| Investigation |
|
ResearchStudy |
|
| Investigation |
@id |
|
|
| Investigation |
filename |
|
|
| Investigation |
identifier |
ResearchStudy.identifier |
|
| Investigation |
title |
ResearchStudy.title |
|
| Investigation |
description |
ResearchStudy.description |
|
| Investigation |
submissionDate |
ResearchStudy.extension:submissionDate.valueDateTime |
|
| Investigation |
publicReleaseDate |
ResearchStudy.extension:publicReleaseDate.valueDateTime |
|
| Investigation |
ontologySourceReferences |
|
Information related to CodeSystems would not be stored centrally in a FHIR resource. Codings would refer to relevant CodeSystems. |
| Investigation |
publications |
ResearchStudy.relatedArtifact |
|
| Investigation |
people |
ResearchStudy.contact.extension:people.valueReference(Practitioner or PractitionerRole) |
Changes planned in R5: New element ResearchStudy.associatedParty with References a.o. to Practitioner and PractitionerRole |
| Investigation |
studies |
ResearchStudy.extension:studies.valueReference(ResearchStudy) |
In FHIR, a smaller study can point to a bigger one with ResearchStudy.partOf |
| Investigation |
comments |
ResearchStudy.note |
|
| Study |
|
ResearchStudy |
|
| Study |
@id |
ResearchStudy.id |
|
| Study |
filename |
|
|
| Study |
identifier |
ResearchStudy.identifier |
|
| Study |
title |
ResearchStudy.title |
|
| Study |
description |
ResearchStudy.description |
|
| Study |
submissionDate |
ResearchStudy.extension:submissionDate.valueDateTime |
|
| Study |
publicReleaseDate |
ResearchStudy.extension:publicReleaseDate.valueDateTime |
|
| Study |
publications |
ResearchStudy.relatedArtifact |
|
| Study |
people |
ResearchStudy.contact.extension:people.valueReference(Practitioner or PractitionerRole) |
Changes planned in R5: New element ResearchStudy.associatedParty with References a.o. to Practitioner and PractitionerRole |
| Study |
studyDesignDescriptors |
|
Several FHIR elements might be suitable, e.g., ResearchStudy.category, ResearchStudy.phase, ResearchStudy.primaryPurposeType, ResearchStudy.focus... |
| Study |
protocols |
ResearchStudy.protocol |
|
| Study |
materials |
ResearchStudy.extension:materials |
|
| Study |
materials.sources |
ResearchStudy.extension:materials.extension:sources.valueReference(Specimen) |
|
| Study |
materials.samples |
ResearchStudy.extension:materials.extension:sources.valueReference(Specimen) |
|
| Study |
materials.otherMaterials |
ResearchStudy.extension:materials.extension:sources.valueReference(Specimen) |
|
| Study |
processSequence |
ResearchStudy.protocol |
|
| Study |
assays |
ResearchStudy.extension:assays.valueReference(Observation) |
|
| Study |
factors |
ResearchStudy.extension:factors |
Changes planned in R5: New element ResearchStudy.outcomeMeasure |
| Study |
characteristicCategories |
|
Data related to material characteristics would be rather stored in a Specimen resource |
| Study |
unitCategories |
|
Data related to units would be rather stored with a Quantity, or through with the extension https://www.hl7.org/fhir/R4/extension-elementdefinition-allowedunits.html |
| Study |
comments |
ResearchStudy.note |
|
| Assay |
|
Observation |
Depending on the type of experiments, other FHIR resources might suit too, such as MolecularSequence. |
| Assay |
@id |
Observation.id |
|
| Assay |
comments |
Observation.note |
|
| Assay |
filename |
|
|
| Assay |
measurementType |
Observation.code |
|
| Assay |
technologyType |
|
This BackboneElement would not be necessary in FHIR |
| Assay |
technologyType.ontologyAnnotation |
Observation.method |
|
| Assay |
technologyPlatform |
Observation.device.resolve().manufacturer and Observation.device.resolve().deviceName |
|
| Assay |
dataFiles |
Observation.extension:dataFiles.Reference(DocumentReference) |
|
| Assay |
materials |
Observation.specimen or Observation.extension:additionalspecimen.Reference(Specimen) |
Changes planned in R5 planned: Possibility to refer to a Specimen or a Group via Observation. Group can includes several Specimen. |
| Assay |
materials.samples |
Observation.specimen or Observation.extension:additionalspecimen.Reference(Specimen) |
|
| Assay |
materials.otherMaterials |
Observation.specimen or Observation.extension:additionalspecimen.Reference(Specimen) |
|
| Assay |
characteristicCategories |
|
Data related to material characteristics would be rather stored in a Specimen resource |
| Assay |
unitCategories |
|
Data related to units would be rather stored with a Quantity, or through with the extension https://www.hl7.org/fhir/R4/extension-elementdefinition-allowedunits.html |
| Assay |
processSequence |
Observation.extension:processSequence.valueReference(PlanDefinition or ActivityDefinition) |
Changes planned in R5: Possibility to instantiate an ObservationDefinition via Observation. PlanDefinition can define an ObservationDefinition. |
| Comment |
|
Annotation |
|
| Comment |
@id |
|
|
| Comment |
name |
Annotation.extension:filename.valueString |
|
| Comment |
value |
Annotation.text |
|
| Data |
|
DocumentReference |
Depending on the concrete data files and types, other FHIR resources such as Media, ImagingStudy or MolecularSequence might be suitable too |
| Data |
@id |
DocumentReference.id |
|
| Data |
name |
DocumentReference.content.attachment.title |
|
| Data |
type |
DocumentReference.category.where(code.memberOf('https://www.nfdi4health.de/fhir/ISA/ValueSet/isa-vs-data-local') |
|
| Data |
comments |
DocumentReference.extension:comments.valueAnnotation |
|
| Factor |
|
ResearchStudy.extension:factors |
Information related to Factor and FactorValues would be stored together in ResearchStudy |
| Factor |
@id |
|
|
| Factor |
factorName |
ResearchStudy.extension:factors.extension:factorName.valueString |
|
| Factor |
factorType |
ResearchStudy.extension:factors.extension:factorType.valueCodeableConcept |
|
| Factor |
comments |
ResearchStudy.extension:factors.extension:comments.valueAnnotation |
|
| FactorValue |
|
|
Information related to Factor and FactorValues would be stored together in ResearchStudy |
| FactorValue |
@id |
|
|
| FactorValue |
category |
|
|
| FactorValue |
value[x] |
ResearchStudy.extension:factors.extension:factorValue.extension:value.(valueCodeableConcept or valueQuantity) |
|
| FactorValue |
unit |
ResearchStudy.extension:factors.extension:factorValue.extension:value.valueQuantity.unit |
|
| MaterialAttribute |
|
|
MaterialAttribute and MaterialAttributeValue would rather be mapped in combination in a Specimen resource, with the attribute being the name of the FHIR element itself, and the attribute value its associated value (e.g., in form of a CodeableConcept). |
| MaterialAttribute |
@id |
|
|
| MaterialAttribute |
characteristicType |
|
|
| MaterialAttributeValue |
|
|
MaterialAttribute and MaterialAttributeValue would rather be mapped in combination in a Specimen resource, with the attribute being the name of the FHIR element itself, and the attribute value its associated value (e.g., in form of a CodeableConcept). |
| MaterialAttributeValue |
@id |
|
|
| MaterialAttributeValue |
category |
|
|
| MaterialAttributeValue |
value[x] |
|
|
| MaterialAttributeValue |
unit |
|
|
| Material |
|
Specimen |
During profiling, differentiation between Samples, Sources and otherMaterials would be necessary. |
| Material |
@id |
Specimen.id |
|
| Material |
name |
|
|
| Material |
type |
Specimen.type.where(code.memberOf('https://www.nfdi4health.de/fhir/ISA/ValueSet/isa-vs-material-local')) |
|
| Material |
characteristics |
|
In FHIR, this element would store information from MaterialAttribute and MaterialAttributeValue |
| Material |
derivesFrom |
Specimen.parent |
|
| OntologyAnnotation |
|
CodeableConcept or Coding or Quantity" |
Data stored directly in the respective FHIR elements in a chosen resource |
| OntologyAnnotation |
@id |
|
|
| OntologyAnnotation |
annotationValue[x] |
CodeableConcept.text or Coding.display or Quantity.value |
|
| OntologyAnnotation |
termSource |
CodeableConcept.coding.system or Quantity.system |
|
| OntologyAnnotation |
termAccession |
CodeableConcept.coding.code or Quantity.code |
|
| OntologyAnnotation |
comments |
CodeableConcept.extension:comments.valueAnnotation pr Quantity.extension:comments.valueAnnotation |
|
| OntologySourceReference |
|
CodeSystem |
In FHIR, Coding, CodeableConcepts, etc. would refer to the relevant CodeSystem via .system |
| OntologySourceReference |
comments |
CodeSystem.extension:comments.where(url='http://hl7.org/fhir/StructureDefinition/codesystem-concept-comments') |
|
| OntologySourceReference |
description |
CodeSystem.description |
|
| OntologySourceReference |
file |
CodeSystem.url |
|
| OntologySourceReference |
name |
CodeSystem.name |
|
| OntologySourceReference |
version |
CodeSystem.version |
|
| Person |
|
Practitioner |
|
| Person |
@id |
Practitioner.id |
|
| Person |
lastName |
Practitioner.name.family |
|
| Person |
firstName |
Practitioner.name.given |
|
| Person |
midInitials |
Practitioner.name.given |
|
| Person |
email |
PractitionerRole.telecom.where(system='email').value |
|
| Person |
phone |
PractitionerRole.telecom.where(system='phone').value |
|
| Person |
fax |
PractitionerRole.telecom.where(system='fax').value |
|
| Person |
address |
PractitionerRole.location.resolve().address |
|
| Person |
affiliation |
PractionerRole.organization |
|
| Person |
roles |
PractitionerRole.code |
|
| Person |
comments |
Practitioner.extension:comments.valueAnnotation |
|
| ProcessParameterValue |
|
|
Information related to ProtocolParameter, and ProcessParameterValue would be stored in a PlanDefinition or ActivityDefinition resource in FHIR |
| ProcessParameterValue |
category |
|
|
| ProcessParameterValue |
value[x] |
|
|
| ProcessParameterValue |
unit |
|
|
| Process |
|
PlanDefinition |
Depending on the type of process, more specific FHIR elements might fit. For example, information related to specimen collection and processing activities should rather be stored in Specimen.collection and Specimen.processing |
| Process |
@id |
PlanDefinition.id |
|
| Process |
name |
PlanDefinition.title |
|
| Process |
executesProtocol |
PlanDefinition.action.definition[x].valueReference(PlanDefinition) |
|
| Process |
parameterValues |
PlanDefinition.action.code or PlanDefinition.action.extension:quantity.valueQuantity |
|
| Process |
performer |
Observation.performer.valueReference(Practitioner or PractitionerRole) |
PlanDefinition specifies for example which type of person should conduct the process, but not the actual person that has performed the process. Depending on the type of Process, further FHIR resources and elements might be suitable: e.g., Specimen.collection.collector to define the Practitioner that collected the Specimen. |
| Process |
date |
Observation.effectiveDateTime |
PlanDefinition specifies for example when a process should take place but not when it actually happened. Depending on the type of Process, further FHIR resources and elements might be suitable: e.g., Specimen.collection.date to define when the Specimen collection happened. |
| Process |
previousProcess |
PlanDefinition.action.definition[x] or PlanDefinition.action.relatedAction |
|
| Process |
nextProcess |
PlanDefinition.action.definition[x] or PlanDefinition.action.relatedAction |
|
| Process |
inputs |
PlanDefinition.input |
|
| Process |
outputs |
PlanDefinition.output |
|
| Process |
comments |
PlanDefinition.extension:comments.valueAnnotation |
|
| ProtocolParameter |
|
|
Information related to ProtocolParameter, and ProcessParameterValue would be stored in a PlanDefinition or ActivityDefinition resource in FHIR |
| ProtocolParameter |
@id |
|
|
| ProtocolParameter |
parameterName |
|
|
| Protocol |
|
PlanDefinition |
|
| Protocol |
@id |
PlanDefinition.id |
|
| Protocol |
comments |
PlanDefinition.extension:comments.valueAnnotation |
|
| Protocol |
name |
PlanDefinition.title |
|
| Protocol |
protocolType |
PlanDefinition.type |
|
| Protocol |
description |
PlanDefinition.description |
|
| Protocol |
uri |
PlanDefinition.url |
|
| Protocol |
version |
PlanDefinition.version |
|
| Protocol |
parameters |
PlanDefinition.action.code or PlanDefinition.action.extension:quantity.valueQuantity |
|
| Protocol |
components |
PlanDefinition.action.participant |
|
| Protocol |
components.componentName |
PlanDefinition.action.participant.extension:componentName.valueString |
|
| Protocol |
components.componentType |
PlanDefinition.action.participant.extension:componentType.valueCodeableConcept |
|
| Publication |
|
RelatedArtifact.where(type='citation') |
Changes planned in R5: Better coverage through the new resource Citation |
| Publication |
comments |
RelatedArtifact.extension:comments.valueAnnotation |
|
| Publication |
pubMedID |
RelatedArtifact.url |
|
| Publication |
doi |
RelatedArtifact.url |
|
| Publication |
authorList |
RelatedArtifact.citation |
|
| Publication |
title |
RelatedArtifact.citation |
|
| Publication |
status |
RelatedArtifact.extension:status.valueCodeableConcept |
|
| Sample |
|
Specimen |
During profiling, differentiation between Samples, Sources and otherMaterials would be necessary. |
| Sample |
@id |
Specimen.id |
|
| Sample |
name |
|
|
| Sample |
characteristics |
|
In FHIR, this element would store information from MaterialAttribute and MaterialAttributeValue |
| Sample |
factorValues |
Specimen.extension:factorValues.valueReference(ResearchStudy).resolve().extension:factors |
|
| Source |
derivesFrom |
Specimen.parent |
|
| Source |
|
Specimen |
During profiling, differentiation between Samples, Sources and otherMaterials would be necessary. |
| Source |
@id |
Specimen.id |
|
| Source |
name |
|
|
| Source |
characteristics |
|
In FHIR, this element would store information from MaterialAttribute and MaterialAttributeValue |