study-design
type: StructureDefinition
node role: treeRoot
id:
  v: study-design
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: StructureDefinition study-design 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:publicationStatus 0..1 CodeableConcept Publication status URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status Binding: Cited Artifact Status Type (preferred) #xD; extension:author 0..* ContactDetail Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author #xD; extension:confidentialityStatement 0..1 string Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sponsor-confidentiality-statement #xD; extension:saeReportingMethod 0..1 string Method for reporting Serious Adverse Events. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sae-reporting-method #xD; extension:studyAmendment 0..1 (Complex) An amendment to a study protocol URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment #xD; title 0..1 string Human readable name of the study #xD; relatesTo #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:quotation 0..1 markdown Quoted portion from related artifact URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to-with-quotation #xD; classifier 0..* CodeableConcept Classification for the study Binding: ResearchStudy Classifier Value Set (preferred) #xD; <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm
    l: structuredefinition-fmm
  value: Integer
    v: 1
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
    l: structuredefinition-wg
  value: Code
    v: cds
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
    l: structuredefinition-standards-status
  value: Code
    v: trial-use
url:
  v: http://hl7.org/fhir/uv/ebm/StructureDefinition/study-design
  l: study-design
identifier:
  system:
    v: urn:ietf:rfc:3986
    l: 3986
  value:
    v: urn:oid:2.16.840.1.113883.4.642.40.44.42.138
version:
  v: 1.0.0-ballot3
name:
  v: StudyDesign
status:
  v: active
date:
  v: 2026-03-27T09:54:14+00:00
publisher:
  v: HL7 International / Clinical Decision Support
contact:
  name:
    v: HL7 International / Clinical Decision Support
  telecom:
    system:
      v: url
    value:
      v: http://www.hl7.org/Special/committees/dss
description:
  v: Profile of ResearchStudy for Evidence Based Medicine IG. The StudyDesign Profile is used to add extensions for additional expressions of study design features with the study protocol.
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: 6.0.0-ballot3
mapping:
  identity:
    v: w5
  uri:
    v: http://hl7.org/fhir/fivews
    l: fivews
  name:
    v: FiveWs Pattern Mapping
mapping:
  identity:
    v: BRIDG5.1
  uri:
    v: https://bridgmodel.nci.nih.gov
    l: bridgmodel.nci.nih.gov
  name:
    v: BRIDG 5.1 Mapping
mapping:
  identity:
    v: v2
  uri:
    v: http://hl7.org/v2
    l: v2
  name:
    v: HL7 V2 Mapping
mapping:
  identity:
    v: rim
  uri:
    v: http://hl7.org/v3
    l: v3
  name:
    v: RIM Mapping
mapping:
  identity:
    v: clinicaltrials-gov
  uri:
    v: http://clinicaltrials.gov
    l: clinicaltrials.gov
  name:
    v: ClinicalTrials.gov Mapping
kind:
  v: resource
abstract:
  v: false
type:
  v: ResearchStudy
  l: ResearchStudy
base definition:
  v: http://hl7.org/fhir/StructureDefinition/ResearchStudy
  l: ResearchStudy
derivation:
  v: constraint
snapshot:
  extension:
    url:
      v: http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version
      l: snapshot-base-version
    value: String
      v: 6.0.0-ballot3
  element:
    id:
      v: ResearchStudy
    path:
      v: ResearchStudy
    short:
      v: Investigation to increase healthcare-related patient-independent knowledge
    definition:
      v: A scientific study intended to increase health-related knowledge. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.
    comment:
      v: The ResearchStudy Resource may be used for any type of research study, such as public health studies evaluating populations or systematic reviews evaluating research studies, and is not limited to clinical trials or limited to studies of individual people.
    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()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        l: DomainResource
    constraint:
      key:
        v: dom-3
      severity:
        v: error
      human:
        v: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
      expression:
        v: contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
      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()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        l: DomainResource
    constraint:
      key:
        v: dom-5
      severity:
        v: error
      human:
        v: If a resource is contained in another resource, it SHALL NOT have a security label
      expression:
        v: contained.meta.security.empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        l: DomainResource
    constraint:
      extension:
        value: Boolean

Boolean
v: true

url:
  v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation
  l: elementdefinition-bestpractice-explanation
value: Markdown
  v: When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.

v: dom-6

v: warning

v: A resource should have narrative for robust management

v: text.`div`.exists()

v: false

v: false

v: false

identity:
  v: rim
map:
  v: Entity, Role, or Act,Observation[classCode=CLNTRL, moodCode=EVN]

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

identity:
  v: BRIDG5.1
map:
  v: ObservationalStudyProtocolVersion; Study; StudyProtocolVersion

identity:
  v: v2
map:
  v: OBX

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: Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: id
      l: id
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
must support:
  v: false
is modifier:
  v: false
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 might not always be associated with version changes to the resource.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.meta
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Meta
    l: Meta
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
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. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
comment:
  v: Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.implicitRules
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: true
is modifier reason:
  v: This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
is summary:
  v: true

id:
  v: 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
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: Language
  strength:
    v: required
  description:
    v: IETF language tag for a human language
  value set:
    v: http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot3
    l: http://hl7.org/fhir/ValueSet/all-languages
  additional:
    purpose:
      v: starter
    value set:
      v: http://hl7.org/fhir/ValueSet/languages|6.0.0-ballot3
      l: http://hl7.org/fhir/ValueSet/languages

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 can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
comment:
  v: Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
alias:
  v: narrative
alias:
  v: html
alias:
  v: xhtml
alias:
  v: display
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Narrative
    l: Narrative
condition:
  v: dom-6
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
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, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
comment:
  v: This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. Contained resources may be a resource type defined in the FHIR specification, or an [additional resource](http://build.fhir.org/resource.html#additional).
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
condition:
  v: dom-2
condition:
  v: dom-4
condition:
  v: dom-3
condition:
  v: dom-5
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: 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
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchStudy.extension:publicationStatus
path:
  v: ResearchStudy.extension
slice name:
  v: publicationStatus
short:
  v: Publication status
definition:
  v: The status of the processing for making the artifact publicly available, not necessarily the same as artifact status (Resource.status).
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/uv/ebm/StructureDefinition/artifact-publication-status
    l: artifact-publication-status
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    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()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchStudy.extension:author
path:
  v: ResearchStudy.extension
slice name:
  v: author
short:
  v: Who authored the artifact
definition:
  v: An individual or organization primarily involved in the creation and maintenance of the artifact.
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/StructureDefinition/artifact-author
    l: artifact-author
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    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()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchStudy.extension:confidentialityStatement
path:
  v: ResearchStudy.extension
slice name:
  v: confidentialityStatement
short:
  v: Sponsor Confidentiality Statement, if applicable.
definition:
  v: Sponsor Confidentiality Statement, if applicable.
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/uv/ebm/StructureDefinition/research-study-sponsor-confidentiality-statement
    l: research-study-sponsor-confidentiality-statement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    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()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchStudy.extension:saeReportingMethod
path:
  v: ResearchStudy.extension
slice name:
  v: saeReportingMethod
short:
  v: Method for reporting Serious Adverse Events.
definition:
  v: Method for reporting Serious Adverse Events.
comment:
  v: Report Serious Adverse Events to the sponsor. Enter SAE reporting method(s). Refer to Section 9.4 for detailed reporting instructions.
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/uv/ebm/StructureDefinition/research-study-sae-reporting-method
    l: research-study-sae-reporting-method
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    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()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchStudy.extension:studyAmendment
path:
  v: ResearchStudy.extension
slice name:
  v: studyAmendment
short:
  v: An amendment to a study protocol
definition:
  v: An amendment to a study protocol.
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/uv/ebm/StructureDefinition/research-study-study-amendment
    l: research-study-study-amendment
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    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()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: false
is modifier:
  v: false
is summary:
  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 and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).
alias:
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alias:
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max:
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    v: DomainResource.modifierExtension
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    v: Extension
    l: Extension
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  key:
    v: ele-1
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    v: All FHIR elements must have a @value or children
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  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.url
path:
  v: ResearchStudy.url
short:
  v: Canonical identifier for this study resource
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  v: Canonical identifier for this study resource, represented as a globally unique URI.
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id:
  v: ResearchStudy.identifier
path:
  v: ResearchStudy.identifier
short:
  v: Business Identifier for study
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  v: Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
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    v: All FHIR elements must have a @value or children
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    v: http://hl7.org/fhir/StructureDefinition/Element
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  v: false
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  map:
    v: Organization's Unique Protocol ID; Secondary IDs
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.identifier
mapping:
  identity:
    v: BRIDG5.1
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    v: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
mapping:
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    v: rim
  map:
    v: .identifier

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  v: ResearchStudy.version
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  v: false

id:
  v: ResearchStudy.title
path:
  v: ResearchStudy.title
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  v: Human readable name of the study
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  v: The human readable name of the research study.
comment:
  v: The protocol should have a descriptive title that identifies the scientific aspects of the trial sufficiently to ensure it is immediately evident what the trial is investigating and on whom, and to allow retrieval from literature or internet searches.
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id:
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  v: Additional names for the study
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    v: All FHIR elements must have a @value or children or both
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id:
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  v: Unique id for inter-element referencing
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    v: n/a

id:
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  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
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  v: 0
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    v: All FHIR elements must have a @value or children
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  v: Extensions that cannot be ignored even if unrecognized
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  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).
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    v: All FHIR elements must have a @value or children
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id:
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    v: error
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    v: All FHIR elements must have a @value or children
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    v: http://hl7.org/fhir/StructureDefinition/Element
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  v: false
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  v: false
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binding:
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      v: TitleType
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    v: extensible
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    v: desc.
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id:
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  target profile:
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    l: http://hl7.org/fhir/StructureDefinition/PlanDefinition
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    v: All FHIR elements must have a @value or children
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  map:
    v: Interventions; Arm/Intervention Cross-Reference
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  map:
    v: StudyProtocolDocumentVersionPublicTitle.name
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  map:
    v: .outboundRelationship[typeCode=DEFN].target

id:
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    v: All FHIR elements must have a @value or children
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  map:
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id:
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id:
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  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).
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  v: ResearchStudy.relatesTo.type
short:
  v: documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
definition:
  v: The type of relationship to the related artifact.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchStudy.relatesTo.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: code
    l: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ArtifactRelationshipType
  strength:
    v: required
  description:
    v: The type of relationship to the related artifact.
  value set:
    v: http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
    l: http://hl7.org/fhir/ValueSet/artifact-relationship-type

id:
  v: ResearchStudy.relatesTo.target[x]
path:
  v: ResearchStudy.relatesTo.target[x]
short:
  v: The artifact that is related to this ResearchStudy
definition:
  v: The artifact that is related to this ResearchStudy Resource.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchStudy.relatesTo.target[x]
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
type:
  code:
    v: Attachment
    l: Attachment
type:
  code:
    v: canonical
    l: canonical
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Resource|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/Resource
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Resource|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/Resource
type:
  code:
    v: markdown
    l: markdown
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchStudy.date
path:
  v: ResearchStudy.date
short:
  v: Date the resource last changed
definition:
  v: The date (and optionally time) when the ResearchStudy Resource was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changes.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.date
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
    l: dateTime
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchStudy.status
path:
  v: ResearchStudy.status
short:
  v: draft | active | retired | unknown
definition:
  v: The publication state of the resource (not of the study).
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchStudy.status
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: code
    l: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: true
is modifier reason:
  v: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: PublicationStatus
  strength:
    v: required
  description:
    v: Codes that convey the current publication status of the research study resource.
  value set:
    v: http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot3
    l: http://hl7.org/fhir/ValueSet/publication-status
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.status
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyOverallStatus.code
mapping:
  identity:
    v: rim
  map:
    v: .status

id:
  v: ResearchStudy.primaryPurposeType
path:
  v: ResearchStudy.primaryPurposeType
short:
  v: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
definition:
  v: The type of study based upon the intent of the study activities. A classification of the intent of the study.
min:
  v: 0
max:
  v: 1
base:
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    v: ResearchStudy.primaryPurposeType
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    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyPrimaryPurposeType
  strength:
    v: preferred
  description:
    v: Codes for the main intent of the study.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-prim-purp-type|6.0.0-ballot3
    l: http://hl7.org/fhir/ValueSet/research-study-prim-purp-type
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolVersion.primaryPurposeTypeCode

id:
  v: ResearchStudy.phase
path:
  v: ResearchStudy.phase
short:
  v: Classifier used for clinical trials
definition:
  v: The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.phase
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    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyTrialPhase
  strength:
    v: preferred
  description:
    v: Classifiers of clinical trial progression for human use.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-trial-phase|6.0.0-ballot3
    l: http://hl7.org/fhir/ValueSet/research-study-trial-phase
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Study Phase
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolVersion.phaseCode

id:
  v: ResearchStudy.studyDesign
path:
  v: ResearchStudy.studyDesign
short:
  v: Classifications of the study design characteristics
definition:
  v: Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.studyDesign
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    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: StudyDesign
  strength:
    v: preferred
  description:
    v: This is a set of terms for study design characteristics.
  value set:
    v: http://hl7.org/fhir/ValueSet/study-design|6.0.0-ballot3
    l: http://hl7.org/fhir/ValueSet/study-design
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode

id:
  v: ResearchStudy.focus
path:
  v: ResearchStudy.focus
short:
  v: Drugs, devices, etc. under study
definition:
  v: The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.focus
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableReference
    l: CodeableReference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Medication|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/Medication
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/DeviceDefinition|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/DeviceDefinition
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/PlanDefinition|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/PlanDefinition
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyFocusType
  strength:
    v: example
  description:
    v: Some example codes of research study focus
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-focus-type|6.0.0-ballot3
    l: http://hl7.org/fhir/ValueSet/research-study-focus-type

id:
  v: ResearchStudy.condition
path:
  v: ResearchStudy.condition
short:
  v: Condition being studied
definition:
  v: The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.condition
  min:
    v: 0
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    v: *
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ConditionCode
  strength:
    v: example
  description:
    v: Identification of the condition or diagnosis.
  value set:
    v: http://hl7.org/fhir/ValueSet/condition-code|6.0.0-ballot3
    l: http://hl7.org/fhir/ValueSet/condition-code
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Conditions
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.what[x]
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyCondition.code

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
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyFocusType
  strength:
    v: example
  description:
    v: Some example codes.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-focus-type|6.0.0-ballot3
    l: http://hl7.org/fhir/ValueSet/research-study-focus-type
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Keywords
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: DocumentVersion.keywordCode; DocumentVersion.keywordText

id:
  v: ResearchStudy.region
path:
  v: ResearchStudy.region
short:
  v: Geographic area for the study
definition:
  v: A country, state or other area where the study is taking place rather than its precise geographic location or address.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.region
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
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:
    v: http://hl7.org/fhir/ValueSet/jurisdiction|6.0.0-ballot3
    l: http://hl7.org/fhir/ValueSet/jurisdiction
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolVersion.participatingLocationCode

id:
  v: ResearchStudy.descriptionSummary
path:
  v: ResearchStudy.descriptionSummary
short:
  v: Brief text explaining the study
definition:
  v: A brief text for explaining the study.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.descriptionSummary
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: markdown
    l: markdown
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchStudy.description
path:
  v: ResearchStudy.description
short:
  v: Detailed narrative of the study
definition:
  v: A detailed and human-readable narrative of the study. E.g., study abstract.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.description
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: markdown
    l: markdown
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Detailed Description
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolDocumentVersion.publicDescription

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.
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
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
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: FiveWs.done[x]
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
mapping:
  identity:
    v: rim
  map:
    v: .effectiveTime

id:
  v: ResearchStudy.site
path:
  v: ResearchStudy.site
short:
  v: Facility where study activities are conducted
definition:
  v: A facility in which study activities are conducted.
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|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/Location
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/ResearchStudy|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/ResearchStudy
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/Organization
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Facility
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.where[x]
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: PlannedStudySite; StudySite

id:
  v: ResearchStudy.note
path:
  v: ResearchStudy.note
short:
  v: Comments made about the study
definition:
  v: Comments made about the study by the performer, subject or other participants.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.note
  min:
    v: 0
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    v: *
type:
  code:
    v: Annotation
    l: Annotation
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: No BRIDG mapping
mapping:
  identity:
    v: rim
  map:
    v: .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]

id:
  v: ResearchStudy.classifier
path:
  v: ResearchStudy.classifier
short:
  v: Classification for the study
definition:
  v: Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.classifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
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must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
binding:
  strength:
    v: preferred
  value set:
    v: http://hl7.org/fhir/uv/ebm/ValueSet/research-study-classifier
    l: research-study-classifier

id:
  v: ResearchStudy.associatedParty
path:
  v: ResearchStudy.associatedParty
short:
  v: Sponsors, collaborators, and other parties
definition:
  v: Sponsors, collaborators, and other parties.
comment:
  v: For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.
requirements:
  v: While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles.
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    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
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  v: false
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  v: false
is summary:
  v: false

id:
  v: ResearchStudy.associatedParty.id
path:
  v: ResearchStudy.associatedParty.id
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  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
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  v: false
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  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.associatedParty.extension
path:
  v: ResearchStudy.associatedParty.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
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max:
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    l: Extension
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    v: All FHIR elements must have a @value or children
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    v: hasValue() or (children().count() > id.count())
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    l: Element
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  v: false
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  v: false
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  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.associatedParty.modifierExtension
path:
  v: ResearchStudy.associatedParty.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).
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alias:
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    v: All FHIR elements must have a @value or children
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    v: hasValue() or (children().count() > id.count())
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  v: true
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  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.associatedParty.name
path:
  v: ResearchStudy.associatedParty.name
short:
  v: Name of associated party
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  v: Name of associated party.
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    v: error
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    v: All FHIR elements must have a @value or children
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    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
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  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchStudy.associatedParty.role
path:
  v: ResearchStudy.associatedParty.role
short:
  v: sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb
definition:
  v: Type of association.
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    v: ele-1
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    v: error
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    v: All FHIR elements must have a @value or children
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    v: hasValue() or (children().count() > id.count())
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    v: http://hl7.org/fhir/StructureDefinition/Element
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  v: false
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  v: false
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  v: false
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  extension:
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      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyPartyRole
  strength:
    v: extensible
  description:
    v: desc.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-party-role|6.0.0-ballot3
    l: http://hl7.org/fhir/ValueSet/research-study-party-role

id:
  v: ResearchStudy.associatedParty.period
path:
  v: ResearchStudy.associatedParty.period
short:
  v: When active in the role
definition:
  v: Identifies the start date and the end date of the associated party in the role.
comment:
  v: The cardinality is 0..* due to the fact that an associated party may be intermittently active in a given role over multiple time periods.
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  v: 0
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  v: *
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    v: ResearchStudy.associatedParty.period
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type:
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    v: Period
    l: Period
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    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() or (children().count() > id.count())
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    l: Element
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  v: false
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  v: false
is summary:
  v: false

id:
  v: ResearchStudy.associatedParty.classifier
path:
  v: ResearchStudy.associatedParty.classifier
short:
  v: nih | fda | government | nonprofit | academic | industry
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  v: A categorization other than role for the associated party.
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    v: ele-1
  severity:
    v: error
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    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
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    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
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  v: false
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  v: false
is summary:
  v: false
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      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyPartyOrganizationType
  strength:
    v: example
  description:
    v: A characterization or type of the entity.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-party-organization-type|6.0.0-ballot3
    l: http://hl7.org/fhir/ValueSet/research-study-party-organization-type

id:
  v: ResearchStudy.associatedParty.party
path:
  v: ResearchStudy.associatedParty.party
short:
  v: Individual or organization associated with study (use practitionerRole to specify their organisation)
definition:
  v: Individual or organization associated with study (use practitionerRole to specify their organisation).
comment:
  v: Suggestions of a better attribute name are appreciated
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    l: http://hl7.org/fhir/StructureDefinition/Practitioner
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    l: http://hl7.org/fhir/StructureDefinition/PractitionerRole
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/Organization
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  key:
    v: ele-1
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    v: error
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    v: All FHIR elements must have a @value or children
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  v: false
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  v: false
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  v: false

id:
  v: ResearchStudy.progressStatus
path:
  v: ResearchStudy.progressStatus
short:
  v: Status of study with time for that status
definition:
  v: Status of study with time for that status.
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    v: ResearchStudy.progressStatus
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    v: All FHIR elements must have a @value or children or both
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  v: false

id:
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path:
  v: ResearchStudy.progressStatus.id
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short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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  v: 0
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      v: string
      l: string
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  v: ele-1
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    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.progressStatus.extension
path:
  v: ResearchStudy.progressStatus.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
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alias:
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  v: ResearchStudy.progressStatus.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).
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  v: user content
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    v: All FHIR elements must have a @value or children
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  identity:
    v: rim
  map:
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id:
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    v: All FHIR elements must have a @value or children
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  v: false
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  v: false
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  v: false
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  extension:
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      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
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    value: String
      v: ResearchStudyStudyStatus
  strength:
    v: extensible
  description:
    v: defn.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-status|6.0.0-ballot3
    l: http://hl7.org/fhir/ValueSet/research-study-status

id:
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path:
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  v: Actual if true else anticipated
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    v: ele-1
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    v: error
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    v: All FHIR elements must have a @value or children
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  v: false
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  v: false
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  v: false

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    v: error
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    v: All FHIR elements must have a @value or children
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  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchStudy.whyStopped
path:
  v: ResearchStudy.whyStopped
short:
  v: accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
definition:
  v: A description and/or code explaining the premature termination of the study.
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    v: All FHIR elements must have a @value or children
  expression:
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  v: false
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  v: false
is summary:
  v: true
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  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyReasonStopped
  strength:
    v: example
  description:
    v: Codes for why the study ended prematurely.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-reason-stopped|6.0.0-ballot3
    l: http://hl7.org/fhir/ValueSet/research-study-reason-stopped
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Why Study Stopped
mapping:
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    v: w5
  map:
    v: FiveWs.why[x]
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyOverallStatus.studyStoppedReasonCode

id:
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path:
  v: ResearchStudy.recruitment
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  v: Target or actual group of participants enrolled in study
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  v: Target or actual group of participants enrolled in study.
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    v: error
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    v: All FHIR elements must have a @value or children or both
  expression:
    v: hasValue() or (children().count() > id.count())
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    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
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  v: false
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  v: false
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: FiveWs.subject[x]
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: InterventionalStudyProtocol.interventionGroupQuantity
mapping:
  identity:
    v: rim
  map:
    v: .participation[typeCode=SBJ].role

id:
  v: ResearchStudy.recruitment.id
path:
  v: ResearchStudy.recruitment.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
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    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.recruitment.extension
path:
  v: ResearchStudy.recruitment.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.recruitment.modifierExtension
path:
  v: ResearchStudy.recruitment.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).
alias:
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alias:
  v: user content
alias:
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  v: 0
max:
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    l: Extension
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    v: ele-1
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    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
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    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
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  v: true
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  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.recruitment.targetNumber
path:
  v: ResearchStudy.recruitment.targetNumber
short:
  v: Estimated total number of participants to be enrolled
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  v: Estimated total number of participants to be enrolled.
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max:
  v: 1
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    v: ResearchStudy.recruitment.targetNumber
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type:
  code:
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    l: unsignedInt
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    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
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    l: Element
must support:
  v: false
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  v: false
is summary:
  v: false

id:
  v: ResearchStudy.recruitment.actualNumber
path:
  v: ResearchStudy.recruitment.actualNumber
short:
  v: Actual total number of participants enrolled in study
definition:
  v: Actual total number of participants enrolled in study.
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    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchStudy.recruitment.eligibility
path:
  v: ResearchStudy.recruitment.eligibility
short:
  v: Inclusion and exclusion criteria
definition:
  v: Inclusion and exclusion criteria. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'.
min:
  v: 0
max:
  v: 1
base:
  path:
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  min:
    v: 0
  max:
    v: 1
type:
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    l: Reference
  target profile:
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    l: http://hl7.org/fhir/StructureDefinition/Group
constraint:
  key:
    v: ele-1
  severity:
    v: error
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    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
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    l: Element
must support:
  v: false
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  v: false
is summary:
  v: false

id:
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path:
  v: ResearchStudy.recruitment.actualGroup
short:
  v: Group of participants who were enrolled in study
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  v: Group of participants who were enrolled in study. The referenced Group Resource should have a membership element value of 'enumerated'.
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    l: http://hl7.org/fhir/StructureDefinition/Group
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    v: All FHIR elements must have a @value or children
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    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
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: FiveWs.subject[x]
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: InterventionalStudyProtocol.interventionGroupQuantity
mapping:
  identity:
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  map:
    v: .participation[typeCode=SBJ].role

id:
  v: ResearchStudy.comparisonGroup
path:
  v: ResearchStudy.comparisonGroup
short:
  v: Defined path through the study for a subject
definition:
  v: Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}.
comment:
  v: In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups.
alias:
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  v: 0
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type:
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    l: BackboneElement
constraint:
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    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children or both
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
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    l: Element
must support:
  v: false
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mapping:
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  map:
    v: Arms
mapping:
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  map:
    v: Arm

id:
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path:
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representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
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type:
  extension:
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    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
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condition:
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mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
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path:
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short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
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alias:
  v: user content
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  v: 0
max:
  v: *
base:
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    v: All FHIR elements must have a @value or children
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    v: hasValue() or (children().count() > id.count())
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mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
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path:
  v: ResearchStudy.comparisonGroup.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).
alias:
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alias:
  v: user content
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    v: All FHIR elements must have a @value or children
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  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
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mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
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  v: ResearchStudy.comparisonGroup.targetNumber
short:
  v: Estimated total number of participants to be enrolled in the comparison group
definition:
  v: Estimated total number of participants to be enrolled in the comparison group.
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max:
  v: 1
base:
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  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
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id:
  v: ResearchStudy.comparisonGroup.actualNumber
path:
  v: ResearchStudy.comparisonGroup.actualNumber
short:
  v: Actual total number of participants enrolled in the comparison group
definition:
  v: Actual total number of participants enrolled in the comparison group.
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    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
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    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchStudy.comparisonGroup.eligibility
path:
  v: ResearchStudy.comparisonGroup.eligibility
short:
  v: Inclusion and exclusion criteria for the comparison group
definition:
  v: Inclusion and exclusion criteria for the comparison group as a subset of the eligibility for the overall study. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'.
min:
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max:
  v: 1
base:
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    v: ResearchStudy.comparisonGroup.eligibility
  min:
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type:
  code:
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    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Group|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/Group
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchStudy.comparisonGroup.observedGroup
path:
  v: ResearchStudy.comparisonGroup.observedGroup
short:
  v: Group of participants who were enrolled in the comparison group
definition:
  v: Group of participants who were enrolled in the comparison group as a subset of those enrolled in the overall study. The referenced Group Resource should have a membership element value of 'enumerated'.
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  v: 0
max:
  v: 1
base:
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    v: ResearchStudy.comparisonGroup.observedGroup
  min:
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    v: 1
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    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Group|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/Group
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    v: ele-1
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    v: error
  human:
    v: All FHIR elements must have a @value or children
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    v: hasValue() or (children().count() > id.count())
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    l: Element
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  v: false
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  v: false
is summary:
  v: false

id:
  v: ResearchStudy.objective
path:
  v: ResearchStudy.objective
short:
  v: A goal for the study
definition:
  v: A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.
min:
  v: 0
max:
  v: *
base:
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    v: ResearchStudy.objective
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    v: 0
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type:
  code:
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    v: ele-1
  severity:
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    v: All FHIR elements must have a @value or children or both
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    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyObjective

id:
  v: ResearchStudy.objective.id
path:
  v: ResearchStudy.objective.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
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base:
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    v: Element.id
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type:
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    url:
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    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
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condition:
  v: ele-1
is modifier:
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mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.objective.extension
path:
  v: ResearchStudy.objective.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
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  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
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type:
  code:
    v: Extension
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  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
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    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
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  v: false
is summary:
  v: false
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  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.objective.modifierExtension
path:
  v: ResearchStudy.objective.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).
alias:
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alias:
  v: user content
alias:
  v: modifiers
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max:
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    v: BackboneElement.modifierExtension
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type:
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constraint:
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    v: All FHIR elements must have a @value or children
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  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
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mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.objective.name
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  v: ResearchStudy.objective.name
short:
  v: Label for the objective
definition:
  v: Unique, human-readable label for this objective of the study.
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  v: 0
max:
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    v: ResearchStudy.objective.name
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    v: 0
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type:
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    l: string
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  key:
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  human:
    v: All FHIR elements must have a @value or children
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    v: http://hl7.org/fhir/StructureDefinition/Element
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  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: No BRIDG mapping (BRIDG has a description, but not a name)

id:
  v: ResearchStudy.objective.type
path:
  v: ResearchStudy.objective.type
short:
  v: primary | secondary | exploratory
definition:
  v: The kind of study objective.
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  v: 0
max:
  v: 1
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    v: ResearchStudy.objective.type
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type:
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  key:
    v: ele-1
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    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
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comment:
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id:
  v: ResearchStudy.objective.outcomeMeasure.eventHandling.description
path:
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short:
  v: Text summary of event handling
definition:
  v: Text summary of event handling.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.objective.outcomeMeasure.eventHandling.description
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: markdown
    l: markdown
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false

id:
  v: ResearchStudy.result
path:
  v: ResearchStudy.result
short:
  v: Link to results generated during the study
definition:
  v: Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.result
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Citation|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/Citation
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Composition|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/Composition
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/DiagnosticReport|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/DiagnosticReport
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Evidence|6.0.0-ballot3
    l: http://hl7.org/fhir/StructureDefinition/Evidence
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

element:
  id:
    v: ResearchStudy
  path:
    v: ResearchStudy
element:
  id:
    v: ResearchStudy.extension
  path:
    v: ResearchStudy.extension
  slicing:
    discriminator:
      type:
        v: value
      path:
        v: url
    ordered:
      v: false
    rules:
      v: open
element:
  id:
    v: ResearchStudy.extension:publicationStatus
  path:
    v: ResearchStudy.extension
  slice name:
    v: publicationStatus
  min:
    v: 0
  max:
    v: 1
  type:
    code:
      v: Extension
      l: Extension
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
      l: artifact-publication-status
element:
  id:
    v: ResearchStudy.extension:author
  path:
    v: ResearchStudy.extension
  slice name:
    v: author
  min:
    v: 0
  max:
    v: *
  type:
    code:
      v: Extension
      l: Extension
    profile:
      v: http://hl7.org/fhir/StructureDefinition/artifact-author
      l: artifact-author
element:
  id:
    v: ResearchStudy.extension:confidentialityStatement
  path:
    v: ResearchStudy.extension
  slice name:
    v: confidentialityStatement
  min:
    v: 0
  max:
    v: 1
  type:
    code:
      v: Extension
      l: Extension
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sponsor-confidentiality-statement
      l: research-study-sponsor-confidentiality-statement
element:
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    v: ResearchStudy.extension:saeReportingMethod
  path:
    v: ResearchStudy.extension
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    v: saeReportingMethod
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    v: 0
  max:
    v: 1
  type:
    code:
      v: Extension
      l: Extension
    profile:
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      l: research-study-sae-reporting-method
element:
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  path:
    v: ResearchStudy.extension
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    v: studyAmendment
  min:
    v: 0
  max:
    v: 1
  type:
    code:
      v: Extension
      l: Extension
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment
      l: research-study-study-amendment
element:
  id:
    v: ResearchStudy.title
  path:
    v: ResearchStudy.title
  comment:
    v: The protocol should have a descriptive title that identifies the scientific aspects of the trial sufficiently to ensure it is immediately evident what the trial is investigating and on whom, and to allow retrieval from literature or internet searches.
element:
  id:
    v: ResearchStudy.relatesTo.extension
  path:
    v: ResearchStudy.relatesTo.extension
  slicing:
    discriminator:
      type:
        v: value
      path:
        v: url
    ordered:
      v: false
    rules:
      v: open
element:
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    v: ResearchStudy.relatesTo.extension:quotation
  path:
    v: ResearchStudy.relatesTo.extension
  slice name:
    v: quotation
  min:
    v: 0
  max:
    v: 1
  type:
    code:
      v: Extension
      l: Extension
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to-with-quotation
      l: relates-to-with-quotation
element:
  id:
    v: ResearchStudy.classifier
  path:
    v: ResearchStudy.classifier
  binding:
    strength:
      v: preferred
    value set:
      v: http://hl7.org/fhir/uv/ebm/ValueSet/research-study-classifier
      l: research-study-classifier