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: Regulatory Questionnaire Response

Official URL: http://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaireResponse Version: 0.1.0
Active as of 2025-11-15 Computable Name: RegulatoryQuestionnaireResponse

A profile on QuestionnaireResponse for structured regulatory responses from a market authorization holder to a health authority. Enforces sender (MAH) and recipient (health authority) via sliced contact with purpose SENDER/RECIPIENT. Supports rich-text answers, CTD-section mapping, and organizational signatures.

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 C 0..* QuestionnaireResponse A structured set of questions and their answers
Constraints: qrs-1
... meta Σ 1..1 Meta Metadata about the resource
.... versionId SΣ 1..1 id Version specific identifier
.... lastUpdated SΣ 1..1 instant When the resource version last changed
.... profile Σ 1..* canonical(StructureDefinition) Profiles this resource claims to conform to

Fixed Value: http://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaireResponse
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text S 1..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
.... status 1..1 code generated | extensions | additional | empty
Binding: NarrativeStatus (required): The status of a resource narrative.
Required Pattern: generated
.... div C 1..1 xhtml Limited xhtml content
Constraints: txt-1, txt-2
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... Slices for identifier Σ 2..* Identifier Business identifier for this set of answers
Slice: Unordered, Open by value:system
.... identifier:qa-request SΣ 1..1 Identifier Business identifier for this set of answers
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: http://hl7.org/fhir/uv/brr/identifier/qa-request
.... identifier:procedure-number SΣ 1..1 Identifier Business identifier for this set of answers
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: https://ema.europa.eu/procedure-number
... questionnaire SΣ 1..1 canonical(BRR Regulatory Questionnaire Profile) 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.
... subject SΣ 1..1 Reference(MedicinalProductDefinition) The subject of the questions
... authored SΣ 1..1 dateTime Date and time the response was authored (submission date)
... item SC 1..* BackboneElement Groups and questions
Constraints: qrs-1, qrs-2
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... linkId SC 1..1 string Pointer to specific item from Questionnaire
.... text S 1..1 string Name for group or question text
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:richText 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText
.... answer C 0..* BackboneElement The response(s) to the question
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... value[x] C 1..1 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.
...... value[x]All Types Content/Rules for all Types
....... Slices for extension Content/Rules for all slices
........ extension:richText 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText
...... 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)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
QuestionnaireResponse.​text.status Base required NarrativeStatus 📍5.0.0 FHIR Std.
QuestionnaireResponse.​identifier:qa-request.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
QuestionnaireResponse.​identifier:procedure-number.​use Base required IdentifierUse 📍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.

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, QuestionnaireResponse.item Nested items can't be beneath 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()
txt-1 error QuestionnaireResponse.text.div The narrative SHALL contain only the basic html formatting elements and attributes described in chapters 7-11 (except section 4 of chapter 9) and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained style attributes htmlChecks()
txt-2 error QuestionnaireResponse.text.div The narrative SHALL have some non-whitespace content htmlChecks()

This structure is derived from QuestionnaireResponse

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. QuestionnaireResponse C 0..* QuestionnaireResponse A structured set of questions and their answers
Constraints: qrs-1
​... Slices for contact S 2..2 Slice: Unordered, Closed by value:purpose.coding.code
​.... contact:sender S 1..1 Sender: Market Authorization Holder (MAH) submitting the response
​..... purpose S 1.. Required Pattern: At least the following
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/brr/CodeSystem/contact-purpose
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SENDER
...... display 1..1 string Representation defined by the system
Fixed Value: Sender (Marketing Authorization Holder)
​..... organization S 1..
​..... telecom S 1..
​..... Slices for extension Slice: Unordered, Open by value:url
​...... extension:signature 0..1 ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
​.... contact:recipient S 1..1 Recipient: Health Authority that issued the questionnaire
​..... purpose S 1.. Required Pattern: At least the following
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/brr/CodeSystem/contact-purpose
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: RECIPIENT
...... display 1..1 string Representation defined by the system
Fixed Value: Recipient (Health Authority)
​..... organization S 1..
​..... telecom S 1..
​..... Slices for extension Slice: Unordered, Open by value:url
​...... extension:signature 0..1 ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
... meta 1..1 Meta Metadata about the resource
.... versionId S 1..1 id Version specific identifier
.... lastUpdated S 1..1 instant When the resource version last changed
.... profile 1..* canonical(StructureDefinition) Profiles this resource claims to conform to
Fixed Value: http://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaireResponse
... text S 1..1 Narrative Text summary of the resource, for human interpretation
.... status 1..1 code generated | extensions | additional | empty
Required Pattern: generated
.... identifier:qa-request S 1..1 Identifier Business identifier for this set of answers
..... system 0..1 uri The namespace for the identifier value
Required Pattern: http://hl7.org/fhir/uv/brr/identifier/qa-request
.... identifier:procedure-number S 1..1 Identifier Business identifier for this set of answers
..... system 0..1 uri The namespace for the identifier value
Required Pattern: https://ema.europa.eu/procedure-number
... questionnaire S 1..1 canonical(BRR Regulatory Questionnaire Profile) Canonical URL of Questionnaire being answered
... status S 1..1 code in-progress | completed | amended | entered-in-error | stopped
... subject S 1..1 Reference(MedicinalProductDefinition) The subject of the questions
... authored S 1..1 dateTime Date and time the response was authored (submission date)
... item S 1..* BackboneElement Groups and questions
​.... code S 1.. ​Binding: http://hl7.org/fhir/uv/brr/ValueSet/ctd-section (required)
.... linkId S 1..1 string Pointer to specific item from Questionnaire
.... text S 1..1 string Name for group or question text
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:richText 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText
.... answer
..... valueString
...... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
....... extension:richText 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
QuestionnaireResponse.​item.code Base required ​ http://hl7.org/fhir/uv/brr/ValueSet/ctd-section Not State Unknown

Constraints

Id Grade Path(s) Description Expression
qrs-1 error QuestionnaireResponse Nested items can't be beneath both item and answer (answer.exists() and item.exists()).not()
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. QuestionnaireResponse C 0..* QuestionnaireResponse A structured set of questions and their answers
Constraints: qrs-1
... id Σ 0..1 id Logical id of this artifact
... meta Σ 1..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId SΣ 1..1 id Version specific identifier
.... lastUpdated SΣ 1..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile Σ 1..* canonical(StructureDefinition) Profiles this resource claims to conform to

Fixed Value: http://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaireResponse
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (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
... text S 1..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
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... status 1..1 code generated | extensions | additional | empty
Binding: NarrativeStatus (required): The status of a resource narrative.
Required Pattern: generated
.... div C 1..1 xhtml Limited xhtml content
Constraints: txt-1, txt-2
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... Slices for identifier Σ 2..* Identifier Business identifier for this set of answers
Slice: Unordered, Open by value:system
.... identifier:qa-request SΣ 1..1 Identifier Business identifier for this set of answers
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: http://hl7.org/fhir/uv/brr/identifier/qa-request
..... value ΣC 0..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:procedure-number SΣ 1..1 Identifier Business identifier for this set of answers
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: https://ema.europa.eu/procedure-number
..... value ΣC 0..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... 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(BRR Regulatory Questionnaire Profile) 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.
... 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 and time the response was authored (submission date)
... author Σ 0..1 Reference(Device | Practitioner | PractitionerRole | Patient | RelatedPerson | 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 SC 1..* BackboneElement Groups and questions
Constraints: qrs-1, qrs-2
.... 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
.... linkId SC 1..1 string Pointer to specific item from Questionnaire
.... definition 0..1 uri ElementDefinition - details for the item
.... text S 1..1 string Name for group or question text
..... id 0..1 string xml:id (or equivalent in JSON)
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:richText 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText
..... value 0..1 string Primitive value for string
Max Length:1048576
.... 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
..... value[x] C 1..1 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.
...... value[x]All Types Content/Rules for all Types
....... id 0..1 string Unique id for inter-element referencing
....... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
........ extension:richText 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText
...... 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)
..... 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.​meta.security Base extensible All Security Labels 📍5.0.0 FHIR Std.
QuestionnaireResponse.​meta.tag Base example Common Tags 📍5.0.0 FHIR Std.
QuestionnaireResponse.​language Base required All Languages 📍5.0.0 FHIR Std.
QuestionnaireResponse.​text.status Base required NarrativeStatus 📍5.0.0 FHIR Std.
QuestionnaireResponse.​identifier:qa-request.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
QuestionnaireResponse.​identifier:qa-request.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
QuestionnaireResponse.​identifier:procedure-number.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
QuestionnaireResponse.​identifier:procedure-number.​type Base extensible Identifier Type Codes 📍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.

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, QuestionnaireResponse.item Nested items can't be beneath 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()
txt-1 error QuestionnaireResponse.text.div The narrative SHALL contain only the basic html formatting elements and attributes described in chapters 7-11 (except section 4 of chapter 9) and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained style attributes htmlChecks()
txt-2 error QuestionnaireResponse.text.div The narrative SHALL have some non-whitespace content htmlChecks()

This structure is derived from QuestionnaireResponse

Summary

Mandatory: 14 elements(9 nested mandatory elements)
Must-Support: 22 elements
Fixed: 1 element

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

  • Unable to summarise extension http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature (no extension found)
  • Unable to summarise extension http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText (no extension found)

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of QuestionnaireResponse.contact (Closed)
  • The element 1 is sliced based on the value of QuestionnaireResponse.identifier

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. QuestionnaireResponse C 0..* QuestionnaireResponse A structured set of questions and their answers
Constraints: qrs-1
... meta Σ 1..1 Meta Metadata about the resource
.... versionId SΣ 1..1 id Version specific identifier
.... lastUpdated SΣ 1..1 instant When the resource version last changed
.... profile Σ 1..* canonical(StructureDefinition) Profiles this resource claims to conform to

Fixed Value: http://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaireResponse
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text S 1..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
.... status 1..1 code generated | extensions | additional | empty
Binding: NarrativeStatus (required): The status of a resource narrative.
Required Pattern: generated
.... div C 1..1 xhtml Limited xhtml content
Constraints: txt-1, txt-2
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... Slices for identifier Σ 2..* Identifier Business identifier for this set of answers
Slice: Unordered, Open by value:system
.... identifier:qa-request SΣ 1..1 Identifier Business identifier for this set of answers
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: http://hl7.org/fhir/uv/brr/identifier/qa-request
.... identifier:procedure-number SΣ 1..1 Identifier Business identifier for this set of answers
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: https://ema.europa.eu/procedure-number
... questionnaire SΣ 1..1 canonical(BRR Regulatory Questionnaire Profile) 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.
... subject SΣ 1..1 Reference(MedicinalProductDefinition) The subject of the questions
... authored SΣ 1..1 dateTime Date and time the response was authored (submission date)
... item SC 1..* BackboneElement Groups and questions
Constraints: qrs-1, qrs-2
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... linkId SC 1..1 string Pointer to specific item from Questionnaire
.... text S 1..1 string Name for group or question text
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:richText 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText
.... answer C 0..* BackboneElement The response(s) to the question
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... value[x] C 1..1 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.
...... value[x]All Types Content/Rules for all Types
....... Slices for extension Content/Rules for all slices
........ extension:richText 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText
...... 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)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
QuestionnaireResponse.​text.status Base required NarrativeStatus 📍5.0.0 FHIR Std.
QuestionnaireResponse.​identifier:qa-request.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
QuestionnaireResponse.​identifier:procedure-number.​use Base required IdentifierUse 📍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.

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, QuestionnaireResponse.item Nested items can't be beneath 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()
txt-1 error QuestionnaireResponse.text.div The narrative SHALL contain only the basic html formatting elements and attributes described in chapters 7-11 (except section 4 of chapter 9) and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained style attributes htmlChecks()
txt-2 error QuestionnaireResponse.text.div The narrative SHALL have some non-whitespace content htmlChecks()

Differential View

This structure is derived from QuestionnaireResponse

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. QuestionnaireResponse C 0..* QuestionnaireResponse A structured set of questions and their answers
Constraints: qrs-1
​... Slices for contact S 2..2 Slice: Unordered, Closed by value:purpose.coding.code
​.... contact:sender S 1..1 Sender: Market Authorization Holder (MAH) submitting the response
​..... purpose S 1.. Required Pattern: At least the following
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/brr/CodeSystem/contact-purpose
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SENDER
...... display 1..1 string Representation defined by the system
Fixed Value: Sender (Marketing Authorization Holder)
​..... organization S 1..
​..... telecom S 1..
​..... Slices for extension Slice: Unordered, Open by value:url
​...... extension:signature 0..1 ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
​.... contact:recipient S 1..1 Recipient: Health Authority that issued the questionnaire
​..... purpose S 1.. Required Pattern: At least the following
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/brr/CodeSystem/contact-purpose
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: RECIPIENT
...... display 1..1 string Representation defined by the system
Fixed Value: Recipient (Health Authority)
​..... organization S 1..
​..... telecom S 1..
​..... Slices for extension Slice: Unordered, Open by value:url
​...... extension:signature 0..1 ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
... meta 1..1 Meta Metadata about the resource
.... versionId S 1..1 id Version specific identifier
.... lastUpdated S 1..1 instant When the resource version last changed
.... profile 1..* canonical(StructureDefinition) Profiles this resource claims to conform to
Fixed Value: http://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaireResponse
... text S 1..1 Narrative Text summary of the resource, for human interpretation
.... status 1..1 code generated | extensions | additional | empty
Required Pattern: generated
.... identifier:qa-request S 1..1 Identifier Business identifier for this set of answers
..... system 0..1 uri The namespace for the identifier value
Required Pattern: http://hl7.org/fhir/uv/brr/identifier/qa-request
.... identifier:procedure-number S 1..1 Identifier Business identifier for this set of answers
..... system 0..1 uri The namespace for the identifier value
Required Pattern: https://ema.europa.eu/procedure-number
... questionnaire S 1..1 canonical(BRR Regulatory Questionnaire Profile) Canonical URL of Questionnaire being answered
... status S 1..1 code in-progress | completed | amended | entered-in-error | stopped
... subject S 1..1 Reference(MedicinalProductDefinition) The subject of the questions
... authored S 1..1 dateTime Date and time the response was authored (submission date)
... item S 1..* BackboneElement Groups and questions
​.... code S 1.. ​Binding: http://hl7.org/fhir/uv/brr/ValueSet/ctd-section (required)
.... linkId S 1..1 string Pointer to specific item from Questionnaire
.... text S 1..1 string Name for group or question text
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:richText 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText
.... answer
..... valueString
...... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
....... extension:richText 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
QuestionnaireResponse.​item.code Base required ​ http://hl7.org/fhir/uv/brr/ValueSet/ctd-section Not State Unknown

Constraints

Id Grade Path(s) Description Expression
qrs-1 error QuestionnaireResponse Nested items can't be beneath both item and answer (answer.exists() and item.exists()).not()

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. QuestionnaireResponse C 0..* QuestionnaireResponse A structured set of questions and their answers
Constraints: qrs-1
... id Σ 0..1 id Logical id of this artifact
... meta Σ 1..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId SΣ 1..1 id Version specific identifier
.... lastUpdated SΣ 1..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile Σ 1..* canonical(StructureDefinition) Profiles this resource claims to conform to

Fixed Value: http://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaireResponse
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (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
... text S 1..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
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... status 1..1 code generated | extensions | additional | empty
Binding: NarrativeStatus (required): The status of a resource narrative.
Required Pattern: generated
.... div C 1..1 xhtml Limited xhtml content
Constraints: txt-1, txt-2
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... Slices for identifier Σ 2..* Identifier Business identifier for this set of answers
Slice: Unordered, Open by value:system
.... identifier:qa-request SΣ 1..1 Identifier Business identifier for this set of answers
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: http://hl7.org/fhir/uv/brr/identifier/qa-request
..... value ΣC 0..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:procedure-number SΣ 1..1 Identifier Business identifier for this set of answers
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: https://ema.europa.eu/procedure-number
..... value ΣC 0..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... 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(BRR Regulatory Questionnaire Profile) 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.
... 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 and time the response was authored (submission date)
... author Σ 0..1 Reference(Device | Practitioner | PractitionerRole | Patient | RelatedPerson | 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 SC 1..* BackboneElement Groups and questions
Constraints: qrs-1, qrs-2
.... 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
.... linkId SC 1..1 string Pointer to specific item from Questionnaire
.... definition 0..1 uri ElementDefinition - details for the item
.... text S 1..1 string Name for group or question text
..... id 0..1 string xml:id (or equivalent in JSON)
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:richText 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText
..... value 0..1 string Primitive value for string
Max Length:1048576
.... 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
..... value[x] C 1..1 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.
...... value[x]All Types Content/Rules for all Types
....... id 0..1 string Unique id for inter-element referencing
....... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
........ extension:richText 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText
...... 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)
..... 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.​meta.security Base extensible All Security Labels 📍5.0.0 FHIR Std.
QuestionnaireResponse.​meta.tag Base example Common Tags 📍5.0.0 FHIR Std.
QuestionnaireResponse.​language Base required All Languages 📍5.0.0 FHIR Std.
QuestionnaireResponse.​text.status Base required NarrativeStatus 📍5.0.0 FHIR Std.
QuestionnaireResponse.​identifier:qa-request.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
QuestionnaireResponse.​identifier:qa-request.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
QuestionnaireResponse.​identifier:procedure-number.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
QuestionnaireResponse.​identifier:procedure-number.​type Base extensible Identifier Type Codes 📍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.

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, QuestionnaireResponse.item Nested items can't be beneath 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()
txt-1 error QuestionnaireResponse.text.div The narrative SHALL contain only the basic html formatting elements and attributes described in chapters 7-11 (except section 4 of chapter 9) and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained style attributes htmlChecks()
txt-2 error QuestionnaireResponse.text.div The narrative SHALL have some non-whitespace content htmlChecks()

This structure is derived from QuestionnaireResponse

Summary

Mandatory: 14 elements(9 nested mandatory elements)
Must-Support: 22 elements
Fixed: 1 element

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

  • Unable to summarise extension http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature (no extension found)
  • Unable to summarise extension http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText (no extension found)

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of QuestionnaireResponse.contact (Closed)
  • The element 1 is sliced based on the value of QuestionnaireResponse.identifier

 

Other representations of profile: CSV, Excel, Schematron