Response to Regulatory Questions (RTQ)
0.1.0 - ci-build

Response to Regulatory Questions (RTQ), published by HL7 International. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/rtq-ig/ and changes regularly. See the Directory of published versions

Resource Profile: RTQ QuestionnaireResponse Profile ( Experimental )

Official URL: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaireresponse Version: 0.1.0
Draft as of 2025-11-20 Computable Name: RTQQuestionnaireResponse

Profile of QuestionnaireResponse for structured responses to regulatory questions and answers in the context of medicinal product variations and other regulatory procedures.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. QuestionnaireResponse S 0..* QuestionnaireResponse RTQ-structured regulatory Q&A response
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... status ?!SΣ 1..1 code in-progress | completed | amended | entered-in-error | stopped
Binding: QuestionnaireResponseStatus (required): Lifecycle status of the questionnaire response.
Fixed Value: completed
... subject SΣ 1..1 Reference(MedicinalProductDefinition) The subject of the questions
... authored SΣ 1..1 dateTime Date the answers were gathered
... author SΣ 1..1 Reference(Organization) The individual or device that received and recorded the answers
... item C 0..* BackboneElement Groups and questions
Constraints: qrs-1, qrs-2
.... Slices for extension Content/Rules for all slices
..... extension:rtq-rendered-text S 0..1 ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-rendered-text]] Extension
URL: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-rendered-text
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... linkId C 1..1 string Pointer to specific item from Questionnaire
.... answer C 0..* BackboneElement The response(s) to the question
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... Slices for value[x] C 1..1 Single-valued answer to the question
Slice: Unordered, Open by type:$this
Binding: QuestionnaireAnswerCodes (example): Binding this is problematic because one value set can't apply to both codes and quantities.
...... valueBoolean boolean
...... valueDecimal decimal
...... valueInteger integer
...... valueDate date
...... valueDateTime dateTime
...... valueTime time
...... valueString string
...... valueUri uri
...... valueAttachment Attachment
...... valueCoding Coding
...... valueQuantity Quantity(SimpleQuantity)
...... valueReference Reference(Resource)
...... value[x]:valueAttachment SC 1..1 Attachment Single-valued answer to the question
...... value[x]:valueString SC 1..1 string Single-valued answer to the question
Binding: QuestionnaireAnswerCodes (example): Binding this is problematic because one value set can't apply to both codes and quantities.

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
QuestionnaireResponse.​status Base required Questionnaire Response Status 📍5.0.0 FHIR Std.
QuestionnaireResponse.​item.answer.value[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.
QuestionnaireResponse.​item.answer.value[x]:valueString Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error QuestionnaireResponse If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error QuestionnaireResponse 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error QuestionnaireResponse 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 QuestionnaireResponse If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice QuestionnaireResponse 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()
qrs-1 error QuestionnaireResponse.item Item cannot contain both item and answer (answer.exists() and item.exists()).not()
qrs-2 error QuestionnaireResponse.item Repeated answers are combined in the answers array of a single item repeat(answer|item).select(item.where(answer.value.exists()).linkId.isDistinct()).allTrue()

This structure is derived from QuestionnaireResponse

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. QuestionnaireResponse S 0..* QuestionnaireResponse RTQ-structured regulatory Q&A response
... questionnaire S 1..1 canonical(Questionnaire) Canonical URL of Questionnaire being answered
... status S 1..1 code in-progress | completed | amended | entered-in-error | stopped
Fixed Value: completed
... subject S 1..1 Reference(MedicinalProductDefinition) The subject of the questions
... author S 1..1 Reference(Organization) The individual or device that received and recorded the answers
... item
.... Slices for extension Content/Rules for all slices
..... extension:rtq-rendered-text S 0..1 ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-rendered-text]] Extension
URL: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-rendered-text
.... answer
..... valueAttachment S 1..1 Attachment Single-valued answer to the question
..... valueString S 1..1 string Single-valued answer to the question

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. QuestionnaireResponse S 0..* QuestionnaireResponse RTQ-structured regulatory Q&A response
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... 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 ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business identifier for this set of answers
... basedOn Σ 0..* Reference(CarePlan | ServiceRequest) Request fulfilled by this QuestionnaireResponse
... partOf Σ 0..* Reference(Observation | Procedure) Part of referenced event
... questionnaire SΣ 1..1 canonical(Questionnaire) Canonical URL of Questionnaire being answered
... status ?!SΣ 1..1 code in-progress | completed | amended | entered-in-error | stopped
Binding: QuestionnaireResponseStatus (required): Lifecycle status of the questionnaire response.
Fixed Value: completed
... subject SΣ 1..1 Reference(MedicinalProductDefinition) The subject of the questions
... encounter Σ 0..1 Reference(Encounter) Encounter the questionnaire response is part of
... authored SΣ 1..1 dateTime Date the answers were gathered
... author SΣ 1..1 Reference(Organization) The individual or device that received and recorded the answers
... source Σ 0..1 Reference(Device | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson) The individual or device that answered the questions
... item C 0..* BackboneElement Groups and questions
Constraints: qrs-1, qrs-2
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... extension:rtq-rendered-text S 0..1 ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-rendered-text]] Extension
URL: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-rendered-text
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... linkId C 1..1 string Pointer to specific item from Questionnaire
.... definition 0..1 uri ElementDefinition - details for the item
.... text 0..1 string Name for group or question text
.... answer C 0..* BackboneElement The response(s) to the question
..... 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
..... Slices for value[x] C 1..1 Single-valued answer to the question
Slice: Unordered, Open by type:$this
Binding: QuestionnaireAnswerCodes (example): Binding this is problematic because one value set can't apply to both codes and quantities.
...... valueBoolean boolean
...... valueDecimal decimal
...... valueInteger integer
...... valueDate date
...... valueDateTime dateTime
...... valueTime time
...... valueString string
...... valueUri uri
...... valueAttachment Attachment
...... valueCoding Coding
...... valueQuantity Quantity(SimpleQuantity)
...... valueReference Reference(Resource)
...... value[x]:valueAttachment SC 1..1 Attachment Single-valued answer to the question
...... value[x]:valueString SC 1..1 string Single-valued answer to the question
Binding: QuestionnaireAnswerCodes (example): Binding this is problematic because one value set can't apply to both codes and quantities.
..... item 0..* See item (QuestionnaireResponse) Child items of question
.... item 0..* See item (QuestionnaireResponse) Child items of group item

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
QuestionnaireResponse.​language Base required All Languages 📍5.0.0 FHIR Std.
QuestionnaireResponse.​status Base required Questionnaire Response Status 📍5.0.0 FHIR Std.
QuestionnaireResponse.​item.answer.value[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.
QuestionnaireResponse.​item.answer.value[x]:valueString Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error QuestionnaireResponse If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error QuestionnaireResponse 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error QuestionnaireResponse 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 QuestionnaireResponse If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice QuestionnaireResponse 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()
qrs-1 error QuestionnaireResponse.item Item cannot contain both item and answer (answer.exists() and item.exists()).not()
qrs-2 error QuestionnaireResponse.item Repeated answers are combined in the answers array of a single item repeat(answer|item).select(item.where(answer.value.exists()).linkId.isDistinct()).allTrue()

This structure is derived from QuestionnaireResponse

Summary

Mandatory: 5 elements
Must-Support: 8 elements
Fixed: 1 element

Extensions

This structure refers to these extensions:

  • Unable to summarise extension http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-rendered-text (no extension found)

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. QuestionnaireResponse S 0..* QuestionnaireResponse RTQ-structured regulatory Q&A response
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... status ?!SΣ 1..1 code in-progress | completed | amended | entered-in-error | stopped
Binding: QuestionnaireResponseStatus (required): Lifecycle status of the questionnaire response.
Fixed Value: completed
... subject SΣ 1..1 Reference(MedicinalProductDefinition) The subject of the questions
... authored SΣ 1..1 dateTime Date the answers were gathered
... author SΣ 1..1 Reference(Organization) The individual or device that received and recorded the answers
... item C 0..* BackboneElement Groups and questions
Constraints: qrs-1, qrs-2
.... Slices for extension Content/Rules for all slices
..... extension:rtq-rendered-text S 0..1 ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-rendered-text]] Extension
URL: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-rendered-text
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... linkId C 1..1 string Pointer to specific item from Questionnaire
.... answer C 0..* BackboneElement The response(s) to the question
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... Slices for value[x] C 1..1 Single-valued answer to the question
Slice: Unordered, Open by type:$this
Binding: QuestionnaireAnswerCodes (example): Binding this is problematic because one value set can't apply to both codes and quantities.
...... valueBoolean boolean
...... valueDecimal decimal
...... valueInteger integer
...... valueDate date
...... valueDateTime dateTime
...... valueTime time
...... valueString string
...... valueUri uri
...... valueAttachment Attachment
...... valueCoding Coding
...... valueQuantity Quantity(SimpleQuantity)
...... valueReference Reference(Resource)
...... value[x]:valueAttachment SC 1..1 Attachment Single-valued answer to the question
...... value[x]:valueString SC 1..1 string Single-valued answer to the question
Binding: QuestionnaireAnswerCodes (example): Binding this is problematic because one value set can't apply to both codes and quantities.

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
QuestionnaireResponse.​status Base required Questionnaire Response Status 📍5.0.0 FHIR Std.
QuestionnaireResponse.​item.answer.value[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.
QuestionnaireResponse.​item.answer.value[x]:valueString Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error QuestionnaireResponse If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error QuestionnaireResponse 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error QuestionnaireResponse 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 QuestionnaireResponse If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice QuestionnaireResponse 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()
qrs-1 error QuestionnaireResponse.item Item cannot contain both item and answer (answer.exists() and item.exists()).not()
qrs-2 error QuestionnaireResponse.item Repeated answers are combined in the answers array of a single item repeat(answer|item).select(item.where(answer.value.exists()).linkId.isDistinct()).allTrue()

Differential View

This structure is derived from QuestionnaireResponse

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. QuestionnaireResponse S 0..* QuestionnaireResponse RTQ-structured regulatory Q&A response
... questionnaire S 1..1 canonical(Questionnaire) Canonical URL of Questionnaire being answered
... status S 1..1 code in-progress | completed | amended | entered-in-error | stopped
Fixed Value: completed
... subject S 1..1 Reference(MedicinalProductDefinition) The subject of the questions
... author S 1..1 Reference(Organization) The individual or device that received and recorded the answers
... item
.... Slices for extension Content/Rules for all slices
..... extension:rtq-rendered-text S 0..1 ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-rendered-text]] Extension
URL: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-rendered-text
.... answer
..... valueAttachment S 1..1 Attachment Single-valued answer to the question
..... valueString S 1..1 string Single-valued answer to the question

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. QuestionnaireResponse S 0..* QuestionnaireResponse RTQ-structured regulatory Q&A response
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... 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 ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business identifier for this set of answers
... basedOn Σ 0..* Reference(CarePlan | ServiceRequest) Request fulfilled by this QuestionnaireResponse
... partOf Σ 0..* Reference(Observation | Procedure) Part of referenced event
... questionnaire SΣ 1..1 canonical(Questionnaire) Canonical URL of Questionnaire being answered
... status ?!SΣ 1..1 code in-progress | completed | amended | entered-in-error | stopped
Binding: QuestionnaireResponseStatus (required): Lifecycle status of the questionnaire response.
Fixed Value: completed
... subject SΣ 1..1 Reference(MedicinalProductDefinition) The subject of the questions
... encounter Σ 0..1 Reference(Encounter) Encounter the questionnaire response is part of
... authored SΣ 1..1 dateTime Date the answers were gathered
... author SΣ 1..1 Reference(Organization) The individual or device that received and recorded the answers
... source Σ 0..1 Reference(Device | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson) The individual or device that answered the questions
... item C 0..* BackboneElement Groups and questions
Constraints: qrs-1, qrs-2
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... extension:rtq-rendered-text S 0..1 ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-rendered-text]] Extension
URL: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-rendered-text
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... linkId C 1..1 string Pointer to specific item from Questionnaire
.... definition 0..1 uri ElementDefinition - details for the item
.... text 0..1 string Name for group or question text
.... answer C 0..* BackboneElement The response(s) to the question
..... 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
..... Slices for value[x] C 1..1 Single-valued answer to the question
Slice: Unordered, Open by type:$this
Binding: QuestionnaireAnswerCodes (example): Binding this is problematic because one value set can't apply to both codes and quantities.
...... valueBoolean boolean
...... valueDecimal decimal
...... valueInteger integer
...... valueDate date
...... valueDateTime dateTime
...... valueTime time
...... valueString string
...... valueUri uri
...... valueAttachment Attachment
...... valueCoding Coding
...... valueQuantity Quantity(SimpleQuantity)
...... valueReference Reference(Resource)
...... value[x]:valueAttachment SC 1..1 Attachment Single-valued answer to the question
...... value[x]:valueString SC 1..1 string Single-valued answer to the question
Binding: QuestionnaireAnswerCodes (example): Binding this is problematic because one value set can't apply to both codes and quantities.
..... item 0..* See item (QuestionnaireResponse) Child items of question
.... item 0..* See item (QuestionnaireResponse) Child items of group item

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
QuestionnaireResponse.​language Base required All Languages 📍5.0.0 FHIR Std.
QuestionnaireResponse.​status Base required Questionnaire Response Status 📍5.0.0 FHIR Std.
QuestionnaireResponse.​item.answer.value[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.
QuestionnaireResponse.​item.answer.value[x]:valueString Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error QuestionnaireResponse If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error QuestionnaireResponse 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error QuestionnaireResponse 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 QuestionnaireResponse If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice QuestionnaireResponse 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()
qrs-1 error QuestionnaireResponse.item Item cannot contain both item and answer (answer.exists() and item.exists()).not()
qrs-2 error QuestionnaireResponse.item Repeated answers are combined in the answers array of a single item repeat(answer|item).select(item.where(answer.value.exists()).linkId.isDistinct()).allTrue()

This structure is derived from QuestionnaireResponse

Summary

Mandatory: 5 elements
Must-Support: 8 elements
Fixed: 1 element

Extensions

This structure refers to these extensions:

  • Unable to summarise extension http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-rendered-text (no extension found)

 

Other representations of profile: CSV, Excel, Schematron