FHIR IG Statistics: StructureDefinition/protocol-amendment-detail
Resources that use this resource
Resources that this resource uses
Narrative
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Source
{
"resourceType": "StructureDefinition",
"id": "protocol-amendment-detail",
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics",
"valueCode": "can-bind"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 0,
"_valueInteger": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol"
}
]
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "draft",
"_valueCode": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol"
}
]
}
}
],
"url": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail",
"version": "0.4.0",
"name": "ResearchStudyStudyAmendmentDetails",
"status": "draft",
"date": "2025-07-18T09:47:38+00:00",
"publisher": "HL7 International / Biomedical Research and Regulation",
"contact": [
{
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [
{
"system": "url",
"value": "http://www.hl7.org/Special/committees/rcrim"
},
{
"system": "email",
"value": "UDP@HL7Vulcan.org"
}
]
}
],
"jurisdiction": [
{
"coding": [
{
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code": "001",
"display": "World"
}
]
}
],
"fhirVersion": "6.0.0-ballot3",
"mapping": [
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
}
],
"kind": "complex-type",
"abstract": false,
"context": [
{
"type": "element",
"expression": "Element"
}
],
"type": "Extension",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension",
"derivation": "constraint",
"snapshot": {
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "6.0.0-ballot3"
}
],
"element": [
{
"id": "Extension",
"path": "Extension",
"short": "Optional Extensions Element",
"definition": "Optional Extension Element - found in all resources.",
"min": 0,
"max": "*",
"base": {
"path": "Extension",
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},
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{
"key": "ele-1",
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"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"mapping": [
{
"identity": "rim",
"map": "n/a,N/A"
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]
},
{
"id": "Extension.id",
"path": "Extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
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"max": "1"
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"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
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"code": "http://hl7.org/fhirpath/System.String"
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"isModifier": false,
"isSummary": false,
"mapping": [
{
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]
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{
"id": "Extension.extension",
"path": "Extension.extension",
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{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 3,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
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{
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"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:detail",
"path": "Extension.extension",
"sliceName": "detail",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
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],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:detail.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
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"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
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],
"code": "http://hl7.org/fhirpath/System.String"
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],
"condition": [
"ele-1"
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"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
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]
},
{
"id": "Extension.extension:detail.extension",
"path": "Extension.extension.extension",
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{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
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"max": "*"
},
"type": [
{
"code": "Extension"
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],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
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{
"id": "Extension.extension:detail.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "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.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
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],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "detail",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:detail.value[x]",
"path": "Extension.extension.value[x]",
"short": "Statement regarding prior amendments",
"definition": "Statement regarding prior amendments.",
"comment": "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).",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
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"type": [
{
"code": "string"
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],
"condition": [
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"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
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]
},
{
"id": "Extension.extension:rationale",
"path": "Extension.extension",
"sliceName": "rationale",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
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"type": [
{
"code": "Extension"
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],
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{
"key": "ele-1",
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"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
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],
"isModifier": false,
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{
"id": "Extension.extension:rationale.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
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"max": "1"
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"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
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],
"code": "http://hl7.org/fhirpath/System.String"
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"isModifier": false,
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"mapping": [
{
"identity": "rim",
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]
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{
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{
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],
"description": "Extensions are always sliced by (at least) url",
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"short": "Extension",
"definition": "An Extension",
"min": 0,
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"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
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"type": [
{
"code": "Extension"
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],
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{
"key": "ele-1",
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"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
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{
"id": "Extension.extension:rationale.url",
"path": "Extension.extension.url",
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"xmlAttr"
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"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "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.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
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"max": "1"
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"type": [
{
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{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
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],
"code": "http://hl7.org/fhirpath/System.String"
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],
"fixedUri": "rationale",
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"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:rationale.value[x]",
"path": "Extension.extension.value[x]",
"short": "Rationale",
"definition": "Rationale.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
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],
"condition": [
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{
"key": "ele-1",
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"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:section",
"path": "Extension.extension",
"sliceName": "section",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
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],
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{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:section.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
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],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:section.extension",
"path": "Extension.extension.extension",
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"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:section.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "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.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
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{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
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],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "section",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:section.value[x]",
"path": "Extension.extension.value[x]",
"short": "Section where the amendment was made",
"definition": "M11 Section where the amendment was made e.g. 1.2 Trial Schema.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
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],
"condition": [
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"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.url",
"path": "Extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "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.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.value[x]",
"path": "Extension.value[x]",
"short": "Value of extension",
"definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/6.0.0-ballot3/extensibility.html) for a list).",
"min": 0,
"max": "0",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
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"type": [
{
"code": "base64Binary"
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{
"code": "boolean"
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{
"code": "canonical"
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{
"code": "code"
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{
"code": "date"
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{
"code": "dateTime"
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{
"code": "decimal"
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{
"code": "id"
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{
"code": "instant"
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{
"code": "integer"
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{
"code": "integer64"
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{
"code": "markdown"
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{
"code": "oid"
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{
"code": "positiveInt"
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{
"code": "string"
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{
"code": "time"
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{
"code": "unsignedInt"
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{
"code": "uri"
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{
"code": "url"
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{
"code": "uuid"
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{
"code": "Address"
},
{
"code": "Age"
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{
"code": "Annotation"
},
{
"code": "Attachment"
},
{
"code": "CodeableConcept"
},
{
"code": "CodeableReference"
},
{
"code": "Coding"
},
{
"code": "ContactPoint"
},
{
"code": "Count"
},
{
"code": "Distance"
},
{
"code": "Duration"
},
{
"code": "HumanName"
},
{
"code": "Identifier"
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{
"code": "Money"
},
{
"code": "Period"
},
{
"code": "Quantity"
},
{
"code": "Range"
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{
"code": "Ratio"
},
{
"code": "RatioRange"
},
{
"code": "Reference"
},
{
"code": "SampledData"
},
{
"code": "Signature"
},
{
"code": "Timing"
},
{
"code": "ContactDetail"
},
{
"code": "DataRequirement"
},
{
"code": "Expression"
},
{
"code": "ParameterDefinition"
},
{
"code": "RelatedArtifact"
},
{
"code": "TriggerDefinition"
},
{
"code": "UsageContext"
},
{
"code": "Availability"
},
{
"code": "ExtendedContactDetail"
},
{
"code": "Dosage"
},
{
"code": "Meta"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
}
]
},
"differential": {
"element": [
{
"id": "Extension.extension",
"path": "Extension.extension",
"min": 3
},
{
"id": "Extension.extension:detail",
"path": "Extension.extension",
"sliceName": "detail",
"min": 1,
"max": "1"
},
{
"id": "Extension.extension:detail.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:detail.url",
"path": "Extension.extension.url",
"fixedUri": "detail"
},
{
"id": "Extension.extension:detail.value[x]",
"path": "Extension.extension.value[x]",
"short": "Statement regarding prior amendments",
"definition": "Statement regarding prior amendments.",
"comment": "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).",
"type": [
{
"code": "string"
}
]
},
{
"id": "Extension.extension:rationale",
"path": "Extension.extension",
"sliceName": "rationale",
"min": 1,
"max": "1"
},
{
"id": "Extension.extension:rationale.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:rationale.url",
"path": "Extension.extension.url",
"fixedUri": "rationale"
},
{
"id": "Extension.extension:rationale.value[x]",
"path": "Extension.extension.value[x]",
"short": "Rationale",
"definition": "Rationale.",
"type": [
{
"code": "string"
}
]
},
{
"id": "Extension.extension:section",
"path": "Extension.extension",
"sliceName": "section",
"min": 1,
"max": "1"
},
{
"id": "Extension.extension:section.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:section.url",
"path": "Extension.extension.url",
"fixedUri": "section"
},
{
"id": "Extension.extension:section.value[x]",
"path": "Extension.extension.value[x]",
"short": "Section where the amendment was made",
"definition": "M11 Section where the amendment was made e.g. 1.2 Trial Schema.",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vs"
}
},
{
"id": "Extension.url",
"path": "Extension.url",
"fixedUri": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail"
},
{
"id": "Extension.value[x]",
"path": "Extension.value[x]",
"max": "0"
}
]
}
}
Extension 
extension 
Slices for extension 
extension:detail 
value[x] 
value[x] 
FHIR