signatureMethod ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:signatureMethod.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Signature Method" ] ; fhir:definition [ fhir:v "Signature Method." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:scopeImpact" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "scopeImpact" ] ; fhir:short [ fhir:v "Provides number or percentage of each group affected by a single amendment" ] ; fhir:definition [ fhir:v "Provides number or percentage of each group affected by a single amendment." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "3" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ; fhir:profile ( [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-scope-impact"^^xsd:anyURI ; fhir:l ] ) ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:primaryReason" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "primaryReason" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:primaryReason.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:primaryReason.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:primaryReason.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "primaryReason"^^xsd:anyURI ; fhir:l fhir:primaryReason ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:primaryReason.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Reason for amendment, e.g. Safety" ] ; fhir:definition [ fhir:v "Reason for amendment, e.g. Safety." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:binding [ fhir:strength [ fhir:v "extensible" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason"^^xsd:anyURI ; fhir:l ] ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:secondaryReason" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "secondaryReason" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:secondaryReason.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:secondaryReason.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:secondaryReason.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "secondaryReason"^^xsd:anyURI ; fhir:l fhir:secondaryReason ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:secondaryReason.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Reason for amendment, e.g. Safety" ] ; fhir:definition [ fhir:v "Reason for amendment, e.g. Safety." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:binding [ fhir:strength [ fhir:v "extensible" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason"^^xsd:anyURI ; fhir:l ] ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:summary" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "summary" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:summary.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:summary.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:summary.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "summary"^^xsd:anyURI ; fhir:l fhir:summary ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:summary.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Summary of changes" ] ; fhir:definition [ fhir:v "Summary of changes." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafety" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "substantialImpactSafety" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafety.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafety.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafety.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "substantialImpactSafety"^^xsd:anyURI ; fhir:l fhir:substantialImpactSafety ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafety.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Substantial impact on safety" ] ; fhir:definition [ fhir:v "Substantial impact on safety." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:binding [ fhir:strength [ fhir:v "required" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no"^^xsd:anyURI ; fhir:l ] ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafetyComment" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "substantialImpactSafetyComment" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafetyComment.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafetyComment.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafetyComment.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "substantialImpactSafetyComment"^^xsd:anyURI ; fhir:l fhir:substantialImpactSafetyComment ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafetyComment.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Comment on substantial impact on safety" ] ; fhir:definition [ fhir:v "Comment on substantial impact on safety." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliability" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "substantialImpactReliability" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliability.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliability.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliability.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "substantialImpactReliability"^^xsd:anyURI ; fhir:l fhir:substantialImpactReliability ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliability.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Substantial impact on reliability" ] ; fhir:definition [ fhir:v "Substantial impact on reliability." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:binding [ fhir:strength [ fhir:v "required" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no"^^xsd:anyURI ; fhir:l ] ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliabilityComment" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "substantialImpactReliabilityComment" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliabilityComment.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliabilityComment.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliabilityComment.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "substantialImpactReliabilityComment"^^xsd:anyURI ; fhir:l fhir:substantialImpactReliabilityComment ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliabilityComment.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Comment on substantial impact on reliability" ] ; fhir:definition [ fhir:v "Comment on substantial impact on reliability." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:details" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "details" ] ; fhir:short [ fhir:v "Provides detail of a single change within an amendment" ] ; fhir:definition [ fhir:v "Provides detail of a single change within an amendment." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ; fhir:profile ( [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-detail"^^xsd:anyURI ; fhir:l ] ) ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:rationale" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "rationale" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:rationale.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:rationale.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:rationale.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "rationale"^^xsd:anyURI ; fhir:l fhir:rationale ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:rationale.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Rationale" ] ; fhir:definition [ fhir:v "Rationale." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:description" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "description" ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:description.id" ] ; fhir:path [ fhir:v "Extension.extension.id" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:condition ( [ fhir:v "ele-1" ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:description.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:slicing [ fhir:discriminator ( [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ fhir:id [ fhir:v "Extension.extension:description.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "description"^^xsd:anyURI ; fhir:l fhir:description ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:description.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Description" ] ; fhir:definition [ fhir:v "Description." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "markdown"^^xsd:anyURI ; fhir:l fhir:markdown ] ] [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.url" ] ; fhir:path [ fhir:v "Extension.url" ] ; fhir:representation ( [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "identifies the meaning of the extension" ] ; fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ; fhir:comment [ fhir:v "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Extension.url" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ; fhir:l ] ; fhir:value [ a fhir:Url ; fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:fixed [ a fhir:Uri ; fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"^^xsd:anyURI ; fhir:l ] ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "Extension.value[x]" ] ; fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:short [ fhir:v "Value of extension" ] ; fhir:definition [ fhir:v "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list)." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "0" ] ; fhir:base [ fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; fhir:type ( [ fhir:code [ fhir:v "base64Binary"^^xsd:anyURI ; fhir:l fhir:base64Binary ] ] [ fhir:code [ fhir:v "boolean"^^xsd:anyURI ; fhir:l fhir:boolean ] ] [ fhir:code [ fhir:v "canonical"^^xsd:anyURI ; fhir:l fhir:canonical ] ] [ fhir:code [ fhir:v "code"^^xsd:anyURI ; fhir:l fhir:code ] ] [ fhir:code [ fhir:v "date"^^xsd:anyURI ; fhir:l fhir:date ] ] [ fhir:code [ fhir:v "dateTime"^^xsd:anyURI ; fhir:l fhir:dateTime ] ] [ fhir:code [ fhir:v "decimal"^^xsd:anyURI ; fhir:l fhir:decimal ] ] [ fhir:code [ fhir:v "id"^^xsd:anyURI ; fhir:l fhir:id ] ] [ fhir:code [ fhir:v "instant"^^xsd:anyURI ; fhir:l fhir:instant ] ] [ fhir:code [ fhir:v "integer"^^xsd:anyURI ; fhir:l fhir:integer ] ] [ fhir:code [ fhir:v "integer64"^^xsd:anyURI ; fhir:l fhir:integer64 ] ] [ fhir:code [ fhir:v "markdown"^^xsd:anyURI ; fhir:l fhir:markdown ] ] [ fhir:code [ fhir:v "oid"^^xsd:anyURI ; fhir:l fhir:oid ] ] [ fhir:code [ fhir:v "positiveInt"^^xsd:anyURI ; fhir:l fhir:positiveInt ] ] [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] [ fhir:code [ fhir:v "time"^^xsd:anyURI ; fhir:l fhir:time ] ] [ fhir:code [ fhir:v "unsignedInt"^^xsd:anyURI ; fhir:l fhir:unsignedInt ] ] [ fhir:code [ fhir:v "uri"^^xsd:anyURI ; fhir:l fhir:uri ] ] [ fhir:code [ fhir:v "url"^^xsd:anyURI ; fhir:l fhir:url ] ] [ fhir:code [ fhir:v "uuid"^^xsd:anyURI ; fhir:l fhir:uuid ] ] [ fhir:code [ fhir:v "Address"^^xsd:anyURI ; fhir:l fhir:Address ] ] [ fhir:code [ fhir:v "Age"^^xsd:anyURI ; fhir:l fhir:Age ] ] [ fhir:code [ fhir:v "Annotation"^^xsd:anyURI ; fhir:l fhir:Annotation ] ] [ fhir:code [ fhir:v "Attachment"^^xsd:anyURI ; fhir:l fhir:Attachment ] ] [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] [ fhir:code [ fhir:v "CodeableReference"^^xsd:anyURI ; fhir:l fhir:CodeableReference ] ] [ fhir:code [ fhir:v "Coding"^^xsd:anyURI ; fhir:l fhir:Coding ] ] [ fhir:code [ fhir:v "ContactPoint"^^xsd:anyURI ; fhir:l fhir:ContactPoint ] ] [ fhir:code [ fhir:v "Count"^^xsd:anyURI ; fhir:l fhir:Count ] ] [ fhir:code [ fhir:v "Distance"^^xsd:anyURI ; fhir:l fhir:Distance ] ] [ fhir:code [ fhir:v "Duration"^^xsd:anyURI ; fhir:l fhir:Duration ] ] [ fhir:code [ fhir:v "HumanName"^^xsd:anyURI ; fhir:l fhir:HumanName ] ] [ fhir:code [ fhir:v "Identifier"^^xsd:anyURI ; fhir:l fhir:Identifier ] ] [ fhir:code [ fhir:v "Money"^^xsd:anyURI ; fhir:l fhir:Money ] ] [ fhir:code [ fhir:v "Period"^^xsd:anyURI ; fhir:l fhir:Period ] ] [ fhir:code [ fhir:v "Quantity"^^xsd:anyURI ; fhir:l fhir:Quantity ] ] [ fhir:code [ fhir:v "Range"^^xsd:anyURI ; fhir:l fhir:Range ] ] [ fhir:code [ fhir:v "Ratio"^^xsd:anyURI ; fhir:l fhir:Ratio ] ] [ fhir:code [ fhir:v "RatioRange"^^xsd:anyURI ; fhir:l fhir:RatioRange ] ] [ fhir:code [ fhir:v "Reference"^^xsd:anyURI ; fhir:l fhir:Reference ] ] [ fhir:code [ fhir:v "SampledData"^^xsd:anyURI ; fhir:l fhir:SampledData ] ] [ fhir:code [ fhir:v "Signature"^^xsd:anyURI ; fhir:l fhir:Signature ] ] [ fhir:code [ fhir:v "Timing"^^xsd:anyURI ; fhir:l fhir:Timing ] ] [ fhir:code [ fhir:v "ContactDetail"^^xsd:anyURI ; fhir:l fhir:ContactDetail ] ] [ fhir:code [ fhir:v "DataRequirement"^^xsd:anyURI ; fhir:l fhir:DataRequirement ] ] [ fhir:code [ fhir:v "Expression"^^xsd:anyURI ; fhir:l fhir:Expression ] ] [ fhir:code [ fhir:v "ParameterDefinition"^^xsd:anyURI ; fhir:l fhir:ParameterDefinition ] ] [ fhir:code [ fhir:v "RelatedArtifact"^^xsd:anyURI ; fhir:l fhir:RelatedArtifact ] ] [ fhir:code [ fhir:v "TriggerDefinition"^^xsd:anyURI ; fhir:l fhir:TriggerDefinition ] ] [ fhir:code [ fhir:v "UsageContext"^^xsd:anyURI ; fhir:l fhir:UsageContext ] ] [ fhir:code [ fhir:v "Availability"^^xsd:anyURI ; fhir:l fhir:Availability ] ] [ fhir:code [ fhir:v "ExtendedContactDetail"^^xsd:anyURI ; fhir:l fhir:ExtendedContactDetail ] ] [ fhir:code [ fhir:v "VirtualServiceDetail"^^xsd:anyURI ; fhir:l fhir:VirtualServiceDetail ] ] [ fhir:code [ fhir:v "Dosage"^^xsd:anyURI ; fhir:l fhir:Dosage ] ] [ fhir:code [ fhir:v "Meta"^^xsd:anyURI ; fhir:l fhir:Meta ] ] ) ; fhir:condition ( [ fhir:v "ext-1" ] ) ; fhir:constraint ( [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:l ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v true ] ; fhir:mapping ( [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] ) ] ; # fhir:differential [ fhir:element ( [ fhir:id [ fhir:v "Extension" ] ; fhir:path [ fhir:v "Extension" ] ; fhir:short [ fhir:v "An amendment to a study protocol" ] ; fhir:definition [ fhir:v "An amendment to a study protocol." ] ] [ fhir:id [ fhir:v "Extension.extension" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:min [ fhir:v "2"^^xsd:nonNegativeInteger ] ] [ fhir:id [ fhir:v "Extension.extension:identifier" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "identifier" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:identifier.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:identifier.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "identifier"^^xsd:anyURI ; fhir:l fhir:identifier ] ] [ fhir:id [ fhir:v "Extension.extension:identifier.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Amendment identifier" ] ; fhir:definition [ fhir:v "Amendment identifier." ] ; fhir:type ( [ fhir:code [ fhir:v "Identifier"^^xsd:anyURI ; fhir:l fhir:Identifier ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:previous" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "previous" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:previous.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:previous.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "previous"^^xsd:anyURI ; fhir:l fhir:previous ] ] [ fhir:id [ fhir:v "Extension.extension:previous.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Statement regarding prior amendments" ] ; fhir:definition [ fhir:v "Statement regarding prior amendments." ] ; fhir:comment [ fhir:v "State {Not applicable. This protocol has not been amended.} or state {This protocol has been amended previously. Details of prior amendments are presented in Prior Protocol Amendment(s).} or include Current Amendment details as appropriate (See instructions)." ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ; fhir:binding [ fhir:strength [ fhir:v "required" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-details-statement"^^xsd:anyURI ; fhir:l ] ] ] [ fhir:id [ fhir:v "Extension.extension:scope" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "scope" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:scope.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:scope.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "scope"^^xsd:anyURI ; fhir:l fhir:scope ] ] [ fhir:id [ fhir:v "Extension.extension:scope.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Global or Not Global" ] ; fhir:definition [ fhir:v "Global or Not Global (Country, Region, or Site)." ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ; fhir:binding [ fhir:strength [ fhir:v "required" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope"^^xsd:anyURI ; fhir:l ] ] ] [ fhir:id [ fhir:v "Extension.extension:country" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "country" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] [ fhir:id [ fhir:v "Extension.extension:country.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:country.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "country"^^xsd:anyURI ; fhir:l fhir:country ] ] [ fhir:id [ fhir:v "Extension.extension:country.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Country" ] ; fhir:definition [ fhir:v "Country." ] ; fhir:comment [ fhir:v "Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; country/region codes. ICH M11 Study Amendment Country Value Set posted at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-country-region-vs.html." ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:region" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "region" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] [ fhir:id [ fhir:v "Extension.extension:region.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:region.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "region"^^xsd:anyURI ; fhir:l fhir:region ] ] [ fhir:id [ fhir:v "Extension.extension:region.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Region" ] ; fhir:definition [ fhir:v "Region." ] ; fhir:comment [ fhir:v "Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; country/region codes. ICH M11 Study Amendment Country Value Set posted at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-country-region-vs.html." ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:site" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "site" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] [ fhir:id [ fhir:v "Extension.extension:site.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:site.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "site"^^xsd:anyURI ; fhir:l fhir:site ] ] [ fhir:id [ fhir:v "Extension.extension:site.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Site" ] ; fhir:definition [ fhir:v "Site." ] ; fhir:type ( [ fhir:code [ fhir:v "Identifier"^^xsd:anyURI ; fhir:l fhir:Identifier ] ] [ fhir:code [ fhir:v "Reference"^^xsd:anyURI ; fhir:l fhir:Reference ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:approvalDate" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "approvalDate" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:approvalDate.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:approvalDate.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "approvalDate"^^xsd:anyURI ; fhir:l fhir:approvalDate ] ] [ fhir:id [ fhir:v "Extension.extension:approvalDate.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Approval date" ] ; fhir:definition [ fhir:v "Approval date." ] ; fhir:type ( [ fhir:code [ fhir:v "date"^^xsd:anyURI ; fhir:l fhir:date ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:signature" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "signature" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:signature.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:signature.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "signature"^^xsd:anyURI ; fhir:l fhir:signature ] ] [ fhir:id [ fhir:v "Extension.extension:signature.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Signature" ] ; fhir:definition [ fhir:v "Signature." ] ; fhir:type ( [ fhir:code [ fhir:v "Signature"^^xsd:anyURI ; fhir:l fhir:Signature ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:signatureUrl" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "signatureUrl" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:signatureUrl.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:signatureUrl.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "signatureUrl"^^xsd:anyURI ; fhir:l fhir:signatureUrl ] ] [ fhir:id [ fhir:v "Extension.extension:signatureUrl.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Signature URL" ] ; fhir:definition [ fhir:v "Signature URL." ] ; fhir:type ( [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] [ fhir:code [ fhir:v "url"^^xsd:anyURI ; fhir:l fhir:url ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:signatureMethod" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "signatureMethod" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:signatureMethod.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:signatureMethod.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "signatureMethod"^^xsd:anyURI ; fhir:l fhir:signatureMethod ] ] [ fhir:id [ fhir:v "Extension.extension:signatureMethod.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Signature Method" ] ; fhir:definition [ fhir:v "Signature Method." ] ; fhir:type ( [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:scopeImpact" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "scopeImpact" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "3" ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ; fhir:profile ( [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-scope-impact"^^xsd:anyURI ; fhir:l ] ) ] ) ] [ fhir:id [ fhir:v "Extension.extension:primaryReason" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "primaryReason" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:primaryReason.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:primaryReason.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "primaryReason"^^xsd:anyURI ; fhir:l fhir:primaryReason ] ] [ fhir:id [ fhir:v "Extension.extension:primaryReason.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Reason for amendment, e.g. Safety" ] ; fhir:definition [ fhir:v "Reason for amendment, e.g. Safety." ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ; fhir:binding [ fhir:strength [ fhir:v "extensible" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason"^^xsd:anyURI ; fhir:l ] ] ] [ fhir:id [ fhir:v "Extension.extension:secondaryReason" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "secondaryReason" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] [ fhir:id [ fhir:v "Extension.extension:secondaryReason.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:secondaryReason.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "secondaryReason"^^xsd:anyURI ; fhir:l fhir:secondaryReason ] ] [ fhir:id [ fhir:v "Extension.extension:secondaryReason.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Reason for amendment, e.g. Safety" ] ; fhir:definition [ fhir:v "Reason for amendment, e.g. Safety." ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ; fhir:binding [ fhir:strength [ fhir:v "extensible" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason"^^xsd:anyURI ; fhir:l ] ] ] [ fhir:id [ fhir:v "Extension.extension:summary" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "summary" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:summary.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:summary.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "summary"^^xsd:anyURI ; fhir:l fhir:summary ] ] [ fhir:id [ fhir:v "Extension.extension:summary.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Summary of changes" ] ; fhir:definition [ fhir:v "Summary of changes." ] ; fhir:type ( [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafety" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "substantialImpactSafety" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafety.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafety.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "substantialImpactSafety"^^xsd:anyURI ; fhir:l fhir:substantialImpactSafety ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafety.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Substantial impact on safety" ] ; fhir:definition [ fhir:v "Substantial impact on safety." ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ; fhir:binding [ fhir:strength [ fhir:v "required" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no"^^xsd:anyURI ; fhir:l ] ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafetyComment" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "substantialImpactSafetyComment" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafetyComment.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafetyComment.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "substantialImpactSafetyComment"^^xsd:anyURI ; fhir:l fhir:substantialImpactSafetyComment ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactSafetyComment.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Comment on substantial impact on safety" ] ; fhir:definition [ fhir:v "Comment on substantial impact on safety." ] ; fhir:type ( [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliability" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "substantialImpactReliability" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliability.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliability.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "substantialImpactReliability"^^xsd:anyURI ; fhir:l fhir:substantialImpactReliability ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliability.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Substantial impact on reliability" ] ; fhir:definition [ fhir:v "Substantial impact on reliability." ] ; fhir:type ( [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ; fhir:l fhir:CodeableConcept ] ] ) ; fhir:binding [ fhir:strength [ fhir:v "required" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no"^^xsd:anyURI ; fhir:l ] ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliabilityComment" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "substantialImpactReliabilityComment" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliabilityComment.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliabilityComment.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "substantialImpactReliabilityComment"^^xsd:anyURI ; fhir:l fhir:substantialImpactReliabilityComment ] ] [ fhir:id [ fhir:v "Extension.extension:substantialImpactReliabilityComment.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Comment on substantial impact on reliability" ] ; fhir:definition [ fhir:v "Comment on substantial impact on reliability." ] ; fhir:type ( [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:details" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "details" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:type ( [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ; fhir:l fhir:Extension ] ; fhir:profile ( [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-detail"^^xsd:anyURI ; fhir:l ] ) ] ) ] [ fhir:id [ fhir:v "Extension.extension:rationale" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "rationale" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:rationale.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:rationale.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "rationale"^^xsd:anyURI ; fhir:l fhir:rationale ] ] [ fhir:id [ fhir:v "Extension.extension:rationale.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Rationale" ] ; fhir:definition [ fhir:v "Rationale." ] ; fhir:type ( [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ] [ fhir:id [ fhir:v "Extension.extension:description" ] ; fhir:path [ fhir:v "Extension.extension" ] ; fhir:sliceName [ fhir:v "description" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] [ fhir:id [ fhir:v "Extension.extension:description.extension" ] ; fhir:path [ fhir:v "Extension.extension.extension" ] ; fhir:max [ fhir:v "0" ] ] [ fhir:id [ fhir:v "Extension.extension:description.url" ] ; fhir:path [ fhir:v "Extension.extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "description"^^xsd:anyURI ; fhir:l fhir:description ] ] [ fhir:id [ fhir:v "Extension.extension:description.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:short [ fhir:v "Description" ] ; fhir:definition [ fhir:v "Description." ] ; fhir:type ( [ fhir:code [ fhir:v "markdown"^^xsd:anyURI ; fhir:l fhir:markdown ] ] [ fhir:code [ fhir:v "string"^^xsd:anyURI ; fhir:l fhir:string ] ] ) ] [ fhir:id [ fhir:v "Extension.url" ] ; fhir:path [ fhir:v "Extension.url" ] ; fhir:fixed [ a fhir:Uri ; fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"^^xsd:anyURI ; fhir:l ] ] [ fhir:id [ fhir:v "Extension.value[x]" ] ; fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:max [ fhir:v "0" ] ] ) ] . # # -------------------------------------------------------------------------------------