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

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

A profile on Questionnaire for structured regulatory questions from a health authority to a market authorization holder during the review of a regulatory application (e.g., EMA Type II Variation). Supports sender/recipient, rich text questions, CTD section mapping, and organizational identifiers with address.

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
.. Questionnaire C 0..* Questionnaire A structured set of questions
Constraints: cnl-0, que-2
... 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/RegulatoryQuestionnaire
... 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 questionnaire
Slice: Unordered, Open by value:system
.... identifier:qa-request SΣ 1..1 Identifier Business identifier for questionnaire
..... 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 questionnaire
..... 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
... version SΣ 1..1 string Business version of the questionnaire
... name SΣC 1..1 string Name for this questionnaire (computer friendly)
... title SΣ 1..1 string Name for this questionnaire (human friendly)
... status ?!SΣC 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... subjectType Σ 1..* code Resource that can be subject of QuestionnaireResponse
Binding: ResourceType (required): One of the resource types defined as part of this version of FHIR.

Required Pattern: MedicinalProductDefinition
... date SΣ 1..1 dateTime Date last changed
... Slices for contact Σ 2..2 ContactDetail Contact details for the publisher
Slice: Unordered, Closed by value:purpose.coding.code
.... contact:sender SΣ 1..1 ContactDetail Contact details for the publisher
..... Slices for extension 1..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... extension:signature 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
..... telecom SΣ 1..* ContactPoint Contact details for individual or organization
.... contact:recipient SΣ 1..1 ContactDetail Contact details for the publisher
..... Slices for extension 1..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... extension:signature 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
..... telecom SΣ 1..* ContactPoint Contact details for individual or organization
... effectivePeriod SΣ 1..1 Period When the questionnaire is expected to be used
... item SC 1..* BackboneElement Questions and sections within the Questionnaire
Constraints: que-1a, que-1b, que-1c, que-3, que-4, que-5, que-6, que-8, que-9, que-10, que-11, que-12, que-13, que-14
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... linkId SC 1..1 string Unique id for item in questionnaire
Constraints: que-15
.... code SC 1..* Coding ​Corresponding concept for this item in a terminology
Binding: http://hl7.org/fhir/uv/brr/ValueSet/ctd-section (required)
.... text S 1..1 string Primary text for the item
..... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:richText 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText
.... type SC 1..1 code group | display | boolean | decimal | integer | date | dateTime +
Binding: QuestionnaireItemType (required): Distinguishes groups from questions and display text and indicates data type for questions.
.... enableWhen ?!C 0..* BackboneElement Only allow data when
Constraints: que-7
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... question 1..1 string The linkId of question that determines whether item is enabled/disabled
..... operator C 1..1 code exists | = | != | > | < | >= | <=
Binding: QuestionnaireItemOperator (required): The criteria by which a question is enabled.
..... answer[x] C 1..1 Value for question comparison based on operator
Binding: QuestionnaireAnswerCodes (example): Allowed values to answer questions.
...... answerBoolean boolean
...... answerDecimal decimal
...... answerInteger integer
...... answerDate date
...... answerDateTime dateTime
...... answerTime time
...... answerString string
...... answerCoding Coding
...... answerQuantity Quantity
...... answerReference Reference(Resource)
.... repeats C 0..1 boolean Whether the item may repeat
.... answerConstraint C 0..1 code optionsOnly | optionsOrType | optionsOrString
Binding: QuestionnaireAnswerConstraint (required): Indicates differnt modes for restricting values when options or valueset are specified
.... answerValueSet C 0..1 canonical(ValueSet) ValueSet containing permitted answers
.... answerOption C 0..* BackboneElement Permitted answer
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... value[x] 1..1 Answer value
Binding: QuestionnaireAnswerCodes (example): Allowed values to answer questions.
...... valueInteger integer
...... valueDate date
...... valueTime time
...... valueString string
...... valueCoding Coding
...... valueReference Reference(Resource)
.... initial C 0..* BackboneElement Initial value(s) when item is first rendered
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... value[x] 1..1 Actual value for initializing the question
Binding: QuestionnaireAnswerCodes (example): Allowed values to answer questions.
...... valueBoolean boolean
...... valueDecimal decimal
...... valueInteger integer
...... valueDate date
...... valueDateTime dateTime
...... valueTime time
...... valueString string
...... valueUri uri
...... valueAttachment Attachment
...... valueCoding Coding
...... valueQuantity Quantity
...... valueReference Reference(Resource)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Questionnaire.text.status Base required NarrativeStatus 📍5.0.0 FHIR Std.
Questionnaire.identifier:qa-request.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.identifier:procedure-number.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.status Base required PublicationStatus 📍5.0.0 FHIR Std.
Questionnaire.subjectType Base required Resource Types 📍5.0.0 FHIR Std.
Questionnaire.item.code Base required ​ http://hl7.org/fhir/uv/brr/ValueSet/ctd-section Not State Unknown
Questionnaire.item.type Base required Questionnaire Item Type 📍5.0.0 FHIR Std.
Questionnaire.item.enableWhen.​operator Base required Questionnaire Item Operator 📍5.0.0 FHIR Std.
Questionnaire.item.enableWhen.​answer[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.
Questionnaire.item.answerConstraint Base required Questionnaire answer constraints value set 📍5.0.0 FHIR Std.
Questionnaire.item.answerOption.​value[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.
Questionnaire.item.initial.​value[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cnl-0 warning Questionnaire Name should be usable as an identifier for the module by machine processing applications such as code generation name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
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()
que-1a error Questionnaire.item Group items must have nested items when Questionanire is complete (type='group' and %resource.status='complete') implies item.empty().not()
que-1b warning Questionnaire.item Groups should have items type='group' implies item.empty().not()
que-1c error Questionnaire.item Display items cannot have child items type='display' implies item.empty()
que-2 error Questionnaire The link ids for groups and questions must be unique within the questionnaire descendants().linkId.isDistinct()
que-3 error Questionnaire.item Display items cannot have a "code" asserted type!='display' or code.empty()
que-4 error Questionnaire.item A question cannot have both answerOption and answerValueSet answerOption.empty() or answerValueSet.empty()
que-5 error Questionnaire.item Only coding, decimal, integer, date, dateTime, time, string or quantity items can have answerOption or answerValueSet (type='coding' or type = 'decimal' or type = 'integer' or type = 'date' or type = 'dateTime' or type = 'time' or type = 'string' or type = 'quantity') or (answerValueSet.empty() and answerOption.empty())
que-6 error Questionnaire.item Required and repeat aren't permitted for display items type!='display' or (required.empty() and repeats.empty())
que-7 error Questionnaire.item.enableWhen If the operator is 'exists', the value must be a boolean operator = 'exists' implies (answer is boolean)
que-8 error Questionnaire.item Initial values can't be specified for groups or display items (type!='group' and type!='display') or initial.empty()
que-9 error Questionnaire.item Read-only can't be specified for "display" items type!='display' or readOnly.empty()
que-10 error Questionnaire.item Maximum length can only be declared for simple question types (type in ('boolean' | 'decimal' | 'integer' | 'string' | 'text' | 'url')) or answerConstraint='optionOrString' or maxLength.empty()
que-11 error Questionnaire.item If one or more answerOption is present, initial cannot be present. Use answerOption.initialSelected instead answerOption.empty() or initial.empty()
que-12 error Questionnaire.item If there are more than one enableWhen, enableBehavior must be specified enableWhen.count() > 1 implies enableBehavior.exists()
que-13 error Questionnaire.item Can only have multiple initial values for repeating items repeats=true or initial.count() <= 1
que-14 warning Questionnaire.item Can only have answerConstraint if answerOption or answerValueSet are present. (This is a warning because extensions may serve the same purpose) answerConstraint.exists() implies answerOption.exists() or answerValueSet.exists()
que-15 warning Questionnaire.item.linkId Link ids should be 255 characters or less $this.length() <= 255
txt-1 error Questionnaire.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 Questionnaire.text.div The narrative SHALL have some non-whitespace content htmlChecks()

This structure is derived from Questionnaire

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Questionnaire 0..* Questionnaire A structured set of questions
... 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/RegulatoryQuestionnaire
... text S 1..1 Narrative Text summary of the resource, for human interpretation
.... status 1..1 code generated | extensions | additional | empty
Required Pattern: generated
... Slices for identifier 2..* Identifier Business identifier for questionnaire
Slice: Unordered, Open by value:system
.... identifier:qa-request S 1..1 Identifier Business identifier for questionnaire
..... 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 questionnaire
..... system 0..1 uri The namespace for the identifier value
Required Pattern: https://ema.europa.eu/procedure-number
... name S 1..1 string Name for this questionnaire (computer friendly)
... title S 1..1 string Name for this questionnaire (human friendly)
... status S 1..1 code draft | active | retired | unknown
... subjectType 1..* code Resource that can be subject of QuestionnaireResponse
Required Pattern: MedicinalProductDefinition
... date S 1..1 dateTime Date last changed
... Slices for contact 2..2 ContactDetail Contact details for the publisher
Slice: Unordered, Closed by value:purpose.coding.code
.... contact:sender S 1..1 ContactDetail Contact details for the publisher
​..... purpose 1.. Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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
​..... organization S 1.. Reference(Organization)
​...... address S 1..
​..... address ..0
..... Slices for extension Content/Rules for all slices
...... extension:signature 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
..... telecom S 1..* ContactPoint Contact details for individual or organization
.... contact:recipient S 1..1 ContactDetail Contact details for the publisher
​..... purpose 1.. Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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
​..... organization S 1.. Reference(Organization)
​...... address S 1..
​..... address ..0
..... Slices for extension Content/Rules for all slices
...... extension:signature 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
..... telecom S 1..* ContactPoint Contact details for individual or organization
... effectivePeriod S 1..1 Period When the questionnaire is expected to be used
... item S 1..* BackboneElement Questions and sections within the Questionnaire
.... linkId S 1..1 string Unique id for item in questionnaire
.... code S 1..* Coding ​Corresponding concept for this item in a terminology
Binding: http://hl7.org/fhir/uv/brr/ValueSet/ctd-section (required)
.... text S 1..1 string Primary text for the item
..... Slices for extension Content/Rules for all slices
...... extension:richText 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText
.... type S 1..1 code group | display | boolean | decimal | integer | date | dateTime +

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Questionnaire.item.code Base required ​ http://hl7.org/fhir/uv/brr/ValueSet/ctd-section Not State Unknown
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Questionnaire C 0..* Questionnaire A structured set of questions
Constraints: cnl-0, que-2
... 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/RegulatoryQuestionnaire
.... 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
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... 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
... url ΣC 0..1 uri Canonical identifier for this questionnaire, represented as an absolute URI (globally unique)
Constraints: cnl-1
... Slices for identifier Σ 2..* Identifier Business identifier for questionnaire
Slice: Unordered, Open by value:system
.... identifier:qa-request SΣ 1..1 Identifier Business identifier for questionnaire
..... 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 questionnaire
..... 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)
... version SΣ 1..1 string Business version of the questionnaire
... versionAlgorithm[x] Σ 0..1 How to compare versions
Binding: VersionAlgorithm (extensible)
.... versionAlgorithmString string
.... versionAlgorithmCoding Coding
... name SΣC 1..1 string Name for this questionnaire (computer friendly)
... title SΣ 1..1 string Name for this questionnaire (human friendly)
... derivedFrom Σ 0..* canonical(Questionnaire) Based on Questionnaire
... status ?!SΣC 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... experimental Σ 0..1 boolean For testing purposes, not real usage
... subjectType Σ 1..* code Resource that can be subject of QuestionnaireResponse
Binding: ResourceType (required): One of the resource types defined as part of this version of FHIR.

Required Pattern: MedicinalProductDefinition
... date SΣ 1..1 dateTime Date last changed
... publisher Σ 0..1 string Name of the publisher/steward (organization or individual)
... Slices for contact Σ 2..2 ContactDetail Contact details for the publisher
Slice: Unordered, Closed by value:purpose.coding.code
.... contact:sender SΣ 1..1 ContactDetail Contact details for the publisher
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 1..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... extension:signature 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
..... name Σ 0..1 string Name of an individual to contact
..... telecom SΣ 1..* ContactPoint Contact details for individual or organization
.... contact:recipient SΣ 1..1 ContactDetail Contact details for the publisher
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 1..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... extension:signature 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
..... name Σ 0..1 string Name of an individual to contact
..... telecom SΣ 1..* ContactPoint Contact details for individual or organization
... description Σ 0..1 markdown Natural language description of the questionnaire
... useContext Σ 0..* UsageContext The context that the content is intended to support
... jurisdiction Σ 0..* CodeableConcept Intended jurisdiction for questionnaire (if applicable)
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
... purpose 0..1 markdown Why this questionnaire is defined
... copyright 0..1 markdown Use and/or publishing restrictions
... copyrightLabel 0..1 string Copyright holder and year(s)
... approvalDate 0..1 date When the questionnaire was approved by publisher
... lastReviewDate 0..1 date When the questionnaire was last reviewed by the publisher
... effectivePeriod SΣ 1..1 Period When the questionnaire is expected to be used
... code Σ 0..* Coding Concept that represents the overall questionnaire
Binding: QuestionnaireQuestionCodes (example): Codes for questionnaires, groups and individual questions.
... item SC 1..* BackboneElement Questions and sections within the Questionnaire
Constraints: que-1a, que-1b, que-1c, que-3, que-4, que-5, que-6, que-8, que-9, que-10, que-11, que-12, que-13, que-14
.... 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 Unique id for item in questionnaire
Constraints: que-15
.... definition 0..1 uri ElementDefinition - details for the item
.... code SC 1..* Coding ​Corresponding concept for this item in a terminology
Binding: http://hl7.org/fhir/uv/brr/ValueSet/ctd-section (required)
.... prefix 0..1 string E.g. "1(a)", "2.5.3"
.... text S 1..1 string Primary text for the item
..... id 0..1 string xml:id (or equivalent in JSON)
..... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:richText 1..* ?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
.... type SC 1..1 code group | display | boolean | decimal | integer | date | dateTime +
Binding: QuestionnaireItemType (required): Distinguishes groups from questions and display text and indicates data type for questions.
.... enableWhen ?!C 0..* BackboneElement Only allow data when
Constraints: que-7
..... 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
..... question 1..1 string The linkId of question that determines whether item is enabled/disabled
..... operator C 1..1 code exists | = | != | > | < | >= | <=
Binding: QuestionnaireItemOperator (required): The criteria by which a question is enabled.
..... answer[x] C 1..1 Value for question comparison based on operator
Binding: QuestionnaireAnswerCodes (example): Allowed values to answer questions.
...... answerBoolean boolean
...... answerDecimal decimal
...... answerInteger integer
...... answerDate date
...... answerDateTime dateTime
...... answerTime time
...... answerString string
...... answerCoding Coding
...... answerQuantity Quantity
...... answerReference Reference(Resource)
.... enableBehavior C 0..1 code all | any
Binding: EnableWhenBehavior (required): Controls how multiple enableWhen values are interpreted - whether all or any must be true.
.... disabledDisplay 0..1 code hidden | protected
Binding: QuestionnaireItemDisabledDisplay (required): Defines how disabled elements should be rendered
.... required C 0..1 boolean Whether the item must be included in data results
.... repeats C 0..1 boolean Whether the item may repeat
.... readOnly C 0..1 boolean Don't allow human editing
.... maxLength C 0..1 integer No more than these many characters
.... answerConstraint C 0..1 code optionsOnly | optionsOrType | optionsOrString
Binding: QuestionnaireAnswerConstraint (required): Indicates differnt modes for restricting values when options or valueset are specified
.... answerValueSet C 0..1 canonical(ValueSet) ValueSet containing permitted answers
.... answerOption C 0..* BackboneElement Permitted answer
..... 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] 1..1 Answer value
Binding: QuestionnaireAnswerCodes (example): Allowed values to answer questions.
...... valueInteger integer
...... valueDate date
...... valueTime time
...... valueString string
...... valueCoding Coding
...... valueReference Reference(Resource)
..... initialSelected 0..1 boolean Whether option is selected by default
.... initial C 0..* BackboneElement Initial value(s) when item is first rendered
..... 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] 1..1 Actual value for initializing the question
Binding: QuestionnaireAnswerCodes (example): Allowed values to answer questions.
...... valueBoolean boolean
...... valueDecimal decimal
...... valueInteger integer
...... valueDate date
...... valueDateTime dateTime
...... valueTime time
...... valueString string
...... valueUri uri
...... valueAttachment Attachment
...... valueCoding Coding
...... valueQuantity Quantity
...... valueReference Reference(Resource)
.... item 0..* See item (Questionnaire) Nested questionnaire items

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Questionnaire.meta.security Base extensible All Security Labels 📍5.0.0 FHIR Std.
Questionnaire.meta.tag Base example Common Tags 📍5.0.0 FHIR Std.
Questionnaire.language Base required All Languages 📍5.0.0 FHIR Std.
Questionnaire.text.status Base required NarrativeStatus 📍5.0.0 FHIR Std.
Questionnaire.identifier:qa-request.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.identifier:qa-request.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Questionnaire.identifier:procedure-number.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.identifier:procedure-number.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Questionnaire.versionAlgorithm[x] Base extensible Version Algorithm 📍5.0.0 FHIR Std.
Questionnaire.status Base required PublicationStatus 📍5.0.0 FHIR Std.
Questionnaire.subjectType Base required Resource Types 📍5.0.0 FHIR Std.
Questionnaire.jurisdiction Base extensible Jurisdiction ValueSet 📍5.0.0 FHIR Std.
Questionnaire.code Base example Questionnaire Question Codes 📍5.0.0 FHIR Std.
Questionnaire.item.code Base required ​ http://hl7.org/fhir/uv/brr/ValueSet/ctd-section Not State Unknown
Questionnaire.item.type Base required Questionnaire Item Type 📍5.0.0 FHIR Std.
Questionnaire.item.enableWhen.​operator Base required Questionnaire Item Operator 📍5.0.0 FHIR Std.
Questionnaire.item.enableWhen.​answer[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.
Questionnaire.item.enableBehavior Base required Enable When Behavior 📍5.0.0 FHIR Std.
Questionnaire.item.disabledDisplay Base required Questionnaire Item Disabled Display 📍5.0.0 FHIR Std.
Questionnaire.item.answerConstraint Base required Questionnaire answer constraints value set 📍5.0.0 FHIR Std.
Questionnaire.item.answerOption.​value[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.
Questionnaire.item.initial.​value[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cnl-0 warning Questionnaire Name should be usable as an identifier for the module by machine processing applications such as code generation name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
cnl-1 warning Questionnaire.url URL should not contain | or # - these characters make processing canonical references problematic exists() implies matches('^[^|# ]+$')
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()
que-1a error Questionnaire.item Group items must have nested items when Questionanire is complete (type='group' and %resource.status='complete') implies item.empty().not()
que-1b warning Questionnaire.item Groups should have items type='group' implies item.empty().not()
que-1c error Questionnaire.item Display items cannot have child items type='display' implies item.empty()
que-2 error Questionnaire The link ids for groups and questions must be unique within the questionnaire descendants().linkId.isDistinct()
que-3 error Questionnaire.item Display items cannot have a "code" asserted type!='display' or code.empty()
que-4 error Questionnaire.item A question cannot have both answerOption and answerValueSet answerOption.empty() or answerValueSet.empty()
que-5 error Questionnaire.item Only coding, decimal, integer, date, dateTime, time, string or quantity items can have answerOption or answerValueSet (type='coding' or type = 'decimal' or type = 'integer' or type = 'date' or type = 'dateTime' or type = 'time' or type = 'string' or type = 'quantity') or (answerValueSet.empty() and answerOption.empty())
que-6 error Questionnaire.item Required and repeat aren't permitted for display items type!='display' or (required.empty() and repeats.empty())
que-7 error Questionnaire.item.enableWhen If the operator is 'exists', the value must be a boolean operator = 'exists' implies (answer is boolean)
que-8 error Questionnaire.item Initial values can't be specified for groups or display items (type!='group' and type!='display') or initial.empty()
que-9 error Questionnaire.item Read-only can't be specified for "display" items type!='display' or readOnly.empty()
que-10 error Questionnaire.item Maximum length can only be declared for simple question types (type in ('boolean' | 'decimal' | 'integer' | 'string' | 'text' | 'url')) or answerConstraint='optionOrString' or maxLength.empty()
que-11 error Questionnaire.item If one or more answerOption is present, initial cannot be present. Use answerOption.initialSelected instead answerOption.empty() or initial.empty()
que-12 error Questionnaire.item If there are more than one enableWhen, enableBehavior must be specified enableWhen.count() > 1 implies enableBehavior.exists()
que-13 error Questionnaire.item Can only have multiple initial values for repeating items repeats=true or initial.count() <= 1
que-14 warning Questionnaire.item Can only have answerConstraint if answerOption or answerValueSet are present. (This is a warning because extensions may serve the same purpose) answerConstraint.exists() implies answerOption.exists() or answerValueSet.exists()
que-15 warning Questionnaire.item.linkId Link ids should be 255 characters or less $this.length() <= 255
txt-1 error Questionnaire.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 Questionnaire.text.div The narrative SHALL have some non-whitespace content htmlChecks()

This structure is derived from Questionnaire

Summary

Mandatory: 26 elements(6 nested mandatory elements)
Must-Support: 24 elements
Fixed: 1 element
Prohibited: 2 elements

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

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Questionnaire C 0..* Questionnaire A structured set of questions
Constraints: cnl-0, que-2
... 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/RegulatoryQuestionnaire
... 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 questionnaire
Slice: Unordered, Open by value:system
.... identifier:qa-request SΣ 1..1 Identifier Business identifier for questionnaire
..... 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 questionnaire
..... 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
... version SΣ 1..1 string Business version of the questionnaire
... name SΣC 1..1 string Name for this questionnaire (computer friendly)
... title SΣ 1..1 string Name for this questionnaire (human friendly)
... status ?!SΣC 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... subjectType Σ 1..* code Resource that can be subject of QuestionnaireResponse
Binding: ResourceType (required): One of the resource types defined as part of this version of FHIR.

Required Pattern: MedicinalProductDefinition
... date SΣ 1..1 dateTime Date last changed
... Slices for contact Σ 2..2 ContactDetail Contact details for the publisher
Slice: Unordered, Closed by value:purpose.coding.code
.... contact:sender SΣ 1..1 ContactDetail Contact details for the publisher
..... Slices for extension 1..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... extension:signature 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
..... telecom SΣ 1..* ContactPoint Contact details for individual or organization
.... contact:recipient SΣ 1..1 ContactDetail Contact details for the publisher
..... Slices for extension 1..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... extension:signature 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
..... telecom SΣ 1..* ContactPoint Contact details for individual or organization
... effectivePeriod SΣ 1..1 Period When the questionnaire is expected to be used
... item SC 1..* BackboneElement Questions and sections within the Questionnaire
Constraints: que-1a, que-1b, que-1c, que-3, que-4, que-5, que-6, que-8, que-9, que-10, que-11, que-12, que-13, que-14
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... linkId SC 1..1 string Unique id for item in questionnaire
Constraints: que-15
.... code SC 1..* Coding ​Corresponding concept for this item in a terminology
Binding: http://hl7.org/fhir/uv/brr/ValueSet/ctd-section (required)
.... text S 1..1 string Primary text for the item
..... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:richText 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText
.... type SC 1..1 code group | display | boolean | decimal | integer | date | dateTime +
Binding: QuestionnaireItemType (required): Distinguishes groups from questions and display text and indicates data type for questions.
.... enableWhen ?!C 0..* BackboneElement Only allow data when
Constraints: que-7
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... question 1..1 string The linkId of question that determines whether item is enabled/disabled
..... operator C 1..1 code exists | = | != | > | < | >= | <=
Binding: QuestionnaireItemOperator (required): The criteria by which a question is enabled.
..... answer[x] C 1..1 Value for question comparison based on operator
Binding: QuestionnaireAnswerCodes (example): Allowed values to answer questions.
...... answerBoolean boolean
...... answerDecimal decimal
...... answerInteger integer
...... answerDate date
...... answerDateTime dateTime
...... answerTime time
...... answerString string
...... answerCoding Coding
...... answerQuantity Quantity
...... answerReference Reference(Resource)
.... repeats C 0..1 boolean Whether the item may repeat
.... answerConstraint C 0..1 code optionsOnly | optionsOrType | optionsOrString
Binding: QuestionnaireAnswerConstraint (required): Indicates differnt modes for restricting values when options or valueset are specified
.... answerValueSet C 0..1 canonical(ValueSet) ValueSet containing permitted answers
.... answerOption C 0..* BackboneElement Permitted answer
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... value[x] 1..1 Answer value
Binding: QuestionnaireAnswerCodes (example): Allowed values to answer questions.
...... valueInteger integer
...... valueDate date
...... valueTime time
...... valueString string
...... valueCoding Coding
...... valueReference Reference(Resource)
.... initial C 0..* BackboneElement Initial value(s) when item is first rendered
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... value[x] 1..1 Actual value for initializing the question
Binding: QuestionnaireAnswerCodes (example): Allowed values to answer questions.
...... valueBoolean boolean
...... valueDecimal decimal
...... valueInteger integer
...... valueDate date
...... valueDateTime dateTime
...... valueTime time
...... valueString string
...... valueUri uri
...... valueAttachment Attachment
...... valueCoding Coding
...... valueQuantity Quantity
...... valueReference Reference(Resource)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Questionnaire.text.status Base required NarrativeStatus 📍5.0.0 FHIR Std.
Questionnaire.identifier:qa-request.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.identifier:procedure-number.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.status Base required PublicationStatus 📍5.0.0 FHIR Std.
Questionnaire.subjectType Base required Resource Types 📍5.0.0 FHIR Std.
Questionnaire.item.code Base required ​ http://hl7.org/fhir/uv/brr/ValueSet/ctd-section Not State Unknown
Questionnaire.item.type Base required Questionnaire Item Type 📍5.0.0 FHIR Std.
Questionnaire.item.enableWhen.​operator Base required Questionnaire Item Operator 📍5.0.0 FHIR Std.
Questionnaire.item.enableWhen.​answer[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.
Questionnaire.item.answerConstraint Base required Questionnaire answer constraints value set 📍5.0.0 FHIR Std.
Questionnaire.item.answerOption.​value[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.
Questionnaire.item.initial.​value[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cnl-0 warning Questionnaire Name should be usable as an identifier for the module by machine processing applications such as code generation name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
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()
que-1a error Questionnaire.item Group items must have nested items when Questionanire is complete (type='group' and %resource.status='complete') implies item.empty().not()
que-1b warning Questionnaire.item Groups should have items type='group' implies item.empty().not()
que-1c error Questionnaire.item Display items cannot have child items type='display' implies item.empty()
que-2 error Questionnaire The link ids for groups and questions must be unique within the questionnaire descendants().linkId.isDistinct()
que-3 error Questionnaire.item Display items cannot have a "code" asserted type!='display' or code.empty()
que-4 error Questionnaire.item A question cannot have both answerOption and answerValueSet answerOption.empty() or answerValueSet.empty()
que-5 error Questionnaire.item Only coding, decimal, integer, date, dateTime, time, string or quantity items can have answerOption or answerValueSet (type='coding' or type = 'decimal' or type = 'integer' or type = 'date' or type = 'dateTime' or type = 'time' or type = 'string' or type = 'quantity') or (answerValueSet.empty() and answerOption.empty())
que-6 error Questionnaire.item Required and repeat aren't permitted for display items type!='display' or (required.empty() and repeats.empty())
que-7 error Questionnaire.item.enableWhen If the operator is 'exists', the value must be a boolean operator = 'exists' implies (answer is boolean)
que-8 error Questionnaire.item Initial values can't be specified for groups or display items (type!='group' and type!='display') or initial.empty()
que-9 error Questionnaire.item Read-only can't be specified for "display" items type!='display' or readOnly.empty()
que-10 error Questionnaire.item Maximum length can only be declared for simple question types (type in ('boolean' | 'decimal' | 'integer' | 'string' | 'text' | 'url')) or answerConstraint='optionOrString' or maxLength.empty()
que-11 error Questionnaire.item If one or more answerOption is present, initial cannot be present. Use answerOption.initialSelected instead answerOption.empty() or initial.empty()
que-12 error Questionnaire.item If there are more than one enableWhen, enableBehavior must be specified enableWhen.count() > 1 implies enableBehavior.exists()
que-13 error Questionnaire.item Can only have multiple initial values for repeating items repeats=true or initial.count() <= 1
que-14 warning Questionnaire.item Can only have answerConstraint if answerOption or answerValueSet are present. (This is a warning because extensions may serve the same purpose) answerConstraint.exists() implies answerOption.exists() or answerValueSet.exists()
que-15 warning Questionnaire.item.linkId Link ids should be 255 characters or less $this.length() <= 255
txt-1 error Questionnaire.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 Questionnaire.text.div The narrative SHALL have some non-whitespace content htmlChecks()

Differential View

This structure is derived from Questionnaire

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Questionnaire 0..* Questionnaire A structured set of questions
... 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/RegulatoryQuestionnaire
... text S 1..1 Narrative Text summary of the resource, for human interpretation
.... status 1..1 code generated | extensions | additional | empty
Required Pattern: generated
... Slices for identifier 2..* Identifier Business identifier for questionnaire
Slice: Unordered, Open by value:system
.... identifier:qa-request S 1..1 Identifier Business identifier for questionnaire
..... 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 questionnaire
..... system 0..1 uri The namespace for the identifier value
Required Pattern: https://ema.europa.eu/procedure-number
... name S 1..1 string Name for this questionnaire (computer friendly)
... title S 1..1 string Name for this questionnaire (human friendly)
... status S 1..1 code draft | active | retired | unknown
... subjectType 1..* code Resource that can be subject of QuestionnaireResponse
Required Pattern: MedicinalProductDefinition
... date S 1..1 dateTime Date last changed
... Slices for contact 2..2 ContactDetail Contact details for the publisher
Slice: Unordered, Closed by value:purpose.coding.code
.... contact:sender S 1..1 ContactDetail Contact details for the publisher
​..... purpose 1.. Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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
​..... organization S 1.. Reference(Organization)
​...... address S 1..
​..... address ..0
..... Slices for extension Content/Rules for all slices
...... extension:signature 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
..... telecom S 1..* ContactPoint Contact details for individual or organization
.... contact:recipient S 1..1 ContactDetail Contact details for the publisher
​..... purpose 1.. Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... 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
​..... organization S 1.. Reference(Organization)
​...... address S 1..
​..... address ..0
..... Slices for extension Content/Rules for all slices
...... extension:signature 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
..... telecom S 1..* ContactPoint Contact details for individual or organization
... effectivePeriod S 1..1 Period When the questionnaire is expected to be used
... item S 1..* BackboneElement Questions and sections within the Questionnaire
.... linkId S 1..1 string Unique id for item in questionnaire
.... code S 1..* Coding ​Corresponding concept for this item in a terminology
Binding: http://hl7.org/fhir/uv/brr/ValueSet/ctd-section (required)
.... text S 1..1 string Primary text for the item
..... Slices for extension Content/Rules for all slices
...... extension:richText 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText
.... type S 1..1 code group | display | boolean | decimal | integer | date | dateTime +

doco Documentation for this format

Terminology Bindings (Differential)

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

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Questionnaire C 0..* Questionnaire A structured set of questions
Constraints: cnl-0, que-2
... 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/RegulatoryQuestionnaire
.... 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
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... 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
... url ΣC 0..1 uri Canonical identifier for this questionnaire, represented as an absolute URI (globally unique)
Constraints: cnl-1
... Slices for identifier Σ 2..* Identifier Business identifier for questionnaire
Slice: Unordered, Open by value:system
.... identifier:qa-request SΣ 1..1 Identifier Business identifier for questionnaire
..... 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 questionnaire
..... 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)
... version SΣ 1..1 string Business version of the questionnaire
... versionAlgorithm[x] Σ 0..1 How to compare versions
Binding: VersionAlgorithm (extensible)
.... versionAlgorithmString string
.... versionAlgorithmCoding Coding
... name SΣC 1..1 string Name for this questionnaire (computer friendly)
... title SΣ 1..1 string Name for this questionnaire (human friendly)
... derivedFrom Σ 0..* canonical(Questionnaire) Based on Questionnaire
... status ?!SΣC 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... experimental Σ 0..1 boolean For testing purposes, not real usage
... subjectType Σ 1..* code Resource that can be subject of QuestionnaireResponse
Binding: ResourceType (required): One of the resource types defined as part of this version of FHIR.

Required Pattern: MedicinalProductDefinition
... date SΣ 1..1 dateTime Date last changed
... publisher Σ 0..1 string Name of the publisher/steward (organization or individual)
... Slices for contact Σ 2..2 ContactDetail Contact details for the publisher
Slice: Unordered, Closed by value:purpose.coding.code
.... contact:sender SΣ 1..1 ContactDetail Contact details for the publisher
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 1..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... extension:signature 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
..... name Σ 0..1 string Name of an individual to contact
..... telecom SΣ 1..* ContactPoint Contact details for individual or organization
.... contact:recipient SΣ 1..1 ContactDetail Contact details for the publisher
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 1..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... extension:signature 1..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature]] Extension
URL: http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature
..... name Σ 0..1 string Name of an individual to contact
..... telecom SΣ 1..* ContactPoint Contact details for individual or organization
... description Σ 0..1 markdown Natural language description of the questionnaire
... useContext Σ 0..* UsageContext The context that the content is intended to support
... jurisdiction Σ 0..* CodeableConcept Intended jurisdiction for questionnaire (if applicable)
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
... purpose 0..1 markdown Why this questionnaire is defined
... copyright 0..1 markdown Use and/or publishing restrictions
... copyrightLabel 0..1 string Copyright holder and year(s)
... approvalDate 0..1 date When the questionnaire was approved by publisher
... lastReviewDate 0..1 date When the questionnaire was last reviewed by the publisher
... effectivePeriod SΣ 1..1 Period When the questionnaire is expected to be used
... code Σ 0..* Coding Concept that represents the overall questionnaire
Binding: QuestionnaireQuestionCodes (example): Codes for questionnaires, groups and individual questions.
... item SC 1..* BackboneElement Questions and sections within the Questionnaire
Constraints: que-1a, que-1b, que-1c, que-3, que-4, que-5, que-6, que-8, que-9, que-10, que-11, que-12, que-13, que-14
.... 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 Unique id for item in questionnaire
Constraints: que-15
.... definition 0..1 uri ElementDefinition - details for the item
.... code SC 1..* Coding ​Corresponding concept for this item in a terminology
Binding: http://hl7.org/fhir/uv/brr/ValueSet/ctd-section (required)
.... prefix 0..1 string E.g. "1(a)", "2.5.3"
.... text S 1..1 string Primary text for the item
..... id 0..1 string xml:id (or equivalent in JSON)
..... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:richText 1..* ?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
.... type SC 1..1 code group | display | boolean | decimal | integer | date | dateTime +
Binding: QuestionnaireItemType (required): Distinguishes groups from questions and display text and indicates data type for questions.
.... enableWhen ?!C 0..* BackboneElement Only allow data when
Constraints: que-7
..... 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
..... question 1..1 string The linkId of question that determines whether item is enabled/disabled
..... operator C 1..1 code exists | = | != | > | < | >= | <=
Binding: QuestionnaireItemOperator (required): The criteria by which a question is enabled.
..... answer[x] C 1..1 Value for question comparison based on operator
Binding: QuestionnaireAnswerCodes (example): Allowed values to answer questions.
...... answerBoolean boolean
...... answerDecimal decimal
...... answerInteger integer
...... answerDate date
...... answerDateTime dateTime
...... answerTime time
...... answerString string
...... answerCoding Coding
...... answerQuantity Quantity
...... answerReference Reference(Resource)
.... enableBehavior C 0..1 code all | any
Binding: EnableWhenBehavior (required): Controls how multiple enableWhen values are interpreted - whether all or any must be true.
.... disabledDisplay 0..1 code hidden | protected
Binding: QuestionnaireItemDisabledDisplay (required): Defines how disabled elements should be rendered
.... required C 0..1 boolean Whether the item must be included in data results
.... repeats C 0..1 boolean Whether the item may repeat
.... readOnly C 0..1 boolean Don't allow human editing
.... maxLength C 0..1 integer No more than these many characters
.... answerConstraint C 0..1 code optionsOnly | optionsOrType | optionsOrString
Binding: QuestionnaireAnswerConstraint (required): Indicates differnt modes for restricting values when options or valueset are specified
.... answerValueSet C 0..1 canonical(ValueSet) ValueSet containing permitted answers
.... answerOption C 0..* BackboneElement Permitted answer
..... 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] 1..1 Answer value
Binding: QuestionnaireAnswerCodes (example): Allowed values to answer questions.
...... valueInteger integer
...... valueDate date
...... valueTime time
...... valueString string
...... valueCoding Coding
...... valueReference Reference(Resource)
..... initialSelected 0..1 boolean Whether option is selected by default
.... initial C 0..* BackboneElement Initial value(s) when item is first rendered
..... 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] 1..1 Actual value for initializing the question
Binding: QuestionnaireAnswerCodes (example): Allowed values to answer questions.
...... valueBoolean boolean
...... valueDecimal decimal
...... valueInteger integer
...... valueDate date
...... valueDateTime dateTime
...... valueTime time
...... valueString string
...... valueUri uri
...... valueAttachment Attachment
...... valueCoding Coding
...... valueQuantity Quantity
...... valueReference Reference(Resource)
.... item 0..* See item (Questionnaire) Nested questionnaire items

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Questionnaire.meta.security Base extensible All Security Labels 📍5.0.0 FHIR Std.
Questionnaire.meta.tag Base example Common Tags 📍5.0.0 FHIR Std.
Questionnaire.language Base required All Languages 📍5.0.0 FHIR Std.
Questionnaire.text.status Base required NarrativeStatus 📍5.0.0 FHIR Std.
Questionnaire.identifier:qa-request.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.identifier:qa-request.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Questionnaire.identifier:procedure-number.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.identifier:procedure-number.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Questionnaire.versionAlgorithm[x] Base extensible Version Algorithm 📍5.0.0 FHIR Std.
Questionnaire.status Base required PublicationStatus 📍5.0.0 FHIR Std.
Questionnaire.subjectType Base required Resource Types 📍5.0.0 FHIR Std.
Questionnaire.jurisdiction Base extensible Jurisdiction ValueSet 📍5.0.0 FHIR Std.
Questionnaire.code Base example Questionnaire Question Codes 📍5.0.0 FHIR Std.
Questionnaire.item.code Base required ​ http://hl7.org/fhir/uv/brr/ValueSet/ctd-section Not State Unknown
Questionnaire.item.type Base required Questionnaire Item Type 📍5.0.0 FHIR Std.
Questionnaire.item.enableWhen.​operator Base required Questionnaire Item Operator 📍5.0.0 FHIR Std.
Questionnaire.item.enableWhen.​answer[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.
Questionnaire.item.enableBehavior Base required Enable When Behavior 📍5.0.0 FHIR Std.
Questionnaire.item.disabledDisplay Base required Questionnaire Item Disabled Display 📍5.0.0 FHIR Std.
Questionnaire.item.answerConstraint Base required Questionnaire answer constraints value set 📍5.0.0 FHIR Std.
Questionnaire.item.answerOption.​value[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.
Questionnaire.item.initial.​value[x] Base example Questionnaire Answer Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cnl-0 warning Questionnaire Name should be usable as an identifier for the module by machine processing applications such as code generation name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
cnl-1 warning Questionnaire.url URL should not contain | or # - these characters make processing canonical references problematic exists() implies matches('^[^|# ]+$')
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()
que-1a error Questionnaire.item Group items must have nested items when Questionanire is complete (type='group' and %resource.status='complete') implies item.empty().not()
que-1b warning Questionnaire.item Groups should have items type='group' implies item.empty().not()
que-1c error Questionnaire.item Display items cannot have child items type='display' implies item.empty()
que-2 error Questionnaire The link ids for groups and questions must be unique within the questionnaire descendants().linkId.isDistinct()
que-3 error Questionnaire.item Display items cannot have a "code" asserted type!='display' or code.empty()
que-4 error Questionnaire.item A question cannot have both answerOption and answerValueSet answerOption.empty() or answerValueSet.empty()
que-5 error Questionnaire.item Only coding, decimal, integer, date, dateTime, time, string or quantity items can have answerOption or answerValueSet (type='coding' or type = 'decimal' or type = 'integer' or type = 'date' or type = 'dateTime' or type = 'time' or type = 'string' or type = 'quantity') or (answerValueSet.empty() and answerOption.empty())
que-6 error Questionnaire.item Required and repeat aren't permitted for display items type!='display' or (required.empty() and repeats.empty())
que-7 error Questionnaire.item.enableWhen If the operator is 'exists', the value must be a boolean operator = 'exists' implies (answer is boolean)
que-8 error Questionnaire.item Initial values can't be specified for groups or display items (type!='group' and type!='display') or initial.empty()
que-9 error Questionnaire.item Read-only can't be specified for "display" items type!='display' or readOnly.empty()
que-10 error Questionnaire.item Maximum length can only be declared for simple question types (type in ('boolean' | 'decimal' | 'integer' | 'string' | 'text' | 'url')) or answerConstraint='optionOrString' or maxLength.empty()
que-11 error Questionnaire.item If one or more answerOption is present, initial cannot be present. Use answerOption.initialSelected instead answerOption.empty() or initial.empty()
que-12 error Questionnaire.item If there are more than one enableWhen, enableBehavior must be specified enableWhen.count() > 1 implies enableBehavior.exists()
que-13 error Questionnaire.item Can only have multiple initial values for repeating items repeats=true or initial.count() <= 1
que-14 warning Questionnaire.item Can only have answerConstraint if answerOption or answerValueSet are present. (This is a warning because extensions may serve the same purpose) answerConstraint.exists() implies answerOption.exists() or answerValueSet.exists()
que-15 warning Questionnaire.item.linkId Link ids should be 255 characters or less $this.length() <= 255
txt-1 error Questionnaire.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 Questionnaire.text.div The narrative SHALL have some non-whitespace content htmlChecks()

This structure is derived from Questionnaire

Summary

Mandatory: 26 elements(6 nested mandatory elements)
Must-Support: 24 elements
Fixed: 1 element
Prohibited: 2 elements

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

 

Other representations of profile: CSV, Excel, Schematron