profile-ResearchSubject
type: StructureDefinition
node role: treeRoot
id:
  v: profile-ResearchSubject
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: StructureDefinition profile-ResearchSubject Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> ResearchSubject 0..* ResearchSubject(4.0.1) Physical entity which is the primary unit of interest in the study #xD; status #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:status 0..1 code STU3: candidate | enrolled | active | suspended | withdrawn | completed additional codes URL: http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchSubject.status Binding: R3ResearchSubjectStatusForR4 (0.1.0) (required): Indicates the progression of a study subject through a study #xD; <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
    l: structuredefinition-wg
  value: Code
    v: fhir
extension:
  extension:
    url:
      v: packageId
      l: packageId
    value: Id
      v: hl7.fhir.uv.xver-r3.r4
  extension:
    url:
      v: version
      l: version
    value: String
      v: 0.1.0
  url:
    v: http://hl7.org/fhir/StructureDefinition/package-source
    l: package-source
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm
    l: structuredefinition-fmm
  value: Integer
    v: 0
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom
        l: structuredefinition-conformance-derivedFrom
      value: Canonical
        v: http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r3.r4
        l: hl7.fhir.uv.xver-r3.r4
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
    l: structuredefinition-standards-status
  value: Code
    v: trial-use
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom
        l: structuredefinition-conformance-derivedFrom
      value: Canonical
        v: http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r3.r4
        l: hl7.fhir.uv.xver-r3.r4
url:
  v: http://hl7.org/fhir/3.0/StructureDefinition/profile-ResearchSubject
  l: profile-ResearchSubject
version:
  v: 0.1.0
name:
  v: Profile_R3_ResearchSubject_R4
title:
  v: Cross-version Profile for STU3.ResearchSubject for use in FHIR R4
status:
  v: active
experimental:
  v: false
date:
  v: 2026-03-17T16:03:23.0913059-05:00
publisher:
  v: FHIR Infrastructure
contact:
  name:
    v: FHIR Infrastructure
  telecom:
    system:
      v: url
    value:
      v: http://www.hl7.org/Special/committees/fiwg
description:
  v: This cross-version profile allows STU3 ResearchSubject content to be represented via FHIR R4 ResearchSubject resources.
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 001
    display:
      v: World
fhir version:
  v: 4.0.1
mapping:
  identity:
    v: BRIDG5.1
  uri:
    v: https://bridgmodel.nci.nih.gov
    l: bridgmodel.nci.nih.gov
  name:
    v: BRIDG 5.1 Mapping
mapping:
  identity:
    v: v2
  uri:
    v: http://hl7.org/v2
    l: v2
  name:
    v: HL7 v2 Mapping
mapping:
  identity:
    v: rim
  uri:
    v: http://hl7.org/v3
    l: v3
  name:
    v: RIM Mapping
mapping:
  identity:
    v: w5
  uri:
    v: http://hl7.org/fhir/fivews
    l: fivews
  name:
    v: FiveWs Pattern Mapping
kind:
  v: resource
abstract:
  v: false
type:
  v: ResearchSubject
  l: ResearchSubject
base definition:
  v: http://hl7.org/fhir/StructureDefinition/ResearchSubject|4.0.1
  l: http://hl7.org/fhir/StructureDefinition/ResearchSubject
derivation:
  v: constraint
snapshot:
  extension:
    url:
      v: http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version
      l: snapshot-base-version
    value: String
      v: 4.0.1
  element:
    id:
      v: ResearchSubject
    path:
      v: ResearchSubject
    short:
      v: Physical entity which is the primary unit of interest in the study
    definition:
      v: A physical entity which is the primary unit of operational and/or administrative interest in a study.
    comment:
      v: Need to make sure we encompass public health studies.
    alias:
      v: Study Subject
    min:
      v: 0
    max:
      v: *
    base:
      path:
        v: ResearchSubject
      min:
        v: 0
      max:
        v: *
    constraint:
      key:
        v: dom-2
      severity:
        v: error
      human:
        v: If the resource is contained in another resource, it SHALL NOT contain nested Resources
      expression:
        v: contained.contained.empty()
      xpath:
        v: not(parent::f:contained and f:contained)
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource|4.0.1
        l: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-3
      severity:
        v: error
      human:
        v: 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:
        v: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
      xpath:
        v: not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource|4.0.1
        l: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-4
      severity:
        v: error

v: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated

v: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()

v: not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))

key:
  v: dom-5
severity:
  v: error
human:
  v: If a resource is contained in another resource, it SHALL NOT have a security label
expression:
  v: contained.meta.security.empty()
xpath:
  v: not(exists(f:contained/*/f:meta/f:security))
source:
  v: http://hl7.org/fhir/StructureDefinition/DomainResource|4.0.1
  l: http://hl7.org/fhir/StructureDefinition/DomainResource

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice
    l: elementdefinition-bestpractice
  value: Boolean
    v: true
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation
    l: elementdefinition-bestpractice-explanation
  value: Markdown
    v: 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:
  v: dom-6
severity:
  v: warning
human:
  v: A resource should have narrative for robust management
expression:
  v: text.`div`.exists()
xpath:
  v: exists(f:text/h:div)
source:
  v: http://hl7.org/fhir/StructureDefinition/DomainResource|4.0.1
  l: http://hl7.org/fhir/StructureDefinition/DomainResource

v: false

v: false

identity:
  v: rim
map:
  v: Entity. Role, or Act

identity:
  v: BRIDG5.1
map:
  v: StudySubject

identity:
  v: v2
map:
  v: OBX

identity:
  v: rim
map:
  v: Observation[classCode=CLNTRL, moodCode=EVN]

id:
  v: ResearchSubject.id
path:
  v: ResearchSubject.id
short:
  v: Logical id of this artifact
definition:
  v: The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
comment:
  v: The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: id
      l: id
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
is modifier:
  v: false
is summary:
  v: true

id:
  v: ResearchSubject.meta
path:
  v: ResearchSubject.meta
short:
  v: Metadata about the resource
definition:
  v: 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:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.meta
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Meta
    l: Meta
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true

id:
  v: ResearchSubject.implicitRules
path:
  v: ResearchSubject.implicitRules
short:
  v: A set of rules under which this content was created
definition:
  v: 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:
  v: 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 it's narrative along with other profiles, value sets, etc.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.implicitRules
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
is summary:
  v: true

id:
  v: ResearchSubject.language
path:
  v: ResearchSubject.language
short:
  v: Language of the resource content
definition:
  v: The base language in which the resource is written.
comment:
  v: 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:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.language
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
    l: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet
      l: elementdefinition-maxValueSet
    value: Canonical
      v: http://hl7.org/fhir/ValueSet/all-languages|4.0.1
      l: http://hl7.org/fhir/ValueSet/all-languages
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: Language
  strength:
    v: preferred
  description:
    v: A human language.
  value set:
    v: http://hl7.org/fhir/ValueSet/languages|4.0.1
    l: http://hl7.org/fhir/ValueSet/languages

id:
  v: ResearchSubject.text
path:
  v: ResearchSubject.text
short:
  v: Text summary of the resource, for human interpretation
definition:
  v: 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:
  v: Contained 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 information is added later.
alias:
  v: narrative
alias:
  v: html
alias:
  v: xhtml
alias:
  v: display
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Narrative
    l: Narrative
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: Act.text?

id:
  v: ResearchSubject.contained
path:
  v: ResearchSubject.contained
short:
  v: Contained, inline Resources
definition:
  v: These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
comment:
  v: 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:
  v: inline resources
alias:
  v: anonymous resources
alias:
  v: contained resources
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.contained
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Resource
    l: Resource
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchSubject.extension
path:
  v: ResearchSubject.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, 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:
  v: 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:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchSubject.modifierExtension
path:
  v: ResearchSubject.modifierExtension
short:
  v: Extensions that cannot be ignored
definition:
  v: 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 manageable, 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: 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:
  v: 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/R4/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchSubject.identifier
path:
  v: ResearchSubject.identifier
short:
  v: Business Identifier for research subject in a study
definition:
  v: Identifiers assigned to this research subject for a study.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchSubject.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Identifier
    l: Identifier
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.identifier
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudySubject > Subject.identifier
mapping:
  identity:
    v: rim
  map:
    v: .identifier

id:
  v: ResearchSubject.status
path:
  v: ResearchSubject.status
short:
  v: candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
definition:
  v: The current state of the subject.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchSubject.status
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: code
    l: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: 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
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchSubjectStatus
  strength:
    v: required
  description:
    v: Indicates the progression of a study subject through a study.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1
    l: http://hl7.org/fhir/ValueSet/research-subject-status
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.status
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudySubject.statusCode
mapping:
  identity:
    v: rim
  map:
    v: .status

id:
  v: ResearchSubject.status.id
path:
  v: ResearchSubject.status.id
representation:
  v: xmlAttr
short:
  v: xml:id (or equivalent in JSON)
definition:
  v: unique id for the element within a resource (for internal references)
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchSubject.status.extension
path:
  v: ResearchSubject.status.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  ordered:
    v: false
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
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    v: 0
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    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
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  source:
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    l: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchSubject.status.extension:status
path:
  v: ResearchSubject.status.extension
slice name:
  v: status
short:
  v: STU3: candidate | enrolled | active | suspended | withdrawn | completed additional codes
definition:
  v: STU3: `ResearchSubject.status` additional codes
comment:
  v: Element `ResearchSubject.status` is mapped to FHIR R4 element `ResearchSubject.status` as `RelatedTo`. The mappings for `ResearchSubject.status` do not allow expression of the necessary codes, per the bindings on the source and target. The target context `ResearchSubject.status` is a modifier element, so this extension does not need to be defined as a modifier. This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.
min:
  v: 0
max:
  v: 1
base:
  path:
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type:
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    v: Extension
    l: Extension
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    v: http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchSubject.status|0.1.0
    l: http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchSubject.status
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchSubject.status.value
path:
  v: ResearchSubject.status.value
representation:
  v: xmlAttr
short:
  v: Primitive value for code
definition:
  v: Primitive value for code
min:
  v: 0
max:
  v: 1
base:
  path:
    v: string.value
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/regex
      l: regex
    value: String
      v: [^\s]+(\s[^\s]+)*
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchSubject.period
path:
  v: ResearchSubject.period
short:
  v: Start and end of participation
definition:
  v: The dates the subject began and ended their participation in the study.
alias:
  v: timing
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchSubject.period
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Period
    l: Period
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.planned
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: PerformedStudySubjectMilestone.studyReferenceDateRange

id:
  v: ResearchSubject.study
path:
  v: ResearchSubject.study
short:
  v: Study subject is part of
definition:
  v: Reference to the study the subject is participating in.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchSubject.study
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/ResearchStudy|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/ResearchStudy
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudySubjectProtocolVersionRelationship

id:
  v: ResearchSubject.individual
path:
  v: ResearchSubject.individual
short:
  v: Who is part of study
definition:
  v: The record of the person or animal who is involved in the study.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchSubject.individual
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Patient|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Patient
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudySubject

id:
  v: ResearchSubject.assignedArm
path:
  v: ResearchSubject.assignedArm
short:
  v: What path should be followed
definition:
  v: The name of the arm in the study the subject is expected to follow as part of this study.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchSubject.assignedArm
  min:
    v: 0
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    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject

id:
  v: ResearchSubject.actualArm
path:
  v: ResearchSubject.actualArm
short:
  v: What path was followed
definition:
  v: The name of the arm in the study the subject actually followed as part of this study.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchSubject.actualArm
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject

id:
  v: ResearchSubject.consent
path:
  v: ResearchSubject.consent
short:
  v: Agreement to participate in study
definition:
  v: A record of the patient's informed agreement to participate in the study.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchSubject.consent
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Consent|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Consent
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicator in that the informedConsentIndicator can be derived from the data in the Consent resource.

element:
  id:
    v: ResearchSubject
  path:
    v: ResearchSubject
element:
  id:
    v: ResearchSubject.status.extension
  path:
    v: ResearchSubject.status.extension
  slicing:
    discriminator:
      type:
        v: value
      path:
        v: url
    ordered:
      v: false
    rules:
      v: open
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    v: 0
  max:
    v: *
element:
  id:
    v: ResearchSubject.status.extension:status
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    v: ResearchSubject.status.extension
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    v: status
  short:
    v: STU3: candidate | enrolled | active | suspended | withdrawn | completed additional codes
  definition:
    v: STU3: `ResearchSubject.status` additional codes
  comment:
    v: Element `ResearchSubject.status` is mapped to FHIR R4 element `ResearchSubject.status` as `RelatedTo`. The mappings for `ResearchSubject.status` do not allow expression of the necessary codes, per the bindings on the source and target. The target context `ResearchSubject.status` is a modifier element, so this extension does not need to be defined as a modifier. This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.
  min:
    v: 0
  max:
    v: 1
  base:
    path:
      v: DomainResource.extension
    min:
      v: 0
    max:
      v: *
  type:
    code:
      v: Extension
      l: Extension
    profile:
      v: http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchSubject.status|0.1.0
      l: http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchSubject.status