FHIR IG analytics| Package | hl7.fhir.uv.xver-r3.r5 |
| Resource Type | StructureDefinition |
| Id | StructureDefinition-profile-ResearchStudy.json |
| FHIR Version | R5 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition profile-ResearchStudy
FHIR
FHIRsmith
{
"resourceType": "StructureDefinition",
"id": "profile-ResearchStudy",
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "fhir"
},
{
"extension": [
{
"url": "packageId",
"valueId": "hl7.fhir.uv.xver-r3.r5"
},
{
"url": "version",
"valueString": "0.1.0"
}
],
"url": "http://hl7.org/fhir/StructureDefinition/package-source"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 0,
"_valueInteger": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r3.r5"
}
]
}
},
{
"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/xver/ImplementationGuide/hl7.fhir.uv.xver-r3.r5"
}
]
}
}
],
"url": "http://hl7.org/fhir/3.0/StructureDefinition/profile-ResearchStudy",
"version": "0.1.0",
"name": "Profile_R3_ResearchStudy_R5",
"title": "Cross-version Profile for STU3.ResearchStudy for use in FHIR R5",
"status": "active",
"experimental": false,
"date": "2026-03-17T16:04:59.2570075-05:00",
"publisher": "FHIR Infrastructure",
"contact": [
{
"name": "FHIR Infrastructure",
"telecom": [
{
"system": "url",
"value": "http://www.hl7.org/Special/committees/fiwg"
}
]
}
],
"description": "This cross-version profile allows STU3 ResearchStudy content to be represented via FHIR R5 ResearchStudy resources.",
"jurisdiction": [
{
"coding": [
{
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code": "001",
"display": "World"
}
]
}
],
"fhirVersion": "5.0.0",
"mapping": [
{
"identity": "w5",
"uri": "http://hl7.org/fhir/fivews",
"name": "FiveWs Pattern Mapping"
},
{
"identity": "BRIDG5.1",
"uri": "https://bridgmodel.nci.nih.gov",
"name": "BRIDG 5.1 Mapping"
},
{
"identity": "v2",
"uri": "http://hl7.org/v2",
"name": "HL7 V2 Mapping"
},
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
},
{
"identity": "clinicaltrials-gov",
"uri": "http://clinicaltrials.gov",
"name": "ClinicalTrials.gov Mapping"
}
],
"kind": "resource",
"abstract": false,
"type": "ResearchStudy",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/ResearchStudy|5.0.0",
"derivation": "constraint",
"snapshot": {
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "5.0.0"
}
],
"element": [
{
"id": "ResearchStudy",
"path": "ResearchStudy",
"short": "Investigation to increase healthcare-related patient-independent knowledge",
"definition": "A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.",
"comment": "Need to make sure we encompass public health studies.",
"alias": [
"Clinical Trial",
"Study"
],
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy",
"min": 0,
"max": "*"
},
"constraint": [
{
"key": "dom-2",
"severity": "error",
"human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression": "contained.contained.empty()",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource|5.0.0"
},
{
"key": "dom-3",
"severity": "error",
"human": "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
"expression": "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource|5.0.0"
},
{
"key": "dom-4",
"severity": "error",
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource|5.0.0"
},
{
"key": "dom-5",
"severity": "error",
"human": "If a resource is contained in another resource, it SHALL NOT have a security label",
"expression": "contained.meta.security.empty()",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource|5.0.0"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean": true
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown": "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
}
],
"key": "dom-6",
"severity": "warning",
"human": "A resource should have narrative for robust management",
"expression": "text.`div`.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "Entity, Role, or Act,Observation[classCode=CLNTRL, moodCode=EVN]"
},
{
"identity": "w5",
"map": "clinical.diagnostics"
},
{
"identity": "BRIDG5.1",
"map": "ObservationalStudyProtocolVersion; Study;\nStudyProtocolVersion"
},
{
"identity": "v2",
"map": "OBX"
}
]
},
{
"id": "ResearchStudy.id",
"path": "ResearchStudy.id",
"short": "Logical id of this artifact",
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment": "Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.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"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchStudy.meta",
"path": "ResearchStudy.meta",
"short": "Metadata about the resource",
"definition": "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.meta",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Meta"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchStudy.meta.id",
"path": "ResearchStudy.meta.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": "ResearchStudy.meta.extension",
"path": "ResearchStudy.meta.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"ordered": false,
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.meta.extension:meta",
"path": "ResearchStudy.meta.extension",
"sliceName": "meta",
"short": "STU3: meta additional types",
"definition": "STU3: `ResearchStudy.meta` additional types (Meta) additional types from child elements (lastUpdated, profile, security, tag, versionId)",
"comment": "Element `ResearchStudy.meta` is mapped to FHIR R5 element `ResearchStudy.meta` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.meta` do not cover the following types: Meta.\nThe mappings for `ResearchStudy.meta` do not cover the following types based on type expansion: lastUpdated, profile, security, tag, versionId.",
"min": 0,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.meta|0.1.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.meta.versionId",
"path": "ResearchStudy.meta.versionId",
"short": "Version specific identifier",
"definition": "The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.",
"comment": "The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.",
"min": 0,
"max": "1",
"base": {
"path": "Meta.versionId",
"min": 0,
"max": "1"
},
"type": [
{
"code": "id"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchStudy.meta.lastUpdated",
"path": "ResearchStudy.meta.lastUpdated",
"short": "When the resource version last changed",
"definition": "When the resource last changed - e.g. when the version changed.",
"comment": "This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a [read](http://hl7.org/fhir/R5/http.html#read) interaction.",
"min": 0,
"max": "1",
"base": {
"path": "Meta.lastUpdated",
"min": 0,
"max": "1"
},
"type": [
{
"code": "instant"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchStudy.meta.source",
"path": "ResearchStudy.meta.source",
"short": "Identifies where the resource comes from",
"definition": "A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](http://hl7.org/fhir/R5/provenance.html#) information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.",
"comment": "The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference. \n\nThis element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.",
"min": 0,
"max": "1",
"base": {
"path": "Meta.source",
"min": 0,
"max": "1"
},
"type": [
{
"code": "uri"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchStudy.meta.profile",
"path": "ResearchStudy.meta.profile",
"short": "Profiles this resource claims to conform to",
"definition": "A list of profiles (references to [StructureDefinition](http://hl7.org/fhir/R5/structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](http://hl7.org/fhir/R5/structuredefinition-definitions.html#StructureDefinition.url).",
"comment": "It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.",
"min": 0,
"max": "*",
"base": {
"path": "Meta.profile",
"min": 0,
"max": "*"
},
"type": [
{
"code": "canonical",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/StructureDefinition|5.0.0"
]
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchStudy.meta.security",
"path": "ResearchStudy.meta.security",
"short": "Security Labels applied to this resource",
"definition": "Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.",
"comment": "The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.",
"min": 0,
"max": "*",
"base": {
"path": "Meta.security",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Coding"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SecurityLabels"
}
],
"strength": "extensible",
"description": "Security Labels from the Healthcare Privacy and Security Classification System.",
"valueSet": "http://hl7.org/fhir/ValueSet/security-labels|5.0.0"
}
},
{
"id": "ResearchStudy.meta.tag",
"path": "ResearchStudy.meta.tag",
"short": "Tags applied to this resource",
"definition": "Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.",
"comment": "The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.",
"min": 0,
"max": "*",
"base": {
"path": "Meta.tag",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Coding"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Tags"
}
],
"strength": "example",
"description": "Codes that represent various types of tags, commonly workflow-related; e.g. \"Needs review by Dr. Jones\".",
"valueSet": "http://hl7.org/fhir/ValueSet/common-tags|5.0.0"
}
},
{
"id": "ResearchStudy.implicitRules",
"path": "ResearchStudy.implicitRules",
"short": "A set of rules under which this content was created",
"definition": "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
"comment": "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.implicitRules",
"min": 0,
"max": "1"
},
"type": [
{
"code": "uri"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": true,
"isModifierReason": "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation",
"isSummary": true
},
{
"id": "ResearchStudy.language",
"path": "ResearchStudy.language",
"short": "Language of the resource content",
"definition": "The base language in which the resource is written.",
"comment": "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
"min": 0,
"max": "1",
"base": {
"path": "Resource.language",
"min": 0,
"max": "1"
},
"type": [
{
"code": "code"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
}
],
"strength": "required",
"description": "IETF language tag for a human language",
"valueSet": "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
"additional": [
{
"purpose": "starter",
"valueSet": "http://hl7.org/fhir/ValueSet/languages|5.0.0"
}
]
}
},
{
"id": "ResearchStudy.text",
"path": "ResearchStudy.text",
"short": "Text summary of the resource, for human interpretation",
"definition": "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
"comment": "Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.",
"alias": [
"narrative",
"html",
"xhtml",
"display"
],
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.text",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Narrative"
}
],
"condition": [
"dom-6"
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "Act.text?"
}
]
},
{
"id": "ResearchStudy.text.id",
"path": "ResearchStudy.text.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": "ResearchStudy.text.extension",
"path": "ResearchStudy.text.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"ordered": false,
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.text.extension:text",
"path": "ResearchStudy.text.extension",
"sliceName": "text",
"short": "STU3: text additional types",
"definition": "STU3: `ResearchStudy.text` additional types (Narrative) additional types from child elements (div, status)",
"comment": "Element `ResearchStudy.text` is mapped to FHIR R5 element `ResearchStudy.text` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.text` do not cover the following types: Narrative.\nThe mappings for `ResearchStudy.text` do not cover the following types based on type expansion: div, status.\nContained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded in formation is added later.",
"min": 0,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.text|0.1.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.text.status",
"path": "ResearchStudy.text.status",
"short": "generated | extensions | additional | empty",
"definition": "The status of the narrative - whether it's entirely generated (from just the defined data or the extensions too), or whether a human authored it and it may contain additional data.",
"min": 1,
"max": "1",
"base": {
"path": "Narrative.status",
"min": 1,
"max": "1"
},
"type": [
{
"code": "code"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "NarrativeStatus"
}
],
"strength": "required",
"description": "The status of a resource narrative.",
"valueSet": "http://hl7.org/fhir/ValueSet/narrative-status|5.0.0"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.text.div",
"path": "ResearchStudy.text.div",
"short": "Limited xhtml content",
"definition": "The actual narrative content, a stripped down version of XHTML.",
"comment": "The contents of the html element are an XHTML fragment containing only the basic html formatting elements described in chapters 7-11 and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained stylesheets. The XHTML content SHALL NOT contain a head, a body, external stylesheet references, scripts, forms, base/link/xlink, frames, iframes and objects.",
"min": 1,
"max": "1",
"base": {
"path": "Narrative.div",
"min": 1,
"max": "1"
},
"type": [
{
"code": "xhtml"
}
],
"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|5.0.0"
},
{
"key": "txt-1",
"severity": "error",
"human": "The narrative SHALL contain only the basic html formatting elements and attributes described in chapters 7-11 (except section 4 of chapter 9) and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained style attributes",
"expression": "htmlChecks()",
"source": "http://hl7.org/fhir/StructureDefinition/Narrative|5.0.0"
},
{
"key": "txt-2",
"severity": "error",
"human": "The narrative SHALL have some non-whitespace content",
"expression": "htmlChecks()",
"source": "http://hl7.org/fhir/StructureDefinition/Narrative|5.0.0"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.contained",
"path": "ResearchStudy.contained",
"short": "Contained, inline Resources",
"definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.",
"comment": "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.",
"alias": [
"inline resources",
"anonymous resources",
"contained resources"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.contained",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Resource"
}
],
"condition": [
"dom-2",
"dom-4",
"dom-3",
"dom-5"
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.extension",
"path": "ResearchStudy.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.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|5.0.0"
},
{
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.extension:category",
"path": "ResearchStudy.extension",
"sliceName": "category",
"short": "STU3: Classifications for the study (new)",
"definition": "STU3: `ResearchStudy.category` (new:CodeableConcept)",
"comment": "Element `ResearchStudy.category` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.\nElement `ResearchStudy.category` has no mapping targets in FHIR R5. Typically, this is because the element has been added (is a new element).",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.category|0.1.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.extension:contact",
"path": "ResearchStudy.extension",
"sliceName": "contact",
"short": "STU3: Contact details for the study (new)",
"definition": "STU3: `ResearchStudy.contact` (new:ContactDetail)",
"comment": "Element `ResearchStudy.contact` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.\nElement `ResearchStudy.contact` has no mapping targets in FHIR R5. Typically, this is because the element has been added (is a new element).",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.contact|0.1.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.extension:jurisdiction",
"path": "ResearchStudy.extension",
"sliceName": "jurisdiction",
"short": "STU3: Geographic region(s) for study (new)",
"definition": "STU3: `ResearchStudy.jurisdiction` (new:CodeableConcept)",
"comment": "Element `ResearchStudy.jurisdiction` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.\nElement `ResearchStudy.jurisdiction` has no mapping targets in FHIR R5. Typically, this is because the element has been added (is a new element).",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.jurisdiction|0.1.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.extension:enrollment",
"path": "ResearchStudy.extension",
"sliceName": "enrollment",
"short": "STU3: Inclusion & exclusion criteria (new)",
"definition": "STU3: `ResearchStudy.enrollment` (new:Reference(Group))",
"comment": "Element `ResearchStudy.enrollment` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.\nElement `ResearchStudy.enrollment` has no mapping targets in FHIR R5. Typically, this is because the element has been added (is a new element).\nThe Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.enrollment|0.1.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.extension:sponsor",
"path": "ResearchStudy.extension",
"sliceName": "sponsor",
"short": "STU3: Organization responsible for the study (new)",
"definition": "STU3: `ResearchStudy.sponsor` (new:Reference(Organization))",
"comment": "Element `ResearchStudy.sponsor` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.\nElement `ResearchStudy.sponsor` has no mapping targets in FHIR R5. Typically, this is because the element has been added (is a new element).",
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.sponsor|0.1.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.extension:principalInvestigator",
"path": "ResearchStudy.extension",
"sliceName": "principalInvestigator",
"short": "STU3: The individual responsible for the study (new)",
"definition": "STU3: `ResearchStudy.principalInvestigator` (new:Reference(Practitioner))",
"comment": "Element `ResearchStudy.principalInvestigator` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.\nElement `ResearchStudy.principalInvestigator` has no mapping targets in FHIR R5. Typically, this is because the element has been added (is a new element).",
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.principalInvestigator|0.1.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.extension:reasonStopped",
"path": "ResearchStudy.extension",
"sliceName": "reasonStopped",
"short": "STU3: Reason for terminating study early (new)",
"definition": "STU3: `ResearchStudy.reasonStopped` (new:CodeableConcept)",
"comment": "Element `ResearchStudy.reasonStopped` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.\nElement `ResearchStudy.reasonStopped` has no mapping targets in FHIR R5. Typically, this is because the element has been added (is a new element).",
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.reasonStopped|0.1.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.modifierExtension",
"path": "ResearchStudy.modifierExtension",
"short": "Extensions that cannot be ignored",
"definition": "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"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.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.modifierExtension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.url",
"path": "ResearchStudy.url",
"short": "Canonical identifier for this study resource",
"definition": "Canonical identifier for this study resource, represented as a globally unique URI.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.url",
"min": 0,
"max": "1"
},
"type": [
{
"code": "uri"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.identifier",
"path": "ResearchStudy.identifier",
"short": "Business Identifier for study",
"definition": "Identifiers assigned to this research study by the sponsor or other systems.",
"requirements": "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.identifier",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Identifier"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Organization's Unique Protocol ID; Secondary IDs"
},
{
"identity": "w5",
"map": "FiveWs.identifier"
},
{
"identity": "BRIDG5.1",
"map": "No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)"
},
{
"identity": "rim",
"map": ".identifier"
}
]
},
{
"id": "ResearchStudy.identifier.id",
"path": "ResearchStudy.identifier.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": "ResearchStudy.identifier.extension",
"path": "ResearchStudy.identifier.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"ordered": false,
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.identifier.extension:identifier",
"path": "ResearchStudy.identifier.extension",
"sliceName": "identifier",
"short": "STU3: identifier additional types",
"definition": "STU3: `ResearchStudy.identifier` additional types (Identifier) additional types from child elements (assigner, period, system, type, use, value)",
"comment": "Element `ResearchStudy.identifier` is mapped to FHIR R5 element `ResearchStudy.identifier` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.identifier` do not cover the following types: Identifier.\nThe mappings for `ResearchStudy.identifier` do not cover the following types based on type expansion: assigner, period, system, type, use, value.",
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.identifier|0.1.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.identifier.use",
"path": "ResearchStudy.identifier.use",
"short": "usual | official | temp | secondary | old (If known)",
"definition": "The purpose of this identifier.",
"comment": "Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.",
"requirements": "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.",
"min": 0,
"max": "1",
"base": {
"path": "Identifier.use",
"min": 0,
"max": "1"
},
"type": [
{
"code": "code"
}
],
"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|5.0.0"
}
],
"isModifier": true,
"isModifierReason": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one.",
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "IdentifierUse"
}
],
"strength": "required",
"description": "Identifies the purpose for this identifier, if known .",
"valueSet": "http://hl7.org/fhir/ValueSet/identifier-use|5.0.0"
},
"mapping": [
{
"identity": "v2",
"map": "N/A"
},
{
"identity": "rim",
"map": "Role.code or implied by context"
}
]
},
{
"id": "ResearchStudy.identifier.type",
"path": "ResearchStudy.identifier.type",
"short": "Description of identifier",
"definition": "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.",
"comment": "This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.",
"requirements": "Allows users to make use of identifiers when the identifier system is not known.",
"min": 0,
"max": "1",
"base": {
"path": "Identifier.type",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "IdentifierType"
}
],
"strength": "extensible",
"description": "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.",
"valueSet": "http://hl7.org/fhir/ValueSet/identifier-type|5.0.0"
},
"mapping": [
{
"identity": "v2",
"map": "CX.5"
},
{
"identity": "rim",
"map": "Role.code or implied by context"
}
]
},
{
"id": "ResearchStudy.identifier.system",
"path": "ResearchStudy.identifier.system",
"short": "The namespace for the identifier value",
"definition": "Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.",
"comment": "Identifier.system is always case sensitive.",
"requirements": "There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.",
"min": 0,
"max": "1",
"base": {
"path": "Identifier.system",
"min": 0,
"max": "1"
},
"type": [
{
"code": "uri"
}
],
"example": [
{
"label": "General",
"valueUri": "http://www.acme.com/identifiers/patient"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "v2",
"map": "CX.4 / EI-2-4"
},
{
"identity": "rim",
"map": "II.root or Role.id.root"
},
{
"identity": "servd",
"map": "./IdentifierType"
}
]
},
{
"id": "ResearchStudy.identifier.value",
"path": "ResearchStudy.identifier.value",
"short": "The value that is unique",
"definition": "The portion of the identifier typically relevant to the user and which is unique within the context of the system.",
"comment": "If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.",
"min": 0,
"max": "1",
"base": {
"path": "Identifier.value",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"example": [
{
"label": "General",
"valueString": "123456"
}
],
"condition": [
"ident-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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "v2",
"map": "CX.1 / EI.1"
},
{
"identity": "rim",
"map": "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"
},
{
"identity": "servd",
"map": "./Value"
}
]
},
{
"id": "ResearchStudy.identifier.period",
"path": "ResearchStudy.identifier.period",
"short": "Time period when id is/was valid for use",
"definition": "Time period during which identifier is/was valid for use.",
"min": 0,
"max": "1",
"base": {
"path": "Identifier.period",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Period"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "v2",
"map": "CX.7 + CX.8"
},
{
"identity": "rim",
"map": "Role.effectiveTime or implied by context"
},
{
"identity": "servd",
"map": "./StartDate and ./EndDate"
}
]
},
{
"id": "ResearchStudy.identifier.assigner",
"path": "ResearchStudy.identifier.assigner",
"short": "Organization that issued id (may be just text)",
"definition": "Organization that issued/manages the identifier.",
"comment": "The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.",
"min": 0,
"max": "1",
"base": {
"path": "Identifier.assigner",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Organization|5.0.0"
]
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "v2",
"map": "CX.4 / (CX.4,CX.9,CX.10)"
},
{
"identity": "rim",
"map": "II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"
},
{
"identity": "servd",
"map": "./IdentifierIssuingAuthority"
}
]
},
{
"id": "ResearchStudy.version",
"path": "ResearchStudy.version",
"short": "The business version for the study record",
"definition": "The business version for the study record.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.version",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.name",
"path": "ResearchStudy.name",
"short": "Name for this study (computer friendly)",
"definition": "Name for this study (computer friendly).",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.name",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.title",
"path": "ResearchStudy.title",
"short": "Human readable name of the study",
"definition": "The human readable name of the research study.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.title",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Brief Title"
},
{
"identity": "BRIDG5.1",
"map": "No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)"
}
]
},
{
"id": "ResearchStudy.label",
"path": "ResearchStudy.label",
"short": "Additional names for the study",
"definition": "Additional names for the study.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.label",
"min": 0,
"max": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.label.id",
"path": "ResearchStudy.label.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": "string"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchStudy.label.extension",
"path": "ResearchStudy.label.extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchStudy.label.modifierExtension",
"path": "ResearchStudy.label.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"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.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.label.type",
"path": "ResearchStudy.label.type",
"short": "primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid",
"definition": "Kind of name.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.label.type",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "TitleType"
}
],
"strength": "extensible",
"description": "desc.",
"valueSet": "http://hl7.org/fhir/ValueSet/title-type|5.0.0"
}
},
{
"id": "ResearchStudy.label.value",
"path": "ResearchStudy.label.value",
"short": "The name",
"definition": "The name.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.label.value",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.protocol",
"path": "ResearchStudy.protocol",
"short": "Steps followed in executing study",
"definition": "The set of steps expected to be performed as part of the execution of the study.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.protocol",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/PlanDefinition|5.0.0"
]
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Interventions; Arm/Intervention Cross-Reference"
},
{
"identity": "BRIDG5.1",
"map": "StudyProtocolDocumentVersionPublicTitle.name"
},
{
"identity": "rim",
"map": ".outboundRelationship[typeCode=DEFN].target"
}
]
},
{
"id": "ResearchStudy.protocol.id",
"path": "ResearchStudy.protocol.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": "ResearchStudy.protocol.extension",
"path": "ResearchStudy.protocol.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"ordered": false,
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.protocol.extension:protocol",
"path": "ResearchStudy.protocol.extension",
"sliceName": "protocol",
"short": "STU3: protocol additional types",
"definition": "STU3: `ResearchStudy.protocol` additional types from child elements (display, identifier, reference)",
"comment": "Element `ResearchStudy.protocol` is mapped to FHIR R5 element `ResearchStudy.protocol` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.protocol` do not cover the following types based on type expansion: display, identifier, reference.\nThe standard extension `alternate-reference` has been mapped as the representation of FHIR STU3 element `ResearchStudy.protocol` with unmapped reference targets: PlanDefinition.",
"min": 0,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/StructureDefinition/alternate-reference|5.2.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.protocol.reference",
"path": "ResearchStudy.protocol.reference",
"short": "Literal reference, Relative, internal or absolute URL",
"definition": "A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.",
"comment": "Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure \"[type]/[id]\" then it should be assumed that the reference is to a FHIR RESTful server.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.reference",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ref-2",
"ref-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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.protocol.type",
"path": "ResearchStudy.protocol.type",
"short": "Type the reference refers to (e.g. \"Patient\") - must be a resource in resources",
"definition": "The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.\n\nThe type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. \"Patient\" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).",
"comment": "This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.type",
"min": 0,
"max": "1"
},
"type": [
{
"code": "uri"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "FHIRResourceTypeExt"
}
],
"strength": "extensible",
"description": "Aa resource (or, for logical models, the URI of the logical model).",
"valueSet": "http://hl7.org/fhir/ValueSet/resource-types|5.0.0"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.protocol.identifier",
"path": "ResearchStudy.protocol.identifier",
"short": "Logical reference, when literal reference is not known",
"definition": "An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.",
"comment": "When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. \n\nWhen both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference\n\nApplications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.\n\nReference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).\n\nThis element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.identifier",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Identifier"
}
],
"condition": [
"ref-2"
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": ".identifier"
}
]
},
{
"id": "ResearchStudy.protocol.display",
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}
],
"path": "ResearchStudy.protocol.display",
"short": "Text alternative for the resource",
"definition": "Plain text narrative that identifies the resource in addition to the resource reference.",
"comment": "This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.display",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ref-2"
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.partOf",
"path": "ResearchStudy.partOf",
"short": "Part of larger study",
"definition": "A larger research study of which this particular study is a component or step.",
"requirements": "Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.",
"alias": [
"container"
],
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.partOf",
"min": 0,
"max": "*"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-hierarchy",
"valueBoolean": true
}
],
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/ResearchStudy|5.0.0"
]
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "BRIDG5.1",
"map": "CompanionStudyRelationship"
},
{
"identity": "rim",
"map": ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"
}
]
},
{
"id": "ResearchStudy.partOf.id",
"path": "ResearchStudy.partOf.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": "ResearchStudy.partOf.extension",
"path": "ResearchStudy.partOf.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"ordered": false,
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.partOf.extension:partOf",
"path": "ResearchStudy.partOf.extension",
"sliceName": "partOf",
"short": "STU3: partOf additional types",
"definition": "STU3: `ResearchStudy.partOf` additional types from child elements (display, identifier, reference)",
"comment": "Element `ResearchStudy.partOf` is mapped to FHIR R5 element `ResearchStudy.partOf` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.partOf` do not cover the following types based on type expansion: display, identifier, reference.\nThe standard extension `alternate-reference` has been mapped as the representation of FHIR STU3 element `ResearchStudy.partOf` with unmapped reference targets: ResearchStudy.",
"min": 0,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/StructureDefinition/alternate-reference|5.2.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.partOf.reference",
"path": "ResearchStudy.partOf.reference",
"short": "Literal reference, Relative, internal or absolute URL",
"definition": "A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.",
"comment": "Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure \"[type]/[id]\" then it should be assumed that the reference is to a FHIR RESTful server.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.reference",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ref-2",
"ref-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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.partOf.type",
"path": "ResearchStudy.partOf.type",
"short": "Type the reference refers to (e.g. \"Patient\") - must be a resource in resources",
"definition": "The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.\n\nThe type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. \"Patient\" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).",
"comment": "This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.type",
"min": 0,
"max": "1"
},
"type": [
{
"code": "uri"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "FHIRResourceTypeExt"
}
],
"strength": "extensible",
"description": "Aa resource (or, for logical models, the URI of the logical model).",
"valueSet": "http://hl7.org/fhir/ValueSet/resource-types|5.0.0"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.partOf.identifier",
"path": "ResearchStudy.partOf.identifier",
"short": "Logical reference, when literal reference is not known",
"definition": "An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.",
"comment": "When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. \n\nWhen both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference\n\nApplications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.\n\nReference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).\n\nThis element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.identifier",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Identifier"
}
],
"condition": [
"ref-2"
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": ".identifier"
}
]
},
{
"id": "ResearchStudy.partOf.display",
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}
],
"path": "ResearchStudy.partOf.display",
"short": "Text alternative for the resource",
"definition": "Plain text narrative that identifies the resource in addition to the resource reference.",
"comment": "This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.display",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ref-2"
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.relatedArtifact",
"path": "ResearchStudy.relatedArtifact",
"short": "References, URLs, and attachments",
"definition": "Citations, references, URLs and other related documents. When using relatedArtifact to share URLs, the relatedArtifact.type will often be set to one of \"documentation\" or \"supported-with\" and the URL value will often be in relatedArtifact.document.url but another possible location is relatedArtifact.resource when it is a canonical URL.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.relatedArtifact",
"min": 0,
"max": "*"
},
"type": [
{
"code": "RelatedArtifact"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Citations, Links, Available Study Data/Documents"
},
{
"identity": "BRIDG5.1",
"map": "StudyProtocolDocument, StudyProtocolDocumentVersion"
}
]
},
{
"id": "ResearchStudy.relatedArtifact.id",
"path": "ResearchStudy.relatedArtifact.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": "ResearchStudy.relatedArtifact.extension",
"path": "ResearchStudy.relatedArtifact.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"ordered": false,
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.relatedArtifact.extension:relatedArtifact",
"path": "ResearchStudy.relatedArtifact.extension",
"sliceName": "relatedArtifact",
"short": "STU3: References and dependencies additional types",
"definition": "STU3: `ResearchStudy.relatedArtifact` additional types (RelatedArtifact) additional types from child elements (citation, display, document, resource, type, url)",
"comment": "Element `ResearchStudy.relatedArtifact` is mapped to FHIR R5 element `ResearchStudy.relatedArtifact` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.relatedArtifact` do not cover the following types: RelatedArtifact.\nThe mappings for `ResearchStudy.relatedArtifact` do not cover the following types based on type expansion: citation, display, document, resource, type, url.",
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.relatedArtifact|0.1.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.relatedArtifact.type",
"path": "ResearchStudy.relatedArtifact.type",
"short": "documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as",
"definition": "The type of relationship to the related artifact.",
"comment": "The presence of both sides of a relationship type (e.g. successor and predecessor) is required to support use cases where one side of a relationship is not represented in FHIR. However, this feature SHALL NOT be used to create bi-directional resource links in FHIR instances. Specifically, following the methodology of \"new points to old\" and \"many points to one\", when using related artifact elements to describe and reference FHIR resources, the type element SHALL be drawn from the fhir-related-artifact-type ValueSet.",
"min": 1,
"max": "1",
"base": {
"path": "RelatedArtifact.type",
"min": 1,
"max": "1"
},
"type": [
{
"code": "code"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "RelatedArtifactType"
}
],
"strength": "required",
"description": "The type of relationship to the related artifact.",
"valueSet": "http://hl7.org/fhir/ValueSet/related-artifact-type|5.0.0"
}
},
{
"id": "ResearchStudy.relatedArtifact.classifier",
"path": "ResearchStudy.relatedArtifact.classifier",
"short": "Additional classifiers",
"definition": "Provides additional classifiers of the related artifact.",
"min": 0,
"max": "*",
"base": {
"path": "RelatedArtifact.classifier",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "RelatedArtifactClassifier"
}
],
"strength": "example",
"description": "Additional classifiers for the related artifact.",
"valueSet": "http://hl7.org/fhir/ValueSet/citation-artifact-classifier|5.0.0"
}
},
{
"id": "ResearchStudy.relatedArtifact.label",
"path": "ResearchStudy.relatedArtifact.label",
"short": "Short label",
"definition": "A short label that can be used to reference the citation from elsewhere in the containing artifact, such as a footnote index.",
"min": 0,
"max": "1",
"base": {
"path": "RelatedArtifact.label",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchStudy.relatedArtifact.display",
"path": "ResearchStudy.relatedArtifact.display",
"short": "Brief description of the related artifact",
"definition": "A brief description of the document or knowledge resource being referenced, suitable for display to a consumer.",
"min": 0,
"max": "1",
"base": {
"path": "RelatedArtifact.display",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchStudy.relatedArtifact.citation",
"path": "ResearchStudy.relatedArtifact.citation",
"short": "Bibliographic citation for the artifact",
"definition": "A bibliographic citation for the related artifact. This text SHOULD be formatted according to an accepted citation format.",
"comment": "Additional structured information about citations should be captured as extensions.",
"min": 0,
"max": "1",
"base": {
"path": "RelatedArtifact.citation",
"min": 0,
"max": "1"
},
"type": [
{
"code": "markdown"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchStudy.relatedArtifact.document",
"path": "ResearchStudy.relatedArtifact.document",
"short": "What document is being referenced",
"definition": "The document being referenced, represented as an attachment. This is exclusive with the resource element.",
"min": 0,
"max": "1",
"base": {
"path": "RelatedArtifact.document",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Attachment"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchStudy.relatedArtifact.resource",
"path": "ResearchStudy.relatedArtifact.resource",
"short": "What artifact is being referenced",
"definition": "The related artifact, such as a library, value set, profile, or other knowledge resource.",
"comment": "If the type is predecessor, this is a reference to the succeeding knowledge resource. If the type is successor, this is a reference to the prior knowledge resource.",
"min": 0,
"max": "1",
"base": {
"path": "RelatedArtifact.resource",
"min": 0,
"max": "1"
},
"type": [
{
"code": "canonical",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Resource|5.0.0"
]
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchStudy.relatedArtifact.resourceReference",
"path": "ResearchStudy.relatedArtifact.resourceReference",
"short": "What artifact, if not a conformance resource",
"definition": "The related artifact, if the artifact is not a canonical resource, or a resource reference to a canonical resource.",
"comment": "If both resource and resourceReference are present, they SHOULD be consistent and reference the same resource. Although relatedArtifact is intended to support references to definitional resources, there are cases where non-definitional resources can be definitional (such as Location where the kind is mode). Related artifacts SHOULD be used to reference definitional resources, and profiles SHOULD be used to make that explicit for particular use cases.",
"min": 0,
"max": "1",
"base": {
"path": "RelatedArtifact.resourceReference",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Resource|5.0.0"
]
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchStudy.relatedArtifact.publicationStatus",
"path": "ResearchStudy.relatedArtifact.publicationStatus",
"short": "draft | active | retired | unknown",
"definition": "The publication status of the artifact being referred to.",
"min": 0,
"max": "1",
"base": {
"path": "RelatedArtifact.publicationStatus",
"min": 0,
"max": "1"
},
"type": [
{
"code": "code"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "RelatedArtifactPublicationStatus"
}
],
"strength": "required",
"description": "Publication status of an artifact being referred to.",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status|5.0.0"
}
},
{
"id": "ResearchStudy.relatedArtifact.publicationDate",
"path": "ResearchStudy.relatedArtifact.publicationDate",
"short": "Date of publication of the artifact being referred to",
"definition": "The date of publication of the artifact being referred to.",
"min": 0,
"max": "1",
"base": {
"path": "RelatedArtifact.publicationDate",
"min": 0,
"max": "1"
},
"type": [
{
"code": "date"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchStudy.date",
"path": "ResearchStudy.date",
"short": "Date the resource last changed",
"definition": "The date (and optionally time) when the ResearchStudy Resource was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changes.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.date",
"min": 0,
"max": "1"
},
"type": [
{
"code": "dateTime"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.status",
"path": "ResearchStudy.status",
"short": "draft | active | retired | unknown",
"definition": "The publication state of the resource (not of the study).",
"min": 1,
"max": "1",
"base": {
"path": "ResearchStudy.status",
"min": 1,
"max": "1"
},
"type": [
{
"code": "code"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": true,
"isModifierReason": "This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid",
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
}
],
"strength": "required",
"description": "Codes that convey the current publication status of the research study resource.",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status|5.0.0"
},
"mapping": [
{
"identity": "w5",
"map": "FiveWs.status"
},
{
"identity": "BRIDG5.1",
"map": "StudyOverallStatus.code"
},
{
"identity": "rim",
"map": ".status"
}
]
},
{
"id": "ResearchStudy.status.id",
"path": "ResearchStudy.status.id",
"representation": [
"xmlAttr"
],
"short": "xml:id (or equivalent in JSON)",
"definition": "unique id for the element within a resource (for internal references)",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.status.extension",
"path": "ResearchStudy.status.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.status.extension:status",
"path": "ResearchStudy.status.extension",
"sliceName": "status",
"short": "STU3: draft | in-progress | suspended | stopped | completed | entered-in-error additional codes",
"definition": "STU3: `ResearchStudy.status` additional codes",
"comment": "Element `ResearchStudy.status` is mapped to FHIR R5 element `ResearchStudy.status` as `RelatedTo`.\nThe mappings for `ResearchStudy.status` do not allow expression of the necessary codes, per the bindings on the source and target.\nThe target context `ResearchStudy.status` is a modifier element, so this extension does not need to be defined as a modifier.\nThis element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.",
"min": 0,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.status|0.1.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.status.value",
"path": "ResearchStudy.status.value",
"representation": [
"xmlAttr"
],
"short": "Primitive value for code",
"definition": "Primitive value for code",
"min": 0,
"max": "1",
"base": {
"path": "string.value",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "code"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/regex",
"valueString": "[^\\s]+( [^\\s]+)*"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.primaryPurposeType",
"path": "ResearchStudy.primaryPurposeType",
"short": "treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility",
"definition": "The type of study based upon the intent of the study activities. A classification of the intent of the study.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.primaryPurposeType",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyPrimaryPurposeType"
}
],
"strength": "preferred",
"description": "Codes for the main intent of the study.",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-prim-purp-type|5.0.0"
},
"mapping": [
{
"identity": "BRIDG5.1",
"map": "StudyProtocolVersion.primaryPurposeTypeCode"
}
]
},
{
"id": "ResearchStudy.phase",
"path": "ResearchStudy.phase",
"short": "n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4",
"definition": "The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.phase",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyPhase"
}
],
"strength": "example",
"description": "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-phase|5.0.0"
},
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Study Phase"
},
{
"identity": "BRIDG5.1",
"map": "StudyProtocolVersion.phaseCode"
}
]
},
{
"id": "ResearchStudy.studyDesign",
"path": "ResearchStudy.studyDesign",
"short": "Classifications of the study design characteristics",
"definition": "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.studyDesign",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "StudyDesign"
}
],
"strength": "preferred",
"description": "This is a set of terms for study design characteristics.",
"valueSet": "http://hl7.org/fhir/ValueSet/study-design|5.0.0"
},
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"
},
{
"identity": "BRIDG5.1",
"map": "InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"
}
]
},
{
"id": "ResearchStudy.focus",
"path": "ResearchStudy.focus",
"short": "Drugs, devices, etc. under study",
"definition": "The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.focus",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableReference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Medication|5.0.0",
"http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|5.0.0",
"http://hl7.org/fhir/StructureDefinition/SubstanceDefinition|5.0.0",
"http://hl7.org/fhir/StructureDefinition/EvidenceVariable|5.0.0"
]
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyFocusType"
}
],
"strength": "example",
"description": "Common codes of research study focus",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-focus-type|5.0.0"
}
},
{
"id": "ResearchStudy.condition",
"path": "ResearchStudy.condition",
"short": "Condition being studied",
"definition": "The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion \"healthy volunteer\", but the target condition code would be a Lupus SNOMED code.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.condition",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ConditionCode"
}
],
"strength": "example",
"description": "Identification of the condition or diagnosis.",
"valueSet": "http://hl7.org/fhir/ValueSet/condition-code|5.0.0"
},
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Conditions"
},
{
"identity": "w5",
"map": "FiveWs.what[x]"
},
{
"identity": "BRIDG5.1",
"map": "StudyCondition.code"
}
]
},
{
"id": "ResearchStudy.keyword",
"path": "ResearchStudy.keyword",
"short": "Used to search for the study",
"definition": "Key terms to aid in searching for or filtering the study.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.keyword",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyKeyword"
}
],
"strength": "example",
"description": "Words associated with the study that may be useful in discovery."
},
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Keywords"
},
{
"identity": "BRIDG5.1",
"map": "DocumentVersion.keywordCode; DocumentVersion.keywordText"
}
]
},
{
"id": "ResearchStudy.region",
"path": "ResearchStudy.region",
"short": "Geographic area for the study",
"definition": "A country, state or other area where the study is taking place rather than its precise geographic location or address.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.region",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Jurisdiction"
}
],
"strength": "extensible",
"description": "Countries and regions within which this artifact is targeted for use.",
"valueSet": "http://hl7.org/fhir/ValueSet/jurisdiction|5.0.0"
},
"mapping": [
{
"identity": "BRIDG5.1",
"map": "StudyProtocolVersion.participatingLocationCode"
}
]
},
{
"id": "ResearchStudy.descriptionSummary",
"path": "ResearchStudy.descriptionSummary",
"short": "Brief text explaining the study",
"definition": "A brief text for explaining the study.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.descriptionSummary",
"min": 0,
"max": "1"
},
"type": [
{
"code": "markdown"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.description",
"path": "ResearchStudy.description",
"short": "Detailed narrative of the study",
"definition": "A detailed and human-readable narrative of the study. E.g., study abstract.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.description",
"min": 0,
"max": "1"
},
"type": [
{
"code": "markdown"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Detailed Description"
},
{
"identity": "BRIDG5.1",
"map": "StudyProtocolDocumentVersion.publicDescription"
}
]
},
{
"id": "ResearchStudy.period",
"path": "ResearchStudy.period",
"short": "When the study began and ended",
"definition": "Identifies the start date and the expected (or actual, depending on status) end date for the study.",
"alias": [
"timing"
],
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.period",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Period"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Study Start Date (start); Study Completion Date (end)"
},
{
"identity": "w5",
"map": "FiveWs.done[x]"
},
{
"identity": "BRIDG5.1",
"map": "ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration"
},
{
"identity": "rim",
"map": ".effectiveTime"
}
]
},
{
"id": "ResearchStudy.period.id",
"path": "ResearchStudy.period.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": "ResearchStudy.period.extension",
"path": "ResearchStudy.period.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"ordered": false,
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.period.extension:period",
"path": "ResearchStudy.period.extension",
"sliceName": "period",
"short": "STU3: period additional types",
"definition": "STU3: `ResearchStudy.period` additional types (Period) additional types from child elements (end, start)",
"comment": "Element `ResearchStudy.period` is mapped to FHIR R5 element `ResearchStudy.period` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.period` do not cover the following types: Period.\nThe mappings for `ResearchStudy.period` do not cover the following types based on type expansion: end, start.",
"min": 0,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.period|0.1.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.period.start",
"path": "ResearchStudy.period.start",
"short": "Starting time with inclusive boundary",
"definition": "The start of the period. The boundary is inclusive.",
"comment": "If the low element is missing, the meaning is that the low boundary is not known.",
"min": 0,
"max": "1",
"base": {
"path": "Period.start",
"min": 0,
"max": "1"
},
"type": [
{
"code": "dateTime"
}
],
"condition": [
"per-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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "v2",
"map": "DR.1"
},
{
"identity": "rim",
"map": "./low"
}
]
},
{
"id": "ResearchStudy.period.end",
"path": "ResearchStudy.period.end",
"short": "End time with inclusive boundary, if not ongoing",
"definition": "The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.",
"comment": "The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.",
"min": 0,
"max": "1",
"base": {
"path": "Period.end",
"min": 0,
"max": "1"
},
"type": [
{
"code": "dateTime"
}
],
"meaningWhenMissing": "If the end of the period is missing, it means that the period is ongoing",
"condition": [
"per-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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "v2",
"map": "DR.2"
},
{
"identity": "rim",
"map": "./high"
}
]
},
{
"id": "ResearchStudy.site",
"path": "ResearchStudy.site",
"short": "Facility where study activities are conducted",
"definition": "A facility in which study activities are conducted.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.site",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Location|5.0.0",
"http://hl7.org/fhir/StructureDefinition/ResearchStudy|5.0.0",
"http://hl7.org/fhir/StructureDefinition/Organization|5.0.0"
]
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Facility"
},
{
"identity": "w5",
"map": "FiveWs.where[x]"
},
{
"identity": "BRIDG5.1",
"map": "PlannedStudySite; StudySite"
}
]
},
{
"id": "ResearchStudy.site.id",
"path": "ResearchStudy.site.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": "ResearchStudy.site.extension",
"path": "ResearchStudy.site.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"ordered": false,
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.site.extension:site",
"path": "ResearchStudy.site.extension",
"sliceName": "site",
"short": "STU3: Location involved in study execution additional types",
"definition": "STU3: `ResearchStudy.site` additional types from child elements (display, identifier, reference)",
"comment": "Element `ResearchStudy.site` is mapped to FHIR R5 element `ResearchStudy.site` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.site` do not cover the following types based on type expansion: display, identifier, reference.\nThe standard extension `alternate-reference` has been mapped as the representation of FHIR STU3 element `ResearchStudy.site` with unmapped reference targets: Location.",
"min": 0,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/StructureDefinition/alternate-reference|5.2.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.site.reference",
"path": "ResearchStudy.site.reference",
"short": "Literal reference, Relative, internal or absolute URL",
"definition": "A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.",
"comment": "Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure \"[type]/[id]\" then it should be assumed that the reference is to a FHIR RESTful server.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.reference",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ref-2",
"ref-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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.site.type",
"path": "ResearchStudy.site.type",
"short": "Type the reference refers to (e.g. \"Patient\") - must be a resource in resources",
"definition": "The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.\n\nThe type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. \"Patient\" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).",
"comment": "This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.type",
"min": 0,
"max": "1"
},
"type": [
{
"code": "uri"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "FHIRResourceTypeExt"
}
],
"strength": "extensible",
"description": "Aa resource (or, for logical models, the URI of the logical model).",
"valueSet": "http://hl7.org/fhir/ValueSet/resource-types|5.0.0"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.site.identifier",
"path": "ResearchStudy.site.identifier",
"short": "Logical reference, when literal reference is not known",
"definition": "An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.",
"comment": "When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. \n\nWhen both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference\n\nApplications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.\n\nReference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).\n\nThis element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.identifier",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Identifier"
}
],
"condition": [
"ref-2"
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": ".identifier"
}
]
},
{
"id": "ResearchStudy.site.display",
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}
],
"path": "ResearchStudy.site.display",
"short": "Text alternative for the resource",
"definition": "Plain text narrative that identifies the resource in addition to the resource reference.",
"comment": "This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.display",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ref-2"
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.note",
"path": "ResearchStudy.note",
"short": "Comments made about the study",
"definition": "Comments made about the study by the performer, subject or other participants.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.note",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Annotation"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "BRIDG5.1",
"map": "No BRIDG mapping"
},
{
"identity": "rim",
"map": ".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]"
}
]
},
{
"id": "ResearchStudy.note.id",
"path": "ResearchStudy.note.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": "ResearchStudy.note.extension",
"path": "ResearchStudy.note.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"ordered": false,
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.note.extension:note",
"path": "ResearchStudy.note.extension",
"sliceName": "note",
"short": "STU3: Comments made about the event additional types",
"definition": "STU3: `ResearchStudy.note` additional types (Annotation) additional types from child elements (author[x], text, time)",
"comment": "Element `ResearchStudy.note` is mapped to FHIR R5 element `ResearchStudy.note` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.note` do not cover the following types: Annotation.\nThe mappings for `ResearchStudy.note` do not cover the following types based on type expansion: author[x], text, time.",
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.note|0.1.0"
]
}
],
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.note.author[x]",
"path": "ResearchStudy.note.author[x]",
"short": "Individual responsible for the annotation",
"definition": "The individual responsible for making the annotation.",
"comment": "Organization is used when there's no need for specific attribution as to who made the comment.",
"min": 0,
"max": "1",
"base": {
"path": "Annotation.author[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Practitioner|5.0.0",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole|5.0.0",
"http://hl7.org/fhir/StructureDefinition/Patient|5.0.0",
"http://hl7.org/fhir/StructureDefinition/RelatedPerson|5.0.0",
"http://hl7.org/fhir/StructureDefinition/Organization|5.0.0"
]
},
{
"code": "string"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "v2",
"map": "N/A"
},
{
"identity": "rim",
"map": "Act.participant[typeCode=AUT].role"
}
]
},
{
"id": "ResearchStudy.note.time",
"path": "ResearchStudy.note.time",
"short": "When the annotation was made",
"definition": "Indicates when this particular annotation was made.",
"min": 0,
"max": "1",
"base": {
"path": "Annotation.time",
"min": 0,
"max": "1"
},
"type": [
{
"code": "dateTime"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "v2",
"map": "N/A"
},
{
"identity": "rim",
"map": "Act.effectiveTime"
}
]
},
{
"id": "ResearchStudy.note.text",
"path": "ResearchStudy.note.text",
"short": "The annotation - text content (as markdown)",
"definition": "The text of the annotation in markdown format.",
"min": 1,
"max": "1",
"base": {
"path": "Annotation.text",
"min": 1,
"max": "1"
},
"type": [
{
"code": "markdown"
}
],
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "v2",
"map": "N/A"
},
{
"identity": "rim",
"map": "Act.text"
}
]
},
{
"id": "ResearchStudy.classifier",
"path": "ResearchStudy.classifier",
"short": "Classification for the study",
"definition": "Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.classifier",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyClassifiers"
}
],
"strength": "example",
"description": "desc.",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-classifiers|5.0.0"
}
},
{
"id": "ResearchStudy.associatedParty",
"path": "ResearchStudy.associatedParty",
"short": "Sponsors, collaborators, and other parties",
"definition": "Sponsors, collaborators, and other parties.",
"comment": "For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.",
"requirements": "While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.associatedParty",
"min": 0,
"max": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.associatedParty.id",
"path": "ResearchStudy.associatedParty.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": "string"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchStudy.associatedParty.extension",
"path": "ResearchStudy.associatedParty.extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchStudy.associatedParty.modifierExtension",
"path": "ResearchStudy.associatedParty.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"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.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.associatedParty.name",
"path": "ResearchStudy.associatedParty.name",
"short": "Name of associated party",
"definition": "Name of associated party.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.associatedParty.name",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.associatedParty.role",
"path": "ResearchStudy.associatedParty.role",
"short": "sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair",
"definition": "Type of association.",
"min": 1,
"max": "1",
"base": {
"path": "ResearchStudy.associatedParty.role",
"min": 1,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyPartyRole"
}
],
"strength": "extensible",
"description": "desc.",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-party-role|5.0.0"
}
},
{
"id": "ResearchStudy.associatedParty.period",
"path": "ResearchStudy.associatedParty.period",
"short": "When active in the role",
"definition": "Identifies the start date and the end date of the associated party in the role.",
"comment": "The cardinality is 0..* due to the fact that an associated party may be intermittently active in a given role over multiple time periods.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.associatedParty.period",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Period"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.associatedParty.classifier",
"path": "ResearchStudy.associatedParty.classifier",
"short": "nih | fda | government | nonprofit | academic | industry",
"definition": "A categorization other than role for the associated party.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.associatedParty.classifier",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyPartyOrganizationType"
}
],
"strength": "example",
"description": "A characterization or type of the entity.",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-party-organization-type|5.0.0"
}
},
{
"id": "ResearchStudy.associatedParty.party",
"path": "ResearchStudy.associatedParty.party",
"short": "Individual or organization associated with study (use practitionerRole to specify their organisation)",
"definition": "Individual or organization associated with study (use practitionerRole to specify their organisation).",
"comment": "Suggestions of a better attribute name are appreciated",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.associatedParty.party",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Practitioner|5.0.0",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole|5.0.0",
"http://hl7.org/fhir/StructureDefinition/Organization|5.0.0"
]
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.progressStatus",
"path": "ResearchStudy.progressStatus",
"short": "Status of study with time for that status",
"definition": "Status of study with time for that status.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.progressStatus",
"min": 0,
"max": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.progressStatus.id",
"path": "ResearchStudy.progressStatus.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": "string"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchStudy.progressStatus.extension",
"path": "ResearchStudy.progressStatus.extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchStudy.progressStatus.modifierExtension",
"path": "ResearchStudy.progressStatus.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"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.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.progressStatus.state",
"path": "ResearchStudy.progressStatus.state",
"short": "Label for status or state (e.g. recruitment status)",
"definition": "Label for status or state (e.g. recruitment status).",
"min": 1,
"max": "1",
"base": {
"path": "ResearchStudy.progressStatus.state",
"min": 1,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyStudyStatus"
}
],
"strength": "extensible",
"description": "defn.",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-status|5.0.0"
}
},
{
"id": "ResearchStudy.progressStatus.actual",
"path": "ResearchStudy.progressStatus.actual",
"short": "Actual if true else anticipated",
"definition": "An indication of whether or not the date is a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated date.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.progressStatus.actual",
"min": 0,
"max": "1"
},
"type": [
{
"code": "boolean"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.progressStatus.period",
"path": "ResearchStudy.progressStatus.period",
"short": "Date range",
"definition": "Date range.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.progressStatus.period",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Period"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.whyStopped",
"path": "ResearchStudy.whyStopped",
"short": "accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design",
"definition": "A description and/or code explaining the premature termination of the study.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.whyStopped",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyReasonStopped"
}
],
"strength": "example",
"description": "Codes for why the study ended prematurely.",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-reason-stopped|5.0.0"
},
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Why Study Stopped"
},
{
"identity": "w5",
"map": "FiveWs.why[x]"
},
{
"identity": "BRIDG5.1",
"map": "StudyOverallStatus.studyStoppedReasonCode"
}
]
},
{
"id": "ResearchStudy.recruitment",
"path": "ResearchStudy.recruitment",
"short": "Target or actual group of participants enrolled in study",
"definition": "Target or actual group of participants enrolled in study.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.recruitment",
"min": 0,
"max": "1"
},
"type": [
{
"code": "BackboneElement"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"
},
{
"identity": "w5",
"map": "FiveWs.subject[x]"
},
{
"identity": "BRIDG5.1",
"map": "InterventionalStudyProtocol.interventionGroupQuantity"
},
{
"identity": "rim",
"map": ".participation[typeCode=SBJ].role"
}
]
},
{
"id": "ResearchStudy.recruitment.id",
"path": "ResearchStudy.recruitment.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": "string"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchStudy.recruitment.extension",
"path": "ResearchStudy.recruitment.extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchStudy.recruitment.modifierExtension",
"path": "ResearchStudy.recruitment.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"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.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.recruitment.targetNumber",
"path": "ResearchStudy.recruitment.targetNumber",
"short": "Estimated total number of participants to be enrolled",
"definition": "Estimated total number of participants to be enrolled.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.recruitment.targetNumber",
"min": 0,
"max": "1"
},
"type": [
{
"code": "unsignedInt"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.recruitment.actualNumber",
"path": "ResearchStudy.recruitment.actualNumber",
"short": "Actual total number of participants enrolled in study",
"definition": "Actual total number of participants enrolled in study.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.recruitment.actualNumber",
"min": 0,
"max": "1"
},
"type": [
{
"code": "unsignedInt"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.recruitment.eligibility",
"path": "ResearchStudy.recruitment.eligibility",
"short": "Inclusion and exclusion criteria",
"definition": "Inclusion and exclusion criteria.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.recruitment.eligibility",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Group|5.0.0",
"http://hl7.org/fhir/StructureDefinition/EvidenceVariable|5.0.0"
]
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.recruitment.actualGroup",
"path": "ResearchStudy.recruitment.actualGroup",
"short": "Group of participants who were enrolled in study",
"definition": "Group of participants who were enrolled in study.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.recruitment.actualGroup",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Group|5.0.0"
]
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"
},
{
"identity": "w5",
"map": "FiveWs.subject[x]"
},
{
"identity": "BRIDG5.1",
"map": "InterventionalStudyProtocol.interventionGroupQuantity"
},
{
"identity": "rim",
"map": ".participation[typeCode=SBJ].role"
}
]
},
{
"id": "ResearchStudy.comparisonGroup",
"path": "ResearchStudy.comparisonGroup",
"short": "Defined path through the study for a subject",
"definition": "Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}.",
"comment": "In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups.",
"alias": [
"arm"
],
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.comparisonGroup",
"min": 0,
"max": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Arms"
},
{
"identity": "BRIDG5.1",
"map": "Arm"
}
]
},
{
"id": "ResearchStudy.comparisonGroup.id",
"path": "ResearchStudy.comparisonGroup.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": "string"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchStudy.comparisonGroup.extension",
"path": "ResearchStudy.comparisonGroup.extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchStudy.comparisonGroup.modifierExtension",
"path": "ResearchStudy.comparisonGroup.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"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.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.comparisonGroup.linkId",
"path": "ResearchStudy.comparisonGroup.linkId",
"short": "Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily",
"definition": "Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.comparisonGroup.linkId",
"min": 0,
"max": "1"
},
"type": [
{
"code": "id"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.comparisonGroup.name",
"path": "ResearchStudy.comparisonGroup.name",
"short": "Label for study comparisonGroup",
"definition": "Unique, human-readable label for this comparisonGroup of the study.",
"min": 1,
"max": "1",
"base": {
"path": "ResearchStudy.comparisonGroup.name",
"min": 1,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Arm Label"
},
{
"identity": "BRIDG5.1",
"map": "Arm.name"
}
]
},
{
"id": "ResearchStudy.comparisonGroup.type",
"path": "ResearchStudy.comparisonGroup.type",
"short": "Categorization of study comparisonGroup",
"definition": "Categorization of study comparisonGroup, e.g. experimental, active comparator, placebo comparater.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.comparisonGroup.type",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyArmType"
}
],
"strength": "extensible",
"description": "desc.",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-arm-type|5.0.0"
},
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Arm Type"
},
{
"identity": "BRIDG5.1",
"map": "Arm.typeCode"
}
]
},
{
"id": "ResearchStudy.comparisonGroup.description",
"path": "ResearchStudy.comparisonGroup.description",
"short": "Short explanation of study path",
"definition": "A succinct description of the path through the study that would be followed by a subject adhering to this comparisonGroup.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.comparisonGroup.description",
"min": 0,
"max": "1"
},
"type": [
{
"code": "markdown"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "clinicaltrials-gov",
"map": "Arm Description"
},
{
"identity": "BRIDG5.1",
"map": "Arm.description"
}
]
},
{
"id": "ResearchStudy.comparisonGroup.intendedExposure",
"path": "ResearchStudy.comparisonGroup.intendedExposure",
"short": "Interventions or exposures in this comparisonGroup or cohort",
"definition": "Interventions or exposures in this comparisonGroup or cohort.",
"requirements": "this is necessary for ClinicalTrials.gov use which relates 1 to many interventions to comparisonGroups (aka arms)",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.comparisonGroup.intendedExposure",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/EvidenceVariable|5.0.0"
]
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.comparisonGroup.observedGroup",
"path": "ResearchStudy.comparisonGroup.observedGroup",
"short": "Group of participants who were enrolled in study comparisonGroup",
"definition": "Group of participants who were enrolled in study comparisonGroup.",
"requirements": "This is necessary to relate comparisonGroups to actual groups",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.comparisonGroup.observedGroup",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Group|5.0.0"
]
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.objective",
"path": "ResearchStudy.objective",
"short": "A goal for the study",
"definition": "A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.objective",
"min": 0,
"max": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "BRIDG5.1",
"map": "StudyObjective"
}
]
},
{
"id": "ResearchStudy.objective.id",
"path": "ResearchStudy.objective.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": "string"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchStudy.objective.extension",
"path": "ResearchStudy.objective.extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchStudy.objective.modifierExtension",
"path": "ResearchStudy.objective.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"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.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.objective.name",
"path": "ResearchStudy.objective.name",
"short": "Label for the objective",
"definition": "Unique, human-readable label for this objective of the study.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.objective.name",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "BRIDG5.1",
"map": "No BRIDG mapping (BRIDG has a description, but not a name)"
}
]
},
{
"id": "ResearchStudy.objective.type",
"path": "ResearchStudy.objective.type",
"short": "primary | secondary | exploratory",
"definition": "The kind of study objective.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.objective.type",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyObjectiveType"
}
],
"strength": "preferred",
"description": "Codes for the kind of study objective.",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-objective-type|5.0.0"
},
"mapping": [
{
"identity": "BRIDG5.1",
"map": "StudyObjective.typeCode"
}
]
},
{
"id": "ResearchStudy.objective.description",
"path": "ResearchStudy.objective.description",
"short": "Description of the objective",
"definition": "Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description).",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.objective.description",
"min": 0,
"max": "1"
},
"type": [
{
"code": "markdown"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.outcomeMeasure",
"path": "ResearchStudy.outcomeMeasure",
"short": "A variable measured during the study",
"definition": "An \"outcome measure\", \"endpoint\", \"effect measure\" or \"measure of effect\" is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.",
"comment": "A study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.outcomeMeasure",
"min": 0,
"max": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.outcomeMeasure.id",
"path": "ResearchStudy.outcomeMeasure.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": "string"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchStudy.outcomeMeasure.extension",
"path": "ResearchStudy.outcomeMeasure.extension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchStudy.outcomeMeasure.modifierExtension",
"path": "ResearchStudy.outcomeMeasure.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"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.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"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|5.0.0"
},
{
"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|5.0.0"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchStudy.outcomeMeasure.name",
"path": "ResearchStudy.outcomeMeasure.name",
"short": "Label for the outcome",
"definition": "Label for the outcome.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.outcomeMeasure.name",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.outcomeMeasure.type",
"path": "ResearchStudy.outcomeMeasure.type",
"short": "primary | secondary | exploratory",
"definition": "The parameter or characteristic being assessed as one of the values by which the study is assessed.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.outcomeMeasure.type",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyObjectiveType"
}
],
"strength": "preferred",
"description": "defn.",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-objective-type|5.0.0"
}
},
{
"id": "ResearchStudy.outcomeMeasure.description",
"path": "ResearchStudy.outcomeMeasure.description",
"short": "Description of the outcome",
"definition": "Description of the outcome.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.outcomeMeasure.description",
"min": 0,
"max": "1"
},
"type": [
{
"code": "markdown"
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.outcomeMeasure.reference",
"path": "ResearchStudy.outcomeMeasure.reference",
"short": "Structured outcome definition",
"definition": "Structured outcome definition.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchStudy.outcomeMeasure.reference",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/EvidenceVariable|5.0.0"
]
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchStudy.result",
"path": "ResearchStudy.result",
"short": "Link to results generated during the study",
"definition": "Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov.",
"min": 0,
"max": "*",
"base": {
"path": "ResearchStudy.result",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/EvidenceReport|5.0.0",
"http://hl7.org/fhir/StructureDefinition/Citation|5.0.0",
"http://hl7.org/fhir/StructureDefinition/DiagnosticReport|5.0.0"
]
}
],
"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|5.0.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true
}
]
},
"differential": {
"element": [
{
"id": "ResearchStudy",
"path": "ResearchStudy"
},
{
"id": "ResearchStudy.meta.extension",
"path": "ResearchStudy.meta.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 0,
"max": "*"
},
{
"id": "ResearchStudy.meta.extension:meta",
"path": "ResearchStudy.meta.extension",
"sliceName": "meta",
"short": "STU3: meta additional types",
"definition": "STU3: `ResearchStudy.meta` additional types (Meta) additional types from child elements (lastUpdated, profile, security, tag, versionId)",
"comment": "Element `ResearchStudy.meta` is mapped to FHIR R5 element `ResearchStudy.meta` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.meta` do not cover the following types: Meta.\nThe mappings for `ResearchStudy.meta` do not cover the following types based on type expansion: lastUpdated, profile, security, tag, versionId.",
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.meta|0.1.0"
]
}
]
},
{
"id": "ResearchStudy.text.extension",
"path": "ResearchStudy.text.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 0,
"max": "*"
},
{
"id": "ResearchStudy.text.extension:text",
"path": "ResearchStudy.text.extension",
"sliceName": "text",
"short": "STU3: text additional types",
"definition": "STU3: `ResearchStudy.text` additional types (Narrative) additional types from child elements (div, status)",
"comment": "Element `ResearchStudy.text` is mapped to FHIR R5 element `ResearchStudy.text` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.text` do not cover the following types: Narrative.\nThe mappings for `ResearchStudy.text` do not cover the following types based on type expansion: div, status.\nContained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded in formation is added later.",
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.text|0.1.0"
]
}
]
},
{
"id": "ResearchStudy.extension",
"path": "ResearchStudy.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 0,
"max": "*"
},
{
"id": "ResearchStudy.extension:category",
"path": "ResearchStudy.extension",
"sliceName": "category",
"short": "STU3: Classifications for the study (new)",
"definition": "STU3: `ResearchStudy.category` (new:CodeableConcept)",
"comment": "Element `ResearchStudy.category` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.\nElement `ResearchStudy.category` has no mapping targets in FHIR R5. Typically, this is because the element has been added (is a new element).",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.category|0.1.0"
]
}
]
},
{
"id": "ResearchStudy.extension:contact",
"path": "ResearchStudy.extension",
"sliceName": "contact",
"short": "STU3: Contact details for the study (new)",
"definition": "STU3: `ResearchStudy.contact` (new:ContactDetail)",
"comment": "Element `ResearchStudy.contact` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.\nElement `ResearchStudy.contact` has no mapping targets in FHIR R5. Typically, this is because the element has been added (is a new element).",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.contact|0.1.0"
]
}
]
},
{
"id": "ResearchStudy.extension:jurisdiction",
"path": "ResearchStudy.extension",
"sliceName": "jurisdiction",
"short": "STU3: Geographic region(s) for study (new)",
"definition": "STU3: `ResearchStudy.jurisdiction` (new:CodeableConcept)",
"comment": "Element `ResearchStudy.jurisdiction` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.\nElement `ResearchStudy.jurisdiction` has no mapping targets in FHIR R5. Typically, this is because the element has been added (is a new element).",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.jurisdiction|0.1.0"
]
}
]
},
{
"id": "ResearchStudy.extension:enrollment",
"path": "ResearchStudy.extension",
"sliceName": "enrollment",
"short": "STU3: Inclusion & exclusion criteria (new)",
"definition": "STU3: `ResearchStudy.enrollment` (new:Reference(Group))",
"comment": "Element `ResearchStudy.enrollment` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.\nElement `ResearchStudy.enrollment` has no mapping targets in FHIR R5. Typically, this is because the element has been added (is a new element).\nThe Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.enrollment|0.1.0"
]
}
]
},
{
"id": "ResearchStudy.extension:sponsor",
"path": "ResearchStudy.extension",
"sliceName": "sponsor",
"short": "STU3: Organization responsible for the study (new)",
"definition": "STU3: `ResearchStudy.sponsor` (new:Reference(Organization))",
"comment": "Element `ResearchStudy.sponsor` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.\nElement `ResearchStudy.sponsor` has no mapping targets in FHIR R5. Typically, this is because the element has been added (is a new element).",
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.sponsor|0.1.0"
]
}
]
},
{
"id": "ResearchStudy.extension:principalInvestigator",
"path": "ResearchStudy.extension",
"sliceName": "principalInvestigator",
"short": "STU3: The individual responsible for the study (new)",
"definition": "STU3: `ResearchStudy.principalInvestigator` (new:Reference(Practitioner))",
"comment": "Element `ResearchStudy.principalInvestigator` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.\nElement `ResearchStudy.principalInvestigator` has no mapping targets in FHIR R5. Typically, this is because the element has been added (is a new element).",
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.principalInvestigator|0.1.0"
]
}
]
},
{
"id": "ResearchStudy.extension:reasonStopped",
"path": "ResearchStudy.extension",
"sliceName": "reasonStopped",
"short": "STU3: Reason for terminating study early (new)",
"definition": "STU3: `ResearchStudy.reasonStopped` (new:CodeableConcept)",
"comment": "Element `ResearchStudy.reasonStopped` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.\nElement `ResearchStudy.reasonStopped` has no mapping targets in FHIR R5. Typically, this is because the element has been added (is a new element).",
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.reasonStopped|0.1.0"
]
}
]
},
{
"id": "ResearchStudy.identifier.extension",
"path": "ResearchStudy.identifier.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 0,
"max": "*"
},
{
"id": "ResearchStudy.identifier.extension:identifier",
"path": "ResearchStudy.identifier.extension",
"sliceName": "identifier",
"short": "STU3: identifier additional types",
"definition": "STU3: `ResearchStudy.identifier` additional types (Identifier) additional types from child elements (assigner, period, system, type, use, value)",
"comment": "Element `ResearchStudy.identifier` is mapped to FHIR R5 element `ResearchStudy.identifier` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.identifier` do not cover the following types: Identifier.\nThe mappings for `ResearchStudy.identifier` do not cover the following types based on type expansion: assigner, period, system, type, use, value.",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.identifier|0.1.0"
]
}
]
},
{
"id": "ResearchStudy.protocol.extension",
"path": "ResearchStudy.protocol.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 0,
"max": "*"
},
{
"id": "ResearchStudy.protocol.extension:protocol",
"path": "ResearchStudy.protocol.extension",
"sliceName": "protocol",
"short": "STU3: protocol additional types",
"definition": "STU3: `ResearchStudy.protocol` additional types from child elements (display, identifier, reference)",
"comment": "Element `ResearchStudy.protocol` is mapped to FHIR R5 element `ResearchStudy.protocol` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.protocol` do not cover the following types based on type expansion: display, identifier, reference.\nThe standard extension `alternate-reference` has been mapped as the representation of FHIR STU3 element `ResearchStudy.protocol` with unmapped reference targets: PlanDefinition.",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/StructureDefinition/alternate-reference|5.2.0"
]
}
]
},
{
"id": "ResearchStudy.partOf.extension",
"path": "ResearchStudy.partOf.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 0,
"max": "*"
},
{
"id": "ResearchStudy.partOf.extension:partOf",
"path": "ResearchStudy.partOf.extension",
"sliceName": "partOf",
"short": "STU3: partOf additional types",
"definition": "STU3: `ResearchStudy.partOf` additional types from child elements (display, identifier, reference)",
"comment": "Element `ResearchStudy.partOf` is mapped to FHIR R5 element `ResearchStudy.partOf` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.partOf` do not cover the following types based on type expansion: display, identifier, reference.\nThe standard extension `alternate-reference` has been mapped as the representation of FHIR STU3 element `ResearchStudy.partOf` with unmapped reference targets: ResearchStudy.",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/StructureDefinition/alternate-reference|5.2.0"
]
}
]
},
{
"id": "ResearchStudy.relatedArtifact.extension",
"path": "ResearchStudy.relatedArtifact.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 0,
"max": "*"
},
{
"id": "ResearchStudy.relatedArtifact.extension:relatedArtifact",
"path": "ResearchStudy.relatedArtifact.extension",
"sliceName": "relatedArtifact",
"short": "STU3: References and dependencies additional types",
"definition": "STU3: `ResearchStudy.relatedArtifact` additional types (RelatedArtifact) additional types from child elements (citation, display, document, resource, type, url)",
"comment": "Element `ResearchStudy.relatedArtifact` is mapped to FHIR R5 element `ResearchStudy.relatedArtifact` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.relatedArtifact` do not cover the following types: RelatedArtifact.\nThe mappings for `ResearchStudy.relatedArtifact` do not cover the following types based on type expansion: citation, display, document, resource, type, url.",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.relatedArtifact|0.1.0"
]
}
]
},
{
"id": "ResearchStudy.status.extension",
"path": "ResearchStudy.status.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 0,
"max": "*"
},
{
"id": "ResearchStudy.status.extension:status",
"path": "ResearchStudy.status.extension",
"sliceName": "status",
"short": "STU3: draft | in-progress | suspended | stopped | completed | entered-in-error additional codes",
"definition": "STU3: `ResearchStudy.status` additional codes",
"comment": "Element `ResearchStudy.status` is mapped to FHIR R5 element `ResearchStudy.status` as `RelatedTo`.\nThe mappings for `ResearchStudy.status` do not allow expression of the necessary codes, per the bindings on the source and target.\nThe target context `ResearchStudy.status` is a modifier element, so this extension does not need to be defined as a modifier.\nThis element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.",
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.status|0.1.0"
]
}
]
},
{
"id": "ResearchStudy.period.extension",
"path": "ResearchStudy.period.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 0,
"max": "*"
},
{
"id": "ResearchStudy.period.extension:period",
"path": "ResearchStudy.period.extension",
"sliceName": "period",
"short": "STU3: period additional types",
"definition": "STU3: `ResearchStudy.period` additional types (Period) additional types from child elements (end, start)",
"comment": "Element `ResearchStudy.period` is mapped to FHIR R5 element `ResearchStudy.period` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.period` do not cover the following types: Period.\nThe mappings for `ResearchStudy.period` do not cover the following types based on type expansion: end, start.",
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.period|0.1.0"
]
}
]
},
{
"id": "ResearchStudy.site.extension",
"path": "ResearchStudy.site.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 0,
"max": "*"
},
{
"id": "ResearchStudy.site.extension:site",
"path": "ResearchStudy.site.extension",
"sliceName": "site",
"short": "STU3: Location involved in study execution additional types",
"definition": "STU3: `ResearchStudy.site` additional types from child elements (display, identifier, reference)",
"comment": "Element `ResearchStudy.site` is mapped to FHIR R5 element `ResearchStudy.site` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.site` do not cover the following types based on type expansion: display, identifier, reference.\nThe standard extension `alternate-reference` has been mapped as the representation of FHIR STU3 element `ResearchStudy.site` with unmapped reference targets: Location.",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/StructureDefinition/alternate-reference|5.2.0"
]
}
]
},
{
"id": "ResearchStudy.note.extension",
"path": "ResearchStudy.note.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 0,
"max": "*"
},
{
"id": "ResearchStudy.note.extension:note",
"path": "ResearchStudy.note.extension",
"sliceName": "note",
"short": "STU3: Comments made about the event additional types",
"definition": "STU3: `ResearchStudy.note` additional types (Annotation) additional types from child elements (author[x], text, time)",
"comment": "Element `ResearchStudy.note` is mapped to FHIR R5 element `ResearchStudy.note` as `SourceIsBroaderThanTarget`.\nThe mappings for `ResearchStudy.note` do not cover the following types: Annotation.\nThe mappings for `ResearchStudy.note` do not cover the following types based on type expansion: author[x], text, time.",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.note|0.1.0"
]
}
]
}
]
}
}