{
"description": "Amendment to a protocol. This is originally from EBM.",
"_filename": "StructureDefinition-protocol-amendment.json",
"package_name": "hl7.fhir.uv.pharmaceutical-research-protocol",
"date": "2025-08-01T12:18:30+00:00",
"derivation": "constraint",
"publisher": "HL7 International / Biomedical Research and Regulation",
"fhirVersion": "6.0.0-ballot3",
"jurisdiction": [ {
"coding": [ {
"code": "001",
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"display": "World"
} ]
} ],
"name": "M11_ProtocolAmendment",
"mapping": [ {
"uri": "http://hl7.org/v3",
"name": "RIM Mapping",
"identity": "rim"
} ],
"abstract": false,
"type": "Extension",
"experimental": null,
"resourceType": "StructureDefinition",
"title": null,
"package_version": "1.0.0-ballot",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics",
"valueCode": "can-bind"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 1
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "trial-use",
"_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"
} ]
}
} ],
"snapshot": {
"element": [ {
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"source": "http://hl7.org/fhir/StructureDefinition/Element",
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}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
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"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Extension",
"min": 0,
"definition": "Representation of amendments to a study protocol.",
"isModifier": false,
"short": "Amendment to a protocol - from EBM",
"max": "*",
"id": "Extension",
"comment": "The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases.",
"base": {
"max": "*",
"min": 0,
"path": "Extension"
}
}, {
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"map": "n/a",
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} ],
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"code": "http://hl7.org/fhirpath/System.String",
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"valueUrl": "id"
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"isSummary": false
}, {
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"human": "All FHIR elements must have a @value or children",
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"path": "Extension.extension",
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"max": "*",
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}, {
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} ],
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} ]
},
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"max": "0",
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"max": "*",
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"path": "Element.extension"
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}, {
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} ],
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"max": "1",
"id": "Extension.extension:scope.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"definition": "C218673 Global, Country, Region, or Site.",
"isModifier": false,
"short": "Global, Not Global",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-scope-vs"
},
"max": "1",
"id": "Extension.extension:scope.value[x]",
"condition": [ "ext-1" ],
"comment": "If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. \n If amending a single-country study, enter global. \n If the amendment does not apply to all sites in the trial, select Not Global and utilize one of the identifiers based on amendment scope. \n Use the ISO-3166 region or country identifier (for example, DE or EU).",
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"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
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"type": [ {
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} ],
"sliceName": "country",
"max": "*",
"id": "Extension.extension:country",
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"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
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"short": "Unique id for inter-element referencing",
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} ],
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"code": "http://hl7.org/fhirpath/System.String",
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"valueUrl": "id"
} ]
} ],
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"path": "Element.id"
},
"isSummary": false
}, {
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"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
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} ],
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} ]
},
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"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:country.extension",
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"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "country",
"mapping": [ {
"map": "N/A",
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} ],
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} ]
} ],
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"max": "1",
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"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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
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} ],
"path": "Extension.extension.value[x]",
"min": 0,
"definition": "C20108",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs"
},
"max": "1",
"id": "Extension.extension:country.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
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"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
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} ],
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"short": "Extension",
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"sliceName": "region",
"max": "*",
"id": "Extension.extension:region",
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"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
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"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
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} ]
} ],
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}, {
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} ],
"path": "Extension.extension.extension",
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},
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"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:region.extension",
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"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "region",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
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"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:region.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
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"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs"
},
"max": "1",
"id": "Extension.extension:region.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
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} ],
"path": "Extension.extension",
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"type": [ {
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"sliceName": "site",
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"max": "*",
"min": 0,
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},
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}, {
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"short": "Unique id for inter-element referencing",
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"map": "n/a",
"identity": "rim"
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} ],
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"max": "1",
"id": "Extension.extension:site.id",
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"base": {
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"isSummary": false
}, {
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"key": "ele-1",
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},
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},
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}, {
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"short": "identifies the meaning of the extension",
"fixedUri": "site",
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} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:site.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
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} ],
"path": "Extension.extension.value[x]",
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"max": "1",
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"base": {
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"min": 0,
"path": "Extension.value[x]"
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}, {
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} ],
"path": "Extension.extension",
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"type": [ {
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"sliceName": "approvalDate",
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"id": "Extension.extension:approvalDate",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
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"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
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"identity": "rim"
} ],
"type": [ {
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} ],
"representation": [ "xmlAttr" ],
"max": "1",
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"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.extension",
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"definition": "An Extension",
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"short": "Extension",
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"discriminator": [ {
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} ]
},
"type": [ {
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"max": "0",
"id": "Extension.extension:approvalDate.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
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"isSummary": false
}, {
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"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
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"short": "identifies the meaning of the extension",
"fixedUri": "approvalDate",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
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} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:approvalDate.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"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).",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "date"
} ],
"max": "1",
"id": "Extension.extension:approvalDate.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"type": [ {
"code": "Extension"
} ],
"sliceName": "signature",
"max": "1",
"id": "Extension.extension:signature",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:signature.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:signature.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "signature",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:signature.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"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).",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Signature"
} ],
"max": "1",
"id": "Extension.extension:signature.value[x]",
"condition": [ "ext-1" ],
"comment": "//TODO Need to review the example",
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"type": [ {
"code": "Extension"
} ],
"sliceName": "signatureURL",
"max": "1",
"id": "Extension.extension:signatureURL",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:signatureURL.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:signatureURL.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "signatureURL",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:signatureURL.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"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).",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "Extension.extension:signatureURL.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"type": [ {
"code": "Extension"
} ],
"sliceName": "signatureMethod",
"max": "1",
"id": "Extension.extension:signatureMethod",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:signatureMethod.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:signatureMethod.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "signatureMethod",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:signatureMethod.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"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).",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "Extension.extension:signatureMethod.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "Provides number or percentage of each group affected by a single amendment",
"isModifier": false,
"short": "Extension",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact" ]
} ],
"sliceName": "scopeImpact",
"max": "3",
"id": "Extension.extension:scopeImpact",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"type": [ {
"code": "Extension"
} ],
"sliceName": "primaryReason",
"max": "1",
"id": "Extension.extension:primaryReason",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:primaryReason.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:primaryReason.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "primaryReason",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:primaryReason.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"definition": "Reason for amendment, e.g. Safety.",
"isModifier": false,
"short": "Reason for amendment, e.g. Safety",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs"
},
"max": "1",
"id": "Extension.extension:primaryReason.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"type": [ {
"code": "Extension"
} ],
"sliceName": "secondaryReason",
"max": "1",
"id": "Extension.extension:secondaryReason",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:secondaryReason.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:secondaryReason.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "secondaryReason",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:secondaryReason.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"definition": "Reason for amendment, e.g. Manufacturing change.",
"isModifier": false,
"short": "Reason for amendment, e.g. Manufacturing change",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs"
},
"max": "1",
"id": "Extension.extension:secondaryReason.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"type": [ {
"code": "Extension"
} ],
"sliceName": "summary",
"max": "1",
"id": "Extension.extension:summary",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:summary.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:summary.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "summary",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:summary.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"definition": "Summary of amendmets.",
"isModifier": false,
"short": "summary of changes",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "Extension.extension:summary.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"type": [ {
"code": "Extension"
} ],
"sliceName": "substantialImpactSafety",
"max": "1",
"id": "Extension.extension:substantialImpactSafety",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:substantialImpactSafety.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:substantialImpactSafety.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "substantialImpactSafety",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:substantialImpactSafety.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"definition": "Substantial impact on safety.",
"isModifier": false,
"short": "Substantial impact on safety",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs"
},
"max": "1",
"id": "Extension.extension:substantialImpactSafety.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"type": [ {
"code": "Extension"
} ],
"sliceName": "substantialImpactSafetyComment",
"max": "1",
"id": "Extension.extension:substantialImpactSafetyComment",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:substantialImpactSafetyComment.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.extension",
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"definition": "An Extension",
"isModifier": false,
"short": "Extension",
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"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:substantialImpactSafetyComment.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "substantialImpactSafetyComment",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:substantialImpactSafetyComment.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"definition": "Comment on substantial impact on safety.",
"isModifier": false,
"short": "Comment on substantial impact on safety",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "Extension.extension:substantialImpactSafetyComment.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"type": [ {
"code": "Extension"
} ],
"sliceName": "substantialImpactReliability",
"max": "1",
"id": "Extension.extension:substantialImpactReliability",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:substantialImpactReliability.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.extension",
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"definition": "An Extension",
"isModifier": false,
"short": "Extension",
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"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:substantialImpactReliability.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "substantialImpactReliability",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:substantialImpactReliability.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"definition": "Substantial impact on reliability.",
"isModifier": false,
"short": "Substantial impact on reliability",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs"
},
"max": "1",
"id": "Extension.extension:substantialImpactReliability.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension",
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"definition": "An Extension",
"isModifier": false,
"short": "Extension",
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"code": "Extension"
} ],
"sliceName": "substantialImpactReliabilityComment",
"max": "1",
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"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:substantialImpactReliabilityComment.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
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"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:substantialImpactReliabilityComment.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "substantialImpactReliabilityComment",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:substantialImpactReliabilityComment.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
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"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
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"definition": "Comment on substantial impact on reliability.",
"isModifier": false,
"short": "Comment on substantial impact on reliability",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "Extension.extension:substantialImpactReliabilityComment.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "Provides detail of a single amendment - repeats within the overal amendment report",
"isModifier": false,
"short": "Extension",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail" ]
} ],
"sliceName": "details",
"max": "*",
"id": "Extension.extension:details",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
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} ],
"path": "Extension.extension",
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"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"type": [ {
"code": "Extension"
} ],
"sliceName": "rationale",
"max": "1",
"id": "Extension.extension:rationale",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:rationale.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:rationale.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "rationale",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:rationale.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"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).",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "Extension.extension:rationale.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"type": [ {
"code": "Extension"
} ],
"sliceName": "description",
"max": "1",
"id": "Extension.extension:description",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:description.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:description.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "description",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:description.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"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).",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "Extension.extension:description.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"path": "Extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.value[x]",
"min": 0,
"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).",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "base64Binary"
}, {
"code": "boolean"
}, {
"code": "canonical"
}, {
"code": "code"
}, {
"code": "date"
}, {
"code": "dateTime"
}, {
"code": "decimal"
}, {
"code": "id"
}, {
"code": "instant"
}, {
"code": "integer"
}, {
"code": "integer64"
}, {
"code": "markdown"
}, {
"code": "oid"
}, {
"code": "positiveInt"
}, {
"code": "string"
}, {
"code": "time"
}, {
"code": "unsignedInt"
}, {
"code": "uri"
}, {
"code": "url"
}, {
"code": "uuid"
}, {
"code": "Address"
}, {
"code": "Age"
}, {
"code": "Annotation"
}, {
"code": "Attachment"
}, {
"code": "CodeableConcept"
}, {
"code": "CodeableReference"
}, {
"code": "Coding"
}, {
"code": "ContactPoint"
}, {
"code": "Count"
}, {
"code": "Distance"
}, {
"code": "Duration"
}, {
"code": "HumanName"
}, {
"code": "Identifier"
}, {
"code": "Money"
}, {
"code": "Period"
}, {
"code": "Quantity"
}, {
"code": "Range"
}, {
"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"
} ],
"max": "0",
"id": "Extension.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
} ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "6.0.0-ballot3"
} ]
},
"status": "draft",
"id": "0a3a915c-4336-4d5b-aa36-de34e9f0dcf2",
"kind": "complex-type",
"url": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment",
"context": [ {
"type": "element",
"expression": "ResearchStudy"
} ],
"version": "1.0.0-ballot",
"differential": {
"element": [ {
"id": "Extension",
"path": "Extension",
"short": "Amendment to a protocol - from EBM",
"comment": "The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases.",
"definition": "Representation of amendments to a study protocol."
}, {
"id": "Extension.extension",
"min": 1,
"path": "Extension.extension"
}, {
"id": "Extension.extension:scope",
"max": "1",
"min": 1,
"path": "Extension.extension",
"sliceName": "scope"
}, {
"id": "Extension.extension:scope.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:scope.url",
"path": "Extension.extension.url",
"fixedUri": "scope"
}, {
"id": "Extension.extension:scope.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "code"
} ],
"short": "Global, Not Global",
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-scope-vs"
},
"comment": "If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. \n If amending a single-country study, enter global. \n If the amendment does not apply to all sites in the trial, select Not Global and utilize one of the identifiers based on amendment scope. \n Use the ISO-3166 region or country identifier (for example, DE or EU).",
"definition": "C218673 Global, Country, Region, or Site."
}, {
"id": "Extension.extension:country",
"max": "*",
"min": 0,
"path": "Extension.extension",
"sliceName": "country"
}, {
"id": "Extension.extension:country.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:country.url",
"path": "Extension.extension.url",
"fixedUri": "country"
}, {
"id": "Extension.extension:country.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs"
},
"definition": "C20108"
}, {
"id": "Extension.extension:region",
"max": "*",
"min": 0,
"path": "Extension.extension",
"sliceName": "region"
}, {
"id": "Extension.extension:region.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:region.url",
"path": "Extension.extension.url",
"fixedUri": "region"
}, {
"id": "Extension.extension:region.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs"
},
"definition": "C218674"
}, {
"id": "Extension.extension:site",
"max": "*",
"min": 0,
"path": "Extension.extension",
"sliceName": "site"
}, {
"id": "Extension.extension:site.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:site.url",
"path": "Extension.extension.url",
"fixedUri": "site"
}, {
"id": "Extension.extension:site.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "Identifier"
} ],
"definition": "C83081"
}, {
"id": "Extension.extension:approvalDate",
"max": "1",
"min": 0,
"path": "Extension.extension",
"sliceName": "approvalDate"
}, {
"id": "Extension.extension:approvalDate.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:approvalDate.url",
"path": "Extension.extension.url",
"fixedUri": "approvalDate"
}, {
"id": "Extension.extension:approvalDate.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "date"
} ]
}, {
"id": "Extension.extension:signature",
"max": "1",
"min": 0,
"path": "Extension.extension",
"sliceName": "signature"
}, {
"id": "Extension.extension:signature.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:signature.url",
"path": "Extension.extension.url",
"fixedUri": "signature"
}, {
"id": "Extension.extension:signature.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "Signature"
} ],
"comment": "//TODO Need to review the example"
}, {
"id": "Extension.extension:signatureURL",
"max": "1",
"min": 0,
"path": "Extension.extension",
"sliceName": "signatureURL"
}, {
"id": "Extension.extension:signatureURL.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:signatureURL.url",
"path": "Extension.extension.url",
"fixedUri": "signatureURL"
}, {
"id": "Extension.extension:signatureURL.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "string"
} ]
}, {
"id": "Extension.extension:signatureMethod",
"max": "1",
"min": 0,
"path": "Extension.extension",
"sliceName": "signatureMethod"
}, {
"id": "Extension.extension:signatureMethod.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:signatureMethod.url",
"path": "Extension.extension.url",
"fixedUri": "signatureMethod"
}, {
"id": "Extension.extension:signatureMethod.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "string"
} ]
}, {
"id": "Extension.extension:scopeImpact",
"max": "3",
"min": 0,
"path": "Extension.extension",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact" ]
} ],
"sliceName": "scopeImpact"
}, {
"id": "Extension.extension:primaryReason",
"max": "1",
"min": 0,
"path": "Extension.extension",
"sliceName": "primaryReason"
}, {
"id": "Extension.extension:primaryReason.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:primaryReason.url",
"path": "Extension.extension.url",
"fixedUri": "primaryReason"
}, {
"id": "Extension.extension:primaryReason.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "CodeableConcept"
} ],
"short": "Reason for amendment, e.g. Safety",
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs"
},
"definition": "Reason for amendment, e.g. Safety."
}, {
"id": "Extension.extension:secondaryReason",
"max": "1",
"min": 0,
"path": "Extension.extension",
"sliceName": "secondaryReason"
}, {
"id": "Extension.extension:secondaryReason.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:secondaryReason.url",
"path": "Extension.extension.url",
"fixedUri": "secondaryReason"
}, {
"id": "Extension.extension:secondaryReason.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "CodeableConcept"
} ],
"short": "Reason for amendment, e.g. Manufacturing change",
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs"
},
"definition": "Reason for amendment, e.g. Manufacturing change."
}, {
"id": "Extension.extension:summary",
"max": "1",
"min": 0,
"path": "Extension.extension",
"sliceName": "summary"
}, {
"id": "Extension.extension:summary.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:summary.url",
"path": "Extension.extension.url",
"fixedUri": "summary"
}, {
"id": "Extension.extension:summary.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "string"
} ],
"short": "summary of changes",
"definition": "Summary of amendmets."
}, {
"id": "Extension.extension:substantialImpactSafety",
"max": "1",
"min": 0,
"path": "Extension.extension",
"sliceName": "substantialImpactSafety"
}, {
"id": "Extension.extension:substantialImpactSafety.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:substantialImpactSafety.url",
"path": "Extension.extension.url",
"fixedUri": "substantialImpactSafety"
}, {
"id": "Extension.extension:substantialImpactSafety.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "code"
} ],
"short": "Substantial impact on safety",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs"
},
"definition": "Substantial impact on safety."
}, {
"id": "Extension.extension:substantialImpactSafetyComment",
"max": "1",
"min": 0,
"path": "Extension.extension",
"sliceName": "substantialImpactSafetyComment"
}, {
"id": "Extension.extension:substantialImpactSafetyComment.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:substantialImpactSafetyComment.url",
"path": "Extension.extension.url",
"fixedUri": "substantialImpactSafetyComment"
}, {
"id": "Extension.extension:substantialImpactSafetyComment.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "string"
} ],
"short": "Comment on substantial impact on safety",
"definition": "Comment on substantial impact on safety."
}, {
"id": "Extension.extension:substantialImpactReliability",
"max": "1",
"min": 0,
"path": "Extension.extension",
"sliceName": "substantialImpactReliability"
}, {
"id": "Extension.extension:substantialImpactReliability.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:substantialImpactReliability.url",
"path": "Extension.extension.url",
"fixedUri": "substantialImpactReliability"
}, {
"id": "Extension.extension:substantialImpactReliability.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "code"
} ],
"short": "Substantial impact on reliability",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs"
},
"definition": "Substantial impact on reliability."
}, {
"id": "Extension.extension:substantialImpactReliabilityComment",
"max": "1",
"min": 0,
"path": "Extension.extension",
"sliceName": "substantialImpactReliabilityComment"
}, {
"id": "Extension.extension:substantialImpactReliabilityComment.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:substantialImpactReliabilityComment.url",
"path": "Extension.extension.url",
"fixedUri": "substantialImpactReliabilityComment"
}, {
"id": "Extension.extension:substantialImpactReliabilityComment.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "string"
} ],
"short": "Comment on substantial impact on reliability",
"definition": "Comment on substantial impact on reliability."
}, {
"id": "Extension.extension:details",
"max": "*",
"min": 0,
"path": "Extension.extension",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail" ]
} ],
"sliceName": "details"
}, {
"id": "Extension.extension:rationale",
"max": "1",
"min": 0,
"path": "Extension.extension",
"sliceName": "rationale"
}, {
"id": "Extension.extension:rationale.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:rationale.url",
"path": "Extension.extension.url",
"fixedUri": "rationale"
}, {
"id": "Extension.extension:rationale.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "string"
} ]
}, {
"id": "Extension.extension:description",
"max": "1",
"min": 0,
"path": "Extension.extension",
"sliceName": "description"
}, {
"id": "Extension.extension:description.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:description.url",
"path": "Extension.extension.url",
"fixedUri": "description"
}, {
"id": "Extension.extension:description.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "string"
} ]
}, {
"id": "Extension.url",
"path": "Extension.url",
"fixedUri": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment"
}, {
"id": "Extension.value[x]",
"max": "0",
"path": "Extension.value[x]"
} ]
},
"contact": [ {
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
}, {
"value": "UDP@HL7Vulcan.org",
"system": "email"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension"
}