hr-research-subject
type: StructureDefinition
node role: treeRoot
id:
  v: hr-research-subject
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: StructureDefinition hr-research-subject Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> ResearchSubject 0..* ResearchSubject Participant or object which is the recipient of investigative activities in a study identifier S 0..* Identifier Enrolment identifier, where the site issues one separately status S 1..1 code draft | active | retired | unknown progress S 0..* BackboneElement Screening, enrolment and withdrawal subjectState S 0..1 CodeableConcept 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| on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn period S 0..1 Period Period of participation study S 1..1 Reference(Healthy Route Study) Study subject is part of subject S 1..1 Reference(Healthy Route Patient) Who or what is part of study actualComparisonGroup S 0..1 id Case or control consent S 1..* Reference(Healthy Route Consent) Agreement to participate in study <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
url:
  v: https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-research-subject
version:
  v: 0.1.0
name:
  v: HRResearchSubject
title:
  v: Healthy Route Study Participation
status:
  v: draft
experimental:
  v: false
date:
  v: 2026-09-04T13:29:51+00:00
publisher:
  v: Savannah Informatics
contact:
  name:
    v: Savannah Informatics
  telecom:
    system:
      v: url
    value:
      v: https://savannahghi.org
contact:
  name:
    v: Savannah Informatics
  telecom:
    system:
      v: url
    value:
      v: https://savannahghi.org
description:
  v: One participant's enrolment onto one country's protocol, and the consent that permitted it.
purpose:
  v: Joins a participant to a protocol and to the permission that allowed them to be enrolled. It is the resource that answers whether a given person was in the study at a given time, which is distinct from whether the study holds data about them.
fhir version:
  v: 5.0.0
mapping:
  identity:
    v: w5
  uri:
    v: http://hl7.org/fhir/fivews
  name:
    v: FiveWs Pattern Mapping
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
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: 5.0.0
  element:
    id:
      v: ResearchSubject
    path:
      v: ResearchSubject
    short:
      v: Participant or object which is the recipient of investigative activities in a study
    definition:
      v: A ResearchSubject is a participant or object which is the recipient of investigative activities in a research 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()
      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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
      source:
        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()
      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()
      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()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    must support:
      v: false
    is modifier:
      v: false
    is summary:
      v: false
    mapping:
      identity:
        v: rim
      map:
        v: Entity, Role, or Act,Observation[classCode=CLNTRL, moodCode=EVN]
    mapping:
      identity:
        v: w5
      map:
        v: clinical.diagnostics
    mapping:
      identity:
        v: BRIDG5.1
      map:
        v: StudySubject
    mapping:
      identity:
        v: v2

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: OBX

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: Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
min:
  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
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
must support:
  v: false
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
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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
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 its 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
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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
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 its 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
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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Language
  strength:
    v: required
  description:
    v: IETF language tag for a human language
  value set:
    v: http://hl7.org/fhir/ValueSet/all-languages|5.0.0
    link: 5.0
    link: .0
  additional:
    purpose:
      v: starter
    value set:
      v: http://hl7.org/fhir/ValueSet/languages|5.0.0
      link: 5.0
      link: .0

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 a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
alias:
  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: dom-6
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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
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, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
comment:
  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
condition:
  v: dom-2
condition:
  v: dom-4
condition:
  v: dom-3
condition:
  v: dom-5
must support:
  v: false
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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  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
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())
  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()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
must support:
  v: false
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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. 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/R5/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
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())
  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()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
must support:
  v: false
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: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchSubject.identifier
path:
  v: ResearchSubject.identifier
short:
  v: Enrolment identifier, where the site issues one separately
definition:
  v: Identifiers assigned to this research subject for a study.
comment:
  v: Distinct from the participant identifier on HRPatient, which is retained across rescreening. A participant screened twice has one participant identifier and, if the site issues enrolment identifiers, two of those.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchSubject.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: 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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
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: draft | active | retired | unknown
definition:
  v: The publication state of the resource (not of the subject).
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchSubject.status
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: 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())
  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: PublicationStatus
  strength:
    v: required
  description:
    v: Codes that convey the current publication status of the research study resource.
  value set:
    v: http://hl7.org/fhir/ValueSet/publication-status|5.0.0
    link: 5.0
    link: .0
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.progress
path:
  v: ResearchSubject.progress
short:
  v: Screening, enrolment and withdrawal
definition:
  v: The current state (status) of the subject and resons for status change where appropriate.
comment:
  v: This is intended to deal with the confusion routinely created by haing two conflated concepts of being in a particular state and having achieved a particular milestone. In strict terms a milestone is a point of time event that results in a change from one state to another. The state before the milestone is achieved is often given the same name as the milestone, and sometimes the state may have the same description. For instance "Randomised" and "Visit 1" may be different milestones but the state remains at "on study" after each of them. It is likely that more than one "state" pattern will be recorded for a subject and a type has been introduced to allow this simultaneous recording.
requirements:
  v: Screen failure is a defined outcome in both protocols, not an absence of data: a participant who consents and is then found ineligible has been screened, and the count of them is reported. Recording the state and the date it was reached is what allows a screen failure to be distinguished from a withdrawal and from an enrolment still in progress.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchSubject.progress
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchSubject.progress.id
path:
  v: ResearchSubject.progress.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
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchSubject.progress.extension
path:
  v: ResearchSubject.progress.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 element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  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
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())
  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()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: 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.progress.modifierExtension
path:
  v: ResearchSubject.progress.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. 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/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: 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())
  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()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: 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 element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchSubject.progress.type
path:
  v: ResearchSubject.progress.type
short:
  v: state | milestone
definition:
  v: Identifies the aspect of the subject's journey that the state refers to.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchSubject.progress.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
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    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ResearchSubjectStateType
  strength:
    v: example
  description:
    v: Identifies the kind of state being refered to.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-subject-state-type|5.0.0
    link: 5.0
    link: .0

id:
  v: ResearchSubject.progress.subjectState
path:
  v: ResearchSubject.progress.subjectState
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: 0
max:
  v: 1
base:
  path:
    v: ResearchSubject.progress.subjectState
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ResearchSubjectProgresss
  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-state|5.0.0
    link: 5.0
    link: .0
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.progress.milestone
path:
  v: ResearchSubject.progress.milestone
short:
  v: SignedUp | Screened | Randomized
definition:
  v: The milestones the subject has passed through.
comment:
  v: There can be multiple entries but it is also valid to just have the most recent. This should npt be rlied upon as the full path the subject has taken.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchSubject.progress.milestone
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ResearchSubjectMilestone
  strength:
    v: example
  description:
    v: Indicates the progression of a study subject through the study milestones.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-subject-milestone|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.status
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudySubject.statusCode

id:
  v: ResearchSubject.progress.reason
path:
  v: ResearchSubject.progress.reason
short:
  v: State change reason
definition:
  v: The reason for the state change. If coded it should follow the formal subject state model.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchSubject.progress.reason
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: StateChangeReason
  strength:
    v: example
  description:
    v: Indicates why the state of the subject changed.
  value set:
    v: http://terminology.hl7.org/ValueSet/state-change-reason
    link: http://terminology.hl7.org/ValueSet/state-change-reason

id:
  v: ResearchSubject.progress.startDate
path:
  v: ResearchSubject.progress.startDate
short:
  v: State change date
definition:
  v: The date when the new status started.
comment:
  v: This is NOT the date the change in state was recorded.
requirements:
  v: This was originally defined as the date when the change in status occurred. This assumed all states were recorded which is not true. Hence the need to track the end of the state.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchSubject.progress.startDate
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchSubject.progress.endDate
path:
  v: ResearchSubject.progress.endDate
short:
  v: State change date
definition:
  v: The date when the state ended.
requirements:
  v: See the requirement on the start date.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchSubject.progress.endDate
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchSubject.period
path:
  v: ResearchSubject.period
short:
  v: Period 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
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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
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
  target profile:
    v: https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-research-study
    link: https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-research-study
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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudySubjectProtocolVersionRelationship

id:
  v: ResearchSubject.subject
path:
  v: ResearchSubject.subject
short:
  v: Who or what is part of study
definition:
  v: The record of the person, animal or other entity involved in the study.
comment:
  v: Constrained to Patient. The base resource also admits Group, Specimen, Device, Medication, Substance and BiologicallyDerivedProduct, none of which is enrolled onto a protocol in this study.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchSubject.subject
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-patient
    link: https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudySubject

id:
  v: ResearchSubject.assignedComparisonGroup
path:
  v: ResearchSubject.assignedComparisonGroup
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: Maybe this is really PlanDefinition.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchSubject.assignedComparisonGroup
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: id
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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject

id:
  v: ResearchSubject.actualComparisonGroup
path:
  v: ResearchSubject.actualComparisonGroup
short:
  v: Case or control
definition:
  v: The name of the arm in the study the subject actually followed as part of this study.
comment:
  v: These are observational studies with a case and a control group defined by previously documented kidney function, not trials with assigned arms. The group a participant falls into is a fact about them rather than an allocation, so actualComparisonGroup is used and assignedComparisonGroup is not.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchSubject.actualComparisonGroup
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: id
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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
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.
comment:
  v: One reference per permission granted or refused, because permissions are recorded as separate resources. A participant who consented to the study but refused image retention has two references here, one permitting and one denying.
requirements:
  v: Required, where the base resource makes it optional. Enrolment without a recorded consent is the finding a monitor is looking for, and a reference that may legitimately be absent cannot distinguish a participant who was never consented from one whose consent was recorded elsewhere.
min:
  v: 1
max:
  v: *
base:
  path:
    v: ResearchSubject.consent
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
  target profile:
    v: https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-consent
    link: https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-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())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
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.identifier
  path:
    v: ResearchSubject.identifier
  short:
    v: Enrolment identifier, where the site issues one separately
  comment:
    v: Distinct from the participant identifier on HRPatient, which is retained across rescreening. A participant screened twice has one participant identifier and, if the site issues enrolment identifiers, two of those.
  must support:
    v: true
element:
  id:
    v: ResearchSubject.status
  path:
    v: ResearchSubject.status
  must support:
    v: true
element:
  id:
    v: ResearchSubject.progress
  path:
    v: ResearchSubject.progress
  short:
    v: Screening, enrolment and withdrawal
  requirements:
    v: Screen failure is a defined outcome in both protocols, not an absence of data: a participant who consents and is then found ineligible has been screened, and the count of them is reported. Recording the state and the date it was reached is what allows a screen failure to be distinguished from a withdrawal and from an enrolment still in progress.
  must support:
    v: true
element:
  id:
    v: ResearchSubject.progress.subjectState
  path:
    v: ResearchSubject.progress.subjectState
  must support:
    v: true
element:
  id:
    v: ResearchSubject.period
  path:
    v: ResearchSubject.period
  short:
    v: Period of participation
  must support:
    v: true
element:
  id:
    v: ResearchSubject.study
  path:
    v: ResearchSubject.study
  type:
    code:
      v: Reference
    target profile:
      v: https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-research-study
      link: https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-research-study
  must support:
    v: true
element:
  id:
    v: ResearchSubject.subject
  path:
    v: ResearchSubject.subject
  comment:
    v: Constrained to Patient. The base resource also admits Group, Specimen, Device, Medication, Substance and BiologicallyDerivedProduct, none of which is enrolled onto a protocol in this study.
  type:
    code:
      v: Reference
    target profile:
      v: https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-patient
      link: https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-patient
  must support:
    v: true
element:
  id:
    v: ResearchSubject.actualComparisonGroup
  path:
    v: ResearchSubject.actualComparisonGroup
  short:
    v: Case or control
  comment:
    v: These are observational studies with a case and a control group defined by previously documented kidney function, not trials with assigned arms. The group a participant falls into is a fact about them rather than an allocation, so actualComparisonGroup is used and assignedComparisonGroup is not.
  must support:
    v: true
element:
  id:
    v: ResearchSubject.consent
  path:
    v: ResearchSubject.consent
  comment:
    v: One reference per permission granted or refused, because permissions are recorded as separate resources. A participant who consented to the study but refused image retention has two references here, one permitting and one denying.
  requirements:
    v: Required, where the base resource makes it optional. Enrolment without a recorded consent is the finding a monitor is looking for, and a reference that may legitimately be absent cannot distinguish a participant who was never consented from one whose consent was recorded elsewhere.
  min:
    v: 1
  type:
    code:
      v: Reference
    target profile:
      v: https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-consent
      link: https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-consent
  must support:
    v: true