FHIR IG analytics| Package | hl7.fhir.uv.clinical-study-protocol |
| Resource Type | StructureDefinition |
| Id | StructureDefinition-m11-protocol-summary.json |
| FHIR Version | R6 |
| Source | https://build.fhir.org/ig/HL7/vulcan-udp-ig/StructureDefinition-m11-protocol-summary.html |
| URL | http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary |
| Version | 1.0.0-ballot2 |
| Status | active |
| Date | 2026-06-22T17:54:57+00:00 |
| Name | M11_ProtocolSummary |
| Realm | uv |
| Authority | hl7 |
| Description | Summary to a protocol. |
| Copyright | Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license CDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license For more licensing information and links see: [licenses.html](licenses.html) |
| Type | Extension |
| Kind | complex-type |
No resources found
| ValueSet | ||
| hl7.fhir.uv.clinical-study-protocol#current | m11-blindedRoles-vs | ICH M11 ... |
| hl7.fhir.uv.clinical-study-protocol#current | m11-controlType-vs | ICH M11 ... |
| hl7.fhir.uv.clinical-study-protocol#current | m11-independentCommittees-vs | ICH M11 ... |
| hl7.fhir.uv.clinical-study-protocol#current | m11-interventionAssignmentMethod-vs | ICH M11 ... |
| hl7.fhir.uv.clinical-study-protocol#current | m11-interventionModel-vs | ICH M11 Intervention Model Value Set Terminology |
| hl7.fhir.uv.clinical-study-protocol#current | m11-populationType-vs | ICH M11 ... |
| hl7.fhir.uv.clinical-study-protocol#current | m11-siteDistribution-vs | ICH M11 ... |
| hl7.fhir.uv.clinical-study-protocol#current | m11-siteGeographicscope-vs | ICH M11 ... |
| hl7.fhir.uv.clinical-study-protocol#current | m11-target-Maximum-vs | UDP ... |
| hl7.fhir.uv.clinical-study-protocol#current | m11-trialBlindSchema-vs | ICH M11 ... |
| hl7.fhir.uv.clinical-study-protocol#current | m11-yes-no-vs | ICH M11 No Yes Value Set Terminology |
| Resource | Version |
|---|---|
| hl7.fhir.uv.clinical-study-protocol#current:ResearchStudy/Exemplar-Protocol-Summary | R5 |
Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition m11-protocol-summary
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Extension | 0..* | Extension | Summary of a protocol | |
  extension | 34..* | Extension | Extension | |
 Slices for extension | Content/Rules for all slices | |||
   extension:objectiveAndEstimandSummary | S | 1..1 | Extension | Extension |
  extension | 0..0 | Extension | ||
| url | 1..1 | uri | "objectiveAndEstimandSummary" | |
  value[x] | 0..1 | C218839 Primary and Secondary Objectives and Estimands | ||
  valueMarkdown | markdown | |||
 valueString | string | |||
| extension:interventionModel | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "interventionModel" | |
 value[x] | 0..1 | CodeableConcept | C217277 Intervention Model Binding: ICH M11 Intervention Model Value Set Terminology (required) | |
| extension:populationType | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "populationType" | |
| value[x] | 0..1 | CodeableConcept | C217278 Population Type Binding: ICH M11 ... (required) | |
| extension:controlType | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "controlType" | |
| value[x] | 0..1 | CodeableConcept | C217279 Control Type Binding: ICH M11 ... (required) | |
| extension:populationDiagnosisOrCondition | S | 1..* | Extension | Extension |
| url | 1..1 | uri | "populationDiagnosisOrCondition" | |
| extension:comparator | 1..* | Extension | Extension | |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "comparator" | |
 value[x] | 0..1 | Reference(MedicinalProductDefinition) | Comparator | |
| extension:minimumAge | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "minimumAge" | |
| value[x] | 0..1 | Quantity | C49693/C25301 Minimum Age value/units | |
| extension:unitsOfMinimumAge | S | 1..1 | Extension | Extension |
| url | 1..1 | uri | "unitsOfMinimumAge" | |
| extension:maximumAge | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "maximumAge" | |
| value[x] | 0..1 | Quantity | C49694/C25301 Maximum Age value/units | |
| extension:unitsOfMaximumAge | S | 1..1 | Extension | Extension |
| url | 1..1 | uri | "unitsOfMaximumAge" | |
| extension:interventionAssignmentMethod | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "interventionAssignmentMethod" | |
| value[x] | 0..1 | CodeableConcept | C217280 Intervention Assignment Method Binding: ICH M11 ... (required) | |
| extension:randomisationType | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "randomisationType" | |
| value[x] | 0..1 | C223137 Randomisation Type | ||
| valueString | string | |||
| valueCodeableConcept | CodeableConcept | |||
| extension:otherInterventionAssignmentMethod | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "otherInterventionAssignmentMethod" | |
| value[x] | 0..1 | string | C223138 Other Intervention Assignment Method | |
| extension:stratificationIndicator | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "stratificationIndicator" | |
| value[x] | 0..1 | CodeableConcept | C223136 Stratification Indicator Binding: ICH M11 No Yes Value Set Terminology (required) | |
| extension:siteDistribution | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "siteDistribution" | |
| value[x] | 0..1 | CodeableConcept | C217049 Site Distribution Binding: ICH M11 ... (required) | |
| extension:siteGeographicScope | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "siteGeographicScope" | |
| value[x] | 0..1 | CodeableConcept | C217050: Site geographic scope Binding: ICH M11 ... (required) | |
| extension:masterProtocolIndicator | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "masterProtocolIndicator" | |
| value[x] | 0..1 | CodeableConcept | C217046 Master Protocol Indicator Binding: ICH M11 No Yes Value Set Terminology (required) | |
| extension:drug-DeviceCombinationProductIndicator | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "drug-DeviceCombinationProductIndicator" | |
| value[x] | 0..1 | CodeableConcept | C217046 Drug-Device Combination Product Indicator Binding: ICH M11 No Yes Value Set Terminology (required) | |
| extension:adaptiveTrialDesignIndicator | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "adaptiveTrialDesignIndicator" | |
| value[x] | 0..1 | CodeableConcept | C217046 Adaptive Trial Design Indicator Binding: ICH M11 No Yes Value Set Terminology (required) | |
| extension:numberOfArms | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "numberOfArms" | |
| value[x] | 0..1 | integer | C98771 Number of Arms | |
| extension:trialBlindSchema | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "trialBlindSchema" | |
| value[x] | 0..1 | CodeableConcept | C217051 Trial Blind Schema Binding: ICH M11 ... (required) | |
| extension:blindedRoles | S | 1..* | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "blindedRoles" | |
| value[x] | 0..1 | CodeableConcept | C217281: Blinded Roles Binding: ICH M11 ... (required) | |
| extension:targetOrMaximum | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "targetOrMaximum" | |
| value[x] | 0..1 | CodeableConcept | Target-Maximum Binding: UDP ... (required) | |
| extension:numberOfParticipants | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "numberOfParticipants" | |
| value[x] | 0..1 | integer | C49692 Number of Participants | |
| extension:totalPlannedDurationOfTrialIntervention | 1..1 | Extension | Extension | |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "totalPlannedDurationOfTrialIntervention" | |
| value[x] | 0..1 | Quantity | C218712/C218713 total planned duration of trial intervention value/units | |
| extension:alternateDescriptionOfPlannedDurationOfTrialIntervention | 1..1 | Extension | Extension | |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "alternateDescriptionOfPlannedDurationOfTrialIntervention" | |
| value[x] | 0..1 | string | C218714 alternate description of planned duration of trial intervention if duration will vary | |
| extension:totalPlannedDurationOfTrialParticipation | 1..1 | Extension | Extension | |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "totalPlannedDurationOfTrialParticipation" | |
| value[x] | 0..1 | Quantity | C218715/C218716 total planned duration of trial participation value/units | |
| extension:alternateDescriptionOfPlannedDurationOfTrialParticipation | 1..1 | Extension | Extension | |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "alternateDescriptionOfPlannedDurationOfTrialParticipation" | |
| value[x] | 0..1 | string | C218717 alternate description of planned duration of trial participation if duration will vary | |
| extension:additionalDescriptionofDuration | 1..1 | Extension | Extension | |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "additionalDescriptionofDuration" | |
| value[x] | 0..1 | string | C218838 Additional Description of Duration | |
| extension:independentCommittees | S | 1..* | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "independentCommittees" | |
| value[x] | 0..1 | CodeableConcept | C217282 Independent Committees Binding: ICH M11 ... (required) | |
| extension:otherCommittees | 1..* | Extension | Extension | |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "otherCommittees" | |
| value[x] | 0..1 | string | C218719 Other Committees | |
| extension:trialSchema | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "trialSchema" | |
| value[x] | 0..1 | string | C93682 Trial Schema | |
| extension:schemaNotes | 1..1 | Extension | Extension | |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "schemaNotes" | |
| value[x] | 0..1 | string | C218720 Schema Notes | |
 extension:scheduleofActivities | S | 1..1 | Extension | Extension |
| extension | 0..0 | Extension | ||
| url | 1..1 | uri | "scheduleofActivities" | |
| value[x] | 0..1 | string | C132349 Schedule of Activities | |
| url | 1..1 | uri | "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary" | |
| value[x] | 0..0 | Value of extension | ||
| Documentation for this format | ||||
FHIR
FHIRsmith{
"resourceType": "StructureDefinition",
"id": "m11-protocol-summary",
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics",
"valueCode": "can-bind"
},
{
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"valueInteger": 2
},
{
"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/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"
}
]
}
}
],
"url": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary",
"version": "1.0.0-ballot2",
"name": "M11_ProtocolSummary",
"status": "active",
"date": "2026-06-22T17:54:57+00:00",
"publisher": "HL7 International / Biomedical Research and Regulation",
"contact": [
{
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [
{
"system": "url",
"value": "http://www.hl7.org/Special/committees/rcrim"
},
{
"system": "email",
"value": "UDP@HL7Vulcan.org"
}
]
}
],
"description": "Summary to a protocol.",
"jurisdiction": [
{
"coding": [
{
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code": "001",
"display": "World"
}
]
}
],
"copyright": "Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. \nThe ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. \n\nCDISC publishes semantics for the ICH M11 protocol data elements and valid \nvalue sets. This terminology set is published and stored in the NCI Thesaurus \nSubset C217023 - ICH M11 Terminology \n(https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) \n\nThe NCI Thesaurus is released under the CC BY 4.0 license\n\nCDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license\n\nFor more licensing information and links see: [licenses.html](licenses.html)",
"fhirVersion": "6.0.0-ballot3",
"mapping": [
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
}
],
"kind": "complex-type",
"abstract": false,
"context": [
{
"type": "element",
"expression": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile#ResearchStudy"
}
],
"type": "Extension",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension",
"derivation": "constraint",
"snapshot": {
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "6.0.0-ballot3"
}
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"element": [
{
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"path": "Extension",
"short": "Summary of a protocol",
"definition": "Representation of summary of a study protocol.",
"comment": "This is Section 1 of the ICH Technical Summary and Guideline.",
"min": 0,
"max": "*",
"base": {
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"min": 0,
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{
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"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false
},
{
"id": "Extension.id",
"path": "Extension.id",
"representation": [
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],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
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"min": 0,
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"valueUrl": "id"
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],
"code": "http://hl7.org/fhirpath/System.String"
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"condition": [
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"isModifier": false,
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"mapping": [
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{
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"path": "Extension.extension",
"slicing": {
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{
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"path": "url"
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],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
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"definition": "An Extension",
"min": 34,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
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"code": "Extension"
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"constraint": [
{
"key": "ele-1",
"severity": "error",
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"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:objectiveAndEstimandSummary",
"path": "Extension.extension",
"sliceName": "objectiveAndEstimandSummary",
"short": "Extension",
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"min": 1,
"max": "1",
"base": {
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"min": 0,
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},
{
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{
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"path": "Extension.extension.extension",
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"type": "value",
"path": "url"
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],
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"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
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"min": 0,
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],
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"isSummary": false
},
{
"id": "Extension.extension:objectiveAndEstimandSummary.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
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],
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"isModifier": false,
"isSummary": true,
"mapping": [
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"map": "N/A"
}
]
},
{
"id": "Extension.extension:objectiveAndEstimandSummary.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218839 Primary and Secondary Objectives and Estimands",
"definition": "A descriptive summary of the primary and secondary objectives and their associated estimands related to the trial.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "markdown"
},
{
"code": "string"
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"condition": [
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"constraint": [
{
"key": "ele-1",
"severity": "error",
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"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:interventionModel",
"path": "Extension.extension",
"sliceName": "interventionModel",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:interventionModel.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
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{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
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],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
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],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:interventionModel.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:interventionModel.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "interventionModel",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:interventionModel.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217277 Intervention Model",
"definition": "The overall design configuration for assigning intervention to participants.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionModel-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:populationType",
"path": "Extension.extension",
"sliceName": "populationType",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:populationType.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:populationType.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:populationType.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "populationType",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:populationType.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217278 Population Type",
"definition": "A characterisation or classification of the trial population.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-populationType-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:controlType",
"path": "Extension.extension",
"sliceName": "controlType",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:controlType.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:controlType.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:controlType.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "controlType",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:controlType.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217279 Control Type",
"definition": "A characterization or classification of the comparator against which the study intervention is evaluated.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-controlType-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:populationDiagnosisOrCondition",
"path": "Extension.extension",
"sliceName": "populationDiagnosisOrCondition",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:populationDiagnosisOrCondition.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:populationDiagnosisOrCondition.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Additional content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:populationDiagnosisOrCondition.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "populationDiagnosisOrCondition",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:populationDiagnosisOrCondition.value[x]",
"path": "Extension.extension.value[x]",
"short": "Value of extension",
"definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"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"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:comparator",
"path": "Extension.extension",
"sliceName": "comparator",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:comparator.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:comparator.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:comparator.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "comparator",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:comparator.value[x]",
"path": "Extension.extension.value[x]",
"short": "Comparator",
"definition": "The comparator against which the study intervention is evaluated.",
"comment": "M11 CC97054 requires a narrative representation of the comparator - the name.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"
]
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:minimumAge",
"path": "Extension.extension",
"sliceName": "minimumAge",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:minimumAge.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:minimumAge.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:minimumAge.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "minimumAge",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:minimumAge.value[x]",
"path": "Extension.extension.value[x]",
"short": "C49693/C25301 Minimum Age value/units",
"definition": "The anticipated minimum age of the participants to be entered in a clinical trial.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Quantity"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:unitsOfMinimumAge",
"path": "Extension.extension",
"sliceName": "unitsOfMinimumAge",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:unitsOfMinimumAge.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:unitsOfMinimumAge.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Additional content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:unitsOfMinimumAge.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "unitsOfMinimumAge",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:unitsOfMinimumAge.value[x]",
"path": "Extension.extension.value[x]",
"short": "Value of extension",
"definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"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"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:maximumAge",
"path": "Extension.extension",
"sliceName": "maximumAge",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:maximumAge.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:maximumAge.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:maximumAge.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "maximumAge",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:maximumAge.value[x]",
"path": "Extension.extension.value[x]",
"short": "C49694/C25301 Maximum Age value/units",
"definition": "The anticipated maximum age of the participants to be entered in a clinical trial.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Quantity"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:unitsOfMaximumAge",
"path": "Extension.extension",
"sliceName": "unitsOfMaximumAge",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:unitsOfMaximumAge.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:unitsOfMaximumAge.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Additional content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:unitsOfMaximumAge.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "unitsOfMaximumAge",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:unitsOfMaximumAge.value[x]",
"path": "Extension.extension.value[x]",
"short": "Value of extension",
"definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"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"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:interventionAssignmentMethod",
"path": "Extension.extension",
"sliceName": "interventionAssignmentMethod",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:interventionAssignmentMethod.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:interventionAssignmentMethod.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:interventionAssignmentMethod.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "interventionAssignmentMethod",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:interventionAssignmentMethod.value[x]",
"path": "Extension.extension.value[x]",
"short": " C217280 Intervention Assignment Method",
"definition": "The process used to assign trial participants to a trial intervention or trial arm.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionAssignmentMethod-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:randomisationType",
"path": "Extension.extension",
"sliceName": "randomisationType",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:randomisationType.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:randomisationType.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:randomisationType.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "randomisationType",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:randomisationType.value[x]",
"path": "Extension.extension.value[x]",
"short": "C223137 Randomisation Type",
"definition": "The type of randomisation to be used (e.g., simple randomisation, block randomisation)",
"comment": "this is just a text description - implementers may want to provide a value set that tehe text can be drawn from.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
},
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:otherInterventionAssignmentMethod",
"path": "Extension.extension",
"sliceName": "otherInterventionAssignmentMethod",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:otherInterventionAssignmentMethod.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:otherInterventionAssignmentMethod.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:otherInterventionAssignmentMethod.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "otherInterventionAssignmentMethod",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:otherInterventionAssignmentMethod.value[x]",
"path": "Extension.extension.value[x]",
"short": "C223138 Other Intervention Assignment Method",
"definition": "If applicable, describe the other intervention assignment method.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:stratificationIndicator",
"path": "Extension.extension",
"sliceName": "stratificationIndicator",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:stratificationIndicator.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:stratificationIndicator.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:stratificationIndicator.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "stratificationIndicator",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:stratificationIndicator.value[x]",
"path": "Extension.extension.value[x]",
"short": "C223136 Stratification Indicator",
"definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:siteDistribution",
"path": "Extension.extension",
"sliceName": "siteDistribution",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:siteDistribution.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:siteDistribution.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:siteDistribution.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "siteDistribution",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:siteDistribution.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217049 Site Distribution",
"definition": "An indication as to whether the occurrence applies to a single or multiple trial sites.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteDistribution-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:siteGeographicScope",
"path": "Extension.extension",
"sliceName": "siteGeographicScope",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:siteGeographicScope.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:siteGeographicScope.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:siteGeographicScope.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "siteGeographicScope",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:siteGeographicScope.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217050: Site geographic scope",
"definition": "An indication as to whether the trial is taking place in one or more countries.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteGeographicscope-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:masterProtocolIndicator",
"path": "Extension.extension",
"sliceName": "masterProtocolIndicator",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:masterProtocolIndicator.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:masterProtocolIndicator.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:masterProtocolIndicator.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "masterProtocolIndicator",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:masterProtocolIndicator.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217046 Master Protocol Indicator",
"definition": "An indication as to whether the protocol is a master protocol.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:drug-DeviceCombinationProductIndicator",
"path": "Extension.extension",
"sliceName": "drug-DeviceCombinationProductIndicator",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:drug-DeviceCombinationProductIndicator.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:drug-DeviceCombinationProductIndicator.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:drug-DeviceCombinationProductIndicator.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "drug-DeviceCombinationProductIndicator",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:drug-DeviceCombinationProductIndicator.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217046 Drug-Device Combination Product Indicator",
"definition": "An indication as to whether the clinical trial is testing a drug-device combination product.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:adaptiveTrialDesignIndicator",
"path": "Extension.extension",
"sliceName": "adaptiveTrialDesignIndicator",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:adaptiveTrialDesignIndicator.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:adaptiveTrialDesignIndicator.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:adaptiveTrialDesignIndicator.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "adaptiveTrialDesignIndicator",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:adaptiveTrialDesignIndicator.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217046 Adaptive Trial Design Indicator",
"definition": "An indication as to whether the clinical trial uses an adaptive trial design.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:numberOfArms",
"path": "Extension.extension",
"sliceName": "numberOfArms",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:numberOfArms.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:numberOfArms.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:numberOfArms.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "numberOfArms",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:numberOfArms.value[x]",
"path": "Extension.extension.value[x]",
"short": "C98771 Number of Arms",
"definition": "The planned number of intervention groups.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "integer"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:trialBlindSchema",
"path": "Extension.extension",
"sliceName": "trialBlindSchema",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:trialBlindSchema.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:trialBlindSchema.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:trialBlindSchema.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "trialBlindSchema",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:trialBlindSchema.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217051 Trial Blind Schema",
"definition": "The type of experimental design used to describe the level of awareness of the trial participants and/ or personnel as it relates to the respective intervention(s) or assessments being observed, received or administered.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-trialBlindSchema-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:blindedRoles",
"path": "Extension.extension",
"sliceName": "blindedRoles",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:blindedRoles.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:blindedRoles.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:blindedRoles.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "blindedRoles",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:blindedRoles.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217281: Blinded Roles",
"definition": "An identifying designation assigned to a blinded individual within a clinical trial that corresponds with their function",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blindedRoles-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:targetOrMaximum",
"path": "Extension.extension",
"sliceName": "targetOrMaximum",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:targetOrMaximum.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:targetOrMaximum.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:targetOrMaximum.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "targetOrMaximum",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:targetOrMaximum.value[x]",
"path": "Extension.extension.value[x]",
"short": "Target-Maximum",
"definition": "A characterisation or classification of the trial participant numbers as to whether the numbers reflect a target or maximum.",
"comment": "The ICH spec has this as optional boilerplate text but it has to be a variable to be processable",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-target-Maximum-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:numberOfParticipants",
"path": "Extension.extension",
"sliceName": "numberOfParticipants",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:numberOfParticipants.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:numberOfParticipants.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:numberOfParticipants.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "numberOfParticipants",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:numberOfParticipants.value[x]",
"path": "Extension.extension.value[x]",
"short": "C49692 Number of Participants",
"definition": "The planned number of participant be entered in a clinical trial.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "integer"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialIntervention",
"path": "Extension.extension",
"sliceName": "totalPlannedDurationOfTrialIntervention",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialIntervention.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialIntervention.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialIntervention.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "totalPlannedDurationOfTrialIntervention",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialIntervention.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218712/C218713 total planned duration of trial intervention value/units",
"definition": "The total planned duration of trial intervention",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Quantity"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention",
"path": "Extension.extension",
"sliceName": "alternateDescriptionOfPlannedDurationOfTrialIntervention",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "alternateDescriptionOfPlannedDurationOfTrialIntervention",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218714 alternate description of planned duration of trial intervention if duration will vary",
"definition": "An alternative textual narrative for the planned duration of trial intervention.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialParticipation",
"path": "Extension.extension",
"sliceName": "totalPlannedDurationOfTrialParticipation",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialParticipation.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialParticipation.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialParticipation.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "totalPlannedDurationOfTrialParticipation",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialParticipation.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218715/C218716 total planned duration of trial participation value/units",
"definition": "The total planned duration of trial participation",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Quantity"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation",
"path": "Extension.extension",
"sliceName": "alternateDescriptionOfPlannedDurationOfTrialParticipation",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "alternateDescriptionOfPlannedDurationOfTrialParticipation",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218717 alternate description of planned duration of trial participation if duration will vary",
"definition": "An alternative narrative for the planned duration of trial participation.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:additionalDescriptionofDuration",
"path": "Extension.extension",
"sliceName": "additionalDescriptionofDuration",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:additionalDescriptionofDuration.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:additionalDescriptionofDuration.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:additionalDescriptionofDuration.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "additionalDescriptionofDuration",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:additionalDescriptionofDuration.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218838 Additional Description of Duration",
"definition": "A narrative providing additional details about the duration of an participant's use of a trial intervention or their planned participation time in the trial.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:independentCommittees",
"path": "Extension.extension",
"sliceName": "independentCommittees",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:independentCommittees.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:independentCommittees.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:independentCommittees.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "independentCommittees",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:independentCommittees.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217282 Independent Committees",
"definition": "An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-independentCommittees-vs"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:otherCommittees",
"path": "Extension.extension",
"sliceName": "otherCommittees",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:otherCommittees.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:otherCommittees.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:otherCommittees.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "otherCommittees",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:otherCommittees.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218719 Other Committees",
"definition": "A committee that is different than the one(s) previously specified or mentioned.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:trialSchema",
"path": "Extension.extension",
"sliceName": "trialSchema",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:trialSchema.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:trialSchema.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:trialSchema.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "trialSchema",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:trialSchema.value[x]",
"path": "Extension.extension.value[x]",
"short": "C93682 Trial Schema",
"definition": "A diagram that outlines the decision points (e.g. randomisation, response evaluation) that define the different paths a participant could take through the trial.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:schemaNotes",
"path": "Extension.extension",
"sliceName": "schemaNotes",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:schemaNotes.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:schemaNotes.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:schemaNotes.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "schemaNotes",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:schemaNotes.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218720 Schema Notes",
"definition": "A brief written record describing the trial schematic.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:scheduleofActivities",
"path": "Extension.extension",
"sliceName": "scheduleofActivities",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:scheduleofActivities.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:scheduleofActivities.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:scheduleofActivities.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "scheduleofActivities",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:scheduleofActivities.value[x]",
"path": "Extension.extension.value[x]",
"short": "C132349 Schedule of Activities",
"definition": "The schedule of activities captures the procedures that will be accomplished at each trial visit, contact with participants. A tabular format is recommended.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.url",
"path": "Extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary",
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.value[x]",
"path": "Extension.value[x]",
"short": "Value of extension",
"definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
"min": 0,
"max": "0",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"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"
}
],
"condition": [
"ext-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
}
]
},
"differential": {
"element": [
{
"id": "Extension",
"path": "Extension",
"short": "Summary of a protocol",
"definition": "Representation of summary of a study protocol.",
"comment": "This is Section 1 of the ICH Technical Summary and Guideline."
},
{
"id": "Extension.extension",
"path": "Extension.extension",
"min": 34
},
{
"id": "Extension.extension:objectiveAndEstimandSummary",
"path": "Extension.extension",
"sliceName": "objectiveAndEstimandSummary",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:objectiveAndEstimandSummary.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:objectiveAndEstimandSummary.url",
"path": "Extension.extension.url",
"fixedUri": "objectiveAndEstimandSummary"
},
{
"id": "Extension.extension:objectiveAndEstimandSummary.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218839 Primary and Secondary Objectives and Estimands",
"definition": "A descriptive summary of the primary and secondary objectives and their associated estimands related to the trial.",
"type": [
{
"code": "markdown"
},
{
"code": "string"
}
]
},
{
"id": "Extension.extension:interventionModel",
"path": "Extension.extension",
"sliceName": "interventionModel",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:interventionModel.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:interventionModel.url",
"path": "Extension.extension.url",
"fixedUri": "interventionModel"
},
{
"id": "Extension.extension:interventionModel.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217277 Intervention Model",
"definition": "The overall design configuration for assigning intervention to participants.",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionModel-vs"
}
},
{
"id": "Extension.extension:populationType",
"path": "Extension.extension",
"sliceName": "populationType",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:populationType.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:populationType.url",
"path": "Extension.extension.url",
"fixedUri": "populationType"
},
{
"id": "Extension.extension:populationType.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217278 Population Type",
"definition": "A characterisation or classification of the trial population.",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-populationType-vs"
}
},
{
"id": "Extension.extension:controlType",
"path": "Extension.extension",
"sliceName": "controlType",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:controlType.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:controlType.url",
"path": "Extension.extension.url",
"fixedUri": "controlType"
},
{
"id": "Extension.extension:controlType.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217279 Control Type",
"definition": "A characterization or classification of the comparator against which the study intervention is evaluated.",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-controlType-vs"
}
},
{
"id": "Extension.extension:populationDiagnosisOrCondition",
"path": "Extension.extension",
"sliceName": "populationDiagnosisOrCondition",
"min": 1,
"max": "*",
"mustSupport": true
},
{
"id": "Extension.extension:populationDiagnosisOrCondition.url",
"path": "Extension.extension.url",
"fixedUri": "populationDiagnosisOrCondition"
},
{
"id": "Extension.extension:comparator",
"path": "Extension.extension",
"sliceName": "comparator",
"min": 1,
"max": "*"
},
{
"id": "Extension.extension:comparator.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:comparator.url",
"path": "Extension.extension.url",
"fixedUri": "comparator"
},
{
"id": "Extension.extension:comparator.value[x]",
"path": "Extension.extension.value[x]",
"short": "Comparator",
"definition": "The comparator against which the study intervention is evaluated.",
"comment": "M11 CC97054 requires a narrative representation of the comparator - the name.",
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"
]
}
]
},
{
"id": "Extension.extension:minimumAge",
"path": "Extension.extension",
"sliceName": "minimumAge",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:minimumAge.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:minimumAge.url",
"path": "Extension.extension.url",
"fixedUri": "minimumAge"
},
{
"id": "Extension.extension:minimumAge.value[x]",
"path": "Extension.extension.value[x]",
"short": "C49693/C25301 Minimum Age value/units",
"definition": "The anticipated minimum age of the participants to be entered in a clinical trial.",
"type": [
{
"code": "Quantity"
}
]
},
{
"id": "Extension.extension:unitsOfMinimumAge",
"path": "Extension.extension",
"sliceName": "unitsOfMinimumAge",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:unitsOfMinimumAge.url",
"path": "Extension.extension.url",
"fixedUri": "unitsOfMinimumAge"
},
{
"id": "Extension.extension:maximumAge",
"path": "Extension.extension",
"sliceName": "maximumAge",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:maximumAge.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:maximumAge.url",
"path": "Extension.extension.url",
"fixedUri": "maximumAge"
},
{
"id": "Extension.extension:maximumAge.value[x]",
"path": "Extension.extension.value[x]",
"short": "C49694/C25301 Maximum Age value/units",
"definition": "The anticipated maximum age of the participants to be entered in a clinical trial.",
"type": [
{
"code": "Quantity"
}
]
},
{
"id": "Extension.extension:unitsOfMaximumAge",
"path": "Extension.extension",
"sliceName": "unitsOfMaximumAge",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:unitsOfMaximumAge.url",
"path": "Extension.extension.url",
"fixedUri": "unitsOfMaximumAge"
},
{
"id": "Extension.extension:interventionAssignmentMethod",
"path": "Extension.extension",
"sliceName": "interventionAssignmentMethod",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:interventionAssignmentMethod.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:interventionAssignmentMethod.url",
"path": "Extension.extension.url",
"fixedUri": "interventionAssignmentMethod"
},
{
"id": "Extension.extension:interventionAssignmentMethod.value[x]",
"path": "Extension.extension.value[x]",
"short": " C217280 Intervention Assignment Method",
"definition": "The process used to assign trial participants to a trial intervention or trial arm.",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionAssignmentMethod-vs"
}
},
{
"id": "Extension.extension:randomisationType",
"path": "Extension.extension",
"sliceName": "randomisationType",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:randomisationType.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:randomisationType.url",
"path": "Extension.extension.url",
"fixedUri": "randomisationType"
},
{
"id": "Extension.extension:randomisationType.value[x]",
"path": "Extension.extension.value[x]",
"short": "C223137 Randomisation Type",
"definition": "The type of randomisation to be used (e.g., simple randomisation, block randomisation)",
"comment": "this is just a text description - implementers may want to provide a value set that tehe text can be drawn from.",
"type": [
{
"code": "string"
},
{
"code": "CodeableConcept"
}
]
},
{
"id": "Extension.extension:otherInterventionAssignmentMethod",
"path": "Extension.extension",
"sliceName": "otherInterventionAssignmentMethod",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:otherInterventionAssignmentMethod.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:otherInterventionAssignmentMethod.url",
"path": "Extension.extension.url",
"fixedUri": "otherInterventionAssignmentMethod"
},
{
"id": "Extension.extension:otherInterventionAssignmentMethod.value[x]",
"path": "Extension.extension.value[x]",
"short": "C223138 Other Intervention Assignment Method",
"definition": "If applicable, describe the other intervention assignment method.",
"type": [
{
"code": "string"
}
]
},
{
"id": "Extension.extension:stratificationIndicator",
"path": "Extension.extension",
"sliceName": "stratificationIndicator",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:stratificationIndicator.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:stratificationIndicator.url",
"path": "Extension.extension.url",
"fixedUri": "stratificationIndicator"
},
{
"id": "Extension.extension:stratificationIndicator.value[x]",
"path": "Extension.extension.value[x]",
"short": "C223136 Stratification Indicator",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"
}
},
{
"id": "Extension.extension:siteDistribution",
"path": "Extension.extension",
"sliceName": "siteDistribution",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:siteDistribution.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:siteDistribution.url",
"path": "Extension.extension.url",
"fixedUri": "siteDistribution"
},
{
"id": "Extension.extension:siteDistribution.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217049 Site Distribution",
"definition": "An indication as to whether the occurrence applies to a single or multiple trial sites.",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteDistribution-vs"
}
},
{
"id": "Extension.extension:siteGeographicScope",
"path": "Extension.extension",
"sliceName": "siteGeographicScope",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:siteGeographicScope.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:siteGeographicScope.url",
"path": "Extension.extension.url",
"fixedUri": "siteGeographicScope"
},
{
"id": "Extension.extension:siteGeographicScope.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217050: Site geographic scope",
"definition": "An indication as to whether the trial is taking place in one or more countries.",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteGeographicscope-vs"
}
},
{
"id": "Extension.extension:masterProtocolIndicator",
"path": "Extension.extension",
"sliceName": "masterProtocolIndicator",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:masterProtocolIndicator.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:masterProtocolIndicator.url",
"path": "Extension.extension.url",
"fixedUri": "masterProtocolIndicator"
},
{
"id": "Extension.extension:masterProtocolIndicator.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217046 Master Protocol Indicator",
"definition": "An indication as to whether the protocol is a master protocol.",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"
}
},
{
"id": "Extension.extension:drug-DeviceCombinationProductIndicator",
"path": "Extension.extension",
"sliceName": "drug-DeviceCombinationProductIndicator",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:drug-DeviceCombinationProductIndicator.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:drug-DeviceCombinationProductIndicator.url",
"path": "Extension.extension.url",
"fixedUri": "drug-DeviceCombinationProductIndicator"
},
{
"id": "Extension.extension:drug-DeviceCombinationProductIndicator.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217046 Drug-Device Combination Product Indicator",
"definition": "An indication as to whether the clinical trial is testing a drug-device combination product.",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"
}
},
{
"id": "Extension.extension:adaptiveTrialDesignIndicator",
"path": "Extension.extension",
"sliceName": "adaptiveTrialDesignIndicator",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:adaptiveTrialDesignIndicator.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:adaptiveTrialDesignIndicator.url",
"path": "Extension.extension.url",
"fixedUri": "adaptiveTrialDesignIndicator"
},
{
"id": "Extension.extension:adaptiveTrialDesignIndicator.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217046 Adaptive Trial Design Indicator",
"definition": "An indication as to whether the clinical trial uses an adaptive trial design.",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"
}
},
{
"id": "Extension.extension:numberOfArms",
"path": "Extension.extension",
"sliceName": "numberOfArms",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:numberOfArms.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:numberOfArms.url",
"path": "Extension.extension.url",
"fixedUri": "numberOfArms"
},
{
"id": "Extension.extension:numberOfArms.value[x]",
"path": "Extension.extension.value[x]",
"short": "C98771 Number of Arms",
"definition": "The planned number of intervention groups.",
"type": [
{
"code": "integer"
}
]
},
{
"id": "Extension.extension:trialBlindSchema",
"path": "Extension.extension",
"sliceName": "trialBlindSchema",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:trialBlindSchema.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:trialBlindSchema.url",
"path": "Extension.extension.url",
"fixedUri": "trialBlindSchema"
},
{
"id": "Extension.extension:trialBlindSchema.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217051 Trial Blind Schema",
"definition": "The type of experimental design used to describe the level of awareness of the trial participants and/ or personnel as it relates to the respective intervention(s) or assessments being observed, received or administered.",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-trialBlindSchema-vs"
}
},
{
"id": "Extension.extension:blindedRoles",
"path": "Extension.extension",
"sliceName": "blindedRoles",
"min": 1,
"max": "*",
"mustSupport": true
},
{
"id": "Extension.extension:blindedRoles.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:blindedRoles.url",
"path": "Extension.extension.url",
"fixedUri": "blindedRoles"
},
{
"id": "Extension.extension:blindedRoles.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217281: Blinded Roles",
"definition": "An identifying designation assigned to a blinded individual within a clinical trial that corresponds with their function",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blindedRoles-vs"
}
},
{
"id": "Extension.extension:targetOrMaximum",
"path": "Extension.extension",
"sliceName": "targetOrMaximum",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:targetOrMaximum.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:targetOrMaximum.url",
"path": "Extension.extension.url",
"fixedUri": "targetOrMaximum"
},
{
"id": "Extension.extension:targetOrMaximum.value[x]",
"path": "Extension.extension.value[x]",
"short": "Target-Maximum",
"definition": "A characterisation or classification of the trial participant numbers as to whether the numbers reflect a target or maximum.",
"comment": "The ICH spec has this as optional boilerplate text but it has to be a variable to be processable",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-target-Maximum-vs"
}
},
{
"id": "Extension.extension:numberOfParticipants",
"path": "Extension.extension",
"sliceName": "numberOfParticipants",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:numberOfParticipants.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:numberOfParticipants.url",
"path": "Extension.extension.url",
"fixedUri": "numberOfParticipants"
},
{
"id": "Extension.extension:numberOfParticipants.value[x]",
"path": "Extension.extension.value[x]",
"short": "C49692 Number of Participants",
"definition": "The planned number of participant be entered in a clinical trial.",
"type": [
{
"code": "integer"
}
]
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialIntervention",
"path": "Extension.extension",
"sliceName": "totalPlannedDurationOfTrialIntervention",
"min": 1,
"max": "1"
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialIntervention.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialIntervention.url",
"path": "Extension.extension.url",
"fixedUri": "totalPlannedDurationOfTrialIntervention"
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialIntervention.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218712/C218713 total planned duration of trial intervention value/units",
"definition": "The total planned duration of trial intervention",
"type": [
{
"code": "Quantity"
}
]
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention",
"path": "Extension.extension",
"sliceName": "alternateDescriptionOfPlannedDurationOfTrialIntervention",
"min": 1,
"max": "1"
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.url",
"path": "Extension.extension.url",
"fixedUri": "alternateDescriptionOfPlannedDurationOfTrialIntervention"
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218714 alternate description of planned duration of trial intervention if duration will vary",
"definition": "An alternative textual narrative for the planned duration of trial intervention.",
"type": [
{
"code": "string"
}
]
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialParticipation",
"path": "Extension.extension",
"sliceName": "totalPlannedDurationOfTrialParticipation",
"min": 1,
"max": "1"
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialParticipation.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialParticipation.url",
"path": "Extension.extension.url",
"fixedUri": "totalPlannedDurationOfTrialParticipation"
},
{
"id": "Extension.extension:totalPlannedDurationOfTrialParticipation.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218715/C218716 total planned duration of trial participation value/units",
"definition": "The total planned duration of trial participation",
"type": [
{
"code": "Quantity"
}
]
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation",
"path": "Extension.extension",
"sliceName": "alternateDescriptionOfPlannedDurationOfTrialParticipation",
"min": 1,
"max": "1"
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.url",
"path": "Extension.extension.url",
"fixedUri": "alternateDescriptionOfPlannedDurationOfTrialParticipation"
},
{
"id": "Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218717 alternate description of planned duration of trial participation if duration will vary",
"definition": "An alternative narrative for the planned duration of trial participation.",
"type": [
{
"code": "string"
}
]
},
{
"id": "Extension.extension:additionalDescriptionofDuration",
"path": "Extension.extension",
"sliceName": "additionalDescriptionofDuration",
"min": 1,
"max": "1"
},
{
"id": "Extension.extension:additionalDescriptionofDuration.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:additionalDescriptionofDuration.url",
"path": "Extension.extension.url",
"fixedUri": "additionalDescriptionofDuration"
},
{
"id": "Extension.extension:additionalDescriptionofDuration.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218838 Additional Description of Duration",
"definition": "A narrative providing additional details about the duration of an participant's use of a trial intervention or their planned participation time in the trial.",
"type": [
{
"code": "string"
}
]
},
{
"id": "Extension.extension:independentCommittees",
"path": "Extension.extension",
"sliceName": "independentCommittees",
"min": 1,
"max": "*",
"mustSupport": true
},
{
"id": "Extension.extension:independentCommittees.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:independentCommittees.url",
"path": "Extension.extension.url",
"fixedUri": "independentCommittees"
},
{
"id": "Extension.extension:independentCommittees.value[x]",
"path": "Extension.extension.value[x]",
"short": "C217282 Independent Committees",
"definition": "An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities.",
"type": [
{
"code": "CodeableConcept"
}
],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-independentCommittees-vs"
}
},
{
"id": "Extension.extension:otherCommittees",
"path": "Extension.extension",
"sliceName": "otherCommittees",
"min": 1,
"max": "*"
},
{
"id": "Extension.extension:otherCommittees.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:otherCommittees.url",
"path": "Extension.extension.url",
"fixedUri": "otherCommittees"
},
{
"id": "Extension.extension:otherCommittees.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218719 Other Committees",
"definition": "A committee that is different than the one(s) previously specified or mentioned.",
"type": [
{
"code": "string"
}
]
},
{
"id": "Extension.extension:trialSchema",
"path": "Extension.extension",
"sliceName": "trialSchema",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:trialSchema.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:trialSchema.url",
"path": "Extension.extension.url",
"fixedUri": "trialSchema"
},
{
"id": "Extension.extension:trialSchema.value[x]",
"path": "Extension.extension.value[x]",
"short": "C93682 Trial Schema",
"definition": "A diagram that outlines the decision points (e.g. randomisation, response evaluation) that define the different paths a participant could take through the trial.",
"type": [
{
"code": "string"
}
]
},
{
"id": "Extension.extension:schemaNotes",
"path": "Extension.extension",
"sliceName": "schemaNotes",
"min": 1,
"max": "1"
},
{
"id": "Extension.extension:schemaNotes.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:schemaNotes.url",
"path": "Extension.extension.url",
"fixedUri": "schemaNotes"
},
{
"id": "Extension.extension:schemaNotes.value[x]",
"path": "Extension.extension.value[x]",
"short": "C218720 Schema Notes",
"definition": "A brief written record describing the trial schematic.",
"type": [
{
"code": "string"
}
]
},
{
"id": "Extension.extension:scheduleofActivities",
"path": "Extension.extension",
"sliceName": "scheduleofActivities",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:scheduleofActivities.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:scheduleofActivities.url",
"path": "Extension.extension.url",
"fixedUri": "scheduleofActivities"
},
{
"id": "Extension.extension:scheduleofActivities.value[x]",
"path": "Extension.extension.value[x]",
"short": "C132349 Schedule of Activities",
"definition": "The schedule of activities captures the procedures that will be accomplished at each trial visit, contact with participants. A tabular format is recommended.",
"type": [
{
"code": "string"
}
]
},
{
"id": "Extension.url",
"path": "Extension.url",
"fixedUri": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary"
},
{
"id": "Extension.value[x]",
"path": "Extension.value[x]",
"max": "0"
}
]
}
}