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 ( Experimental )

Official URL: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaire Version: 0.1.0
Draft as of 2025-11-21 Computable Name: RTQQuestionnaire

Profile of Questionnaire for regulatory exchange of questions, issues and information requests between regulators and industry in the medicinal product lifecycle.

Usages:

  • This Profile is not used by any profiles in this Implementation Guide

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 SΣ 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 SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to

Fixed Value: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaire
... 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
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... Slices for identifier SΣ 1..2 Identifier Business identifier for questionnaire
Slice: Unordered, Closed by value:type.coding.code
.... identifier:company SΣ 0..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 .
..... type SΣ 1..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.
...... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: As shown
....... id 0..0 string Unique id for inter-element referencing
....... extension 0..0 Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type
....... version 0..0 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: company-id
....... display 1..1 string Representation defined by the system
Fixed Value: Company-issued Identifier
....... userSelected 0..0 boolean If this coding was chosen directly by the user
.... identifier:regulator 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 .
..... type SΣ 1..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.
...... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: As shown
....... id 0..0 string Unique id for inter-element referencing
....... extension 0..0 Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type
....... version 0..0 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: regulator-id
....... display 1..1 string Representation defined by the system
Fixed Value: Regulator-issued Identifier
....... userSelected 0..0 boolean If this coding was chosen directly by the user
... version SΣ 1..1 string Business version of the questionnaire
... status ?!ΣC 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... subjectType SΣ 1..* code Resource that can be subject of QuestionnaireResponse
Binding: http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs (extensible)
... Slices for contact SΣ 2..2 ContactDetail Sender (issuing regulatory authority) and receiver (MAH/applicant) contact details
Slice: Unordered, Closed by value:organization.name
.... contact:sender SΣ 1..1 ContactDetail Contact details of the issuing competent authority (regulator)
.... contact:receiver SΣ 1..1 ContactDetail Contact details of the marketing authorisation holder/applicant
... item SC 0..* BackboneElement Question in the regulatory 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 C 1..1 string Unique id for item in questionnaire
Constraints: que-15
.... code SC 1..* Coding CTD-based category code that classifies the regulatory topic of this question/group
Binding: http://hl7.org/fhir/uv/rtq/ValueSet/ctd-categories-full (extensible): Codes from the full CTD hierarchy as defined in the RTQ CTD Categories CodeSystem. Additional codes beyond the standard CTD structure may be defined locally or in future versions of the CodeSystem when new regulatory topics are required.
..... system SΣ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full
..... code SΣC 1..1 code CTD section/subsection code (e.g., 2-3-s-4-2-1)
..... display SΣC 1..1 string Human-readable title of the CTD category
.... text S 1..1 string Primary text for the item
..... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:rendering-xhtml S 1..1 string String equivalent with html markup
URL: http://hl7.org/fhir/StructureDefinition/rendering-xhtml
.... type C 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.identifier:company.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.identifier:company.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Questionnaire.identifier:regulator.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.identifier:regulator.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Questionnaire.status Base required PublicationStatus 📍5.0.0 FHIR Std.
Questionnaire.subjectType Base extensible http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs Not State Unknown
Questionnaire.item.code Base extensible http://hl7.org/fhir/uv/rtq/ValueSet/ctd-categories-full 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

This structure is derived from Questionnaire

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Questionnaire 0..* Questionnaire A structured set of questions
... meta S 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 S 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
Fixed Value: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaire
... text S 1..1 Narrative Text summary of the resource, for human interpretation
... Slices for identifier S 1..2 Identifier Business identifier for questionnaire
Slice: Unordered, Closed by value:type.coding.code
.... identifier:company S 0..1 Identifier Business identifier for questionnaire
..... type S 1..1 CodeableConcept Description of identifier
...... coding 1..1 Coding Code defined by a terminology system
Fixed Value: As shown
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: company-id
....... display 1..1 string Representation defined by the system
Fixed Value: Company-issued Identifier
.... identifier:regulator S 1..1 Identifier Business identifier for questionnaire
..... type S 1..1 CodeableConcept Description of identifier
...... coding 1..1 Coding Code defined by a terminology system
Fixed Value: As shown
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: regulator-id
....... display 1..1 string Representation defined by the system
Fixed Value: Regulator-issued Identifier
... subjectType S 1..* code Resource that can be subject of QuestionnaireResponse
Binding: http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs (extensible)
... publisher 0..0 Name of the publisher/steward (organization or individual)
... Slices for contact S 2..2 ContactDetail Sender (issuing regulatory authority) and receiver (MAH/applicant) contact details
Slice: Unordered, Closed by value:organization.name
.... contact:sender S 1..1 ContactDetail Contact details of the issuing competent authority (regulator)
​..... organization S 1.. Issuing competent authority
​...... identifier S 1.. Regulatory authority identifier (e.g., OMS Location ID)
​...... name S 1.. Official name of the issuing regulatory authority
​...... address S 1..1 Official address of the issuing competent authority
​....... text S 1.. Full formatted address of the issuing authority
​....... line S 1..* Street address lines of the issuing authority
​....... city S 1.. City of the issuing competent authority
​....... district S 0.. District (sub-division of city) of the issuing authority
​....... state S 0.. State, province or region of the issuing authority
​....... postalCode S 1.. Postal code of the issuing authority
​....... country S 1.. Country of the issuing competent authority
​...... contact S 1.. Primary contact at the issuing authority
​....... Slices for telecom S 2..2 Slice: Unordered, Closed by value:system
​........ telecom:email 1..1 Official email for the designated regulatory contact
​......... system Fixed Value: email
​......... value 1..
​........ telecom:phone 0..1 Telephone number for the responsible regulatory contact
​......... system Fixed Value: phone
​......... value 1..
.... contact:receiver S 1..1 ContactDetail Contact details of the marketing authorisation holder/applicant
​..... organization S 1.. Marketing authorisation holder / applicant organisation
​...... identifier S 1.. Organisation identifier of the MAH/applicant (e.g., OMS Organization ID)
​...... name S 1.. Legal name of the MAH/applicant
​...... address S 1..1 Official registered address of the marketing authorisation holder/sponsor
​....... text S 1.. Full formatted address of the MAH/sponsor (human-readable)
​....... line S 1..* Street address lines of the MAH/sponsor
​....... city S 1.. City of the MAH/sponsor registered address
​....... district S 0.. District or borough (if applicable)
​....... state S 0.. State, province or region of the MAH/sponsor
​....... postalCode S 1..
​....... country S 1.. Country of the MAH/sponsor registered address
​...... contact S 1.. Regulatory affairs contact person at the MAH/applicant
​....... Slices for telecom S 2..2 Slice: Unordered, Closed by value:system
​........ telecom:email 1..1 Regulatory contact email of the MAH/applicant
​......... system Fixed Value: email
​......... value 1..
​........ telecom:phone 1..1 Telephone number of the regulatory contact at the MAH/applicant
​......... system Fixed Value: phone
​......... value 1..
... item S 0..* BackboneElement Question in the regulatory questionnaire
.... code S 1..* Coding CTD-based category code that classifies the regulatory topic of this question/group
Binding: http://hl7.org/fhir/uv/rtq/ValueSet/ctd-categories-full (extensible): Codes from the full CTD hierarchy as defined in the RTQ CTD Categories CodeSystem. Additional codes beyond the standard CTD structure may be defined locally or in future versions of the CodeSystem when new regulatory topics are required.
..... system S 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full
..... code S 1..1 code CTD section/subsection code (e.g., 2-3-s-4-2-1)
..... display S 1..1 string Human-readable title of the CTD category
.... text S 1..1 string Primary text for the item
..... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:rendering-xhtml S 1..1 string String equivalent with html markup
URL: http://hl7.org/fhir/StructureDefinition/rendering-xhtml

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Questionnaire.subjectType Base extensible http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs Not State Unknown
Questionnaire.item.code Base extensible http://hl7.org/fhir/uv/rtq/ValueSet/ctd-categories-full 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 SΣ 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 SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to

Fixed Value: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaire
.... 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
... 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 SΣ 1..2 Identifier Business identifier for questionnaire
Slice: Unordered, Closed by value:type.coding.code
.... identifier:company SΣ 0..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 SΣ 1..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.
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: As shown
....... id 0..0 string Unique id for inter-element referencing
....... extension 0..0 Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type
....... version 0..0 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: company-id
....... display 1..1 string Representation defined by the system
Fixed Value: Company-issued Identifier
....... userSelected 0..0 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... system Σ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... 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:regulator 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 SΣ 1..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.
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: As shown
....... id 0..0 string Unique id for inter-element referencing
....... extension 0..0 Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type
....... version 0..0 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: regulator-id
....... display 1..1 string Representation defined by the system
Fixed Value: Regulator-issued Identifier
....... userSelected 0..0 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... system Σ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... 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 ΣC 0..1 string Name for this questionnaire (computer friendly)
... title Σ 0..1 string Name for this questionnaire (human friendly)
... derivedFrom Σ 0..* canonical(Questionnaire) Based on Questionnaire
... status ?!ΣC 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 SΣ 1..* code Resource that can be subject of QuestionnaireResponse
Binding: http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs (extensible)
... date Σ 0..1 dateTime Date last changed
... Slices for contact SΣ 2..2 ContactDetail Sender (issuing regulatory authority) and receiver (MAH/applicant) contact details
Slice: Unordered, Closed by value:organization.name
.... contact:sender SΣ 1..1 ContactDetail Contact details of the issuing competent authority (regulator)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... name Σ 0..1 string Name of an individual to contact
..... telecom Σ 0..* ContactPoint Contact details for individual or organization
.... contact:receiver SΣ 1..1 ContactDetail Contact details of the marketing authorisation holder/applicant
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... name Σ 0..1 string Name of an individual to contact
..... telecom Σ 0..* 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 Σ 0..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 0..* BackboneElement Question in the regulatory 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 C 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 CTD-based category code that classifies the regulatory topic of this question/group
Binding: http://hl7.org/fhir/uv/rtq/ValueSet/ctd-categories-full (extensible): Codes from the full CTD hierarchy as defined in the RTQ CTD Categories CodeSystem. Additional codes beyond the standard CTD structure may be defined locally or in future versions of the CodeSystem when new regulatory topics are required.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system SΣ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full
..... version Σ 0..1 string Version of the system - if relevant
..... code SΣC 1..1 code CTD section/subsection code (e.g., 2-3-s-4-2-1)
..... display SΣC 1..1 string Human-readable title of the CTD category
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... 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:rendering-xhtml S 1..1 string String equivalent with html markup
URL: http://hl7.org/fhir/StructureDefinition/rendering-xhtml
..... value 0..1 string Primitive value for string
Max Length:1048576
.... type C 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.identifier:company.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.identifier:company.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Questionnaire.identifier:regulator.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.identifier:regulator.​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 extensible http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs Not State Unknown
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 extensible http://hl7.org/fhir/uv/rtq/ValueSet/ctd-categories-full 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

This structure is derived from Questionnaire

Summary

Mandatory: 13 elements(36 nested mandatory elements)
Must-Support: 48 elements
Fixed: 8 elements
Prohibited: 1 element

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

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

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Questionnaire C 0..* Questionnaire A structured set of questions
Constraints: cnl-0, que-2
... meta SΣ 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 SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to

Fixed Value: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaire
... 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
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... Slices for identifier SΣ 1..2 Identifier Business identifier for questionnaire
Slice: Unordered, Closed by value:type.coding.code
.... identifier:company SΣ 0..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 .
..... type SΣ 1..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.
...... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: As shown
....... id 0..0 string Unique id for inter-element referencing
....... extension 0..0 Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type
....... version 0..0 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: company-id
....... display 1..1 string Representation defined by the system
Fixed Value: Company-issued Identifier
....... userSelected 0..0 boolean If this coding was chosen directly by the user
.... identifier:regulator 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 .
..... type SΣ 1..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.
...... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: As shown
....... id 0..0 string Unique id for inter-element referencing
....... extension 0..0 Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type
....... version 0..0 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: regulator-id
....... display 1..1 string Representation defined by the system
Fixed Value: Regulator-issued Identifier
....... userSelected 0..0 boolean If this coding was chosen directly by the user
... version SΣ 1..1 string Business version of the questionnaire
... status ?!ΣC 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
... subjectType SΣ 1..* code Resource that can be subject of QuestionnaireResponse
Binding: http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs (extensible)
... Slices for contact SΣ 2..2 ContactDetail Sender (issuing regulatory authority) and receiver (MAH/applicant) contact details
Slice: Unordered, Closed by value:organization.name
.... contact:sender SΣ 1..1 ContactDetail Contact details of the issuing competent authority (regulator)
.... contact:receiver SΣ 1..1 ContactDetail Contact details of the marketing authorisation holder/applicant
... item SC 0..* BackboneElement Question in the regulatory 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 C 1..1 string Unique id for item in questionnaire
Constraints: que-15
.... code SC 1..* Coding CTD-based category code that classifies the regulatory topic of this question/group
Binding: http://hl7.org/fhir/uv/rtq/ValueSet/ctd-categories-full (extensible): Codes from the full CTD hierarchy as defined in the RTQ CTD Categories CodeSystem. Additional codes beyond the standard CTD structure may be defined locally or in future versions of the CodeSystem when new regulatory topics are required.
..... system SΣ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full
..... code SΣC 1..1 code CTD section/subsection code (e.g., 2-3-s-4-2-1)
..... display SΣC 1..1 string Human-readable title of the CTD category
.... text S 1..1 string Primary text for the item
..... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:rendering-xhtml S 1..1 string String equivalent with html markup
URL: http://hl7.org/fhir/StructureDefinition/rendering-xhtml
.... type C 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.identifier:company.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.identifier:company.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Questionnaire.identifier:regulator.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.identifier:regulator.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Questionnaire.status Base required PublicationStatus 📍5.0.0 FHIR Std.
Questionnaire.subjectType Base extensible http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs Not State Unknown
Questionnaire.item.code Base extensible http://hl7.org/fhir/uv/rtq/ValueSet/ctd-categories-full 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

Differential View

This structure is derived from Questionnaire

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Questionnaire 0..* Questionnaire A structured set of questions
... meta S 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 S 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
Fixed Value: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaire
... text S 1..1 Narrative Text summary of the resource, for human interpretation
... Slices for identifier S 1..2 Identifier Business identifier for questionnaire
Slice: Unordered, Closed by value:type.coding.code
.... identifier:company S 0..1 Identifier Business identifier for questionnaire
..... type S 1..1 CodeableConcept Description of identifier
...... coding 1..1 Coding Code defined by a terminology system
Fixed Value: As shown
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: company-id
....... display 1..1 string Representation defined by the system
Fixed Value: Company-issued Identifier
.... identifier:regulator S 1..1 Identifier Business identifier for questionnaire
..... type S 1..1 CodeableConcept Description of identifier
...... coding 1..1 Coding Code defined by a terminology system
Fixed Value: As shown
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: regulator-id
....... display 1..1 string Representation defined by the system
Fixed Value: Regulator-issued Identifier
... subjectType S 1..* code Resource that can be subject of QuestionnaireResponse
Binding: http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs (extensible)
... publisher 0..0 Name of the publisher/steward (organization or individual)
... Slices for contact S 2..2 ContactDetail Sender (issuing regulatory authority) and receiver (MAH/applicant) contact details
Slice: Unordered, Closed by value:organization.name
.... contact:sender S 1..1 ContactDetail Contact details of the issuing competent authority (regulator)
​..... organization S 1.. Issuing competent authority
​...... identifier S 1.. Regulatory authority identifier (e.g., OMS Location ID)
​...... name S 1.. Official name of the issuing regulatory authority
​...... address S 1..1 Official address of the issuing competent authority
​....... text S 1.. Full formatted address of the issuing authority
​....... line S 1..* Street address lines of the issuing authority
​....... city S 1.. City of the issuing competent authority
​....... district S 0.. District (sub-division of city) of the issuing authority
​....... state S 0.. State, province or region of the issuing authority
​....... postalCode S 1.. Postal code of the issuing authority
​....... country S 1.. Country of the issuing competent authority
​...... contact S 1.. Primary contact at the issuing authority
​....... Slices for telecom S 2..2 Slice: Unordered, Closed by value:system
​........ telecom:email 1..1 Official email for the designated regulatory contact
​......... system Fixed Value: email
​......... value 1..
​........ telecom:phone 0..1 Telephone number for the responsible regulatory contact
​......... system Fixed Value: phone
​......... value 1..
.... contact:receiver S 1..1 ContactDetail Contact details of the marketing authorisation holder/applicant
​..... organization S 1.. Marketing authorisation holder / applicant organisation
​...... identifier S 1.. Organisation identifier of the MAH/applicant (e.g., OMS Organization ID)
​...... name S 1.. Legal name of the MAH/applicant
​...... address S 1..1 Official registered address of the marketing authorisation holder/sponsor
​....... text S 1.. Full formatted address of the MAH/sponsor (human-readable)
​....... line S 1..* Street address lines of the MAH/sponsor
​....... city S 1.. City of the MAH/sponsor registered address
​....... district S 0.. District or borough (if applicable)
​....... state S 0.. State, province or region of the MAH/sponsor
​....... postalCode S 1..
​....... country S 1.. Country of the MAH/sponsor registered address
​...... contact S 1.. Regulatory affairs contact person at the MAH/applicant
​....... Slices for telecom S 2..2 Slice: Unordered, Closed by value:system
​........ telecom:email 1..1 Regulatory contact email of the MAH/applicant
​......... system Fixed Value: email
​......... value 1..
​........ telecom:phone 1..1 Telephone number of the regulatory contact at the MAH/applicant
​......... system Fixed Value: phone
​......... value 1..
... item S 0..* BackboneElement Question in the regulatory questionnaire
.... code S 1..* Coding CTD-based category code that classifies the regulatory topic of this question/group
Binding: http://hl7.org/fhir/uv/rtq/ValueSet/ctd-categories-full (extensible): Codes from the full CTD hierarchy as defined in the RTQ CTD Categories CodeSystem. Additional codes beyond the standard CTD structure may be defined locally or in future versions of the CodeSystem when new regulatory topics are required.
..... system S 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full
..... code S 1..1 code CTD section/subsection code (e.g., 2-3-s-4-2-1)
..... display S 1..1 string Human-readable title of the CTD category
.... text S 1..1 string Primary text for the item
..... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:rendering-xhtml S 1..1 string String equivalent with html markup
URL: http://hl7.org/fhir/StructureDefinition/rendering-xhtml

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Questionnaire.subjectType Base extensible http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs Not State Unknown
Questionnaire.item.code Base extensible http://hl7.org/fhir/uv/rtq/ValueSet/ctd-categories-full 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 SΣ 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 SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to

Fixed Value: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaire
.... 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
... 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 SΣ 1..2 Identifier Business identifier for questionnaire
Slice: Unordered, Closed by value:type.coding.code
.... identifier:company SΣ 0..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 SΣ 1..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.
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: As shown
....... id 0..0 string Unique id for inter-element referencing
....... extension 0..0 Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type
....... version 0..0 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: company-id
....... display 1..1 string Representation defined by the system
Fixed Value: Company-issued Identifier
....... userSelected 0..0 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... system Σ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... 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:regulator 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 SΣ 1..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.
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: As shown
....... id 0..0 string Unique id for inter-element referencing
....... extension 0..0 Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type
....... version 0..0 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: regulator-id
....... display 1..1 string Representation defined by the system
Fixed Value: Regulator-issued Identifier
....... userSelected 0..0 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... system Σ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... 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 ΣC 0..1 string Name for this questionnaire (computer friendly)
... title Σ 0..1 string Name for this questionnaire (human friendly)
... derivedFrom Σ 0..* canonical(Questionnaire) Based on Questionnaire
... status ?!ΣC 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 SΣ 1..* code Resource that can be subject of QuestionnaireResponse
Binding: http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs (extensible)
... date Σ 0..1 dateTime Date last changed
... Slices for contact SΣ 2..2 ContactDetail Sender (issuing regulatory authority) and receiver (MAH/applicant) contact details
Slice: Unordered, Closed by value:organization.name
.... contact:sender SΣ 1..1 ContactDetail Contact details of the issuing competent authority (regulator)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... name Σ 0..1 string Name of an individual to contact
..... telecom Σ 0..* ContactPoint Contact details for individual or organization
.... contact:receiver SΣ 1..1 ContactDetail Contact details of the marketing authorisation holder/applicant
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... name Σ 0..1 string Name of an individual to contact
..... telecom Σ 0..* 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 Σ 0..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 0..* BackboneElement Question in the regulatory 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 C 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 CTD-based category code that classifies the regulatory topic of this question/group
Binding: http://hl7.org/fhir/uv/rtq/ValueSet/ctd-categories-full (extensible): Codes from the full CTD hierarchy as defined in the RTQ CTD Categories CodeSystem. Additional codes beyond the standard CTD structure may be defined locally or in future versions of the CodeSystem when new regulatory topics are required.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system SΣ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full
..... version Σ 0..1 string Version of the system - if relevant
..... code SΣC 1..1 code CTD section/subsection code (e.g., 2-3-s-4-2-1)
..... display SΣC 1..1 string Human-readable title of the CTD category
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... 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:rendering-xhtml S 1..1 string String equivalent with html markup
URL: http://hl7.org/fhir/StructureDefinition/rendering-xhtml
..... value 0..1 string Primitive value for string
Max Length:1048576
.... type C 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.identifier:company.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.identifier:company.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
Questionnaire.identifier:regulator.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Questionnaire.identifier:regulator.​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 extensible http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs Not State Unknown
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 extensible http://hl7.org/fhir/uv/rtq/ValueSet/ctd-categories-full 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

This structure is derived from Questionnaire

Summary

Mandatory: 13 elements(36 nested mandatory elements)
Must-Support: 48 elements
Fixed: 8 elements
Prohibited: 1 element

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

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

 

Other representations of profile: CSV, Excel, Schematron