{
"description": "An amendment to a study protocol.",
"_filename": "StructureDefinition-research-study-study-amendment.json",
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"date": "2025-03-28T17:11:38+00:00",
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"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": 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.value[x]",
"min": 0,
"definition": "Substantial impact on safety.",
"isModifier": false,
"short": "Substantial impact on safety",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "Extension.extension:substantialImpactSafety.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"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": "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",
"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: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": 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.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": 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": "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",
"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: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": 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.value[x]",
"min": 0,
"definition": "Substantial impact on reliability.",
"isModifier": false,
"short": "Substantial impact on reliability",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "Extension.extension:substantialImpactReliability.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"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": "substantialImpactReliabilityComment",
"max": "1",
"id": "Extension.extension:substantialImpactReliabilityComment",
"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": {
"rules": "open",
"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": 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.value[x]",
"min": 0,
"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": 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": 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.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"
} ],
"max": "1",
"id": "Extension.extension:primaryReason.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": false
}, {
"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/ebm/StructureDefinition/research-study-study-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": 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.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-ballot2/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": false
} ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "6.0.0-ballot2"
} ]
},
"status": "draft",
"id": "7b5e4bca-042f-4255-8a0d-73438eb6d6ac",
"kind": "complex-type",
"url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment",
"identifier": [ {
"value": "urn:oid:2.16.840.1.113883.4.642.40.44.42.97",
"system": "urn:ietf:rfc:3986"
} ],
"context": [ {
"type": "element",
"expression": "ResearchStudy"
} ],
"version": "1.0.0-ballot2",
"differential": {
"element": [ {
"id": "Extension",
"path": "Extension",
"short": "An amendment to a study protocol",
"definition": "An amendment to a study protocol."
}, {
"id": "Extension.extension:details",
"max": "1",
"min": 0,
"path": "Extension.extension",
"sliceName": "details"
}, {
"id": "Extension.extension:details.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:details.url",
"path": "Extension.extension.url",
"fixedUri": "details"
}, {
"id": "Extension.extension:details.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "string"
} ],
"short": "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).",
"definition": "Statement regarding prior amendments."
}, {
"id": "Extension.extension:scope",
"max": "1",
"min": 0,
"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": "string"
} ],
"short": "Global, Coutnry, Region, or Site",
"comment": "If an amendment applies to all sites in the trial, enter “global” and delete the Country, Region and Site Identifier fields. If amending a single-country study, enter “global”. 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. Use the ISO-3166 region or country identifier (for example, DE or EU).",
"definition": "Global, Coutnry, Region, or Site."
}, {
"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"
} ],
"short": "Description",
"definition": "Description."
}, {
"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"
} ],
"short": "Rationale",
"definition": "Rationale."
}, {
"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": "boolean"
} ],
"short": "Substantial impact on safety",
"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": "boolean"
} ],
"short": "Substantial impact on reliability",
"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: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",
"definition": "Reason for amendment, e.g. Safety."
}, {
"id": "Extension.url",
"path": "Extension.url",
"fixedUri": "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment"
}, {
"id": "Extension.value[x]",
"max": "0",
"path": "Extension.value[x]"
} ]
},
"contact": [ {
"name": "HL7 International / Clinical Decision Support",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/dss",
"system": "url"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension"
}