MII IG Kerndatensatz-Modul Onkologie
2027.0.0-ballot.1 - Germany

This page is part of the MII IG Kerndatensatz-Modul Onkologie (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Ressourcenprofil: MII PR Onkologie Studienteilnahme

Offizielle URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-studienteilnahme Version: 2027.0.0-ballot.1
Active Stand: 2026-09-15 Maschinenlesbarer Name: MII_PR_Onko_Studienteilnahme

Dieses Profil beschreibt Studienteilnahmen in der Onkologie

Dieses Profil beschreibt ob und wann ein Patient an einer Studie teilgenommen hat.

Es beinhaltet:

  • eine Referenz auf Patient
  • eine Referenz auf die Primärdiagnose
  • den Observation-Code "709491003 Enrollment in clinical trial (procedure)" (SNOMED-CT)
  • das genaue Ersteinschlusssdatum zu einer Studie mit Ethikvotum
  • den Status zur Studienteilnahme (Ja, Nein, Unbekannt)

Im Falle einer pharmakologischen Studie SOLLTE am besten eine Referenz zu einer Procedure / Systemischen Therapie bestehen, entweder über Observation.partOf = Reference (SystemischeTherapie), Observation.basedOn = Reference (MedicationRequest); oder Procedure.basedOn.

Referenzierung von Studien

Informationen über die genaue Studie (Organisation, StudienID, Studienphase, etc.) KÖNNEN über das Element Observation.focus[studie] mit einer Referenz auf eine ResearchStudy-Ressource aus dem MII Modul Studie bereitgestellt werden.

Die ResearchStudy-Ressource ermöglicht die strukturierte Erfassung von:

  • Studienidentifikatoren (DRKS, ClinicalTrials.gov, EudraCT, Innovationsfonds-Projektnummer)
  • Studientyp und -phase
  • Primäre Studienziele
  • Studienkontext und Indikation
  • Studienstatus

Ein vollständiges Beispiel findet sich in der PRO-B Studienteilnahme, die eine ResearchStudy mit DRKS-Registrierung (DRKS00024015) und Innovationsfonds-Projektnummer (01NVF19013) referenziert.

Mapping Datensatz zu FHIR

Die Zuordnung der Datensatzfelder ist im logischen Modell dokumentiert: MII LM Onkologie.

Mapping Einheitlicher onkologischer Basisdatensatz (oBDS) zu FHIR

Die oBDS-Mappings sind in der Artefaktdarstellung des Profils hinterlegt: MII PR Onkologie Studienteilnahme.

Beispiele

Beispiel 1: Einfache Studienteilnahme

mii-exa-onko-studienteilnahme

Beispiel 2: Studienteilnahme mit ResearchStudy-Referenz (PRO-B Studie)

Dieses Beispiel zeigt die Dokumentation einer Studienteilnahme mit Referenz auf eine ResearchStudy-Ressource, die detaillierte Studieninformationen inkl. DRKS-Registrierung und Innovationsfonds-Projektnummer enthält.

mii-exa-onko-studienteilnahme-prob

ResearchStudy-Ressource:

mii-exa-onko-studie-prob

Usages:

You can also check for usages in the FHIR IG Statistics

Formale Ansichten des Profilinhalts

Beschreibung von Profilen, Differentials, Snapshots und deren Repräsentationen.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... code SΣ 1..1 CodeableConcept Studienteilnahme laut oBDS
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... coding Σ 0..* Coding Code defined by a terminology system

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://snomed.info/sct
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 709491003
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
... subject SΣ 1..1 Reference(Patient) Who and/or what the observation is about
... Slices for focus SΣ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
Slice: Unordered, Open by type:$this.resolve()
.... focus:primaertumor SΣ 0..1 Reference(MII PR Onkologie Diagnose Primärtumor) Referenz zum Primärtumor
.... focus:studie SΣ 0..1 Reference(ResearchStudy) Referenz zur Studie (KDS-Modul Medizinisches Forschungsvorhaben)
... encounter SΣ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] SΣ 0..1 dateTime Studienteilnahme Datum
... value[x] SΣC 1..1 CodeableConcept Actual result
Binding: MII VS Onkologie Studienteilnahme (required)
.... coding Σ 0..* Coding Studienteilnahme
..... system Σ 0..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-studienteilnahme
..... code SΣ 1..1 code Symbol in syntax defined by the system

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.value[x] Base required MII VS Onkologie Studienteilnahme 📦2027.0.0-ballot.1 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 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()
dom-4 error Observation If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Diese Struktur ist abgeleitet von Observation

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation 0..* Observation Measurements and simple assertions
... meta
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... code S 1..1 CodeableConcept Studienteilnahme laut oBDS
.... coding 0..* Coding Code defined by a terminology system
Required Pattern: At least the following
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://snomed.info/sct
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 709491003
... subject S 1..1 Reference(Patient) Who and/or what the observation is about
.... focus:primaertumor S 0..1 Reference(MII PR Onkologie Diagnose Primärtumor) Referenz zum Primärtumor
.... focus:studie S 0..1 Reference(ResearchStudy) Referenz zur Studie (KDS-Modul Medizinisches Forschungsvorhaben)
... encounter S 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] S 0..1 dateTime Studienteilnahme Datum
... value[x] S 1..1 CodeableConcept Actual result
Binding: MII VS Onkologie Studienteilnahme (required)
.... coding 0..* Coding Studienteilnahme
..... system 0..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-studienteilnahme
..... code S 1..1 code Symbol in syntax defined by the system

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Observation.value[x] Base required MII VS Onkologie Studienteilnahme 📦2027.0.0-ballot.1 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Part of referenced event
... status ?!Σ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.
... category 0..* CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
... code SΣ 1..1 CodeableConcept Studienteilnahme laut oBDS
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://snomed.info/sct
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 709491003
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... subject SΣ 1..1 Reference(Patient) Who and/or what the observation is about
... Slices for focus SΣ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
Slice: Unordered, Open by type:$this.resolve()
.... focus:primaertumor SΣ 0..1 Reference(MII PR Onkologie Diagnose Primärtumor) Referenz zum Primärtumor
.... focus:studie SΣ 0..1 Reference(ResearchStudy) Referenz zur Studie (KDS-Modul Medizinisches Forschungsvorhaben)
... encounter SΣ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] SΣ 0..1 dateTime Studienteilnahme Datum
... issued Σ 0..1 instant Date/Time this version was made available
... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] SΣC 1..1 CodeableConcept Actual result
Binding: MII VS Onkologie Studienteilnahme (required)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Studienteilnahme
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 0..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-studienteilnahme
..... version Σ 0..1 string Version of the system - if relevant
..... code SΣ 1..1 code Symbol in syntax defined by the system
..... display Σ 0..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
... note 0..* Annotation Comments about the observation
... bodySite 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
... method 0..1 CodeableConcept How it was done
Binding: ObservationMethods (example): Methods for simple observations.
... specimen 0..1 Reference(Specimen) Specimen used for this observation
... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
... referenceRange C 0..* BackboneElement Provides guide for interpretation
Constraints: obs-3
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... low C 0..1 SimpleQuantity(4.0.1) Low Range, if relevant
.... high C 0..1 SimpleQuantity(4.0.1) High Range, if relevant
.... type 0..1 CodeableConcept Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
.... appliesTo 0..* CodeableConcept Reference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
.... age 0..1 Range Applicable age range, if relevant
.... text 0..1 string Text based reference range in an observation
... hasMember Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... derivedFrom Σ 0..* Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
... component Σ 0..* BackboneElement Component results
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... value[x] Σ 0..1 Actual component result
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
.... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
.... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
.... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.meta.security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
Observation.meta.tag Base example Common Tags 📍4.0.1 FHIR Std.
Observation.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📍4.0.1 FHIR Std.
Observation.code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.value[x] Base required MII VS Onkologie Studienteilnahme 📦2027.0.0-ballot.1 This IG
Observation.dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.
Observation.bodySite Base example SNOMED CT Body Structures 📍4.0.1 FHIR Std.
Observation.method Base example Observation Methods 📍4.0.1 FHIR Std.
Observation.referenceRange.​type Base preferred Observation Reference Range Meaning Codes 📍4.0.1 FHIR Std.
Observation.referenceRange.​appliesTo Base example Observation Reference Range Applies To Codes 📍4.0.1 FHIR Std.
Observation.component.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component.​dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.component.​interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 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()
dom-4 error Observation If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-3 error Observation.referenceRange Must have at least a low or a high or text low.exists() or high.exists() or text.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Diese Struktur ist abgeleitet von Observation

Summary

Mandatory: 2 elements(1 nested mandatory element)
Must-Support: 10 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Observation.focus

Schlüsselelemente-Ansicht

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... code SΣ 1..1 CodeableConcept Studienteilnahme laut oBDS
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... coding Σ 0..* Coding Code defined by a terminology system

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://snomed.info/sct
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 709491003
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
... subject SΣ 1..1 Reference(Patient) Who and/or what the observation is about
... Slices for focus SΣ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
Slice: Unordered, Open by type:$this.resolve()
.... focus:primaertumor SΣ 0..1 Reference(MII PR Onkologie Diagnose Primärtumor) Referenz zum Primärtumor
.... focus:studie SΣ 0..1 Reference(ResearchStudy) Referenz zur Studie (KDS-Modul Medizinisches Forschungsvorhaben)
... encounter SΣ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] SΣ 0..1 dateTime Studienteilnahme Datum
... value[x] SΣC 1..1 CodeableConcept Actual result
Binding: MII VS Onkologie Studienteilnahme (required)
.... coding Σ 0..* Coding Studienteilnahme
..... system Σ 0..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-studienteilnahme
..... code SΣ 1..1 code Symbol in syntax defined by the system

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.value[x] Base required MII VS Onkologie Studienteilnahme 📦2027.0.0-ballot.1 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 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()
dom-4 error Observation If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Differential-Ansicht

Diese Struktur ist abgeleitet von Observation

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation 0..* Observation Measurements and simple assertions
... meta
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... code S 1..1 CodeableConcept Studienteilnahme laut oBDS
.... coding 0..* Coding Code defined by a terminology system
Required Pattern: At least the following
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://snomed.info/sct
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 709491003
... subject S 1..1 Reference(Patient) Who and/or what the observation is about
.... focus:primaertumor S 0..1 Reference(MII PR Onkologie Diagnose Primärtumor) Referenz zum Primärtumor
.... focus:studie S 0..1 Reference(ResearchStudy) Referenz zur Studie (KDS-Modul Medizinisches Forschungsvorhaben)
... encounter S 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] S 0..1 dateTime Studienteilnahme Datum
... value[x] S 1..1 CodeableConcept Actual result
Binding: MII VS Onkologie Studienteilnahme (required)
.... coding 0..* Coding Studienteilnahme
..... system 0..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-studienteilnahme
..... code S 1..1 code Symbol in syntax defined by the system

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Observation.value[x] Base required MII VS Onkologie Studienteilnahme 📦2027.0.0-ballot.1 This IG

Snapshot-AnsichtView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Part of referenced event
... status ?!Σ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.
... category 0..* CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
... code SΣ 1..1 CodeableConcept Studienteilnahme laut oBDS
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://snomed.info/sct
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 709491003
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... subject SΣ 1..1 Reference(Patient) Who and/or what the observation is about
... Slices for focus SΣ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
Slice: Unordered, Open by type:$this.resolve()
.... focus:primaertumor SΣ 0..1 Reference(MII PR Onkologie Diagnose Primärtumor) Referenz zum Primärtumor
.... focus:studie SΣ 0..1 Reference(ResearchStudy) Referenz zur Studie (KDS-Modul Medizinisches Forschungsvorhaben)
... encounter SΣ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] SΣ 0..1 dateTime Studienteilnahme Datum
... issued Σ 0..1 instant Date/Time this version was made available
... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] SΣC 1..1 CodeableConcept Actual result
Binding: MII VS Onkologie Studienteilnahme (required)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Studienteilnahme
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 0..1 uri Identity of the terminology system
Required Pattern: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-studienteilnahme
..... version Σ 0..1 string Version of the system - if relevant
..... code SΣ 1..1 code Symbol in syntax defined by the system
..... display Σ 0..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
... note 0..* Annotation Comments about the observation
... bodySite 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
... method 0..1 CodeableConcept How it was done
Binding: ObservationMethods (example): Methods for simple observations.
... specimen 0..1 Reference(Specimen) Specimen used for this observation
... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
... referenceRange C 0..* BackboneElement Provides guide for interpretation
Constraints: obs-3
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... low C 0..1 SimpleQuantity(4.0.1) Low Range, if relevant
.... high C 0..1 SimpleQuantity(4.0.1) High Range, if relevant
.... type 0..1 CodeableConcept Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
.... appliesTo 0..* CodeableConcept Reference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
.... age 0..1 Range Applicable age range, if relevant
.... text 0..1 string Text based reference range in an observation
... hasMember Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... derivedFrom Σ 0..* Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
... component Σ 0..* BackboneElement Component results
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... value[x] Σ 0..1 Actual component result
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
.... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
.... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
.... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.meta.security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
Observation.meta.tag Base example Common Tags 📍4.0.1 FHIR Std.
Observation.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📍4.0.1 FHIR Std.
Observation.code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.value[x] Base required MII VS Onkologie Studienteilnahme 📦2027.0.0-ballot.1 This IG
Observation.dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.
Observation.bodySite Base example SNOMED CT Body Structures 📍4.0.1 FHIR Std.
Observation.method Base example Observation Methods 📍4.0.1 FHIR Std.
Observation.referenceRange.​type Base preferred Observation Reference Range Meaning Codes 📍4.0.1 FHIR Std.
Observation.referenceRange.​appliesTo Base example Observation Reference Range Applies To Codes 📍4.0.1 FHIR Std.
Observation.component.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component.​dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.component.​interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 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()
dom-4 error Observation If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-3 error Observation.referenceRange Must have at least a low or a high or text low.exists() or high.exists() or text.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Diese Struktur ist abgeleitet von Observation

Summary

Mandatory: 2 elements(1 nested mandatory element)
Must-Support: 10 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Observation.focus

 

Weitere Repräsentationen des Profils: CSV, Excel, Schematron