mii-pr-mtb-studie
type: StructureDefinition
node role: treeRoot
id:
  v: mii-pr-mtb-studie
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: StructureDefinition mii-pr-mtb-studie Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> ResearchStudy 0..* MII_PR_Studie_Studie Investigation to increase healthcare-related patient-independent knowledge #xD; meta S 0..1 Meta Metadata about the resource #xD; profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to #xD; Slices for identifier 0..* Identifier Name für diese Studie Slice: Unordered, Open by value:system #xD; identifier:NCT 0..1 Identifier Name für diese Studie #xD; system 1..1 uri The namespace for the identifier value Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct #xD; value 1..1 string The value that is unique #xD; identifier:DRKS 0..1 Identifier Name für diese Studie #xD; system 1..1 uri The namespace for the identifier value Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks #xD; value 1..1 string The value that is unique #xD; identifier:EudraCT 0..1 Identifier Name für diese Studie #xD; system 1..1 uri The namespace for the identifier value Required Pattern: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract #xD; value 1..1 string The value that is unique #xD; <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
url:
  v: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studie
  l: mii-pr-mtb-studie
version:
  v: 2026.0.0
name:
  v: MII_PR_MTB_Studie
title:
  v: MII PR MTB Studie
status:
  v: active
date:
  v: 2026-02-09T10:07:17+00:00
publisher:
  v: Medizininformatik-Initiative
contact:
  name:
    v: Medizininformatik-Initiative
  telecom:
    system:
      v: url
    value:
      v: https://www.medizininformatik-initiative.de
description:
  v: Onkologische Studie
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 276
fhir version:
  v: 4.0.1
kind:
  v: resource
abstract:
  v: false
type:
  v: ResearchStudy
  l: ResearchStudy
base definition:
  v: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie
  l: mii-pr-studie-studie
derivation:
  v: constraint
snapshot:
  extension:
    url:
      v: http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version
      l: snapshot-base-version
    value: String
      v: 2026.0.1
  element:
    id:
      v: ResearchStudy
    path:
      v: ResearchStudy
    short:
      v: Investigation to increase healthcare-related patient-independent knowledge
    definition:
      v: A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
    comment:
      v: Need to make sure we encompass public health studies.
    alias:
      v: Clinical Trial
    alias:
      v: Study
    min:
      v: 0
    max:
      v: *
    base:
      path:
        v: ResearchStudy
      min:
        v: 0
      max:
        v: *
    constraint:
      key:
        v: dom-2
      severity:
        v: error
      human:
        v: If the resource is contained in another resource, it SHALL NOT contain nested Resources
      expression:
        v: contained.contained.empty()
      xpath:
        v: not(parent::f:contained and f:contained)
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        l: DomainResource
    constraint:
      key:
        v: dom-4
      severity:
        v: error
      human:
        v: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
      expression:
        v: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
      xpath:
        v: not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        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 in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
      xpath:
        v: not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        l: DomainResource
    constraint:
      extension:
        value: Boolean
      extension:
        value: Markdown
      key:
        v: dom-6
      severity:
        v: warning
      human:
        v: A resource should have narrative for robust management
      expression:
        v: text.`div`.exists()
      xpath:
        v: exists(f:text/h:div)
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        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()
      xpath:
        v: not(exists(f:contained/*/f:meta/f:security))
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        l: DomainResource
    mapping:
      identity:
        v: rim
      map:
        v: Entity. Role, or Act
    mapping:
      identity:
        v: BRIDG5.1
      map:
        v: ObservationalStudyProtocolVersion; Study; StudyProtocolVersion
    mapping:
      identity:
        v: v2
      map:
        v: OBX
    mapping:
      identity:
        v: rim
      map:
        v: Observation[classCode=CLNTRL, moodCode=EVN]
  element:
    id:
      v: ResearchStudy.id
    path:
      v: ResearchStudy.id
    short:
      v: Logical id of this artifact
    definition:
      v: The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
    comment:
      v: The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
    min:
      v: 0
    max:
      v: 1
    base:
      path:
        v: Resource.id
      min:
        v: 0
      max:
        v: 1

Boolean
v: true

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

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

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
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

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

id:
  v: ResearchStudy.meta.extension
path:
  v: ResearchStudy.meta.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.meta.versionId
path:
  v: ResearchStudy.meta.versionId
short:
  v: Version specific identifier
definition:
  v: The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.
comment:
  v: The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Meta.versionId
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: id
    l: id
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true

id:
  v: ResearchStudy.meta.lastUpdated
path:
  v: ResearchStudy.meta.lastUpdated
short:
  v: When the resource version last changed
definition:
  v: When the resource last changed - e.g. when the version changed.
comment:
  v: This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a [read](http://hl7.org/fhir/R4/http.html#read) interaction.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Meta.lastUpdated
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: instant
    l: instant
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true

id:
  v: ResearchStudy.meta.source
path:
  v: ResearchStudy.meta.source
short:
  v: Identifies where the resource comes from
definition:
  v: A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](http://hl7.org/fhir/R4/provenance.html#) information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.
comment:
  v: In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Meta.source
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true

id:
  v: ResearchStudy.meta.profile
path:
  v: ResearchStudy.meta.profile
short:
  v: Profiles this resource claims to conform to
definition:
  v: A list of profiles (references to [StructureDefinition](http://hl7.org/fhir/R4/structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](http://hl7.org/fhir/R4/structuredefinition-definitions.html#StructureDefinition.url).
comment:
  v: It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Meta.profile
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: canonical
    l: canonical
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/StructureDefinition|4.0.1
    l: http://hl7.org/fhir/StructureDefinition/StructureDefinition
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true

id:
  v: ResearchStudy.meta.security
path:
  v: ResearchStudy.meta.security
short:
  v: Security Labels applied to this resource
definition:
  v: Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.
comment:
  v: The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Meta.security
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
    l: Coding
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
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: SecurityLabels
  strength:
    v: extensible
  description:
    v: Security Labels from the Healthcare Privacy and Security Classification System.
  value set:
    v: http://hl7.org/fhir/ValueSet/security-labels|4.0.1
    l: http://hl7.org/fhir/ValueSet/security-labels

id:
  v: ResearchStudy.meta.tag
path:
  v: ResearchStudy.meta.tag
short:
  v: Tags applied to this resource
definition:
  v: Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.
comment:
  v: The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.
min:
  v: 0
max:
  v: *
base:
  path:
    v: Meta.tag
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
    l: Coding
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
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: Tags
  strength:
    v: example
  description:
    v: Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
  value set:
    v: http://hl7.org/fhir/ValueSet/common-tags|4.0.1
    l: http://hl7.org/fhir/ValueSet/common-tags

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

id:
  v: 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
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet
      l: elementdefinition-maxValueSet
    value: Canonical
      v: http://hl7.org/fhir/ValueSet/all-languages
      l: all-languages
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: Language
  strength:
    v: preferred
  description:
    v: A human language.
  value set:
    v: http://hl7.org/fhir/ValueSet/languages
    l: languages
mapping:
  identity:
    v: rim
  map:
    v: n/a

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 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: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A
mapping:
  identity:
    v: rim
  map:
    v: Act.text?

id:
  v: ResearchStudy.contained
path:
  v: ResearchStudy.contained
short:
  v: Contained, inline Resources
definition:
  v: These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
comment:
  v: This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
alias:
  v: inline resources
alias:
  v: anonymous resources
alias:
  v: contained resources
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.contained
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Resource
    l: Resource
mapping:
  identity:
    v: rim
  map:
    v: Entity. Role, or Act
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.extension
path:
  v: ResearchStudy.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.extension:Label
path:
  v: ResearchStudy.extension
slice name:
  v: Label
short:
  v: Label
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Backport Label
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Backport Label
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optional Extension Element - found in all resources.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
    l: extension-ResearchStudy.label
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.extension:AssociatedParty
path:
  v: ResearchStudy.extension
slice name:
  v: AssociatedParty
short:
  v: AssociatedParty
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Backport AssociatedParty
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Backport AssociatedParty
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optional Extension Element - found in all resources.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
    l: extension-ResearchStudy.associatedParty
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.extension:Ethikvotum
path:
  v: ResearchStudy.extension
slice name:
  v: Ethikvotum
short:
  v: Ethikvotum
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Ethikvotum
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Ethikvotum
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optional Extension Element - found in all resources.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum
    l: mii-ex-studie-ethikvotum
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.extension:Studienregister
path:
  v: ResearchStudy.extension
slice name:
  v: Studienregister
short:
  v: Studienregister
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Studienregister
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Studienregister
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optional Extension Element - found in all resources.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister
    l: mii-ex-studie-studienregister
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.extension:Eligibility
path:
  v: ResearchStudy.extension
slice name:
  v: Eligibility
short:
  v: Eligibility
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Eligibility
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Eligibility
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optional Extension Element - found in all resources.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
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: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility
    l: mii-ex-studie-eligibility
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.extension:Akronym
path:
  v: ResearchStudy.extension
slice name:
  v: Akronym
short:
  v: Akronym
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Akronym
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Akronym
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optional Extension Element - found in all resources.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
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: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym
    l: mii-ex-studie-akronym
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.extension:Rekrutierung
path:
  v: ResearchStudy.extension
slice name:
  v: Rekrutierung
short:
  v: Rekrutierung
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Rekrutierung
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Rekrutierung
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optional Extension Element - found in all resources.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
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: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung
    l: mii-ex-studie-rekrutierung
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.extension:Finanzierung
path:
  v: ResearchStudy.extension
slice name:
  v: Finanzierung
short:
  v: Finanzierung
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Finanzierung
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: MII EX Studie Finanzierung
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optionales Erweiterungselement – in allen Ressourcen vorhanden.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Optional Extension Element - found in all resources.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
  profile:
    v: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung
    l: mii-ex-studie-finanzierung
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
must support:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.modifierExtension
path:
  v: ResearchStudy.modifierExtension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Extensions that cannot be ignored
definition:
  v: May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.identifier
path:
  v: ResearchStudy.identifier
slicing:
  discriminator:
    type:
      v: value
    path:
      v: system
  description:
    v: Slice für Identifikator eines Studienregisters bzw. studiendurchführenden Organisation anhand von `system`
  ordered:
    v: false
  rules:
    v: open
short:
  v: Name für diese Studie
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Name für diese Studie.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Business Identifier for study.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Identifiers assigned to this research study by the sponsor or other systems.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
requirements:
  v: Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Identifier
    l: Identifier
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX / EI (occasionally, more often EI maps to a resource id or a URL)
mapping:
  identity:
    v: rim
  map:
    v: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
mapping:
  identity:
    v: servd
  map:
    v: Identifier
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Organization's Unique Protocol ID; Secondary IDs
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.identifier
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
mapping:
  identity:
    v: rim
  map:
    v: .identifier

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

id:
  v: ResearchStudy.identifier.extension
path:
  v: ResearchStudy.identifier.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.identifier.use
path:
  v: ResearchStudy.identifier.use
short:
  v: usual | official | temp | secondary | old (If known)
definition:
  v: The purpose of this identifier.
comment:
  v: Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
requirements:
  v: Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.use
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
    l: code
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: IdentifierUse
  strength:
    v: required
  description:
    v: Identifies the purpose for this identifier, if known .
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
    l: http://hl7.org/fhir/ValueSet/identifier-use
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: N/A
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: ResearchStudy.identifier.type
path:
  v: ResearchStudy.identifier.type
short:
  v: Description of identifier
definition:
  v: A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
comment:
  v: This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
requirements:
  v: Allows users to make use of identifiers when the identifier system is not known.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: IdentifierType
  strength:
    v: extensible
  description:
    v: A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-type
    l: identifier-type
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: v2
  map:
    v: CX.5
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: ResearchStudy.identifier.system
path:
  v: ResearchStudy.identifier.system
short:
  v: The namespace for the identifier value
definition:
  v: Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
comment:
  v: Identifier.system is always case sensitive.
requirements:
  v: There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
example:
  label:
    v: General
  value: Uri
    v: http://www.acme.com/identifiers/patient
    l: patient
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / EI-2-4
mapping:
  identity:
    v: rim
  map:
    v: II.root or Role.id.root
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierType

id:
  v: ResearchStudy.identifier.value
path:
  v: ResearchStudy.identifier.value
short:
  v: The value that is unique
definition:
  v: The portion of the identifier typically relevant to the user and which is unique within the context of the system.
comment:
  v: If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
example:
  label:
    v: General
  value: String
    v: 123456
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX.1 / EI.1
mapping:
  identity:
    v: rim
  map:
    v: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
mapping:
  identity:
    v: servd
  map:
    v: ./Value

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

id:
  v: ResearchStudy.identifier.assigner
path:
  v: ResearchStudy.identifier.assigner
short:
  v: Organization that issued id (may be just text)
definition:
  v: Organization that issued/manages the identifier.
comment:
  v: The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.assigner
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    l: Organization
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ref-1
  severity:
    v: error
  human:
    v: SHALL have a contained resource if a local reference is provided
  expression:
    v: reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
  xpath:
    v: not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Reference
    l: Reference
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / (CX.4,CX.9,CX.10)
mapping:
  identity:
    v: rim
  map:
    v: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierIssuingAuthority

id:
  v: ResearchStudy.identifier:NCT
path:
  v: ResearchStudy.identifier
slice name:
  v: NCT
short:
  v: Name für diese Studie
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Name für diese Studie.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Business Identifier for study.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Identifiers assigned to this research study by the sponsor or other systems.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
requirements:
  v: Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Identifier
    l: Identifier
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX / EI (occasionally, more often EI maps to a resource id or a URL)
mapping:
  identity:
    v: rim
  map:
    v: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
mapping:
  identity:
    v: servd
  map:
    v: Identifier
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Organization's Unique Protocol ID; Secondary IDs
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.identifier
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
mapping:
  identity:
    v: rim
  map:
    v: .identifier

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

id:
  v: ResearchStudy.identifier:NCT.extension
path:
  v: ResearchStudy.identifier.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.identifier:NCT.use
path:
  v: ResearchStudy.identifier.use
short:
  v: usual | official | temp | secondary | old (If known)
definition:
  v: The purpose of this identifier.
comment:
  v: Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
requirements:
  v: Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.use
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
    l: code
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: IdentifierUse
  strength:
    v: required
  description:
    v: Identifies the purpose for this identifier, if known .
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
    l: http://hl7.org/fhir/ValueSet/identifier-use
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: N/A
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: ResearchStudy.identifier:NCT.type
path:
  v: ResearchStudy.identifier.type
short:
  v: Description of identifier
definition:
  v: A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
comment:
  v: This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
requirements:
  v: Allows users to make use of identifiers when the identifier system is not known.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: IdentifierType
  strength:
    v: extensible
  description:
    v: A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-type
    l: identifier-type
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: v2
  map:
    v: CX.5
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: ResearchStudy.identifier:NCT.system
path:
  v: ResearchStudy.identifier.system
short:
  v: The namespace for the identifier value
definition:
  v: Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
comment:
  v: Identifier.system is always case sensitive.
requirements:
  v: There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
pattern: Uri
  v: https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct
  l: nct
example:
  label:
    v: General
  value: Uri
    v: http://www.acme.com/identifiers/patient
    l: patient
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / EI-2-4
mapping:
  identity:
    v: rim
  map:
    v: II.root or Role.id.root
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierType

id:
  v: ResearchStudy.identifier:NCT.value
path:
  v: ResearchStudy.identifier.value
short:
  v: The value that is unique
definition:
  v: The portion of the identifier typically relevant to the user and which is unique within the context of the system.
comment:
  v: If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
example:
  label:
    v: General
  value: String
    v: 123456
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX.1 / EI.1
mapping:
  identity:
    v: rim
  map:
    v: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
mapping:
  identity:
    v: servd
  map:
    v: ./Value

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

id:
  v: ResearchStudy.identifier:NCT.assigner
path:
  v: ResearchStudy.identifier.assigner
short:
  v: Organization that issued id (may be just text)
definition:
  v: Organization that issued/manages the identifier.
comment:
  v: The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.assigner
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    l: Organization
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ref-1
  severity:
    v: error
  human:
    v: SHALL have a contained resource if a local reference is provided
  expression:
    v: reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
  xpath:
    v: not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Reference
    l: Reference
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / (CX.4,CX.9,CX.10)
mapping:
  identity:
    v: rim
  map:
    v: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierIssuingAuthority

id:
  v: ResearchStudy.identifier:DRKS
path:
  v: ResearchStudy.identifier
slice name:
  v: DRKS
short:
  v: Name für diese Studie
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Name für diese Studie.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Business Identifier for study.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Identifiers assigned to this research study by the sponsor or other systems.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
requirements:
  v: Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Identifier
    l: Identifier
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX / EI (occasionally, more often EI maps to a resource id or a URL)
mapping:
  identity:
    v: rim
  map:
    v: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
mapping:
  identity:
    v: servd
  map:
    v: Identifier
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Organization's Unique Protocol ID; Secondary IDs
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.identifier
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
mapping:
  identity:
    v: rim
  map:
    v: .identifier

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

id:
  v: ResearchStudy.identifier:DRKS.extension
path:
  v: ResearchStudy.identifier.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.identifier:DRKS.use
path:
  v: ResearchStudy.identifier.use
short:
  v: usual | official | temp | secondary | old (If known)
definition:
  v: The purpose of this identifier.
comment:
  v: Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
requirements:
  v: Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.use
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
    l: code
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: IdentifierUse
  strength:
    v: required
  description:
    v: Identifies the purpose for this identifier, if known .
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
    l: http://hl7.org/fhir/ValueSet/identifier-use
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: N/A
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: ResearchStudy.identifier:DRKS.type
path:
  v: ResearchStudy.identifier.type
short:
  v: Description of identifier
definition:
  v: A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
comment:
  v: This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
requirements:
  v: Allows users to make use of identifiers when the identifier system is not known.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: IdentifierType
  strength:
    v: extensible
  description:
    v: A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-type
    l: identifier-type
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: v2
  map:
    v: CX.5
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: ResearchStudy.identifier:DRKS.system
path:
  v: ResearchStudy.identifier.system
short:
  v: The namespace for the identifier value
definition:
  v: Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
comment:
  v: Identifier.system is always case sensitive.
requirements:
  v: There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
pattern: Uri
  v: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks
  l: drks
example:
  label:
    v: General
  value: Uri
    v: http://www.acme.com/identifiers/patient
    l: patient
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / EI-2-4
mapping:
  identity:
    v: rim
  map:
    v: II.root or Role.id.root
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierType

id:
  v: ResearchStudy.identifier:DRKS.value
path:
  v: ResearchStudy.identifier.value
short:
  v: The value that is unique
definition:
  v: The portion of the identifier typically relevant to the user and which is unique within the context of the system.
comment:
  v: If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
example:
  label:
    v: General
  value: String
    v: 123456
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX.1 / EI.1
mapping:
  identity:
    v: rim
  map:
    v: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
mapping:
  identity:
    v: servd
  map:
    v: ./Value

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

id:
  v: ResearchStudy.identifier:DRKS.assigner
path:
  v: ResearchStudy.identifier.assigner
short:
  v: Organization that issued id (may be just text)
definition:
  v: Organization that issued/manages the identifier.
comment:
  v: The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.assigner
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    l: Organization
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ref-1
  severity:
    v: error
  human:
    v: SHALL have a contained resource if a local reference is provided
  expression:
    v: reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
  xpath:
    v: not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Reference
    l: Reference
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / (CX.4,CX.9,CX.10)
mapping:
  identity:
    v: rim
  map:
    v: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierIssuingAuthority

id:
  v: ResearchStudy.identifier:EudraCT
path:
  v: ResearchStudy.identifier
slice name:
  v: EudraCT
short:
  v: Name für diese Studie
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Name für diese Studie.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Business Identifier for study.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Identifiers assigned to this research study by the sponsor or other systems.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
requirements:
  v: Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Identifier
    l: Identifier
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX / EI (occasionally, more often EI maps to a resource id or a URL)
mapping:
  identity:
    v: rim
  map:
    v: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
mapping:
  identity:
    v: servd
  map:
    v: Identifier
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Organization's Unique Protocol ID; Secondary IDs
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.identifier
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
mapping:
  identity:
    v: rim
  map:
    v: .identifier

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

id:
  v: ResearchStudy.identifier:EudraCT.extension
path:
  v: ResearchStudy.identifier.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.identifier:EudraCT.use
path:
  v: ResearchStudy.identifier.use
short:
  v: usual | official | temp | secondary | old (If known)
definition:
  v: The purpose of this identifier.
comment:
  v: Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
requirements:
  v: Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.use
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
    l: code
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: IdentifierUse
  strength:
    v: required
  description:
    v: Identifies the purpose for this identifier, if known .
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
    l: http://hl7.org/fhir/ValueSet/identifier-use
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: N/A
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: ResearchStudy.identifier:EudraCT.type
path:
  v: ResearchStudy.identifier.type
short:
  v: Description of identifier
definition:
  v: A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
comment:
  v: This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
requirements:
  v: Allows users to make use of identifiers when the identifier system is not known.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: IdentifierType
  strength:
    v: extensible
  description:
    v: A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-type
    l: identifier-type
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: v2
  map:
    v: CX.5
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: ResearchStudy.identifier:EudraCT.system
path:
  v: ResearchStudy.identifier.system
short:
  v: The namespace for the identifier value
definition:
  v: Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
comment:
  v: Identifier.system is always case sensitive.
requirements:
  v: There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
    l: uri
pattern: Uri
  v: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract
  l: eudract
example:
  label:
    v: General
  value: Uri
    v: http://www.acme.com/identifiers/patient
    l: patient
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / EI-2-4
mapping:
  identity:
    v: rim
  map:
    v: II.root or Role.id.root
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierType

id:
  v: ResearchStudy.identifier:EudraCT.value
path:
  v: ResearchStudy.identifier.value
short:
  v: The value that is unique
definition:
  v: The portion of the identifier typically relevant to the user and which is unique within the context of the system.
comment:
  v: If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
example:
  label:
    v: General
  value: String
    v: 123456
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CX.1 / EI.1
mapping:
  identity:
    v: rim
  map:
    v: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
mapping:
  identity:
    v: servd
  map:
    v: ./Value

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

id:
  v: ResearchStudy.identifier:EudraCT.assigner
path:
  v: ResearchStudy.identifier.assigner
short:
  v: Organization that issued id (may be just text)
definition:
  v: Organization that issued/manages the identifier.
comment:
  v: The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.assigner
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    l: Organization
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ref-1
  severity:
    v: error
  human:
    v: SHALL have a contained resource if a local reference is provided
  expression:
    v: reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
  xpath:
    v: not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Reference
    l: Reference
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / (CX.4,CX.9,CX.10)
mapping:
  identity:
    v: rim
  map:
    v: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierIssuingAuthority

id:
  v: ResearchStudy.title
path:
  v: ResearchStudy.title
short:
  v: Name für diese Studie
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Name für diese Studie.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Name for this study.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Ein kurzer, beschreibender und benutzerfreundlicher Bezeichner für die Studie.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Ein kurzer, beschreibender und benutzerfreundlicher Bezeichner für die Studie.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: A short, descriptive user-friendly label for the study.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
comment:
  v: Note that FHIR strings SHALL NOT exceed 1MB in size
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.title
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Brief Title
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)

id:
  v: ResearchStudy.protocol
path:
  v: ResearchStudy.protocol
short:
  v: Steps followed in executing study
definition:
  v: The set of steps expected to be performed as part of the execution of the study.
comment:
  v: References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.protocol
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/PlanDefinition
    l: PlanDefinition
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ref-1
  severity:
    v: error
  human:
    v: SHALL have a contained resource if a local reference is provided
  expression:
    v: reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
  xpath:
    v: not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Reference
    l: Reference
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Interventions; Arm/Intervention Cross-Reference
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolDocumentVersionPublicTitle.name
mapping:
  identity:
    v: rim
  map:
    v: .outboundRelationship[typeCode=DEFN].target

id:
  v: ResearchStudy.partOf
path:
  v: ResearchStudy.partOf
short:
  v: Teil einer größeren Studie.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Teil einer größeren Studie.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Part of larger study.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Eine größere Forschungsstudie, von der diese spezielle Studie ein Bestandteil oder ein Schritt ist.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Eine größere Forschungsstudie, von der diese spezielle Studie ein Bestandteil oder ein Schritt ist.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: A larger research study of which this particular study is a component or step.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
comment:
  v: References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
requirements:
  v: Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.
alias:
  v: container
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.partOf
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/ResearchStudy
    l: ResearchStudy
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ref-1
  severity:
    v: error
  human:
    v: SHALL have a contained resource if a local reference is provided
  expression:
    v: reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
  xpath:
    v: not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Reference
    l: Reference
must support:
  v: true
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: CompanionStudyRelationship
mapping:
  identity:
    v: rim
  map:
    v: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]

id:
  v: ResearchStudy.status
path:
  v: ResearchStudy.status
short:
  v: aktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: aktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Der aktuelle Status der Studie.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Der aktuelle Status der Studie.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: The current state of the study.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
comment:
  v: Note that FHIR strings SHALL NOT exceed 1MB in size
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchStudy.status
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: code
    l: code
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is modifier:
  v: true
is modifier reason:
  v: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyStatus
  strength:
    v: required
  description:
    v: Codes that convey the current status of the research study.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-status|4.0.1
    l: http://hl7.org/fhir/ValueSet/research-study-status
mapping:
  identity:
    v: rim
  map:
    v: n/a
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's activities. A classification of the intent of the study.
comment:
  v: Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.primaryPurposeType
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyPrimaryPurposeType
  strength:
    v: extensible
  description:
    v: Codes for the main intent of the study.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-prim-purp-type
    l: research-study-prim-purp-type
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolVersion.primaryPurposeTypeCode

id:
  v: ResearchStudy.phase
path:
  v: ResearchStudy.phase
short:
  v: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
definition:
  v: The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
comment:
  v: Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.phase
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyPhase
  strength:
    v: example
  description:
    v: Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-phase
    l: research-study-phase
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Study Phase
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolVersion.phaseCode

id:
  v: ResearchStudy.category
path:
  v: ResearchStudy.category
short:
  v: Klassifikationen für die Studie.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Klassifikationen für die Studie.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Classifications for the study.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Codes zur Kategorisierung des Studientyps, wie z. B. experimentell vs. beobachtend, Art der Verblindung, Art der Randomisierung, Sicherheit vs. Wirksamkeit usw.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Codes zur Kategorisierung des Studientyps, wie z. B. experimentell vs. beobachtend, Art der Verblindung, Art der Randomisierung, Sicherheit vs. Wirksamkeit usw.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
comment:
  v: Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.category
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyCategory
  strength:
    v: example
  description:
    v: Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: 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: Untersuchte Medikamente, Geräte usw.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Untersuchte Medikamente, Geräte usw.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Drugs, devices, etc. under study
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Die Medikamente, Nahrungsmittel, Therapien, Geräte oder andere Anliegen oder Interventionen, über die die Studie mehr Informationen gewinnen möchte.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Die Medikamente, Nahrungsmittel, Therapien, Geräte oder andere Anliegen oder Interventionen, über die die Studie mehr Informationen gewinnen möchte.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: The medication, food, therapy, device or other concerns or interventions that the study is seeking to gain more information about.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
comment:
  v: Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.focus
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyFocus
  strength:
    v: example
  description:
    v: Codes for medications, devices and other interventions.
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Focus of Study
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.what[x]
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: InterventionalStudyProtocol.interventionTypeCode

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

id:
  v: ResearchStudy.focus.extension
path:
  v: ResearchStudy.focus.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.focus.coding
path:
  v: ResearchStudy.focus.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 0
max:
  v: *
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
    l: Coding
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
mapping:
  identity:
    v: rim
  map:
    v: CV
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding rdfs:subClassOf dt:CDCoding
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

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

id:
  v: ResearchStudy.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.
comment:
  v: Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.condition
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
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
    l: condition-code
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: 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.contact
path:
  v: ResearchStudy.contact
short:
  v: Contact details for the study
definition:
  v: Contact details to assist a user in learning more about or engaging with the study.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.contact
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: ContactDetail
    l: ContactDetail
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion

id:
  v: ResearchStudy.relatedArtifact
path:
  v: ResearchStudy.relatedArtifact
short:
  v: References and dependencies
definition:
  v: Citations, references and other related documents.
comment:
  v: Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.relatedArtifact
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: RelatedArtifact
    l: RelatedArtifact
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Citations, Links, Available Study Data/Documents
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolDocument, StudyProtocolDocumentVersion

id:
  v: ResearchStudy.keyword
path:
  v: ResearchStudy.keyword
short:
  v: Wird verwendet, um nach der Studie zu suchen.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Wird verwendet, um nach der Studie zu suchen.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Used to search for the study.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Schlüsselbegriffe, die bei der Suche nach oder Filterung der Studie helfen.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Schlüsselbegriffe, die bei der Suche nach oder Filterung der Studie helfen.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Key terms to aid in searching for or filtering the study.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
comment:
  v: Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.keyword
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyKeyword
  strength:
    v: example
  description:
    v: Words associated with the study that may be useful in discovery.
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Keywords
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: DocumentVersion.keywordCode; DocumentVersion.keywordText

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

id:
  v: ResearchStudy.keyword.extension
path:
  v: ResearchStudy.keyword.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.keyword.coding
path:
  v: ResearchStudy.keyword.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 0
max:
  v: *
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
    l: Coding
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
mapping:
  identity:
    v: rim
  map:
    v: CV
mapping:
  identity:
    v: orim
  map:
    v: fhir:Coding rdfs:subClassOf dt:CDCoding
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

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

id:
  v: ResearchStudy.location
path:
  v: ResearchStudy.location
short:
  v: Geographic region(s) for study
definition:
  v: Indicates a country, state or other region where the study is taking place.
comment:
  v: Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.location
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
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
    l: jurisdiction
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolVersion.participatingLocationCode

id:
  v: ResearchStudy.description
path:
  v: ResearchStudy.description
short:
  v: What this is study doing
definition:
  v: A full description of how the study is being conducted.
comment:
  v: Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.description
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: markdown
    l: markdown
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Detailed Description
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyProtocolDocumentVersion.publicDescription

id:
  v: ResearchStudy.enrollment
path:
  v: ResearchStudy.enrollment
short:
  v: Inclusion & exclusion criteria
definition:
  v: Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".
comment:
  v: The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.
alias:
  v: patient
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.enrollment
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Group
    l: Group
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ref-1
  severity:
    v: error
  human:
    v: SHALL have a contained resource if a local reference is provided
  expression:
    v: reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
  xpath:
    v: not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Reference
    l: Reference
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
mapping:
  identity:
    v: 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
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.subject

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.
comment:
  v: A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See [Duration](http://hl7.org/fhir/R4/datatypes.html#Duration).
alias:
  v: timing
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.period
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Period
    l: Period
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: per-1
  severity:
    v: error
  human:
    v: If present, start SHALL have a lower value than end
  expression:
    v: start.hasValue().not() or end.hasValue().not() or (start <= end)
  xpath:
    v: not(exists(f:start/@value)) or not(exists(f:end/@value)) or (xs:dateTime(f:start/@value) <= xs:dateTime(f:end/@value))
  source:
    v: http://hl7.org/fhir/StructureDefinition/Period
    l: Period
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: DR
mapping:
  identity:
    v: rim
  map:
    v: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
mapping:
  identity:
    v: 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.sponsor
path:
  v: ResearchStudy.sponsor
short:
  v: Organization that initiates and is legally responsible for the study
definition:
  v: An organization that initiates the investigation and is legally responsible for the study.
comment:
  v: References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.sponsor
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    l: Organization
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ref-1
  severity:
    v: error
  human:
    v: SHALL have a contained resource if a local reference is provided
  expression:
    v: reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
  xpath:
    v: not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Reference
    l: Reference
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Sponsor
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.actor
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
mapping:
  identity:
    v: rim
  map:
    v: .participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]

id:
  v: ResearchStudy.principalInvestigator
path:
  v: ResearchStudy.principalInvestigator
short:
  v: Researcher who oversees multiple aspects of the study
definition:
  v: A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.
comment:
  v: References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.principalInvestigator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Practitioner
    l: Practitioner
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/PractitionerRole
    l: PractitionerRole
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ref-1
  severity:
    v: error
  human:
    v: SHALL have a contained resource if a local reference is provided
  expression:
    v: reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
  xpath:
    v: not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Reference
    l: Reference
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Principal Investigator
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.actor
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyInvestigator

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.
comment:
  v: References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.site
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Location
    l: Location
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ref-1
  severity:
    v: error
  human:
    v: SHALL have a contained resource if a local reference is provided
  expression:
    v: reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
  xpath:
    v: not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Reference
    l: Reference
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
mapping:
  identity:
    v: 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.reasonStopped
path:
  v: ResearchStudy.reasonStopped
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.
comment:
  v: Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.reasonStopped
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is summary:
  v: true
binding:
  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
    l: research-study-reason-stopped
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Why Study Stopped
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.why[x]
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyOverallStatus.studyStoppedReasonCode

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.
comment:
  v: For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. *Annotations SHOULD NOT* be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.note
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Annotation
    l: Annotation
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: N/A
mapping:
  identity:
    v: rim
  map:
    v: Act
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.arm
path:
  v: ResearchStudy.arm
short:
  v: Definierter Weg durch die Studie für ein Subjekt.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Definierter Weg durch die Studie für ein Subjekt.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Defined path through the study for a subject.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
definition:
  v: Beschreibt eine erwartete Abfolge von Ereignissen für einen der Teilnehmer einer Studie. Z. B. Exposition gegenüber Medikament A, Auswaschphase, Exposition gegenüber Medikament B, Auswaschphase, Nachverfolgung.
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: de
    extension:
      url:
        v: content
        l: content
      value: String
        v: Beschreibt eine erwartete Abfolge von Ereignissen für einen der Teilnehmer einer Studie. Z. B. Exposition gegenüber Medikament A, Auswaschphase, Exposition gegenüber Medikament B, Auswaschphase, Nachverfolgung.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
  extension:
    extension:
      url:
        v: lang
        l: lang
      value: Code
        v: en
    extension:
      url:
        v: content
        l: content
      value: String
        v: Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.
    url:
      v: http://hl7.org/fhir/StructureDefinition/translation
      l: translation
min:
  v: 0
max:
  v: *
base:
  path:
    v: ResearchStudy.arm
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Arms
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: Arm

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

id:
  v: ResearchStudy.arm.extension
path:
  v: ResearchStudy.arm.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.arm.modifierExtension
path:
  v: ResearchStudy.arm.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.arm.name
path:
  v: ResearchStudy.arm.name
short:
  v: Label for study arm
definition:
  v: Unique, human-readable label for this arm of the study.
comment:
  v: Note that FHIR strings SHALL NOT exceed 1MB in size
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ResearchStudy.arm.name
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: string
    l: string
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Arm Label
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: Arm.name

id:
  v: ResearchStudy.arm.type
path:
  v: ResearchStudy.arm.type
short:
  v: Categorization of study arm
definition:
  v: Categorization of study arm, e.g. experimental, active comparator, placebo comparater.
comment:
  v: Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.arm.type
  min:
    v: 0
  max:
    v: 1
type:
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    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Arm Type
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: Arm.typeCode

id:
  v: ResearchStudy.arm.description
path:
  v: ResearchStudy.arm.description
short:
  v: Short explanation of study path
definition:
  v: A succinct description of the path through the study that would be followed by a subject adhering to this arm.
comment:
  v: Note that FHIR strings SHALL NOT exceed 1MB in size
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.arm.description
  min:
    v: 0
  max:
    v: 1
type:
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    v: string
    l: string
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: clinicaltrials-gov
  map:
    v: Arm Description
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: Arm.description

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:
  path:
    v: ResearchStudy.objective
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    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
    l: BackboneElement
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
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:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ResearchStudy.objective.extension
path:
  v: ResearchStudy.objective.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    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()
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    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
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    l: Extension
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
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    v: 0
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    v: *
type:
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    v: Extension
    l: Extension
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
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  xpath:
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  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
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constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
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  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ResearchStudy.objective.name
path:
  v: ResearchStudy.objective.name
short:
  v: Label for the objective
definition:
  v: Unique, human-readable label for this objective of the study.
comment:
  v: Note that FHIR strings SHALL NOT exceed 1MB in size
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.objective.name
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
mapping:
  identity:
    v: rim
  map:
    v: n/a
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.
comment:
  v: Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ResearchStudy.objective.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ele-1
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
      l: elementdefinition-bindingName
    value: String
      v: ResearchStudyObjectiveType
  strength:
    v: preferred
  description:
    v: Codes for the kind of study objective.
  value set:
    v: http://hl7.org/fhir/ValueSet/research-study-objective-type
    l: research-study-objective-type
mapping:
  identity:
    v: rim
  map:
    v: n/a
mapping:
  identity:
    v: v2
  map:
    v: CE/CNE/CWE
mapping:
  identity:
    v: rim
  map:
    v: CD
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept rdfs:subClassOf dt:CD
mapping:
  identity:
    v: BRIDG5.1
  map:
    v: StudyObjective.typeCode

element:
  id:
    v: ResearchStudy
  path:
    v: ResearchStudy
element:
  id:
    v: ResearchStudy.meta
  path:
    v: ResearchStudy.meta
  must support:
    v: true
element:
  id:
    v: ResearchStudy.meta.profile
  path:
    v: ResearchStudy.meta.profile
  must support:
    v: true
element:
  id:
    v: ResearchStudy.identifier
  path:
    v: ResearchStudy.identifier
  slicing:
    discriminator:
      type:
        v: value
      path:
        v: system
    description:
      v: Slice für Identifikator eines Studienregisters bzw. studiendurchführenden Organisation anhand von `system`
    ordered:
      v: false
    rules:
      v: open
element:
  id:
    v: ResearchStudy.identifier:NCT
  path:
    v: ResearchStudy.identifier
  slice name:
    v: NCT
  min:
    v: 0
  max:
    v: 1
element:
  id:
    v: ResearchStudy.identifier:NCT.system
  path:
    v: ResearchStudy.identifier.system
  min:
    v: 1
  pattern: Uri
    v: https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct
    l: nct
element:
  id:
    v: ResearchStudy.identifier:NCT.value
  path:
    v: ResearchStudy.identifier.value
  min:
    v: 1
element:
  id:
    v: ResearchStudy.identifier:DRKS
  path:
    v: ResearchStudy.identifier
  slice name:
    v: DRKS
  min:
    v: 0
  max:
    v: 1
element:
  id:
    v: ResearchStudy.identifier:DRKS.system
  path:
    v: ResearchStudy.identifier.system
  min:
    v: 1
  pattern: Uri
    v: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks
    l: drks
element:
  id:
    v: ResearchStudy.identifier:DRKS.value
  path:
    v: ResearchStudy.identifier.value
  min:
    v: 1
element:
  id:
    v: ResearchStudy.identifier:EudraCT
  path:
    v: ResearchStudy.identifier
  slice name:
    v: EudraCT
  min:
    v: 0
  max:
    v: 1
element:
  id:
    v: ResearchStudy.identifier:EudraCT.system
  path:
    v: ResearchStudy.identifier.system
  min:
    v: 1
  pattern: Uri
    v: https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract
    l: eudract
element:
  id:
    v: ResearchStudy.identifier:EudraCT.value
  path:
    v: ResearchStudy.identifier.value
  min:
    v: 1