profile-ResearchStudy
type: StructureDefinition
node role: treeRoot
id:
  v: profile-ResearchStudy
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: StructureDefinition profile-ResearchStudy Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:url 0..1 uri R5: Canonical identifier for this study resource (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url #xD; extension:version 0..1 string R5: The business version for the study record (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version #xD; extension:name 0..1 string R5: Name for this study (computer friendly) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name #xD; extension:label 0..* (Complex) R5: Additional names for the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label #xD; extension:date 0..1 dateTime R5: Date the resource last changed (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date #xD; extension:primaryPurposeType 0..1 CodeableConcept R5: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.primaryPurposeType Binding: R5ResearchStudyPrimPurpTypeForR3 (0.1.0) (preferred): Codes for the main intent of the study. #xD; extension:phase 0..1 CodeableConcept R5: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.phase Binding: R5ResearchStudyPhaseForR3 (0.1.0) (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. #xD; extension:studyDe…
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
    l: structuredefinition-wg
  value: Code
    v: fhir
extension:
  extension:
    url:
      v: packageId
      l: packageId
    value: Id
      v: hl7.fhir.uv.xver-r5.r3
  extension:
    url:
      v: version
      l: version
    value: String
      v: 0.1.0
  url:
    v: http://hl7.org/fhir/StructureDefinition/package-source
    l: package-source
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm
    l: structuredefinition-fmm
  value: Integer
    v: 0
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom
        l: structuredefinition-conformance-derivedFrom
      value: Uri
        v: http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r5.r3
        l: hl7.fhir.uv.xver-r5.r3
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
    l: structuredefinition-standards-status
  value: Code
    v: trial-use
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom
        l: structuredefinition-conformance-derivedFrom
      value: Uri
        v: http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r5.r3
        l: hl7.fhir.uv.xver-r5.r3
url:
  v: http://hl7.org/fhir/5.0/StructureDefinition/profile-ResearchStudy
  l: profile-ResearchStudy
version:
  v: 0.1.0
name:
  v: Profile_R5_ResearchStudy_R3
title:
  v: Cross-version Profile for R5.ResearchStudy for use in FHIR STU3
status:
  v: active
experimental:
  v: false
date:
  v: 2026-03-17T16:05:13.1303546-05:00
publisher:
  v: FHIR Infrastructure
contact:
  name:
    v: FHIR Infrastructure
  telecom:
    system:
      v: url
    value:
      v: http://www.hl7.org/Special/committees/fiwg
description:
  v: This cross-version profile allows R5 ResearchStudy content to be represented via FHIR STU3 ResearchStudy resources.
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 001
    display:
      v: World
fhir version:
  v: 3.0.2
mapping:
  identity:
    v: v2
  uri:
    v: http://hl7.org/v2
    l: v2
  name:
    v: HL7 v2 Mapping
mapping:
  identity:
    v: rim
  uri:
    v: http://hl7.org/v3
    l: v3
  name:
    v: RIM Mapping
mapping:
  identity:
    v: w5
  uri:
    v: http://hl7.org/fhir/w5
    l: w5
  name:
    v: W5 Mapping
mapping:
  identity:
    v: clinicaltrials-gov
  uri:
    v: http://clinicaltrials.gov
    l: clinicaltrials.gov
  name:
    v: ClinicalTrials.gov Mapping
kind:
  v: resource
abstract:
  v: false
type:
  v: ResearchStudy
base definition:
  v: http://hl7.org/fhir/StructureDefinition/ResearchStudy
  l: ResearchStudy
derivation:
  v: constraint
snapshot:
  element:
    id:
      v: ResearchStudy
    path:
      v: ResearchStudy
    short:
      v: Investigation to increase healthcare-related patient-independent knowledge
    definition:
      v: A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
    comment:
      v: Need to make sure we encompass public health studies.
    alias:
      v: Clinical Trial
    alias:
      v: Study
    min:
      v: 0
    max:
      v: *
    base:
      path:
        v: ResearchStudy
      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
        l: DomainResource
    constraint:
      key:
        v: dom-1
      severity:
        v: error
      human:
        v: If the resource is contained in another resource, it SHALL NOT contain any narrative
      expression:
        v: contained.text.empty()
      xpath:
        v: not(parent::f:contained and f:text)
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        l: 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))

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
expression:
  v: contained.where(('#'+id in %resource.descendants().reference).not()).empty()
xpath:
  v: not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))
source:
  v: http://hl7.org/fhir/StructureDefinition/DomainResource
  l: DomainResource

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

identity:
  v: v2
map:
  v: OBX

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

identity:
  v: w5
map:
  v: clinical.diagnostics

id:
  v: ResearchStudy.id
path:
  v: ResearchStudy.id
short:
  v: Logical id of this artifact
definition:
  v: The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
comment:
  v: The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.id
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: id
    l: id
is summary:
  v: true

id:
  v: ResearchStudy.meta
path:
  v: ResearchStudy.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 may not always be associated with version changes to the resource.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.meta
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Meta
    l: Meta
is summary:
  v: true

id:
  v: ResearchStudy.implicitRules
path:
  v: ResearchStudy.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.
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. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.implicitRules
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
is modifier:
  v: true
is summary:
  v: true

id:
  v: ResearchStudy.language
path:
  v: ResearchStudy.language
short:
  v: Language of the resource content
definition:
  v: The base language in which the resource is written.
comment:
  v: Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.language
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
    l: code
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet
      l: elementdefinition-maxValueSet
    value: Reference
      l: 3.0
      l: .2
      reference:
        v: http://hl7.org/fhir/ValueSet/all-languages|3.0.2
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: Language
  strength:
    v: extensible
  description:
    v: A human language.
  value set: Reference
    l: 3.0
    l: .2
    reference:
      v: http://hl7.org/fhir/ValueSet/languages|3.0.2

id:
  v: ResearchStudy.text
path:
  v: ResearchStudy.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 may 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 in formation is added later.
alias:
  v: narrative
alias:
  v: html
alias:
  v: xhtml
alias:
  v: display
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Narrative
    l: Narrative
condition:
  v: dom-1
mapping:
  identity:
    v: rim
  map:
    v: Act.text?

id:
  v: ResearchStudy.contained
path:
  v: ResearchStudy.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.
alias:
  v: inline resources
alias:
  v: anonymous resources
alias:
  v: contained resources
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.contained
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Resource
    l: Resource
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.extension
path:
  v: ResearchStudy.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  ordered:
    v: false
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension

id:
  v: ResearchStudy.extension:url
path:
  v: ResearchStudy.extension
slice name:
  v: url
short:
  v: R5: Canonical identifier for this study resource (new)
definition:
  v: R5: `ResearchStudy.url` (new:uri)
comment:
  v: Element `ResearchStudy.url` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.url` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:version
path:
  v: ResearchStudy.extension
slice name:
  v: version
short:
  v: R5: The business version for the study record (new)
definition:
  v: R5: `ResearchStudy.version` (new:string)
comment:
  v: Element `ResearchStudy.version` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.version` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:name
path:
  v: ResearchStudy.extension
slice name:
  v: name
short:
  v: R5: Name for this study (computer friendly) (new)
definition:
  v: R5: `ResearchStudy.name` (new:string)
comment:
  v: Element `ResearchStudy.name` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.name` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:label
path:
  v: ResearchStudy.extension
slice name:
  v: label
short:
  v: R5: Additional names for the study (new)
definition:
  v: R5: `ResearchStudy.label` (new:BackboneElement)
comment:
  v: Element `ResearchStudy.label` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.label` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:date
path:
  v: ResearchStudy.extension
slice name:
  v: date
short:
  v: R5: Date the resource last changed (new)
definition:
  v: R5: `ResearchStudy.date` (new:dateTime)
comment:
  v: Element `ResearchStudy.date` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.date` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:primaryPurposeType
path:
  v: ResearchStudy.extension
slice name:
  v: primaryPurposeType
short:
  v: R5: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility (new)
definition:
  v: R5: `ResearchStudy.primaryPurposeType` (new:CodeableConcept)
comment:
  v: Element `ResearchStudy.primaryPurposeType` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.primaryPurposeType` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.primaryPurposeType|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.primaryPurposeType
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:phase
path:
  v: ResearchStudy.extension
slice name:
  v: phase
short:
  v: R5: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 (new)
definition:
  v: R5: `ResearchStudy.phase` (new:CodeableConcept)
comment:
  v: Element `ResearchStudy.phase` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.phase` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.phase|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.phase
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:studyDesign
path:
  v: ResearchStudy.extension
slice name:
  v: studyDesign
short:
  v: R5: Classifications of the study design characteristics (new)
definition:
  v: R5: `ResearchStudy.studyDesign` (new:CodeableConcept)
comment:
  v: Element `ResearchStudy.studyDesign` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.studyDesign` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:condition
path:
  v: ResearchStudy.extension
slice name:
  v: condition
short:
  v: R5: Condition being studied (new)
definition:
  v: R5: `ResearchStudy.condition` (new:CodeableConcept)
comment:
  v: Element `ResearchStudy.condition` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.condition` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.condition|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.condition
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:descriptionSummary
path:
  v: ResearchStudy.extension
slice name:
  v: descriptionSummary
short:
  v: R5: Brief text explaining the study (new)
definition:
  v: R5: `ResearchStudy.descriptionSummary` (new:markdown)
comment:
  v: Element `ResearchStudy.descriptionSummary` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.descriptionSummary` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:classifier
path:
  v: ResearchStudy.extension
slice name:
  v: classifier
short:
  v: R5: Classification for the study (new)
definition:
  v: R5: `ResearchStudy.classifier` (new:CodeableConcept)
comment:
  v: Element `ResearchStudy.classifier` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.classifier` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:associatedParty
path:
  v: ResearchStudy.extension
slice name:
  v: associatedParty
short:
  v: R5: Sponsors, collaborators, and other parties (new)
definition:
  v: R5: `ResearchStudy.associatedParty` (new:BackboneElement)
comment:
  v: Element `ResearchStudy.associatedParty` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.associatedParty` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element). For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:progressStatus
path:
  v: ResearchStudy.extension
slice name:
  v: progressStatus
short:
  v: R5: Status of study with time for that status (new)
definition:
  v: R5: `ResearchStudy.progressStatus` (new:BackboneElement)
comment:
  v: Element `ResearchStudy.progressStatus` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.progressStatus` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:targetNumber
path:
  v: ResearchStudy.extension
slice name:
  v: targetNumber
short:
  v: R5: Estimated total number of participants to be enrolled (new)
definition:
  v: R5: `ResearchStudy.recruitment.targetNumber` (new:unsignedInt)
comment:
  v: Element `ResearchStudy.recruitment.targetNumber` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.recruitment.targetNumber` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:actualNumber
path:
  v: ResearchStudy.extension
slice name:
  v: actualNumber
short:
  v: R5: Actual total number of participants enrolled in study (new)
definition:
  v: R5: `ResearchStudy.recruitment.actualNumber` (new:unsignedInt)
comment:
  v: Element `ResearchStudy.recruitment.actualNumber` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.recruitment.actualNumber` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:actualGroup
path:
  v: ResearchStudy.extension
slice name:
  v: actualGroup
short:
  v: R5: Group of participants who were enrolled in study (new)
definition:
  v: R5: `ResearchStudy.recruitment.actualGroup` (new:Reference(Group))
comment:
  v: Element `ResearchStudy.recruitment.actualGroup` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.recruitment.actualGroup` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:objective
path:
  v: ResearchStudy.extension
slice name:
  v: objective
short:
  v: R5: A goal for the study (new)
definition:
  v: R5: `ResearchStudy.objective` (new:BackboneElement)
comment:
  v: Element `ResearchStudy.objective` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.objective` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:outcomeMeasure
path:
  v: ResearchStudy.extension
slice name:
  v: outcomeMeasure
short:
  v: R5: A variable measured during the study (new)
definition:
  v: R5: `ResearchStudy.outcomeMeasure` (new:BackboneElement)
comment:
  v: Element `ResearchStudy.outcomeMeasure` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.outcomeMeasure` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element). A study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.extension:result
path:
  v: ResearchStudy.extension
slice name:
  v: result
short:
  v: R5: Link to results generated during the study (new)
definition:
  v: R5: `ResearchStudy.result` (new:Reference(EvidenceReport,Citation,DiagnosticReport))
comment:
  v: Element `ResearchStudy.result` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.result` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.modifierExtension
path:
  v: ResearchStudy.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. Usually modifier elements provide negation or qualification. In order 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.
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.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
is modifier:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.identifier
path:
  v: ResearchStudy.identifier
short:
  v: Business Identifier for study
definition:
  v: Identifiers assigned to this research study by the sponsor or other systems.
requirements:
  v: Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.identifier
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    v: 0
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    v: *
type:
  code:
    v: Identifier
    l: Identifier
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Organization's Unique Protocol ID; Secondary IDs
mapping:
  identity:
    v: rim
  map:
    v: .identifier
mapping:
  identity:
    v: w5
  map:
    v: id

id:
  v: ResearchStudy.title
path:
  v: ResearchStudy.title
short:
  v: Name for this study
definition:
  v: A short, descriptive user-friendly label for the study.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.title
  min:
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type:
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    l: string
is summary:
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mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Brief Title

id:
  v: ResearchStudy.protocol
path:
  v: ResearchStudy.protocol
short:
  v: Steps followed in executing study
definition:
  v: The set of steps expected to be performed as part of the execution of the study.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.protocol
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/PlanDefinition
    l: PlanDefinition
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Interventions; Arm/Intervention Cross-Reference
mapping:
  identity:
    v: rim
  map:
    v: .outboundRelationship[typeCode=DEFN].target

id:
  v: ResearchStudy.protocol.id
path:
  v: ResearchStudy.protocol.id
representation:
  v: xmlAttr
short:
  v: xml:id (or equivalent in JSON)
definition:
  v: unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
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  v: 1
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  path:
    v: Element.id
  min:
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type:
  code:
    v: string
    l: string
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.protocol.extension
path:
  v: ResearchStudy.protocol.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  ordered:
    v: false
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
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    v: *
type:
  code:
    v: Extension
    l: Extension

id:
  v: ResearchStudy.protocol.extension:protocol
path:
  v: ResearchStudy.protocol.extension
slice name:
  v: protocol
short:
  v: R5: protocol additional types
definition:
  v: R5: `ResearchStudy.protocol` additional types from child elements (display, identifier, reference, type)
comment:
  v: Element `ResearchStudy.protocol` is mapped to FHIR STU3 element `ResearchStudy.protocol` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.protocol` do not cover the following types based on type expansion: display, identifier, reference, type. The standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `ResearchStudy.protocol` with unmapped reference targets: PlanDefinition.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
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    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/StructureDefinition/alternate-reference
    l: alternate-reference

id:
  v: ResearchStudy.protocol.reference
path:
  v: ResearchStudy.protocol.reference
short:
  v: Literal reference, Relative, internal or absolute URL
definition:
  v: A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.
comment:
  v: Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.
min:
  v: 0
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  v: 1
base:
  path:
    v: Reference.reference
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
condition:
  v: ref-1
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.protocol.identifier
path:
  v: ResearchStudy.protocol.identifier
short:
  v: Logical reference, when literal reference is not known
definition:
  v: An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.
comment:
  v: When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.identifier
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Identifier
    l: Identifier
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: .identifier

id:
  v: ResearchStudy.protocol.display
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
path:
  v: ResearchStudy.protocol.display
short:
  v: Text alternative for the resource
definition:
  v: Plain text narrative that identifies the resource in addition to the resource reference.
comment:
  v: This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.display
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.partOf
path:
  v: ResearchStudy.partOf
short:
  v: Part of larger study
definition:
  v: A larger research study of which this particular study is a component or step.
requirements:
  v: Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.
alias:
  v: container
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.partOf
  min:
    v: 0
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    v: *
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/ResearchStudy
    l: ResearchStudy
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]

id:
  v: ResearchStudy.partOf.id
path:
  v: ResearchStudy.partOf.id
representation:
  v: xmlAttr
short:
  v: xml:id (or equivalent in JSON)
definition:
  v: unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
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  v: 1
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  path:
    v: Element.id
  min:
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type:
  code:
    v: string
    l: string
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.partOf.extension
path:
  v: ResearchStudy.partOf.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  ordered:
    v: false
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
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type:
  code:
    v: Extension
    l: Extension

id:
  v: ResearchStudy.partOf.extension:partOf
path:
  v: ResearchStudy.partOf.extension
slice name:
  v: partOf
short:
  v: R5: partOf additional types
definition:
  v: R5: `ResearchStudy.partOf` additional types from child elements (display, identifier, reference, type)
comment:
  v: Element `ResearchStudy.partOf` is mapped to FHIR STU3 element `ResearchStudy.partOf` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.partOf` do not cover the following types based on type expansion: display, identifier, reference, type. The standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `ResearchStudy.partOf` with unmapped reference targets: ResearchStudy.
min:
  v: 0
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  v: *
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  path:
    v: Element.extension
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    v: 0
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type:
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    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/StructureDefinition/alternate-reference
    l: alternate-reference

id:
  v: ResearchStudy.partOf.reference
path:
  v: ResearchStudy.partOf.reference
short:
  v: Literal reference, Relative, internal or absolute URL
definition:
  v: A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.
comment:
  v: Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.
min:
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    v: Reference.reference
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type:
  code:
    v: string
    l: string
condition:
  v: ref-1
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.partOf.identifier
path:
  v: ResearchStudy.partOf.identifier
short:
  v: Logical reference, when literal reference is not known
definition:
  v: An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.
comment:
  v: When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.
min:
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type:
  code:
    v: Identifier
    l: Identifier
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: .identifier

id:
  v: ResearchStudy.partOf.display
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
path:
  v: ResearchStudy.partOf.display
short:
  v: Text alternative for the resource
definition:
  v: Plain text narrative that identifies the resource in addition to the resource reference.
comment:
  v: This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.
min:
  v: 0
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type:
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is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.status
path:
  v: ResearchStudy.status
short:
  v: draft | in-progress | suspended | stopped | completed | entered-in-error
definition:
  v: The current state of the study.
comment:
  v: This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.
min:
  v: 1
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  v: 1
base:
  path:
    v: ResearchStudy.status
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type:
  code:
    v: code
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is modifier:
  v: true
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyStatus
  strength:
    v: required
  description:
    v: Codes that convey the current status of the research study
  value set: Reference
    l: 3.0
    l: .2
    reference:
      v: http://hl7.org/fhir/ValueSet/research-study-status|3.0.2
mapping:
  identity:
    v: rim
  map:
    v: .status
mapping:
  identity:
    v: w5
  map:
    v: status

id:
  v: ResearchStudy.status.id
path:
  v: ResearchStudy.status.id
representation:
  v: xmlAttr
short:
  v: xml:id (or equivalent in JSON)
definition:
  v: unique id for the element within a resource (for internal references)
min:
  v: 0
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  v: 1
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type:
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    v: string
    l: string

id:
  v: ResearchStudy.status.extension
path:
  v: ResearchStudy.status.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  ordered:
    v: false
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
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  v: 0
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  v: *
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  path:
    v: Element.extension
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id:
  v: ResearchStudy.status.extension:status
path:
  v: ResearchStudy.status.extension
slice name:
  v: status
short:
  v: R5: draft | active | retired | unknown additional codes
definition:
  v: R5: `ResearchStudy.status` additional codes
comment:
  v: Element `ResearchStudy.status` is mapped to FHIR STU3 element `ResearchStudy.status` as `RelatedTo`. The mappings for `ResearchStudy.status` do not allow expression of the necessary codes, per the bindings on the source and target. The target context `ResearchStudy.status` is a modifier element, so this extension does not need to be defined as a modifier.
min:
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  path:
    v: Element.extension
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    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: 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:
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  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.status.value
path:
  v: ResearchStudy.status.value
representation:
  v: xmlAttr
short:
  v: Primitive value for code
definition:
  v: Primitive value for code
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  path:
    v: string.value
  min:
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type:
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    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-regex
      l: structuredefinition-regex
    value: String
      v: [^\s]+([\s]?[^\s]+)*
  code:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-json-type
        l: structuredefinition-json-type
      value: String
        v: string
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-xml-type
        l: structuredefinition-xml-type
      value: String
        v: xsd:token
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-rdf-type
        l: structuredefinition-rdf-type
      value: String
        v: xsd:token

id:
  v: ResearchStudy.category
path:
  v: ResearchStudy.category
short:
  v: Classifications for the study
definition:
  v: Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
min:
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    v: ResearchStudy.category
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type:
  code:
    v: CodeableConcept
    l: CodeableConcept
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyCategory
  strength:
    v: example
  description:
    v: Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Study Type; Primary Purpose; Study Phase; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention

id:
  v: ResearchStudy.focus
path:
  v: ResearchStudy.focus
short:
  v: Drugs, devices, conditions, etc. under study
definition:
  v: The condition(s), medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
min:
  v: 0
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  v: *
base:
  path:
    v: ResearchStudy.focus
  min:
    v: 0
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    v: *
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyFocus
  strength:
    v: example
  description:
    v: Codes for medications, devices, conditions and other interventions
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Conditions or Focus of Study
mapping:
  identity:
    v: w5
  map:
    v: what

id:
  v: ResearchStudy.focus.id
path:
  v: ResearchStudy.focus.id
representation:
  v: xmlAttr
short:
  v: xml:id (or equivalent in JSON)
definition:
  v: unique id for the element within a resource (for internal references). 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:
  code:
    v: string
    l: string
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.focus.extension
path:
  v: ResearchStudy.focus.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  ordered:
    v: false
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
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    v: *
type:
  code:
    v: Extension
    l: Extension

id:
  v: ResearchStudy.focus.extension:focus
path:
  v: ResearchStudy.focus.extension
slice name:
  v: focus
short:
  v: R5: Drugs, devices, etc. under study additional types
definition:
  v: R5: `ResearchStudy.focus` additional types (CodeableReference(http://hl7.org/fhir/StructureDefinition/Medication), CodeableReference(http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition), CodeableReference(http://hl7.org/fhir/StructureDefinition/SubstanceDefinition), CodeableReference(http://hl7.org/fhir/StructureDefinition/EvidenceVariable))
comment:
  v: Element `ResearchStudy.focus` is mapped to FHIR STU3 element `ResearchStudy.focus` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.focus` do not cover the following types: CodeableReference.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus

id:
  v: ResearchStudy.focus.coding
path:
  v: ResearchStudy.focus.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
min:
  v: 0
max:
  v: *
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
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    v: *
type:
  code:
    v: Coding
    l: Coding
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

id:
  v: ResearchStudy.focus.text
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
path:
  v: ResearchStudy.focus.text
short:
  v: Plain text representation of the concept
definition:
  v: A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
comment:
  v: Very often the text is the same as a displayName of one of the codings.
requirements:
  v: The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
min:
  v: 0
max:
  v: 1
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  path:
    v: CodeableConcept.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.9. But note many systems use C*E.2 for this
mapping:
  identity:
    v: rim
  map:
    v: ./originalText[mediaType/code="text/plain"]/data
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

id:
  v: ResearchStudy.contact
path:
  v: ResearchStudy.contact
short:
  v: Contact details for the study
definition:
  v: Contact details to assist a user in learning more about or engaging with the study.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.contact
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: ContactDetail
    l: ContactDetail
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators

id:
  v: ResearchStudy.relatedArtifact
path:
  v: ResearchStudy.relatedArtifact
short:
  v: References and dependencies
definition:
  v: Citations, references and other related documents.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.relatedArtifact
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: RelatedArtifact
    l: RelatedArtifact
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Citations, Links, Available Study Data/Documents

id:
  v: ResearchStudy.keyword
path:
  v: ResearchStudy.keyword
short:
  v: Used to search for the study
definition:
  v: Key terms to aid in searching for or filtering the study.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.keyword
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyKeyword
  strength:
    v: example
  description:
    v: Words associated with the study that may be useful in discovery
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Keywords

id:
  v: ResearchStudy.jurisdiction
path:
  v: ResearchStudy.jurisdiction
short:
  v: Geographic region(s) for study
definition:
  v: Indicates a country, state or other region where the study is taking place.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.jurisdiction
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: Jurisdiction
  strength:
    v: extensible
  description:
    v: Countries and regions within which this artifact is targeted for use
  value set: Reference
    l: 3.0
    l: .2
    reference:
      v: http://hl7.org/fhir/ValueSet/jurisdiction|3.0.2

id:
  v: ResearchStudy.description
path:
  v: ResearchStudy.description
short:
  v: What this is study doing
definition:
  v: A full description of how the study is being conducted.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.description
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: markdown
    l: markdown
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Detailed Description

id:
  v: ResearchStudy.enrollment
path:
  v: ResearchStudy.enrollment
short:
  v: Inclusion & exclusion criteria
definition:
  v: Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".
comment:
  v: The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.
alias:
  v: patient
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.enrollment
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Group
    l: Group
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
mapping:
  identity:
    v: w5
  map:
    v: who.focus

id:
  v: ResearchStudy.enrollment.id
path:
  v: ResearchStudy.enrollment.id
representation:
  v: xmlAttr
short:
  v: xml:id (or equivalent in JSON)
definition:
  v: unique id for the element within a resource (for internal references). 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:
  code:
    v: string
    l: string
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.enrollment.extension
path:
  v: ResearchStudy.enrollment.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  ordered:
    v: false
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension

id:
  v: ResearchStudy.enrollment.extension:eligibility
path:
  v: ResearchStudy.enrollment.extension
slice name:
  v: eligibility
short:
  v: R5: Inclusion and exclusion criteria additional types
definition:
  v: R5: `ResearchStudy.recruitment.eligibility` additional types from child elements (display, identifier, reference, type)
comment:
  v: Element `ResearchStudy.recruitment.eligibility` is mapped to FHIR STU3 element `ResearchStudy.enrollment` as `RelatedTo`. The mappings for `ResearchStudy.recruitment.eligibility` do not cover the following types based on type expansion: display, identifier, reference, type. The standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `ResearchStudy.recruitment.eligibility` with unmapped reference targets: EvidenceVariable, Group.
min:
  v: 0
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  v: 1
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  path:
    v: Element.extension
  min:
    v: 0
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    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/StructureDefinition/alternate-reference
    l: alternate-reference

id:
  v: ResearchStudy.enrollment.reference
path:
  v: ResearchStudy.enrollment.reference
short:
  v: Literal reference, Relative, internal or absolute URL
definition:
  v: A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.
comment:
  v: Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.reference
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
condition:
  v: ref-1
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.enrollment.identifier
path:
  v: ResearchStudy.enrollment.identifier
short:
  v: Logical reference, when literal reference is not known
definition:
  v: An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.
comment:
  v: When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.identifier
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Identifier
    l: Identifier
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: .identifier

id:
  v: ResearchStudy.enrollment.display
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
path:
  v: ResearchStudy.enrollment.display
short:
  v: Text alternative for the resource
definition:
  v: Plain text narrative that identifies the resource in addition to the resource reference.
comment:
  v: This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.display
  min:
    v: 0
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    v: 1
type:
  code:
    v: string
    l: string
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.period
path:
  v: ResearchStudy.period
short:
  v: When the study began and ended
definition:
  v: Identifies the start date and the expected (or actual, depending on status) end date for the study.
requirements:
  v: [The list of types may be constrained as appropriate for the type of event].
alias:
  v: timing
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.period
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Period
    l: Period
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Study Start Date (start); Study Completion Date (end)
mapping:
  identity:
    v: w5
  map:
    v: when.done

id:
  v: ResearchStudy.sponsor
path:
  v: ResearchStudy.sponsor
short:
  v: Organization responsible for the study
definition:
  v: The organization responsible for the execution of the study.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.sponsor
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    l: Organization
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Sponsor
mapping:
  identity:
    v: w5
  map:
    v: who.actor

id:
  v: ResearchStudy.principalInvestigator
path:
  v: ResearchStudy.principalInvestigator
short:
  v: The individual responsible for the study
definition:
  v: Indicates the individual who has primary oversite of the execution of the study.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.principalInvestigator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Practitioner
    l: Practitioner
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Principal Investigator
mapping:
  identity:
    v: w5
  map:
    v: who.actor

id:
  v: ResearchStudy.site
path:
  v: ResearchStudy.site
short:
  v: Location involved in study execution
definition:
  v: Clinic, hospital or other healthcare location that is participating in the study.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.site
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Location
    l: Location
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Facility
mapping:
  identity:
    v: w5
  map:
    v: where

id:
  v: ResearchStudy.site.id
path:
  v: ResearchStudy.site.id
representation:
  v: xmlAttr
short:
  v: xml:id (or equivalent in JSON)
definition:
  v: unique id for the element within a resource (for internal references). 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
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    v: 1
type:
  code:
    v: string
    l: string
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.site.extension
path:
  v: ResearchStudy.site.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  ordered:
    v: false
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension

id:
  v: ResearchStudy.site.extension:site
path:
  v: ResearchStudy.site.extension
slice name:
  v: site
short:
  v: R5: Facility where study activities are conducted
definition:
  v: R5: `ResearchStudy.site`
comment:
  v: Element `ResearchStudy.site` is mapped to FHIR STU3 element `ResearchStudy.site` as `SourceIsBroaderThanTarget`. The standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `ResearchStudy.site` with unmapped reference targets: Location, Organization, ResearchStudy.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/StructureDefinition/alternate-reference
    l: alternate-reference

id:
  v: ResearchStudy.site.reference
path:
  v: ResearchStudy.site.reference
short:
  v: Literal reference, Relative, internal or absolute URL
definition:
  v: A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.
comment:
  v: Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.reference
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
condition:
  v: ref-1
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.site.identifier
path:
  v: ResearchStudy.site.identifier
short:
  v: Logical reference, when literal reference is not known
definition:
  v: An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.
comment:
  v: When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.identifier
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Identifier
    l: Identifier
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: .identifier

id:
  v: ResearchStudy.site.display
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
    l: elementdefinition-translatable
  value: Boolean
    v: true
path:
  v: ResearchStudy.site.display
short:
  v: Text alternative for the resource
definition:
  v: Plain text narrative that identifies the resource in addition to the resource reference.
comment:
  v: This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.display
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.reasonStopped
path:
  v: ResearchStudy.reasonStopped
short:
  v: Reason for terminating study early
definition:
  v: A description and/or code explaining the premature termination of the study.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.reasonStopped
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Why Study Stopped
mapping:
  identity:
    v: w5
  map:
    v: why

id:
  v: ResearchStudy.note
path:
  v: ResearchStudy.note
short:
  v: Comments made about the event
definition:
  v: Comments made about the event by the performer, subject or other participants.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.note
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Annotation
    l: Annotation

id:
  v: ResearchStudy.arm
path:
  v: ResearchStudy.arm
short:
  v: Defined path through the study for a subject
definition:
  v: Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.arm
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Arms

id:
  v: ResearchStudy.arm.id
path:
  v: ResearchStudy.arm.id
representation:
  v: xmlAttr
short:
  v: xml:id (or equivalent in JSON)
definition:
  v: unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
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  path:
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type:
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    v: string
    l: string
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.arm.extension
path:
  v: ResearchStudy.arm.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  ordered:
    v: false
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
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  v: 0
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  v: *
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  path:
    v: Element.extension
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    l: Extension

id:
  v: ResearchStudy.arm.extension:linkId
path:
  v: ResearchStudy.arm.extension
slice name:
  v: linkId
short:
  v: R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new)
definition:
  v: R5: `ResearchStudy.comparisonGroup.linkId` (new:id)
comment:
  v: Element `ResearchStudy.comparisonGroup.linkId` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.comparisonGroup.linkId` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
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    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.arm.extension:intendedExposure
path:
  v: ResearchStudy.arm.extension
slice name:
  v: intendedExposure
short:
  v: R5: Interventions or exposures in this comparisonGroup or cohort (new)
definition:
  v: R5: `ResearchStudy.comparisonGroup.intendedExposure` (new:Reference(EvidenceVariable))
comment:
  v: Element `ResearchStudy.comparisonGroup.intendedExposure` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.comparisonGroup.intendedExposure` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure
condition:
  v: ele-1
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() | (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
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  key:
    v: ext-1
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    v: error
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    v: Must have either extensions or value[x], not both
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    v: extension.exists() != value.exists()
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    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.arm.extension:observedGroup
path:
  v: ResearchStudy.arm.extension
slice name:
  v: observedGroup
short:
  v: R5: Group of participants who were enrolled in study comparisonGroup (new)
definition:
  v: R5: `ResearchStudy.comparisonGroup.observedGroup` (new:Reference(Group))
comment:
  v: Element `ResearchStudy.comparisonGroup.observedGroup` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.comparisonGroup.observedGroup` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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  v: 0
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    v: Extension
    l: Extension
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    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
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    v: error
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    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() | (children().count() > id.count())
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    v: @value|f:*|h:div
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    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
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  key:
    v: ext-1
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    v: error
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    v: Must have either extensions or value[x], not both
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    v: extension.exists() != value.exists()
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    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false

id:
  v: ResearchStudy.arm.modifierExtension
path:
  v: ResearchStudy.arm.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 element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order 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.
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
alias:
  v: modifiers
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  v: 0
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base:
  path:
    v: BackboneElement.modifierExtension
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    v: 0
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    v: *
type:
  code:
    v: Extension
    l: Extension
is modifier:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.arm.name
path:
  v: ResearchStudy.arm.name
short:
  v: Label for study arm
definition:
  v: Unique, human-readable label for this arm of the study.
min:
  v: 1
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  v: 1
base:
  path:
    v: ResearchStudy.arm.name
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type:
  code:
    v: string
    l: string
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Arm Label

id:
  v: ResearchStudy.arm.code
path:
  v: ResearchStudy.arm.code
short:
  v: Categorization of study arm
definition:
  v: Categorization of study arm, e.g. experimental, active comparator, placebo comparater.
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type:
  code:
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mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Arm Type

id:
  v: ResearchStudy.arm.description
path:
  v: ResearchStudy.arm.description
short:
  v: Short explanation of study path
definition:
  v: A succinct description of the path through the study that would be followed by a subject adhering to this arm.
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    v: Arm Description

element:
  id:
    v: ResearchStudy
  path:
    v: ResearchStudy
element:
  id:
    v: ResearchStudy.extension
  path:
    v: ResearchStudy.extension
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      type:
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      path:
        v: url
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      v: open
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element:
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    v: ResearchStudy.extension:url
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    v: R5: Canonical identifier for this study resource (new)
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    v: R5: `ResearchStudy.url` (new:uri)
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    v: Element `ResearchStudy.url` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.url` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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      l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url
element:
  id:
    v: ResearchStudy.extension:version
  path:
    v: ResearchStudy.extension
  slice name:
    v: version
  short:
    v: R5: The business version for the study record (new)
  definition:
    v: R5: `ResearchStudy.version` (new:string)
  comment:
    v: Element `ResearchStudy.version` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.version` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
  min:
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element:
  id:
    v: ResearchStudy.extension:name
  path:
    v: ResearchStudy.extension
  slice name:
    v: name
  short:
    v: R5: Name for this study (computer friendly) (new)
  definition:
    v: R5: `ResearchStudy.name` (new:string)
  comment:
    v: Element `ResearchStudy.name` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.name` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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      l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name
element:
  id:
    v: ResearchStudy.extension:label
  path:
    v: ResearchStudy.extension
  slice name:
    v: label
  short:
    v: R5: Additional names for the study (new)
  definition:
    v: R5: `ResearchStudy.label` (new:BackboneElement)
  comment:
    v: Element `ResearchStudy.label` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.label` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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      l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
element:
  id:
    v: ResearchStudy.extension:date
  path:
    v: ResearchStudy.extension
  slice name:
    v: date
  short:
    v: R5: Date the resource last changed (new)
  definition:
    v: R5: `ResearchStudy.date` (new:dateTime)
  comment:
    v: Element `ResearchStudy.date` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.date` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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    v: 1
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      l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date
element:
  id:
    v: ResearchStudy.extension:primaryPurposeType
  path:
    v: ResearchStudy.extension
  slice name:
    v: primaryPurposeType
  short:
    v: R5: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility (new)
  definition:
    v: R5: `ResearchStudy.primaryPurposeType` (new:CodeableConcept)
  comment:
    v: Element `ResearchStudy.primaryPurposeType` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.primaryPurposeType` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
  min:
    v: 0
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      v: DomainResource.extension
    min:
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code:
  v: Extension
  l: Extension
profile:
  v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.primaryPurposeType|0.1.0
  l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.primaryPurposeType

id:
  v: ResearchStudy.extension:phase
path:
  v: ResearchStudy.extension
slice name:
  v: phase
short:
  v: R5: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 (new)
definition:
  v: R5: `ResearchStudy.phase` (new:CodeableConcept)
comment:
  v: Element `ResearchStudy.phase` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.phase` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.phase

id:
  v: ResearchStudy.extension:studyDesign
path:
  v: ResearchStudy.extension
slice name:
  v: studyDesign
short:
  v: R5: Classifications of the study design characteristics (new)
definition:
  v: R5: `ResearchStudy.studyDesign` (new:CodeableConcept)
comment:
  v: Element `ResearchStudy.studyDesign` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.studyDesign` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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  v: 0
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  v: *
base:
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    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign

id:
  v: ResearchStudy.extension:condition
path:
  v: ResearchStudy.extension
slice name:
  v: condition
short:
  v: R5: Condition being studied (new)
definition:
  v: R5: `ResearchStudy.condition` (new:CodeableConcept)
comment:
  v: Element `ResearchStudy.condition` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.condition` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
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base:
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    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.condition

id:
  v: ResearchStudy.extension:descriptionSummary
path:
  v: ResearchStudy.extension
slice name:
  v: descriptionSummary
short:
  v: R5: Brief text explaining the study (new)
definition:
  v: R5: `ResearchStudy.descriptionSummary` (new:markdown)
comment:
  v: Element `ResearchStudy.descriptionSummary` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.descriptionSummary` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
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base:
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    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary

id:
  v: ResearchStudy.extension:classifier
path:
  v: ResearchStudy.extension
slice name:
  v: classifier
short:
  v: R5: Classification for the study (new)
definition:
  v: R5: `ResearchStudy.classifier` (new:CodeableConcept)
comment:
  v: Element `ResearchStudy.classifier` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.classifier` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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id:
  v: ResearchStudy.extension:associatedParty
path:
  v: ResearchStudy.extension
slice name:
  v: associatedParty
short:
  v: R5: Sponsors, collaborators, and other parties (new)
definition:
  v: R5: `ResearchStudy.associatedParty` (new:BackboneElement)
comment:
  v: Element `ResearchStudy.associatedParty` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.associatedParty` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element). For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.
min:
  v: 0
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    v: 0
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  profile:
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    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty

id:
  v: ResearchStudy.extension:progressStatus
path:
  v: ResearchStudy.extension
slice name:
  v: progressStatus
short:
  v: R5: Status of study with time for that status (new)
definition:
  v: R5: `ResearchStudy.progressStatus` (new:BackboneElement)
comment:
  v: Element `ResearchStudy.progressStatus` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.progressStatus` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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  v: 0
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  v: *
base:
  path:
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    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus

id:
  v: ResearchStudy.extension:targetNumber
path:
  v: ResearchStudy.extension
slice name:
  v: targetNumber
short:
  v: R5: Estimated total number of participants to be enrolled (new)
definition:
  v: R5: `ResearchStudy.recruitment.targetNumber` (new:unsignedInt)
comment:
  v: Element `ResearchStudy.recruitment.targetNumber` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.recruitment.targetNumber` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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base:
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    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber

id:
  v: ResearchStudy.extension:actualNumber
path:
  v: ResearchStudy.extension
slice name:
  v: actualNumber
short:
  v: R5: Actual total number of participants enrolled in study (new)
definition:
  v: R5: `ResearchStudy.recruitment.actualNumber` (new:unsignedInt)
comment:
  v: Element `ResearchStudy.recruitment.actualNumber` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.recruitment.actualNumber` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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  path:
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  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber

id:
  v: ResearchStudy.extension:actualGroup
path:
  v: ResearchStudy.extension
slice name:
  v: actualGroup
short:
  v: R5: Group of participants who were enrolled in study (new)
definition:
  v: R5: `ResearchStudy.recruitment.actualGroup` (new:Reference(Group))
comment:
  v: Element `ResearchStudy.recruitment.actualGroup` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.recruitment.actualGroup` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup

id:
  v: ResearchStudy.extension:objective
path:
  v: ResearchStudy.extension
slice name:
  v: objective
short:
  v: R5: A goal for the study (new)
definition:
  v: R5: `ResearchStudy.objective` (new:BackboneElement)
comment:
  v: Element `ResearchStudy.objective` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.objective` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective

id:
  v: ResearchStudy.extension:outcomeMeasure
path:
  v: ResearchStudy.extension
slice name:
  v: outcomeMeasure
short:
  v: R5: A variable measured during the study (new)
definition:
  v: R5: `ResearchStudy.outcomeMeasure` (new:BackboneElement)
comment:
  v: Element `ResearchStudy.outcomeMeasure` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.outcomeMeasure` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element). A study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP
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  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure

id:
  v: ResearchStudy.extension:result
path:
  v: ResearchStudy.extension
slice name:
  v: result
short:
  v: R5: Link to results generated during the study (new)
definition:
  v: R5: `ResearchStudy.result` (new:Reference(EvidenceReport,Citation,DiagnosticReport))
comment:
  v: Element `ResearchStudy.result` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.result` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
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    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result

id:
  v: ResearchStudy.protocol.extension
path:
  v: ResearchStudy.protocol.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  ordered:
    v: false
  rules:
    v: open
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  v: 0
max:
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id:
  v: ResearchStudy.protocol.extension:protocol
path:
  v: ResearchStudy.protocol.extension
slice name:
  v: protocol
short:
  v: R5: protocol additional types
definition:
  v: R5: `ResearchStudy.protocol` additional types from child elements (display, identifier, reference, type)
comment:
  v: Element `ResearchStudy.protocol` is mapped to FHIR STU3 element `ResearchStudy.protocol` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.protocol` do not cover the following types based on type expansion: display, identifier, reference, type. The standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `ResearchStudy.protocol` with unmapped reference targets: PlanDefinition.
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  path:
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    v: *
type:
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    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/StructureDefinition/alternate-reference
    l: alternate-reference

id:
  v: ResearchStudy.partOf.extension
path:
  v: ResearchStudy.partOf.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  ordered:
    v: false
  rules:
    v: open
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  v: 0
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  v: *

id:
  v: ResearchStudy.partOf.extension:partOf
path:
  v: ResearchStudy.partOf.extension
slice name:
  v: partOf
short:
  v: R5: partOf additional types
definition:
  v: R5: `ResearchStudy.partOf` additional types from child elements (display, identifier, reference, type)
comment:
  v: Element `ResearchStudy.partOf` is mapped to FHIR STU3 element `ResearchStudy.partOf` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.partOf` do not cover the following types based on type expansion: display, identifier, reference, type. The standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `ResearchStudy.partOf` with unmapped reference targets: ResearchStudy.
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  v: 0
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  v: *
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  path:
    v: DomainResource.extension
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    v: 0
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    v: *
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  code:
    v: Extension
    l: Extension
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    v: http://hl7.org/fhir/StructureDefinition/alternate-reference
    l: alternate-reference

id:
  v: ResearchStudy.status.extension
path:
  v: ResearchStudy.status.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
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    v: false
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    v: open
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  v: 0
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id:
  v: ResearchStudy.status.extension:status
path:
  v: ResearchStudy.status.extension
slice name:
  v: status
short:
  v: R5: draft | active | retired | unknown additional codes
definition:
  v: R5: `ResearchStudy.status` additional codes
comment:
  v: Element `ResearchStudy.status` is mapped to FHIR STU3 element `ResearchStudy.status` as `RelatedTo`. The mappings for `ResearchStudy.status` do not allow expression of the necessary codes, per the bindings on the source and target. The target context `ResearchStudy.status` is a modifier element, so this extension does not need to be defined as a modifier.
min:
  v: 0
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    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status

id:
  v: ResearchStudy.focus.extension
path:
  v: ResearchStudy.focus.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
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    v: false
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    v: open
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  v: 0
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id:
  v: ResearchStudy.focus.extension:focus
path:
  v: ResearchStudy.focus.extension
slice name:
  v: focus
short:
  v: R5: Drugs, devices, etc. under study additional types
definition:
  v: R5: `ResearchStudy.focus` additional types (CodeableReference(http://hl7.org/fhir/StructureDefinition/Medication), CodeableReference(http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition), CodeableReference(http://hl7.org/fhir/StructureDefinition/SubstanceDefinition), CodeableReference(http://hl7.org/fhir/StructureDefinition/EvidenceVariable))
comment:
  v: Element `ResearchStudy.focus` is mapped to FHIR STU3 element `ResearchStudy.focus` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.focus` do not cover the following types: CodeableReference.
min:
  v: 0
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    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus

id:
  v: ResearchStudy.enrollment.extension
path:
  v: ResearchStudy.enrollment.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  ordered:
    v: false
  rules:
    v: open
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  v: 0
max:
  v: *

id:
  v: ResearchStudy.enrollment.extension:eligibility
path:
  v: ResearchStudy.enrollment.extension
slice name:
  v: eligibility
short:
  v: R5: Inclusion and exclusion criteria additional types
definition:
  v: R5: `ResearchStudy.recruitment.eligibility` additional types from child elements (display, identifier, reference, type)
comment:
  v: Element `ResearchStudy.recruitment.eligibility` is mapped to FHIR STU3 element `ResearchStudy.enrollment` as `RelatedTo`. The mappings for `ResearchStudy.recruitment.eligibility` do not cover the following types based on type expansion: display, identifier, reference, type. The standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `ResearchStudy.recruitment.eligibility` with unmapped reference targets: EvidenceVariable, Group.
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  v: 0
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  code:
    v: Extension
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  profile:
    v: http://hl7.org/fhir/StructureDefinition/alternate-reference
    l: alternate-reference

id:
  v: ResearchStudy.site.extension
path:
  v: ResearchStudy.site.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  ordered:
    v: false
  rules:
    v: open
min:
  v: 0
max:
  v: *

id:
  v: ResearchStudy.site.extension:site
path:
  v: ResearchStudy.site.extension
slice name:
  v: site
short:
  v: R5: Facility where study activities are conducted
definition:
  v: R5: `ResearchStudy.site`
comment:
  v: Element `ResearchStudy.site` is mapped to FHIR STU3 element `ResearchStudy.site` as `SourceIsBroaderThanTarget`. The standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `ResearchStudy.site` with unmapped reference targets: Location, Organization, ResearchStudy.
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  v: 0
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  v: *
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    v: DomainResource.extension
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    v: *
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  code:
    v: Extension
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    v: http://hl7.org/fhir/StructureDefinition/alternate-reference
    l: alternate-reference

id:
  v: ResearchStudy.arm.extension
path:
  v: ResearchStudy.arm.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  ordered:
    v: false
  rules:
    v: open
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  v: 0
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  v: *

id:
  v: ResearchStudy.arm.extension:linkId
path:
  v: ResearchStudy.arm.extension
slice name:
  v: linkId
short:
  v: R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new)
definition:
  v: R5: `ResearchStudy.comparisonGroup.linkId` (new:id)
comment:
  v: Element `ResearchStudy.comparisonGroup.linkId` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.comparisonGroup.linkId` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
min:
  v: 0
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  v: 1
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  path:
    v: DomainResource.extension
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    v: 0
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    v: *
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  code:
    v: Extension
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    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId

id:
  v: ResearchStudy.arm.extension:intendedExposure
path:
  v: ResearchStudy.arm.extension
slice name:
  v: intendedExposure
short:
  v: R5: Interventions or exposures in this comparisonGroup or cohort (new)
definition:
  v: R5: `ResearchStudy.comparisonGroup.intendedExposure` (new:Reference(EvidenceVariable))
comment:
  v: Element `ResearchStudy.comparisonGroup.intendedExposure` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.comparisonGroup.intendedExposure` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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  v: *
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  path:
    v: DomainResource.extension
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    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure

id:
  v: ResearchStudy.arm.extension:observedGroup
path:
  v: ResearchStudy.arm.extension
slice name:
  v: observedGroup
short:
  v: R5: Group of participants who were enrolled in study comparisonGroup (new)
definition:
  v: R5: `ResearchStudy.comparisonGroup.observedGroup` (new:Reference(Group))
comment:
  v: Element `ResearchStudy.comparisonGroup.observedGroup` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.comparisonGroup.observedGroup` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
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    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup|0.1.0
    l: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup