mii-pr-person-proband
type: StructureDefinition
node role: treeRoot
id:
  v: mii-pr-person-proband
text:
  status:
    v: extensions
  div: Generated Narrative: StructureDefinition mii-pr-person-proband Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> ResearchSubject 0..* ResearchSubject Physical entity which is the primary unit of interest in the study id S 0..1 id Logical id of this artifact meta S 0..1 Meta Metadata about the resource profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to Slices for identifier S 1..* Identifier Business Identifier for research subject in a study Slice: Unordered, Open by pattern:$this identifier:subjectIdentificationCode S 1..1 Identifier Business Identifier for research subject in a study Required Pattern: At least the following type 1..1 CodeableConcept Description of identifier Fixed Value: (complex) coding 1..* Coding Code defined by a terminology system Fixed Value: (complex) system 1..1 uri Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203 code 1..1 code Symbol in syntax defined by the system Fixed Value: ANON type S 0..1 CodeableConcept Description of identifier system S 1..1 uri The namespace for the identifier value value S 1..1 string The value that is unique status S 1..1 code candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn period S 1..1 Period Start and end of participation start S 1..1 dateTime Starting time with inclusive boundary end S 0..1 dateTime End time with inclusive boundary, if not ongoing study S 1..1 Reference(ResearchStudy) Study subject is part of individual S 1..1 Reference(Patient) Who is part of study consent S 1..1 Reference(Consent) Agreement to participate in study <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
url:
  v: https://www.medizininformatik-initiative.de/fhir/core/modul-person/StructureDefinition/ResearchSubject
version:
  v: 2025.0.1
name:
  v: MII_PR_Person_Proband
title:
  v: MII PR Person Proband
status:
  v: retired
date:
  v: 2024-11-11
publisher:
  v: Medizininformatik Initiative
contact:
  name:
    v: Medizininformatik Initiative
  telecom:
    system:
      v: url
    value:
      v: https://www.medizininformatik-initiative.de/
description:
  v: Dieses Profil beschreibt eine Proband*in in der Medizininformatik-Initiative.
fhir version:
  v: 4.0.1
mapping:
  identity:
    v: BRIDG5.1
  uri:
    v: https://bridgmodel.nci.nih.gov
  name:
    v: BRIDG 5.1 Mapping
mapping:
  identity:
    v: v2
  uri:
    v: http://hl7.org/v2
  name:
    v: HL7 v2 Mapping
mapping:
  identity:
    v: rim
  uri:
    v: http://hl7.org/v3
  name:
    v: RIM Mapping
mapping:
  identity:
    v: w5
  uri:
    v: http://hl7.org/fhir/fivews
  name:
    v: FiveWs Pattern Mapping
kind:
  v: resource
abstract:
  v: false
type:
  v: ResearchSubject
base definition:
  v: http://hl7.org/fhir/StructureDefinition/ResearchSubject
  link: http://hl7.org/fhir/StructureDefinition/ResearchSubject
derivation:
  v: constraint
snapshot:
  extension:
    url:
      v: http://hl7.org/fhir/tools/StructureDefinition/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
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-4
      severity:
        v: error
      human:
        v: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
      expression:
        v: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
      xpath:
        v: not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: 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
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      extension:
        value: boolean
      extension:
        value: markdown
      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
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      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
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    mapping:
      identity:
        v: rim
      map:
        v: Entity. Role, or Act
    mapping:
      identity:
        v: BRIDG5.1
      map:
        v: StudySubject
    mapping:
      identity:
        v: v2
      map:
        v: OBX
    mapping:
      identity:
        v: rim
      map:
        v: Observation[classCode=CLNTRL, moodCode=EVN]
  element:
    id:
      v: ResearchSubject.id
    path:
      v: ResearchSubject.id

boolean
v: true

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.

v: Logical id of this artifact

v: The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

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.

v: 0

v: 1

path:
  v: Resource.id
min:
  v: 0
max:
  v: 1

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
  value: url
    v: id
code:
  v: http://hl7.org/fhirpath/System.String

v: true

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
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
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchSubject.meta.id
path:
  v: ResearchSubject.meta.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchSubject.meta.extension
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
  value: code
    v: normative
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version
  value: code
    v: 4.0.0
path:
  v: ResearchSubject.meta.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
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 element. 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: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
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
    link: 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/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchSubject.meta.versionId
path:
  v: ResearchSubject.meta.versionId
short:
  v: Version specific identifier
definition:
  v: 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:
  v: 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:
  v: 0
max:
  v: 1
base:
  path:
    v: Meta.versionId
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: id
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
    link: http://hl7.org/fhir/StructureDefinition/Element
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchSubject.meta.lastUpdated
path:
  v: ResearchSubject.meta.lastUpdated
short:
  v: When the resource version last changed
definition:
  v: When the resource last changed - e.g. when the version changed.
comment:
  v: This value is always populated except when the resource is first being created. 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/R4/http.html#read) interaction.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Meta.lastUpdated
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: instant
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
    link: http://hl7.org/fhir/StructureDefinition/Element
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchSubject.meta.source
path:
  v: ResearchSubject.meta.source
short:
  v: Identifies where the resource comes from
definition:
  v: A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](http://hl7.org/fhir/R4/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:
  v: In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. This 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:
  v: 0
max:
  v: 1
base:
  path:
    v: Meta.source
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
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
    link: http://hl7.org/fhir/StructureDefinition/Element
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchSubject.meta.profile
path:
  v: ResearchSubject.meta.profile
short:
  v: Profiles this resource claims to conform to
definition:
  v: A list of profiles (references to [StructureDefinition](http://hl7.org/fhir/R4/structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](http://hl7.org/fhir/R4/structuredefinition-definitions.html#StructureDefinition.url).
comment:
  v: 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:
  v: 0
max:
  v: *
base:
  path:
    v: Meta.profile
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: canonical
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/StructureDefinition
    link: http://hl7.org/fhir/StructureDefinition/StructureDefinition
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
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchSubject.meta.security
path:
  v: ResearchSubject.meta.security
short:
  v: Security Labels applied to this resource
definition:
  v: Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.
comment:
  v: 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:
  v: 0
max:
  v: *
base:
  path:
    v: Meta.security
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
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
    link: http://hl7.org/fhir/StructureDefinition/Element
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: SecurityLabels
  strength:
    v: extensible
  description:
    v: Security Labels from the Healthcare Privacy and Security Classification System.
  value set:
    v: http://hl7.org/fhir/ValueSet/security-labels
    link: http://hl7.org/fhir/ValueSet/security-labels
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
mapping:
  identity:
    v: rim
  map:
    v: CV
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding rdfs:subClassOf dt:CDCoding

id:
  v: ResearchSubject.meta.tag
path:
  v: ResearchSubject.meta.tag
short:
  v: Tags applied to this resource
definition:
  v: 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:
  v: 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:
  v: 0
max:
  v: *
base:
  path:
    v: Meta.tag
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
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
    link: http://hl7.org/fhir/StructureDefinition/Element
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Tags
  strength:
    v: example
  description:
    v: Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
  value set:
    v: http://hl7.org/fhir/ValueSet/common-tags
    link: http://hl7.org/fhir/ValueSet/common-tags
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
mapping:
  identity:
    v: rim
  map:
    v: CV
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding rdfs:subClassOf dt:CDCoding

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
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
    link: 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
mapping:
  identity:
    v: rim
  map:
    v: n/a

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
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
    link: http://hl7.org/fhir/StructureDefinition/Element
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet
    value: canonical
      v: http://hl7.org/fhir/ValueSet/all-languages
      link: http://hl7.org/fhir/ValueSet/all-languages
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Language
  strength:
    v: preferred
  description:
    v: A human language.
  value set:
    v: http://hl7.org/fhir/ValueSet/languages
    link: http://hl7.org/fhir/ValueSet/languages
mapping:
  identity:
    v: rim
  map:
    v: n/a

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
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
    link: http://hl7.org/fhir/StructureDefinition/Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A
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
mapping:
  identity:
    v: rim
  map:
    v: Entity. Role, or Act
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchSubject.extension
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
  value: code
    v: normative
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version
  value: code
    v: 4.0.0
path:
  v: ResearchSubject.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
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
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
    link: 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/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchSubject.modifierExtension
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
  value: code
    v: normative
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version
  value: code
    v: 4.0.0
path:
  v: ResearchSubject.modifierExtension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
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
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
    link: 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/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchSubject.identifier
path:
  v: ResearchSubject.identifier
slicing:
  discriminator:
    type:
      v: pattern
    path:
      v: $this
  rules:
    v: open
short:
  v: Business Identifier for research subject in a study
definition:
  v: Identifiers assigned to this research subject for a study.
min:
  v: 1
max:
  v: *
base:
  path:
    v: ResearchSubject.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Identifier
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
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX / EI (occasionally, more often EI maps to a resource id or a URL)
mapping:
  identity:
    v: rim
  map:
    v: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
mapping:
  identity:
    v: servd
  map:
    v: Identifier
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.identifier:subjectIdentificationCode
path:
  v: ResearchSubject.identifier
slice name:
  v: subjectIdentificationCode
short:
  v: Business Identifier for research subject in a study
definition:
  v: Identifiers assigned to this research subject for a study.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchSubject.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Identifier
pattern: Identifier
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0203
      code:
        v: ANON
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
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX / EI (occasionally, more often EI maps to a resource id or a URL)
mapping:
  identity:
    v: rim
  map:
    v: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
mapping:
  identity:
    v: servd
  map:
    v: Identifier
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.identifier:subjectIdentificationCode.id
path:
  v: ResearchSubject.identifier.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchSubject.identifier:subjectIdentificationCode.extension
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
  value: code
    v: normative
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version
  value: code
    v: 4.0.0
path:
  v: ResearchSubject.identifier.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
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 element. 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: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
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
    link: 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/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchSubject.identifier:subjectIdentificationCode.use
path:
  v: ResearchSubject.identifier.use
short:
  v: usual | official | temp | secondary | old (If known)
definition:
  v: The purpose of this identifier.
comment:
  v: Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
requirements:
  v: Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.use
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
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
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: IdentifierUse
  strength:
    v: required
  description:
    v: Identifies the purpose for this identifier, if known .
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
    link: 4.0
    link: .1
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: N/A
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: ResearchSubject.identifier:subjectIdentificationCode.type
path:
  v: ResearchSubject.identifier.type
short:
  v: Description of identifier
definition:
  v: A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
comment:
  v: 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:
  v: Allows users to make use of identifiers when the identifier system is not known.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
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
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: IdentifierType
  strength:
    v: extensible
  description:
    v: A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-type
    link: http://hl7.org/fhir/ValueSet/identifier-type
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: v2
  map:
    v: CX.5
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: ResearchSubject.identifier:subjectIdentificationCode.system
path:
  v: ResearchSubject.identifier.system
short:
  v: The namespace for the identifier value
definition:
  v: Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
comment:
  v: Identifier.system is always case sensitive.
requirements:
  v: 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:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
example:
  label:
    v: General
  value: uri
    v: http://www.acme.com/identifiers/patient
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
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / EI-2-4
mapping:
  identity:
    v: rim
  map:
    v: II.root or Role.id.root
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierType

id:
  v: ResearchSubject.identifier:subjectIdentificationCode.value
path:
  v: ResearchSubject.identifier.value
short:
  v: The value that is unique
definition:
  v: The portion of the identifier typically relevant to the user and which is unique within the context of the system.
comment:
  v: 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 [Rendered Value extension](http://hl7.org/fhir/R4/extension-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:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
example:
  label:
    v: General
  value: string
    v: 123456
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
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX.1 / EI.1
mapping:
  identity:
    v: rim
  map:
    v: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
mapping:
  identity:
    v: servd
  map:
    v: ./Value

id:
  v: ResearchSubject.identifier:subjectIdentificationCode.period
path:
  v: ResearchSubject.identifier.period
short:
  v: Time period when id is/was valid for use
definition:
  v: Time period during which identifier is/was valid for use.
comment:
  v: A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See [Duration](http://hl7.org/fhir/R4/datatypes.html#Duration).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.period
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Period
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
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: per-1
  severity:
    v: error
  human:
    v: If present, start SHALL have a lower value than end
  expression:
    v: start.hasValue().not() or end.hasValue().not() or (start <= end)
  xpath:
    v: not(exists(f:start/@value)) or not(exists(f:end/@value)) or (xs:dateTime(f:start/@value) <= xs:dateTime(f:end/@value))
  source:
    v: http://hl7.org/fhir/StructureDefinition/Library
    link: http://hl7.org/fhir/StructureDefinition/Library
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: DR
mapping:
  identity:
    v: rim
  map:
    v: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
mapping:
  identity:
    v: v2
  map:
    v: CX.7 + CX.8
mapping:
  identity:
    v: rim
  map:
    v: Role.effectiveTime or implied by context
mapping:
  identity:
    v: servd
  map:
    v: ./StartDate and ./EndDate

id:
  v: ResearchSubject.identifier:subjectIdentificationCode.assigner
path:
  v: ResearchSubject.identifier.assigner
short:
  v: Organization that issued id (may be just text)
definition:
  v: Organization that issued/manages the identifier.
comment:
  v: 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:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.assigner
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    link: http://hl7.org/fhir/StructureDefinition/Organization
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
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ref-1
  severity:
    v: error
  human:
    v: SHALL have a contained resource if a local reference is provided
  expression:
    v: reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
  xpath:
    v: not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Observation
    link: http://hl7.org/fhir/StructureDefinition/Observation
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / (CX.4,CX.9,CX.10)
mapping:
  identity:
    v: rim
  map:
    v: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierIssuingAuthority

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.
comment:
  v: Note that FHIR strings SHALL NOT exceed 1MB in size
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchSubject.status
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: code
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
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
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
    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
    link: 4.0
    link: .1
mapping:
  identity:
    v: rim
  map:
    v: n/a
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.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.
comment:
  v: A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See [Duration](http://hl7.org/fhir/R4/datatypes.html#Duration).
alias:
  v: timing
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchSubject.period
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Period
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
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: per-1
  severity:
    v: error
  human:
    v: If present, start SHALL have a lower value than end
  expression:
    v: start.hasValue().not() or end.hasValue().not() or (start <= end)
  xpath:
    v: not(exists(f:start/@value)) or not(exists(f:end/@value)) or (xs:dateTime(f:start/@value) <= xs:dateTime(f:end/@value))
  source:
    v: http://hl7.org/fhir/StructureDefinition/Library
    link: http://hl7.org/fhir/StructureDefinition/Library
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: DR
mapping:
  identity:
    v: rim
  map:
    v: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.planned
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: PerformedStudySubjectMilestone.studyReferenceDateRange

id:
  v: ResearchSubject.period.id
path:
  v: ResearchSubject.period.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchSubject.period.extension
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
  value: code
    v: normative
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version
  value: code
    v: 4.0.0
path:
  v: ResearchSubject.period.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
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 element. 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: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
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
    link: 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/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchSubject.period.start
path:
  v: ResearchSubject.period.start
short:
  v: Starting time with inclusive boundary
definition:
  v: The start of the period. The boundary is inclusive.
comment:
  v: If the low element is missing, the meaning is that the low boundary is not known.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Period.start
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
condition:
  v: ele-1
condition:
  v: per-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
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: DR.1
mapping:
  identity:
    v: rim
  map:
    v: ./low

id:
  v: ResearchSubject.period.end
path:
  v: ResearchSubject.period.end
short:
  v: End time with inclusive boundary, if not ongoing
definition:
  v: 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:
  v: The high 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:
  v: 0
max:
  v: 1
base:
  path:
    v: Period.end
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
meaning when missing:
  v: If the end of the period is missing, it means that the period is ongoing
condition:
  v: ele-1
condition:
  v: per-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
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: DR.2
mapping:
  identity:
    v: rim
  map:
    v: ./high

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.
comment:
  v: References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchSubject.study
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/ResearchStudy
    link: http://hl7.org/fhir/StructureDefinition/ResearchStudy
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
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ref-1
  severity:
    v: error
  human:
    v: SHALL have a contained resource if a local reference is provided
  expression:
    v: reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
  xpath:
    v: not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Observation
    link: http://hl7.org/fhir/StructureDefinition/Observation
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
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.
comment:
  v: References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchSubject.individual
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Patient
    link: http://hl7.org/fhir/StructureDefinition/Patient
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
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ref-1
  severity:
    v: error
  human:
    v: SHALL have a contained resource if a local reference is provided
  expression:
    v: reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
  xpath:
    v: not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Observation
    link: http://hl7.org/fhir/StructureDefinition/Observation
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
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.
comment:
  v: Note that FHIR strings SHALL NOT exceed 1MB in size
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchSubject.assignedArm
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
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
    link: http://hl7.org/fhir/StructureDefinition/Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
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.
comment:
  v: Note that FHIR strings SHALL NOT exceed 1MB in size
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchSubject.actualArm
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
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
    link: http://hl7.org/fhir/StructureDefinition/Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
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.
comment:
  v: References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchSubject.consent
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Consent
    link: http://hl7.org/fhir/StructureDefinition/Consent
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
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ref-1
  severity:
    v: error
  human:
    v: SHALL have a contained resource if a local reference is provided
  expression:
    v: reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
  xpath:
    v: not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Observation
    link: http://hl7.org/fhir/StructureDefinition/Observation
must support:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
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.id
  path:
    v: ResearchSubject.id
  must support:
    v: true
element:
  id:
    v: ResearchSubject.meta
  path:
    v: ResearchSubject.meta
  must support:
    v: true
element:
  id:
    v: ResearchSubject.meta.profile
  path:
    v: ResearchSubject.meta.profile
  must support:
    v: true
element:
  id:
    v: ResearchSubject.identifier
  path:
    v: ResearchSubject.identifier
  slicing:
    discriminator:
      type:
        v: pattern
      path:
        v: $this
    rules:
      v: open
  min:
    v: 1
  must support:
    v: true
element:
  id:
    v: ResearchSubject.identifier:subjectIdentificationCode
  path:
    v: ResearchSubject.identifier
  slice name:
    v: subjectIdentificationCode
  min:
    v: 1
  max:
    v: 1
  pattern: Identifier
  must support:
    v: true
element:
  id:
    v: ResearchSubject.identifier:subjectIdentificationCode.type
  path:
    v: ResearchSubject.identifier.type
  must support:
    v: true
element:
  id:
    v: ResearchSubject.identifier:subjectIdentificationCode.system
  path:
    v: ResearchSubject.identifier.system
  min:
    v: 1
  must support:
    v: true
element:
  id:
    v: ResearchSubject.identifier:subjectIdentificationCode.value
  path:
    v: ResearchSubject.identifier.value
  min:
    v: 1
  must support:
    v: true
element:
  id:
    v: ResearchSubject.status
  path:
    v: ResearchSubject.status
  must support:
    v: true
element:
  id:
    v: ResearchSubject.period
  path:
    v: ResearchSubject.period
  min:
    v: 1
  must support:
    v: true
element:
  id:
    v: ResearchSubject.period.start
  path:
    v: ResearchSubject.period.start
  min:
    v: 1
  must support:
    v: true
element:
  id:
    v: ResearchSubject.period.end
  path:
    v: ResearchSubject.period.end
  must support:
    v: true
element:
  id:
    v: ResearchSubject.study
  path:
    v: ResearchSubject.study
  must support:
    v: true
element:
  id:
    v: ResearchSubject.individual
  path:
    v: ResearchSubject.individual
  must support:
    v: true
element:
  id:
    v: ResearchSubject.consent
  path:
    v: ResearchSubject.consent
  min:
    v: 1
  must support:
    v: true

v: ANON