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: RTQQuestionnaire - Detailed Descriptions

Draft as of 2025-11-21

Definitions for the rtq-questionnaire resource profile.

Guidance on how to interpret the contents of this table can be foundhere

0. Questionnaire
Definition

A structured set of questions intended to guide the collection of answers from end-users. Questionnaires provide detailed control over order, presentation, phraseology and grouping to allow coherent, consistent data collection.

ShortA structured set of questions
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate NamesForm, CRF, Survey
Invariantscnl-0: 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}$'))
que-2: The link ids for groups and questions must be unique within the questionnaire (descendants().linkId.isDistinct())
2. Questionnaire.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

ShortMetadata about the resource
Control10..1
TypeMeta
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Questionnaire.meta.versionId
Definition

The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

ShortVersion specific identifier
Comments

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

Control10..1
Typeid
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Questionnaire.meta.lastUpdated
Definition

When the resource last changed - e.g. when the version changed.

ShortWhen the resource version last changed
Comments

This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

Control10..1
Typeinstant
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Questionnaire.meta.profile
Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.


A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

ShortProfiles this resource claims to conform to
Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Control10..1*
Typecanonical(StructureDefinition)
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Fixed Valuehttp://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaire
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Questionnaire.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Questionnaire.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

ShortText summary of the resource, for human interpretation
Comments

Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Control10..1
This element is affected by the following invariants: dom-6
TypeNarrative
Is Modifierfalse
Must Supporttrue
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Questionnaire.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
16. Questionnaire.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
18. Questionnaire.identifier
Definition

A formal identifier that is used to identify this questionnaire when it is represented in other formats, or referenced in a specification, model, design or an instance.

ShortBusiness identifier for questionnaire
Comments

Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this questionnaire outside of FHIR, where it is not possible to use the logical URI.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control10..2*
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Allows externally provided and/or usable business identifiers to be easily associated with the questionnaire.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Questionnaire.identifier. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
  • value @ type.coding.code
  • 20. Questionnaire.identifier:company
    Slice Namecompany
    Definition

    A formal identifier that is used to identify this questionnaire when it is represented in other formats, or referenced in a specification, model, design or an instance.

    ShortBusiness identifier for questionnaire
    Comments

    Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this questionnaire outside of FHIR, where it is not possible to use the logical URI.

    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control0..1*
    TypeIdentifier
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows externally provided and/or usable business identifiers to be easily associated with the questionnaire.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. Questionnaire.identifier:company.use
    Definition

    The purpose of this identifier.

    Shortusual | official | temp | secondary | old (If known)
    Comments

    Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

    Control0..1
    BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
    (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

    Identifies the purpose for this identifier, if known .

    Typecode
    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    24. Questionnaire.identifier:company.type
    Definition

    A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

    ShortDescription of identifier
    Comments

    This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

    Control10..1
    BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type|5.0.0
    (extensible to http://hl7.org/fhir/ValueSet/identifier-type|5.0.0)

    A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows users to make use of identifiers when the identifier system is not known.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. Questionnaire.identifier:company.type.coding
    Definition

    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

    Control10..1*
    TypeCoding
    Is Modifierfalse
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

    Fixed Value{
      "system" : "https://build.fhir.org/ig/HL7/rtq-ig/CodeSystem/rtq-identifier-type",
      "code" : "company-id",
      "display" : "Company-issued Identifier"
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    28. Questionnaire.identifier:regulator
    Slice Nameregulator
    Definition

    A formal identifier that is used to identify this questionnaire when it is represented in other formats, or referenced in a specification, model, design or an instance.

    ShortBusiness identifier for questionnaire
    Comments

    Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this questionnaire outside of FHIR, where it is not possible to use the logical URI.

    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control10..1*
    TypeIdentifier
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows externally provided and/or usable business identifiers to be easily associated with the questionnaire.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. Questionnaire.identifier:regulator.use
    Definition

    The purpose of this identifier.

    Shortusual | official | temp | secondary | old (If known)
    Comments

    Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

    Control0..1
    BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
    (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

    Identifies the purpose for this identifier, if known .

    Typecode
    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    32. Questionnaire.identifier:regulator.type
    Definition

    A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

    ShortDescription of identifier
    Comments

    This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

    Control10..1
    BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type|5.0.0
    (extensible to http://hl7.org/fhir/ValueSet/identifier-type|5.0.0)

    A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows users to make use of identifiers when the identifier system is not known.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    34. Questionnaire.identifier:regulator.type.coding
    Definition

    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

    Control10..1*
    TypeCoding
    Is Modifierfalse
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

    Fixed Value{
      "system" : "https://build.fhir.org/ig/HL7/rtq-ig/CodeSystem/rtq-identifier-type",
      "code" : "regulator-id",
      "display" : "Regulator-issued Identifier"
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    36. Questionnaire.version
    Definition

    The identifier that is used to identify this version of the questionnaire when it is referenced in a specification, model, design or instance. This is an arbitrary value managed by the questionnaire author and is not expected to be globally unique. For example, it might be a timestamp (e.g. yyyymmdd) if a managed version is not available. There is also no expectation that versions can be placed in a lexicographical sequence.

    ShortBusiness version of the questionnaire
    Comments

    There may be different questionnaires that have the same url but different versions. The version can be appended to the url in a reference to allow a reference to a particular business version of the questionnaire with the format. The version SHOULD NOT contain a '#' - see Business Version.

    NoteThis is a business version Id, not a resource version Id (see discussion)
    Control10..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    38. Questionnaire.status
    Definition

    The current state of this questionnaire.

    Shortdraft | active | retired | unknown
    Comments

    A nominal state-transition diagram can be found in the] documentation

    Unknown does not represent 'other' - one of the defined statuses must apply. Unknown is used when the authoring system is not sure what the current status is.

    See guidance around (not) making local changes to elements here.


    A nominal state-transition diagram can be found in the] documentation

    Unknown does not represent 'other' - one of the defined statuses must apply. Unknown is used when the authoring system is not sure what the current status is.

    See guidance around (not) making local changes to elements here.

    Control1..1
    This element is affected by the following invariants: que-1a
    BindingThe codes SHALL be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0
    (required to http://hl7.org/fhir/ValueSet/publication-status|5.0.0)

    The lifecycle status of an artifact.

    Typecode
    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Requirements

    Enables tracking the lifecycle of the content and filtering of questionnaires that are appropriate for use versus not.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    40. Questionnaire.subjectType
    Definition

    The types of subjects that can be the subject of responses created for the questionnaire.

    ShortResource that can be subject of QuestionnaireResponse
    Comments

    If none are specified, then the subject is unlimited.

    Control10..*
    BindingThe codes SHALL be taken from http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vshttp://hl7.org/fhir/ValueSet/resource-types|5.0.0
    (required to http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs)
    Typecode
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Requirements

    Allows enforcing that a QuestionnaireResponse only has a .subject element of the appropriate type.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    42. Questionnaire.publisher
    Definition

    The name of the organization or individual responsible for the release and ongoing maintenance of the questionnaire.

    ShortName of the publisher/steward (organization or individual)
    Comments

    Usually an organization but may be an individual. The publisher (or steward) of the questionnaire is the organization or individual primarily responsible for the maintenance and upkeep of the questionnaire. This is not necessarily the same individual or organization that developed and initially authored the content. The publisher is the primary point of contact for questions or issues with the questionnaire. This item SHOULD be populated unless the information is available from context.

    Control0..01
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Requirements

    Helps establish the "authority/credibility" of the questionnaire. May also allow for contact.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    44. Questionnaire.contact
    Definition

    Exactly two contacts shall be present: one identifying the competent authority that issued the Request to Qualify Questionnaire (sender) and one identifying the marketing authorisation holder or applicant that is required to complete and return the QuestionnaireResponse (receiver). Slicing is based on organization.name to distinguish the two parties.


    Contact details to assist a user in finding and communicating with the publisher.

    ShortSender (issuing regulatory authority) and receiver (MAH/applicant) contact detailsContact details for the publisher
    Comments

    May be a web site, an email address, a telephone number, etc.

    See guidance around (not) making local changes to elements here.


    May be a web site, an email address, a telephone number, etc.

    See guidance around (not) making local changes to elements here.

    Control20..2*
    TypeContactDetail
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    SlicingThis element introduces a set of slices on Questionnaire.contact. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
    • value @ organization.name
    • 46. Questionnaire.contact:sender
      Slice Namesender
      Definition

      Identifies the regulatory authority or agency that has created and sent this Questionnaire to the marketing authorisation holder.


      Contact details to assist a user in finding and communicating with the publisher.

      ShortContact details of the issuing competent authority (regulator)Contact details for the publisher
      Comments

      May be a web site, an email address, a telephone number, etc.

      See guidance around (not) making local changes to elements here.


      May be a web site, an email address, a telephone number, etc.

      See guidance around (not) making local changes to elements here.

      Control10..1*
      TypeContactDetail
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      48. Questionnaire.contact:sender.name
      Definition

      Full official name of the competent authority issuing the Questionnaire (e.g., European Medicines Agency).


      The name of an individual to contact.

      ShortOfficial name of the issuing regulatory authorityName of an individual to contact
      Comments

      If there is no named individual, the telecom information is for the organization as a whole.

      Control10..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      50. Questionnaire.contact:sender.telecom
      Definition

      The contact details for the individual (if a name was provided) or the organization.

      ShortContact details for individual or organization
      Control20..2*
      TypeContactPoint
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      SlicingThis element introduces a set of slices on Questionnaire.contact.telecom. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
      • value @ system
      • 52. Questionnaire.contact:sender.telecom:email
        Slice Nameemail
        Definition

        Official email for the designated regulatory contact


        The contact details for the individual (if a name was provided) or the organization.

        ShortOfficial email for the designated regulatory contactContact details for individual or organization
        Control10..1*
        TypeContactPoint
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        54. Questionnaire.contact:sender.telecom:email.system
        Definition

        Telecommunications form for contact point - what communications system is required to make use of the contact.

        Shortphone | fax | email | pager | url | sms | other
        Control10..1
        This element is affected by the following invariants: cpt-2
        BindingThe codes SHALL be taken from ContactPointSystemhttp://hl7.org/fhir/ValueSet/contact-point-system|5.0.0
        (required to http://hl7.org/fhir/ValueSet/contact-point-system|5.0.0)

        Telecommunications form for contact point.

        Typecode
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Fixed Valueemail
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        56. Questionnaire.contact:sender.telecom:email.value
        Definition

        The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).

        ShortThe actual contact point details
        Comments

        Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.

        Control10..1
        This element is affected by the following invariants: cpt-2
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        Need to support legacy numbers that are not in a tightly controlled format.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        58. Questionnaire.contact:sender.telecom:email.use
        Definition

        Identifies the purpose for the contact point.

        Shorthome | work | temp | old | mobile - purpose of this contact point
        Comments

        Applications can assume that a contact is current unless it explicitly says that it is temporary or old.

        Control0..1
        BindingThe codes SHALL be taken from ContactPointUsehttp://hl7.org/fhir/ValueSet/contact-point-use|5.0.0
        (required to http://hl7.org/fhir/ValueSet/contact-point-use|5.0.0)

        Use of contact point.

        Typecode
        Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary or old contact etc.for a current/permanent one
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        60. Questionnaire.contact:sender.telecom:phone
        Slice Namephone
        Definition

        Telephone number for the responsible regulatory contact.


        The contact details for the individual (if a name was provided) or the organization.

        ShortTelephone number for the responsible regulatory contactContact details for individual or organization
        Control0..1*
        TypeContactPoint
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        62. Questionnaire.contact:sender.telecom:phone.system
        Definition

        Telecommunications form for contact point - what communications system is required to make use of the contact.

        Shortphone | fax | email | pager | url | sms | other
        Control10..1
        This element is affected by the following invariants: cpt-2
        BindingThe codes SHALL be taken from ContactPointSystemhttp://hl7.org/fhir/ValueSet/contact-point-system|5.0.0
        (required to http://hl7.org/fhir/ValueSet/contact-point-system|5.0.0)

        Telecommunications form for contact point.

        Typecode
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Fixed Valuephone
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        64. Questionnaire.contact:sender.telecom:phone.value
        Definition

        The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).

        ShortThe actual contact point details
        Comments

        Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.

        Control10..1
        This element is affected by the following invariants: cpt-2
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        Need to support legacy numbers that are not in a tightly controlled format.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        66. Questionnaire.contact:sender.telecom:phone.use
        Definition

        Identifies the purpose for the contact point.

        Shorthome | work | temp | old | mobile - purpose of this contact point
        Comments

        Applications can assume that a contact is current unless it explicitly says that it is temporary or old.

        Control0..1
        BindingThe codes SHALL be taken from ContactPointUsehttp://hl7.org/fhir/ValueSet/contact-point-use|5.0.0
        (required to http://hl7.org/fhir/ValueSet/contact-point-use|5.0.0)

        Use of contact point.

        Typecode
        Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary or old contact etc.for a current/permanent one
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        68. Questionnaire.contact:receiver
        Slice Namereceiver
        Definition

        Identifies the pharmaceutical company, marketing authorisation holder, submitter or applicant that is the recipient of this Questionnaire and is obliged to provide the completed response.


        Contact details to assist a user in finding and communicating with the publisher.

        ShortContact details of the marketing authorisation holder/applicantContact details for the publisher
        Comments

        May be a web site, an email address, a telephone number, etc.

        See guidance around (not) making local changes to elements here.


        May be a web site, an email address, a telephone number, etc.

        See guidance around (not) making local changes to elements here.

        Control10..1*
        TypeContactDetail
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        70. Questionnaire.contact:receiver.name
        Definition

        Full legal name of the marketing authorisation holder or applicant.


        The name of an individual to contact.

        ShortLegal name of the MAH/applicantName of an individual to contact
        Comments

        If there is no named individual, the telecom information is for the organization as a whole.

        Control10..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        72. Questionnaire.contact:receiver.telecom
        Definition

        The contact details for the individual (if a name was provided) or the organization.

        ShortContact details for individual or organization
        Control20..2*
        TypeContactPoint
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        SlicingThis element introduces a set of slices on Questionnaire.contact.telecom. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
        • value @ system
        • 74. Questionnaire.contact:receiver.telecom:email
          Slice Nameemail
          Definition

          Email address of the person or team at the MAH/applicant responsible for regulatory correspondence related to this regulatory activity.


          The contact details for the individual (if a name was provided) or the organization.

          ShortRegulatory contact email of the MAH/applicantContact details for individual or organization
          Control10..1*
          TypeContactPoint
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          76. Questionnaire.contact:receiver.telecom:email.system
          Definition

          Telecommunications form for contact point - what communications system is required to make use of the contact.

          Shortphone | fax | email | pager | url | sms | other
          Control10..1
          This element is affected by the following invariants: cpt-2
          BindingThe codes SHALL be taken from ContactPointSystemhttp://hl7.org/fhir/ValueSet/contact-point-system|5.0.0
          (required to http://hl7.org/fhir/ValueSet/contact-point-system|5.0.0)

          Telecommunications form for contact point.

          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Fixed Valueemail
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          78. Questionnaire.contact:receiver.telecom:email.value
          Definition

          The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).

          ShortThe actual contact point details
          Comments

          Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.

          Control10..1
          This element is affected by the following invariants: cpt-2
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Need to support legacy numbers that are not in a tightly controlled format.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          80. Questionnaire.contact:receiver.telecom:email.use
          Definition

          Identifies the purpose for the contact point.

          Shorthome | work | temp | old | mobile - purpose of this contact point
          Comments

          Applications can assume that a contact is current unless it explicitly says that it is temporary or old.

          Control0..1
          BindingThe codes SHALL be taken from ContactPointUsehttp://hl7.org/fhir/ValueSet/contact-point-use|5.0.0
          (required to http://hl7.org/fhir/ValueSet/contact-point-use|5.0.0)

          Use of contact point.

          Typecode
          Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary or old contact etc.for a current/permanent one
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          82. Questionnaire.contact:receiver.telecom:phone
          Slice Namephone
          Definition

          Direct telephone number (with country code) of the regulatory contact person at the receiving organisation.


          The contact details for the individual (if a name was provided) or the organization.

          ShortTelephone number of the regulatory contact at the MAH/applicantContact details for individual or organization
          Control10..1*
          TypeContactPoint
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          84. Questionnaire.contact:receiver.telecom:phone.system
          Definition

          Telecommunications form for contact point - what communications system is required to make use of the contact.

          Shortphone | fax | email | pager | url | sms | other
          Control10..1
          This element is affected by the following invariants: cpt-2
          BindingThe codes SHALL be taken from ContactPointSystemhttp://hl7.org/fhir/ValueSet/contact-point-system|5.0.0
          (required to http://hl7.org/fhir/ValueSet/contact-point-system|5.0.0)

          Telecommunications form for contact point.

          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Fixed Valuephone
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          86. Questionnaire.contact:receiver.telecom:phone.value
          Definition

          The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).

          ShortThe actual contact point details
          Comments

          Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.

          Control10..1
          This element is affected by the following invariants: cpt-2
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Need to support legacy numbers that are not in a tightly controlled format.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          88. Questionnaire.contact:receiver.telecom:phone.use
          Definition

          Identifies the purpose for the contact point.

          Shorthome | work | temp | old | mobile - purpose of this contact point
          Comments

          Applications can assume that a contact is current unless it explicitly says that it is temporary or old.

          Control0..1
          BindingThe codes SHALL be taken from ContactPointUsehttp://hl7.org/fhir/ValueSet/contact-point-use|5.0.0
          (required to http://hl7.org/fhir/ValueSet/contact-point-use|5.0.0)

          Use of contact point.

          Typecode
          Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary or old contact etc.for a current/permanent one
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          90. Questionnaire.item
          Definition

          A particular question, question grouping or display text that is part of the questionnaire.

          ShortQuestion in the regulatory questionnaireQuestions and sections within the Questionnaire
          Comments

          The content of the questionnaire is constructed from an ordered, hierarchical collection of items.

          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          que-1a: Group items must have nested items when Questionanire is complete ((type='group' and %resource.status='complete') implies item.empty().not())
          que-1b: Groups should have items (type='group' implies item.empty().not())
          que-1c: Display items cannot have child items (type='display' implies item.empty())
          que-3: Display items cannot have a "code" asserted (type!='display' or code.empty())
          que-4: A question cannot have both answerOption and answerValueSet (answerOption.empty() or answerValueSet.empty())
          que-5: 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: Required and repeat aren't permitted for display items (type!='display' or (required.empty() and repeats.empty()))
          que-8: Initial values can't be specified for groups or display items ((type!='group' and type!='display') or initial.empty())
          que-9: Read-only can't be specified for "display" items (type!='display' or readOnly.empty())
          que-10: 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: If one or more answerOption is present, initial cannot be present. Use answerOption.initialSelected instead (answerOption.empty() or initial.empty())
          que-12: If there are more than one enableWhen, enableBehavior must be specified (enableWhen.count() > 1 implies enableBehavior.exists())
          que-13: Can only have multiple initial values for repeating items (repeats=true or initial.count() <= 1)
          que-14: 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())
          92. Questionnaire.item.extension
          Definition

          An Extension


          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortExtensionAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on Questionnaire.item.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 94. Questionnaire.item.extension:itemReference
            Slice NameitemReference
            Definition

            An extension to allow referencing an RTQDocumentReference from a Questionnaire item (the question).

            ShortSupporting document(s) for this question
            Control0..*
            TypeExtension(RTQ Item Reference Extension) (Extension Type: Reference(RTQ Document Reference))
            Is Modifierfalse
            Must Supporttrue
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            96. Questionnaire.item.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            98. Questionnaire.item.linkId
            Definition

            An identifier that is unique within the Questionnaire allowing linkage to the equivalent item in a QuestionnaireResponse resource.

            ShortUnique id for item in questionnaire
            Comments

            This ''can'' be a meaningful identifier (e.g. a LOINC code) but is not intended to have any meaning. GUIDs or sequential numbers are appropriate here.

            LinkIds can have whitespaces and slashes by design. Tooling should not rely on linkIds being valid XHTML element IDs, and should not directly embed them as such

            Control1..1
            This element is affected by the following invariants: que-2
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summaryfalse
            Requirements

            QuestionnaireResponse does not require omitted items to be included and may have some items that repeat, so linkage based on position alone is not sufficient.


            QuestionnaireResponse does not require omitted items to be included and may have some items that repeat, so linkage based on position alone is not sufficient.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            que-15: Link ids should be 255 characters or less ($this.length() <= 255)
            100. Questionnaire.item.code
            Definition

            A required code from the RTQ CTD Categories CodeSystem (or an allowed extension of it) that identifies which section, subsection, or specific regulatory topic within a medicinal product dossier this questionnaire item pertains to. This enables precise mapping and automated routing in regulatory processes.


            A terminology code that corresponds to this group or question (e.g. a code from LOINC, which defines many questions and answers).

            ShortCTD-based category code that classifies the regulatory topic of this question/groupCorresponding concept for this item in a terminology
            Comments

            Examples: '2-3-s-4-2' = Nonclinical Overview, '3-2-p-5-3' = Microbiological quality control, etc.


            The value may come from the ElementDefinition referred to by .definition.

            Control10..*
            This element is affected by the following invariants: que-3
            BindingUnless not suitable, these codes SHALL be taken from For example codes, see http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-fullhttp://hl7.org/fhir/ValueSet/questionnaire-questions|5.0.0
            (extensible to http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full)

            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.


            Codes for questionnaires, groups and individual questions.

            TypeCoding
            Is Modifierfalse
            Must Supporttrue
            Summaryfalse
            Requirements

            Allows linking of groups of questions to formal terminologies.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            102. Questionnaire.item.code.system
            Definition

            The identification of the code system that defines the meaning of the symbol in the code.

            ShortIdentity of the terminology system
            Comments

            The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

            Control10..1
            Typeuri
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Requirements

            Need to be unambiguous about the source of the definition of the symbol.

            Fixed Valuehttp://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            104. Questionnaire.item.code.code
            Definition

            A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

            ShortCTD section/subsection code (e.g., 2-3-s-4-2-1)Symbol in syntax defined by the system
            Control10..1
            This element is affected by the following invariants: cod-1
            Typecode
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Requirements

            Need to refer to a particular code in the system.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            106. Questionnaire.item.code.display
            Definition

            A representation of the meaning of the code in the system, following the rules of the system.

            ShortHuman-readable title of the CTD categoryRepresentation defined by the system
            Control10..1
            This element is affected by the following invariants: cod-1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summarytrue
            Requirements

            Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            108. Questionnaire.item.text
            Definition

            The name of a section, the text of a question or text content for a display item.

            ShortPrimary text for the item
            Comments

            When using this element to represent the name of a section, use group type item and also make sure to limit the text element to a short string suitable for display as a section heading. Group item instructions should be included as a display type item within the group.

            Control10..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            110. Questionnaire.item.text.extension
            Definition

            An Extension


            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

            ShortExtensionAdditional content defined by implementations
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control10..*
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Alternate Namesextensions, user content
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            SlicingThis element introduces a set of slices on Questionnaire.item.text.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 112. Questionnaire.item.text.extension:rendering-xhtml
              Slice Namerendering-xhtml
              Definition

              This is an equivalent of the string on which the extension is sent, but includes additional XHTML markup, such as bold, italics, styles, tables, etc. Existing restrictions on XHTML content apply. Note that using markdown allows for greater flexibility of display.

              ShortString equivalent with html markup
              Comments

              For questionnaires, see additional guidance and examples in the SDC implementation guide.

              Control1..1
              TypeExtension(XHTML Representation) (Extension Type: string)
              Is Modifierfalse
              Must Supporttrue
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              114. Questionnaire.item.type
              Definition

              The type of questionnaire item this is - whether text for display, a grouping of other items or a particular type of data to be captured (string, integer, Coding, etc.).

              Shortgroup | display | boolean | decimal | integer | date | dateTime +
              Comments

              Additional constraints on the type of answer can be conveyed by extensions. The value may come from the ElementDefinition referred to by .definition.

              Control1..1
              This element is affected by the following invariants: que-9, que-8, que-6, que-5, que-3, que-10, que-1a, que-1b, que-1c
              BindingThe codes SHALL be taken from QuestionnaireItemTypehttp://hl7.org/fhir/ValueSet/item-type|5.0.0
              (required to http://hl7.org/fhir/ValueSet/item-type|5.0.0)

              Distinguishes groups from questions and display text and indicates data type for questions.

              Typecode
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Requirements

              Defines the format in which the user is to be prompted for the answer.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              116. Questionnaire.item.enableWhen
              Definition

              A constraint indicating that this item should only be enabled (displayed/allow answers to be captured) when the specified condition is true.

              ShortOnly allow data when
              Comments

              If multiple repetitions of this extension are present, the interpretation is driven by enableBehavior (either all repetitions must evaluate to true for this item to be enabled, or only one must evaluate to true for the item to be enabled). If the enableWhen.question has multiple answers, the condition evaluates to true if any of the answers for the referenced item match the enableWhen condition. This element is a modifier because if enableWhen is present for an item, "required" is ignored unless one of the enableWhen conditions is met. When an item is disabled, all of its descendants are disabled, regardless of what their own enableWhen logic might evaluate to. If enableWhen logic depends on an item that is disabled, the logic should proceed as though the item is not valued - even if a default value or other value might be retained in memory in the event of the item being re-enabled. In some cases, the comparison between the indicated answer and the specified value may differ only by precision. For example, the enableWhen might be Q1 > 1970, but the answer to Q1 is 1970-10-15. There is not a clear answer as to whether 1970-10-15 should be considered 'greater' than 1970, given that it is an imprecise value. In these indeterminate situations, the form filler has the option of refusing to render the form. If the form is displayed, items where enableWhen is indeterminate SHOULD be treated as enabled with a warning indicating that the questionnaire logic was faulty and it is possible that the item should not be enabled. Questionnaires SHOULD be designed to take into account challenges around varying precision to minimize non-deterministic situations by setting constraints around expected precision, etc.

              Control0..*
              This element is affected by the following invariants: que-12
              TypeBackboneElement
              Is Modifiertrue because If enableWhen is present and the condition evaluates to false, then the Questionnaire behaves as though the elements weren't actually present
              Must Supportfalse
              Summaryfalse
              Requirements

              Allows questionnaires to adapt based on answers to other questions. E.g. If physical gender is specified as a male, no need to capture pregnancy history. Also allows conditional display of instructions or groups of questions.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              que-7: If the operator is 'exists', the value must be a boolean (operator = 'exists' implies (answer is boolean))
              118. Questionnaire.item.enableWhen.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summarytrue
              Requirements

              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

              Alternate Namesextensions, user content, modifiers
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              120. Questionnaire.item.enableWhen.question
              Definition

              The linkId for the question whose answer (or lack of answer) governs whether this item is enabled.

              ShortThe linkId of question that determines whether item is enabled/disabled
              Comments

              If multiple question occurrences are present for the same question (same linkId), then this refers to the nearest question occurrence reachable by tracing first the "ancestor" axis and then the "preceding" axis and then the "following" axis. If there are multiple items with the same linkId and all are equadistant (e.g. a question references a question that appears in a separate repeating group), that is an error. (Consider using the enableWhenExpression extension to define logic to handle such a situation.)

              Control1..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              122. Questionnaire.item.enableWhen.operator
              Definition

              Specifies the criteria by which the question is enabled.

              Shortexists | = | != | > | < | >= | <=
              Control1..1
              This element is affected by the following invariants: que-7
              BindingThe codes SHALL be taken from QuestionnaireItemOperatorhttp://hl7.org/fhir/ValueSet/questionnaire-enable-operator|5.0.0
              (required to http://hl7.org/fhir/ValueSet/questionnaire-enable-operator|5.0.0)

              The criteria by which a question is enabled.

              Typecode
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              124. Questionnaire.item.enableWhen.answer[x]
              Definition

              A value that the referenced question is tested using the specified operator in order for the item to be enabled. If there are multiple answers, a match on any of the answers suffices. If different behavior is desired (all must match, at least 2 must match, etc.), consider using the enableWhenExpression extension.

              ShortValue for question comparison based on operator
              Control1..1
              This element is affected by the following invariants: que-7
              BindingFor example codes, see QuestionnaireAnswerCodeshttp://hl7.org/fhir/ValueSet/questionnaire-answers|5.0.0
              (example to http://hl7.org/fhir/ValueSet/questionnaire-answers|5.0.0)

              Allowed values to answer questions.

              TypeChoice of: boolean, decimal, integer, date, dateTime, time, string, Coding, Quantity, Reference(Resource)
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              126. Questionnaire.item.repeats
              Definition

              An indication, if true, that a QuestionnaireResponse for this item may include multiple answers associated with a single instance of this item (for question-type items) or multiple repetitions of the item (for group-type items).

              ShortWhether the item may repeat
              Comments

              If a question is marked as repeats=true, then multiple answers can be provided for the question in the corresponding QuestionnaireResponse. When rendering the questionnaire, it is up to the rendering software whether to render the question text for each answer repetition (i.e. "repeat the question") or to simply allow entry/selection of multiple answers for the question (repeat the answers). Which is most appropriate visually may depend on the type of answer as well as whether there are nested items.

              The resulting QuestionnaireResponse will be populated the same way regardless of rendering - one 'question' item with multiple answer values.

              The value may come from the ElementDefinition referred to by .definition. When repeats=true for a group, it'll be represented with multiple items with the same linkId in the QuestionnaireResponse. For a question, it'll be represented by a single item with that linkId with multiple answers.

              Control0..1
              This element is affected by the following invariants: que-6, que-13
              Typeboolean
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Requirements

              Items may be used to create set of (related) questions that can be repeated to give multiple answers to such a set.

              Meaning if MissingItems are generally assumed not to repeat unless explicitly specified. Systems SHOULD always populate this value
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              128. Questionnaire.item.answerConstraint
              Definition

              For items that have a defined set of allowed answers (via answerOption or answerValueSet), indicates whether values other than those specified can be selected.

              ShortoptionsOnly | optionsOrType | optionsOrString
              Control0..1
              This element is affected by the following invariants: que-10, que-14
              BindingThe codes SHALL be taken from QuestionnaireAnswerConstrainthttp://hl7.org/fhir/ValueSet/questionnaire-answer-constraint|5.0.0
              (required to http://hl7.org/fhir/ValueSet/questionnaire-answer-constraint|5.0.0)

              Indicates differnt modes for restricting values when options or valueset are specified

              Typecode
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Requirements

              Introduces the ability for questions to have 'other' answers

              Meaning if MissingIf not specified, answerConstraint is presumed to be 'optionsOnly'
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              130. Questionnaire.item.answerValueSet
              Definition

              A reference to a value set containing a list of values representing permitted answers for a question.

              ShortValueSet containing permitted answers
              Comments

              LOINC defines many useful value sets for questionnaire responses. See LOINC Answer Lists. The value may come from the ElementDefinition referred to by .definition.

              Control0..1
              This element is affected by the following invariants: que-5, que-4, que-14
              Typecanonical(ValueSet)
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              132. Questionnaire.item.answerOption
              Definition

              One of the permitted answers for the question.

              ShortPermitted answer
              Comments

              This element can be used when the value set machinery of answerValueSet is deemed too cumbersome or when there's a need to capture possible answers that are not codes.

              Control0..*
              This element is affected by the following invariants: que-5, que-4, que-11, que-14
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              134. Questionnaire.item.answerOption.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summarytrue
              Requirements

              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

              Alternate Namesextensions, user content, modifiers
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              136. Questionnaire.item.answerOption.value[x]
              Definition

              A potential answer that's allowed as the answer to this question.

              ShortAnswer value
              Comments

              The data type of the value must agree with the item.type.

              Control1..1
              BindingFor example codes, see QuestionnaireAnswerCodeshttp://hl7.org/fhir/ValueSet/questionnaire-answers|5.0.0
              (example to http://hl7.org/fhir/ValueSet/questionnaire-answers|5.0.0)

              Allowed values to answer questions.

              TypeChoice of: integer, date, time, string, Coding, Reference(Resource)
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              138. Questionnaire.item.initial
              Definition

              One or more values that should be pre-populated in the answer when initially rendering the questionnaire for user input.

              ShortInitial value(s) when item is first rendered
              Comments

              The user is allowed to change the value and override the default (unless marked as read-only). If the user doesn't change the value, then this initial value will be persisted when the QuestionnaireResponse is initially created. Note that initial values can influence results. The data type of initial.answer[x] must agree with the item.type, and only repeating items can have more then one initial value.

              Control0..*
              This element is affected by the following invariants: que-8, que-13, que-11
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Requirements

              In some workflows, having defaults saves time.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              140. Questionnaire.item.initial.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summarytrue
              Requirements

              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

              Alternate Namesextensions, user content, modifiers
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              142. Questionnaire.item.initial.value[x]
              Definition

              The actual value to for an initial answer.

              ShortActual value for initializing the question
              Comments

              The type of the initial value must be consistent with the type of the item.

              Control1..1
              BindingFor example codes, see QuestionnaireAnswerCodeshttp://hl7.org/fhir/ValueSet/questionnaire-answers|5.0.0
              (example to http://hl7.org/fhir/ValueSet/questionnaire-answers|5.0.0)

              Allowed values to answer questions.

              TypeChoice of: boolean, decimal, integer, date, dateTime, time, string, uri, Attachment, Coding, Quantity, Reference(Resource)
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

              Guidance on how to interpret the contents of this table can be foundhere

              0. Questionnaire
              2. Questionnaire.meta
              Control1..?
              Must Supporttrue
              4. Questionnaire.meta.versionId
              Control1..?
              Must Supporttrue
              6. Questionnaire.meta.lastUpdated
              Control1..?
              Must Supporttrue
              8. Questionnaire.meta.profile
              Control1..1
              Must Supporttrue
              Fixed Valuehttp://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaire
              10. Questionnaire.text
              Control1..?
              Must Supporttrue
              12. Questionnaire.identifier
              NoteThis is a business identifier, not a resource identifier (see discussion)
              Control1..2
              Must Supporttrue
              SlicingThis element introduces a set of slices on Questionnaire.identifier. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
              • value @ type.coding.code
              • 14. Questionnaire.identifier:company
                Slice Namecompany
                NoteThis is a business identifier, not a resource identifier (see discussion)
                Control0..1
                Must Supporttrue
                16. Questionnaire.identifier:company.type
                Control1..?
                Must Supporttrue
                18. Questionnaire.identifier:company.type.coding
                Control1..1
                Fixed Value{
                  "system" : "https://build.fhir.org/ig/HL7/rtq-ig/CodeSystem/rtq-identifier-type",
                  "code" : "company-id",
                  "display" : "Company-issued Identifier"
                }
                20. Questionnaire.identifier:regulator
                Slice Nameregulator
                NoteThis is a business identifier, not a resource identifier (see discussion)
                Control1..1
                Must Supporttrue
                22. Questionnaire.identifier:regulator.type
                Control1..?
                Must Supporttrue
                24. Questionnaire.identifier:regulator.type.coding
                Control1..1
                Fixed Value{
                  "system" : "https://build.fhir.org/ig/HL7/rtq-ig/CodeSystem/rtq-identifier-type",
                  "code" : "regulator-id",
                  "display" : "Regulator-issued Identifier"
                }
                26. Questionnaire.version
                NoteThis is a business version Id, not a resource version Id (see discussion)
                Control1..?
                Must Supporttrue
                28. Questionnaire.subjectType
                Control1..?
                BindingThe codes SHALL be taken from http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs
                (required to http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs)
                Must Supporttrue
                30. Questionnaire.publisher
                Control0..0
                32. Questionnaire.contact
                Definition

                Exactly two contacts shall be present: one identifying the competent authority that issued the Request to Qualify Questionnaire (sender) and one identifying the marketing authorisation holder or applicant that is required to complete and return the QuestionnaireResponse (receiver). Slicing is based on organization.name to distinguish the two parties.

                ShortSender (issuing regulatory authority) and receiver (MAH/applicant) contact details
                Control2..2
                Must Supporttrue
                SlicingThis element introduces a set of slices on Questionnaire.contact. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                • value @ organization.name
                • 34. Questionnaire.contact:sender
                  Slice Namesender
                  Definition

                  Identifies the regulatory authority or agency that has created and sent this Questionnaire to the marketing authorisation holder.

                  ShortContact details of the issuing competent authority (regulator)
                  Control1..1
                  Must Supporttrue
                  36. Questionnaire.contact:sender.name
                  Definition

                  Full official name of the competent authority issuing the Questionnaire (e.g., European Medicines Agency).

                  ShortOfficial name of the issuing regulatory authority
                  Control1..?
                  Must Supporttrue
                  38. Questionnaire.contact:sender.telecom
                  Control2..2
                  Must Supporttrue
                  SlicingThis element introduces a set of slices on Questionnaire.contact.telecom. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                  • value @ system
                  • 40. Questionnaire.contact:sender.telecom:email
                    Slice Nameemail
                    Definition

                    Official email for the designated regulatory contact

                    ShortOfficial email for the designated regulatory contact
                    Control1..1
                    42. Questionnaire.contact:sender.telecom:email.system
                    Control1..?
                    Fixed Valueemail
                    44. Questionnaire.contact:sender.telecom:email.value
                    Control1..?
                    46. Questionnaire.contact:sender.telecom:phone
                    Slice Namephone
                    Definition

                    Telephone number for the responsible regulatory contact.

                    ShortTelephone number for the responsible regulatory contact
                    Control0..1
                    48. Questionnaire.contact:sender.telecom:phone.system
                    Control1..?
                    Fixed Valuephone
                    50. Questionnaire.contact:sender.telecom:phone.value
                    Control1..?
                    52. Questionnaire.contact:receiver
                    Slice Namereceiver
                    Definition

                    Identifies the pharmaceutical company, marketing authorisation holder, submitter or applicant that is the recipient of this Questionnaire and is obliged to provide the completed response.

                    ShortContact details of the marketing authorisation holder/applicant
                    Control1..1
                    Must Supporttrue
                    54. Questionnaire.contact:receiver.name
                    Definition

                    Full legal name of the marketing authorisation holder or applicant.

                    ShortLegal name of the MAH/applicant
                    Control1..?
                    Must Supporttrue
                    56. Questionnaire.contact:receiver.telecom
                    Control2..2
                    Must Supporttrue
                    SlicingThis element introduces a set of slices on Questionnaire.contact.telecom. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                    • value @ system
                    • 58. Questionnaire.contact:receiver.telecom:email
                      Slice Nameemail
                      Definition

                      Email address of the person or team at the MAH/applicant responsible for regulatory correspondence related to this regulatory activity.

                      ShortRegulatory contact email of the MAH/applicant
                      Control1..1
                      60. Questionnaire.contact:receiver.telecom:email.system
                      Control1..?
                      Fixed Valueemail
                      62. Questionnaire.contact:receiver.telecom:email.value
                      Control1..?
                      64. Questionnaire.contact:receiver.telecom:phone
                      Slice Namephone
                      Definition

                      Direct telephone number (with country code) of the regulatory contact person at the receiving organisation.

                      ShortTelephone number of the regulatory contact at the MAH/applicant
                      Control1..1
                      66. Questionnaire.contact:receiver.telecom:phone.system
                      Control1..?
                      Fixed Valuephone
                      68. Questionnaire.contact:receiver.telecom:phone.value
                      Control1..?
                      70. Questionnaire.item
                      ShortQuestion in the regulatory questionnaire
                      Must Supporttrue
                      72. Questionnaire.item.extension
                      SlicingThis element introduces a set of slices on Questionnaire.item.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 74. Questionnaire.item.extension:itemReference
                        Slice NameitemReference
                        ShortSupporting document(s) for this question
                        Control0..*
                        TypeExtension(RTQ Item Reference Extension) (Extension Type: Reference(RTQ Document Reference))
                        Must Supporttrue
                        76. Questionnaire.item.code
                        Definition

                        A required code from the RTQ CTD Categories CodeSystem (or an allowed extension of it) that identifies which section, subsection, or specific regulatory topic within a medicinal product dossier this questionnaire item pertains to. This enables precise mapping and automated routing in regulatory processes.

                        ShortCTD-based category code that classifies the regulatory topic of this question/group
                        Comments

                        Examples: '2-3-s-4-2' = Nonclinical Overview, '3-2-p-5-3' = Microbiological quality control, etc.

                        Control1..?
                        BindingUnless not suitable, these codes SHALL be taken from http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full
                        (extensible to http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full)

                        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.

                        Must Supporttrue
                        78. Questionnaire.item.code.system
                        Control1..?
                        Must Supporttrue
                        Fixed Valuehttp://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full
                        80. Questionnaire.item.code.code
                        ShortCTD section/subsection code (e.g., 2-3-s-4-2-1)
                        Control1..?
                        Must Supporttrue
                        82. Questionnaire.item.code.display
                        ShortHuman-readable title of the CTD category
                        Control1..?
                        Must Supporttrue
                        84. Questionnaire.item.text
                        Control1..?
                        Must Supporttrue
                        86. Questionnaire.item.text.extension
                        Control1..?
                        SlicingThis element introduces a set of slices on Questionnaire.item.text.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 88. Questionnaire.item.text.extension:rendering-xhtml
                          Slice Namerendering-xhtml
                          Control1..1
                          TypeExtension(XHTML Representation) (Extension Type: string)
                          Must Supporttrue

                          Guidance on how to interpret the contents of this table can be foundhere

                          0. Questionnaire
                          Definition

                          A structured set of questions intended to guide the collection of answers from end-users. Questionnaires provide detailed control over order, presentation, phraseology and grouping to allow coherent, consistent data collection.

                          ShortA structured set of questions
                          Control0..*
                          Is Modifierfalse
                          Must Supportfalse
                          Summaryfalse
                          Alternate NamesForm, CRF, Survey
                          Invariantscnl-0: 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}$'))
                          que-2: The link ids for groups and questions must be unique within the questionnaire (descendants().linkId.isDistinct())
                          2. Questionnaire.id
                          Definition

                          The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

                          ShortLogical id of this artifact
                          Comments

                          Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

                          Control0..1
                          Typeid
                          Is Modifierfalse
                          Must Supportfalse
                          Summarytrue
                          4. Questionnaire.meta
                          Definition

                          The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

                          ShortMetadata about the resource
                          Control1..1
                          TypeMeta
                          Is Modifierfalse
                          Must Supporttrue
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          6. Questionnaire.meta.id
                          Definition

                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                          ShortUnique id for inter-element referencing
                          Control0..1
                          This element is affected by the following invariants: ele-1
                          Typeid
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          8. Questionnaire.meta.extension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                          ShortAdditional content defined by implementations
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          SlicingThis element introduces a set of slices on Questionnaire.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 10. Questionnaire.meta.versionId
                            Definition

                            The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

                            ShortVersion specific identifier
                            Comments

                            The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

                            Control1..1
                            Typeid
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supporttrue
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            12. Questionnaire.meta.lastUpdated
                            Definition

                            When the resource last changed - e.g. when the version changed.

                            ShortWhen the resource version last changed
                            Comments

                            This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

                            Control1..1
                            Typeinstant
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supporttrue
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            14. Questionnaire.meta.source
                            Definition

                            A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

                            ShortIdentifies where the resource comes from
                            Comments

                            The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference.

                            This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

                            Control0..1
                            Typeuri
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            16. Questionnaire.meta.profile
                            Definition

                            A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

                            ShortProfiles this resource claims to conform to
                            Comments

                            It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

                            Control1..1
                            Typecanonical(StructureDefinition)
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supporttrue
                            Summarytrue
                            Fixed Valuehttp://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaire
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            18. Questionnaire.meta.security
                            Definition

                            Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

                            ShortSecurity Labels applied to this resource
                            Comments

                            The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

                            Control0..*
                            BindingUnless not suitable, these codes SHALL be taken from AllSecurityLabels
                            (extensible to http://hl7.org/fhir/ValueSet/security-labels|5.0.0)

                            Security Labels from the Healthcare Privacy and Security Classification System.

                            TypeCoding
                            Is Modifierfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            20. Questionnaire.meta.tag
                            Definition

                            Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

                            ShortTags applied to this resource
                            Comments

                            The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

                            Control0..*
                            BindingFor example codes, see CommonTags
                            (example to http://hl7.org/fhir/ValueSet/common-tags|5.0.0)

                            Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

                            TypeCoding
                            Is Modifierfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            22. Questionnaire.implicitRules
                            Definition

                            A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

                            ShortA set of rules under which this content was created
                            Comments

                            Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

                            Control0..1
                            Typeuri
                            Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supportfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            24. Questionnaire.language
                            Definition

                            The base language in which the resource is written.

                            ShortLanguage of the resource content
                            Comments

                            Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

                            Control0..1
                            BindingThe codes SHALL be taken from AllLanguages
                            (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                            IETF language tag for a human language

                            Typecode
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supportfalse
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            26. Questionnaire.text
                            Definition

                            A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

                            ShortText summary of the resource, for human interpretation
                            Comments

                            Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

                            Control1..1
                            This element is affected by the following invariants: dom-6
                            TypeNarrative
                            Is Modifierfalse
                            Must Supporttrue
                            Summaryfalse
                            Alternate Namesnarrative, html, xhtml, display
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            28. Questionnaire.contained
                            Definition

                            These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

                            ShortContained, inline Resources
                            Comments

                            This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

                            Control0..*
                            This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
                            TypeResource
                            Is Modifierfalse
                            Must Supportfalse
                            Summaryfalse
                            Alternate Namesinline resources, anonymous resources, contained resources
                            30. Questionnaire.extension
                            Definition

                            May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                            ShortAdditional content defined by implementations
                            Comments

                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                            Control0..*
                            TypeExtension
                            Is Modifierfalse
                            Must Supportfalse
                            Summaryfalse
                            Alternate Namesextensions, user content
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            32. Questionnaire.modifierExtension
                            Definition

                            May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                            ShortExtensions that cannot be ignored
                            Comments

                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                            Control0..*
                            TypeExtension
                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                            Must Supportfalse
                            Summarytrue
                            Requirements

                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                            Alternate Namesextensions, user content
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            34. Questionnaire.url
                            Definition

                            An absolute URI that is used to identify this questionnaire when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which an authoritative instance of this questionnaire is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the questionnaire is stored on different servers.

                            ShortCanonical identifier for this questionnaire, represented as an absolute URI (globally unique)
                            Comments

                            Can be a urn:uuid: or a urn:oid: but real http: addresses are preferred. Multiple instances may share the same URL if they have a distinct version.

                            The determination of when to create a new version of a resource (same url, new version) vs. defining a new artifact is up to the author. Considerations for making this decision are found in Technical and Business Versions.

                            In some cases, the resource can no longer be found at the stated url, but the url itself cannot change. Implementations can use the meta.source element to indicate where the current master source of the resource can be found.

                            The name of the referenced questionnaire can be conveyed using the http://hl7.org/fhir/StructureDefinition/display extension.

                            Control0..1
                            Typeuri
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supportfalse
                            Summarytrue
                            Requirements

                            Allows the questionnaire to be referenced by a single globally unique identifier.

                            This is the id that will be used to link a QuestionnaireResponse to the Questionnaire the response is for.

                            Invariantscnl-1: URL should not contain | or # - these characters make processing canonical references problematic (exists() implies matches('^[^|# ]+$'))
                            ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            36. Questionnaire.identifier
                            Definition

                            A formal identifier that is used to identify this questionnaire when it is represented in other formats, or referenced in a specification, model, design or an instance.

                            ShortBusiness identifier for questionnaire
                            Comments

                            Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this questionnaire outside of FHIR, where it is not possible to use the logical URI.

                            NoteThis is a business identifier, not a resource identifier (see discussion)
                            Control1..2
                            TypeIdentifier
                            Is Modifierfalse
                            Must Supporttrue
                            Summarytrue
                            Requirements

                            Allows externally provided and/or usable business identifiers to be easily associated with the questionnaire.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            SlicingThis element introduces a set of slices on Questionnaire.identifier. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                            • value @ type.coding.code
                            • 38. Questionnaire.identifier:company
                              Slice Namecompany
                              Definition

                              A formal identifier that is used to identify this questionnaire when it is represented in other formats, or referenced in a specification, model, design or an instance.

                              ShortBusiness identifier for questionnaire
                              Comments

                              Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this questionnaire outside of FHIR, where it is not possible to use the logical URI.

                              NoteThis is a business identifier, not a resource identifier (see discussion)
                              Control0..1
                              TypeIdentifier
                              Is Modifierfalse
                              Must Supporttrue
                              Summarytrue
                              Requirements

                              Allows externally provided and/or usable business identifiers to be easily associated with the questionnaire.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              40. Questionnaire.identifier:company.id
                              Definition

                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                              ShortUnique id for inter-element referencing
                              Control0..1
                              This element is affected by the following invariants: ele-1
                              Typeid
                              Is Modifierfalse
                              XML FormatIn the XML format, this property is represented as an attribute.
                              Summaryfalse
                              42. Questionnaire.identifier:company.extension
                              Definition

                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                              ShortAdditional content defined by implementations
                              Comments

                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                              Control0..*
                              TypeExtension
                              Is Modifierfalse
                              Summaryfalse
                              Alternate Namesextensions, user content
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              SlicingThis element introduces a set of slices on Questionnaire.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • value @ url
                              • 44. Questionnaire.identifier:company.use
                                Definition

                                The purpose of this identifier.

                                Shortusual | official | temp | secondary | old (If known)
                                Comments

                                Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                                Control0..1
                                BindingThe codes SHALL be taken from IdentifierUse
                                (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

                                Identifies the purpose for this identifier, if known .

                                Typecode
                                Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summarytrue
                                Requirements

                                Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                46. Questionnaire.identifier:company.type
                                Definition

                                A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                                ShortDescription of identifier
                                Comments

                                This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

                                Control1..1
                                BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
                                (extensible to http://hl7.org/fhir/ValueSet/identifier-type|5.0.0)

                                A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supporttrue
                                Summarytrue
                                Requirements

                                Allows users to make use of identifiers when the identifier system is not known.

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                48. Questionnaire.identifier:company.type.id
                                Definition

                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                ShortUnique id for inter-element referencing
                                Control0..1
                                This element is affected by the following invariants: ele-1
                                Typeid
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Summaryfalse
                                50. Questionnaire.identifier:company.type.extension
                                Definition

                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                ShortAdditional content defined by implementations
                                Comments

                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                Control0..*
                                TypeExtension
                                Is Modifierfalse
                                Summaryfalse
                                Alternate Namesextensions, user content
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                SlicingThis element introduces a set of slices on Questionnaire.identifier.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                • value @ url
                                • 52. Questionnaire.identifier:company.type.coding
                                  Definition

                                  A reference to a code defined by a terminology system.

                                  ShortCode defined by a terminology system
                                  Comments

                                  Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                  Control1..1
                                  TypeCoding
                                  Is Modifierfalse
                                  Summarytrue
                                  Requirements

                                  Allows for alternative encodings within a code system, and translations to other code systems.

                                  Fixed Value{
                                    "system" : "https://build.fhir.org/ig/HL7/rtq-ig/CodeSystem/rtq-identifier-type",
                                    "code" : "company-id",
                                    "display" : "Company-issued Identifier"
                                  }
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  54. Questionnaire.identifier:company.type.text
                                  Definition

                                  A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                  ShortPlain text representation of the concept
                                  Comments

                                  Very often the text is the same as a displayName of one of the codings.

                                  Control0..1
                                  Typestring
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Summarytrue
                                  Requirements

                                  The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  56. Questionnaire.identifier:company.system
                                  Definition

                                  Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

                                  ShortThe namespace for the identifier value
                                  Comments

                                  Identifier.system is always case sensitive.

                                  Control0..1
                                  Typeuri
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Summarytrue
                                  Requirements

                                  There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

                                  ExampleGeneral: http://www.acme.com/identifiers/patient
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  58. Questionnaire.identifier:company.value
                                  Definition

                                  The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                                  ShortThe value that is unique
                                  Comments

                                  If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

                                  Control0..1
                                  This element is affected by the following invariants: ident-1
                                  Typestring
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Summarytrue
                                  ExampleGeneral: 123456
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  60. Questionnaire.identifier:company.period
                                  Definition

                                  Time period during which identifier is/was valid for use.

                                  ShortTime period when id is/was valid for use
                                  Control0..1
                                  TypePeriod
                                  Is Modifierfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  62. Questionnaire.identifier:company.assigner
                                  Definition

                                  Organization that issued/manages the identifier.

                                  ShortOrganization that issued id (may be just text)
                                  Comments

                                  The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

                                  Control0..1
                                  TypeReference(Organization)
                                  Is Modifierfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  64. Questionnaire.identifier:regulator
                                  Slice Nameregulator
                                  Definition

                                  A formal identifier that is used to identify this questionnaire when it is represented in other formats, or referenced in a specification, model, design or an instance.

                                  ShortBusiness identifier for questionnaire
                                  Comments

                                  Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this questionnaire outside of FHIR, where it is not possible to use the logical URI.

                                  NoteThis is a business identifier, not a resource identifier (see discussion)
                                  Control1..1
                                  TypeIdentifier
                                  Is Modifierfalse
                                  Must Supporttrue
                                  Summarytrue
                                  Requirements

                                  Allows externally provided and/or usable business identifiers to be easily associated with the questionnaire.

                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  66. Questionnaire.identifier:regulator.id
                                  Definition

                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                  ShortUnique id for inter-element referencing
                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  Typeid
                                  Is Modifierfalse
                                  XML FormatIn the XML format, this property is represented as an attribute.
                                  Summaryfalse
                                  68. Questionnaire.identifier:regulator.extension
                                  Definition

                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                  ShortAdditional content defined by implementations
                                  Comments

                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                  Control0..*
                                  TypeExtension
                                  Is Modifierfalse
                                  Summaryfalse
                                  Alternate Namesextensions, user content
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                  SlicingThis element introduces a set of slices on Questionnaire.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                  • value @ url
                                  • 70. Questionnaire.identifier:regulator.use
                                    Definition

                                    The purpose of this identifier.

                                    Shortusual | official | temp | secondary | old (If known)
                                    Comments

                                    Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                                    Control0..1
                                    BindingThe codes SHALL be taken from IdentifierUse
                                    (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

                                    Identifies the purpose for this identifier, if known .

                                    Typecode
                                    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Requirements

                                    Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    72. Questionnaire.identifier:regulator.type
                                    Definition

                                    A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                                    ShortDescription of identifier
                                    Comments

                                    This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

                                    Control1..1
                                    BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
                                    (extensible to http://hl7.org/fhir/ValueSet/identifier-type|5.0.0)

                                    A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Must Supporttrue
                                    Summarytrue
                                    Requirements

                                    Allows users to make use of identifiers when the identifier system is not known.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    74. Questionnaire.identifier:regulator.type.id
                                    Definition

                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                    ShortUnique id for inter-element referencing
                                    Control0..1
                                    This element is affected by the following invariants: ele-1
                                    Typeid
                                    Is Modifierfalse
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    Summaryfalse
                                    76. Questionnaire.identifier:regulator.type.extension
                                    Definition

                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                    ShortAdditional content defined by implementations
                                    Comments

                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                    Control0..*
                                    TypeExtension
                                    Is Modifierfalse
                                    Summaryfalse
                                    Alternate Namesextensions, user content
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                    SlicingThis element introduces a set of slices on Questionnaire.identifier.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                    • value @ url
                                    • 78. Questionnaire.identifier:regulator.type.coding
                                      Definition

                                      A reference to a code defined by a terminology system.

                                      ShortCode defined by a terminology system
                                      Comments

                                      Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                      Control1..1
                                      TypeCoding
                                      Is Modifierfalse
                                      Summarytrue
                                      Requirements

                                      Allows for alternative encodings within a code system, and translations to other code systems.

                                      Fixed Value{
                                        "system" : "https://build.fhir.org/ig/HL7/rtq-ig/CodeSystem/rtq-identifier-type",
                                        "code" : "regulator-id",
                                        "display" : "Regulator-issued Identifier"
                                      }
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      80. Questionnaire.identifier:regulator.type.text
                                      Definition

                                      A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                      ShortPlain text representation of the concept
                                      Comments

                                      Very often the text is the same as a displayName of one of the codings.

                                      Control0..1
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Requirements

                                      The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      82. Questionnaire.identifier:regulator.system
                                      Definition

                                      Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

                                      ShortThe namespace for the identifier value
                                      Comments

                                      Identifier.system is always case sensitive.

                                      Control0..1
                                      Typeuri
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Requirements

                                      There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

                                      ExampleGeneral: http://www.acme.com/identifiers/patient
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      84. Questionnaire.identifier:regulator.value
                                      Definition

                                      The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                                      ShortThe value that is unique
                                      Comments

                                      If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

                                      Control0..1
                                      This element is affected by the following invariants: ident-1
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      ExampleGeneral: 123456
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      86. Questionnaire.identifier:regulator.period
                                      Definition

                                      Time period during which identifier is/was valid for use.

                                      ShortTime period when id is/was valid for use
                                      Control0..1
                                      TypePeriod
                                      Is Modifierfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      88. Questionnaire.identifier:regulator.assigner
                                      Definition

                                      Organization that issued/manages the identifier.

                                      ShortOrganization that issued id (may be just text)
                                      Comments

                                      The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

                                      Control0..1
                                      TypeReference(Organization)
                                      Is Modifierfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      90. Questionnaire.version
                                      Definition

                                      The identifier that is used to identify this version of the questionnaire when it is referenced in a specification, model, design or instance. This is an arbitrary value managed by the questionnaire author and is not expected to be globally unique. For example, it might be a timestamp (e.g. yyyymmdd) if a managed version is not available. There is also no expectation that versions can be placed in a lexicographical sequence.

                                      ShortBusiness version of the questionnaire
                                      Comments

                                      There may be different questionnaires that have the same url but different versions. The version can be appended to the url in a reference to allow a reference to a particular business version of the questionnaire with the format. The version SHOULD NOT contain a '#' - see Business Version.

                                      NoteThis is a business version Id, not a resource version Id (see discussion)
                                      Control1..1
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supporttrue
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      92. Questionnaire.versionAlgorithm[x]
                                      Definition

                                      Indicates the mechanism used to compare versions to determine which is more current.

                                      ShortHow to compare versions
                                      Comments

                                      If set as a string, this is a FHIRPath expression that has two additional context variables passed in - %version1 and %version2 and will return a negative number if version1 is newer, a positive number if version2 and a 0 if the version ordering can't be successfully be determined.

                                      Control0..1
                                      BindingUnless not suitable, these codes SHALL be taken from VersionAlgorithm
                                      (extensible to http://hl7.org/fhir/ValueSet/version-algorithm|5.0.0)
                                      TypeChoice of: string, Coding
                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      94. Questionnaire.name
                                      Definition

                                      A natural language name identifying the questionnaire. This name should be usable as an identifier for the module by machine processing applications such as code generation.

                                      ShortName for this questionnaire (computer friendly)
                                      Comments

                                      The name is not expected to be globally unique. The name should be a simple alphanumeric type no-whitespace name to ensure that it is machine-processing friendly.

                                      Control0..1
                                      This element is affected by the following invariants: cnl-0
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supportfalse
                                      Summarytrue
                                      Requirements

                                      Supports code generation.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      96. Questionnaire.title
                                      Definition

                                      A short, descriptive, user-friendly title for the questionnaire.

                                      ShortName for this questionnaire (human friendly)
                                      Comments

                                      This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc.

                                      Control0..1
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      98. Questionnaire.derivedFrom
                                      Definition

                                      The URL of a Questionnaire that this Questionnaire is based on.

                                      ShortBased on Questionnaire
                                      Comments

                                      This element covers a broad range of relationships, from 'somewhat inspired by' to 'fully compliant with'. There is a standard extensionthat allows clearer differentiation between the specifics of the derivation relationship where this is needed - e.g. to determine substitutability and validation expectations - http://hl7.org/fhir/StructureDefinition/questionnaire-derivationType.

                                      Control0..*
                                      Typecanonical(Questionnaire)
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supportfalse
                                      Summarytrue
                                      Requirements

                                      Allows a Questionnaire to be created based on another Questionnaire.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      100. Questionnaire.status
                                      Definition

                                      The current state of this questionnaire.

                                      Shortdraft | active | retired | unknown
                                      Comments

                                      A nominal state-transition diagram can be found in the] documentation

                                      Unknown does not represent 'other' - one of the defined statuses must apply. Unknown is used when the authoring system is not sure what the current status is.

                                      See guidance around (not) making local changes to elements here.

                                      Control1..1
                                      This element is affected by the following invariants: que-1a
                                      BindingThe codes SHALL be taken from PublicationStatus
                                      (required to http://hl7.org/fhir/ValueSet/publication-status|5.0.0)

                                      The lifecycle status of an artifact.

                                      Typecode
                                      Is Modifiertrue because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supportfalse
                                      Summarytrue
                                      Requirements

                                      Enables tracking the lifecycle of the content and filtering of questionnaires that are appropriate for use versus not.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      102. Questionnaire.experimental
                                      Definition

                                      A Boolean value to indicate that this questionnaire is authored for testing purposes (or education/evaluation/marketing) and is not intended for genuine usage.

                                      ShortFor testing purposes, not real usage
                                      Comments

                                      Allows filtering of questionnaires that are appropriate for use versus not.

                                      Control0..1
                                      Typeboolean
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supportfalse
                                      Summarytrue
                                      Requirements

                                      Enables experimental content to be developed following the same lifecycle that would be used for a production-level questionnaire.

                                      Meaning if MissingIf absent, this resource is treated as though it is not experimental.
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      104. Questionnaire.subjectType
                                      Definition

                                      The types of subjects that can be the subject of responses created for the questionnaire.

                                      ShortResource that can be subject of QuestionnaireResponse
                                      Comments

                                      If none are specified, then the subject is unlimited.

                                      Control1..*
                                      BindingThe codes SHALL be taken from http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs
                                      (required to http://hl7.org/fhir/uv/rtq/ValueSet/rtq-questionnaire-type-vs)
                                      Typecode
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supporttrue
                                      Summarytrue
                                      Requirements

                                      Allows enforcing that a QuestionnaireResponse only has a .subject element of the appropriate type.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      106. Questionnaire.date
                                      Definition

                                      The date (and optionally time) when the questionnaire was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the questionnaire changes.

                                      ShortDate last changed
                                      Comments

                                      The date is often not tracked until the resource is published, but may be present on draft content. Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the questionnaire. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource.

                                      See guidance around (not) making local changes to elements here.

                                      Control0..1
                                      TypedateTime
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supportfalse
                                      Summarytrue
                                      Alternate NamesRevision Date
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      108. Questionnaire.publisher
                                      Definition

                                      The name of the organization or individual responsible for the release and ongoing maintenance of the questionnaire.

                                      ShortName of the publisher/steward (organization or individual)
                                      Comments

                                      Usually an organization but may be an individual. The publisher (or steward) of the questionnaire is the organization or individual primarily responsible for the maintenance and upkeep of the questionnaire. This is not necessarily the same individual or organization that developed and initially authored the content. The publisher is the primary point of contact for questions or issues with the questionnaire. This item SHOULD be populated unless the information is available from context.

                                      Control0..0
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supportfalse
                                      Summarytrue
                                      Requirements

                                      Helps establish the "authority/credibility" of the questionnaire. May also allow for contact.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      110. Questionnaire.contact
                                      Definition

                                      Exactly two contacts shall be present: one identifying the competent authority that issued the Request to Qualify Questionnaire (sender) and one identifying the marketing authorisation holder or applicant that is required to complete and return the QuestionnaireResponse (receiver). Slicing is based on organization.name to distinguish the two parties.

                                      ShortSender (issuing regulatory authority) and receiver (MAH/applicant) contact details
                                      Comments

                                      May be a web site, an email address, a telephone number, etc.

                                      See guidance around (not) making local changes to elements here.

                                      Control2..2
                                      TypeContactDetail
                                      Is Modifierfalse
                                      Must Supporttrue
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      SlicingThis element introduces a set of slices on Questionnaire.contact. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                      • value @ organization.name
                                      • 112. Questionnaire.contact:sender
                                        Slice Namesender
                                        Definition

                                        Identifies the regulatory authority or agency that has created and sent this Questionnaire to the marketing authorisation holder.

                                        ShortContact details of the issuing competent authority (regulator)
                                        Comments

                                        May be a web site, an email address, a telephone number, etc.

                                        See guidance around (not) making local changes to elements here.

                                        Control1..1
                                        TypeContactDetail
                                        Is Modifierfalse
                                        Must Supporttrue
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        114. Questionnaire.contact:sender.id
                                        Definition

                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                        ShortUnique id for inter-element referencing
                                        Control0..1
                                        This element is affected by the following invariants: ele-1
                                        Typeid
                                        Is Modifierfalse
                                        XML FormatIn the XML format, this property is represented as an attribute.
                                        Summaryfalse
                                        116. Questionnaire.contact:sender.extension
                                        Definition

                                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                        ShortAdditional content defined by implementations
                                        Comments

                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                        Control0..*
                                        TypeExtension
                                        Is Modifierfalse
                                        Summaryfalse
                                        Alternate Namesextensions, user content
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        SlicingThis element introduces a set of slices on Questionnaire.contact.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                        • value @ url
                                        • 118. Questionnaire.contact:sender.name
                                          Definition

                                          Full official name of the competent authority issuing the Questionnaire (e.g., European Medicines Agency).

                                          ShortOfficial name of the issuing regulatory authority
                                          Comments

                                          If there is no named individual, the telecom information is for the organization as a whole.

                                          Control1..1
                                          Typestring
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Must Supporttrue
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          120. Questionnaire.contact:sender.telecom
                                          Definition

                                          The contact details for the individual (if a name was provided) or the organization.

                                          ShortContact details for individual or organization
                                          Control2..2
                                          TypeContactPoint
                                          Is Modifierfalse
                                          Must Supporttrue
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          SlicingThis element introduces a set of slices on Questionnaire.contact.telecom. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                          • value @ system
                                          • 122. Questionnaire.contact:sender.telecom:email
                                            Slice Nameemail
                                            Definition

                                            Official email for the designated regulatory contact

                                            ShortOfficial email for the designated regulatory contact
                                            Control1..1
                                            TypeContactPoint
                                            Is Modifierfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            124. Questionnaire.contact:sender.telecom:email.id
                                            Definition

                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                            ShortUnique id for inter-element referencing
                                            Control0..1
                                            This element is affected by the following invariants: ele-1
                                            Typeid
                                            Is Modifierfalse
                                            XML FormatIn the XML format, this property is represented as an attribute.
                                            Summaryfalse
                                            126. Questionnaire.contact:sender.telecom:email.extension
                                            Definition

                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                            ShortAdditional content defined by implementations
                                            Comments

                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                            Control0..*
                                            TypeExtension
                                            Is Modifierfalse
                                            Summaryfalse
                                            Alternate Namesextensions, user content
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                            SlicingThis element introduces a set of slices on Questionnaire.contact.telecom.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                            • value @ url
                                            • 128. Questionnaire.contact:sender.telecom:email.system
                                              Definition

                                              Telecommunications form for contact point - what communications system is required to make use of the contact.

                                              Shortphone | fax | email | pager | url | sms | other
                                              Control1..1
                                              This element is affected by the following invariants: cpt-2
                                              BindingThe codes SHALL be taken from ContactPointSystem
                                              (required to http://hl7.org/fhir/ValueSet/contact-point-system|5.0.0)

                                              Telecommunications form for contact point.

                                              Typecode
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Summarytrue
                                              Fixed Valueemail
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              130. Questionnaire.contact:sender.telecom:email.value
                                              Definition

                                              The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).

                                              ShortThe actual contact point details
                                              Comments

                                              Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.

                                              Control1..1
                                              This element is affected by the following invariants: cpt-2
                                              Typestring
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Summarytrue
                                              Requirements

                                              Need to support legacy numbers that are not in a tightly controlled format.

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              132. Questionnaire.contact:sender.telecom:email.use
                                              Definition

                                              Identifies the purpose for the contact point.

                                              Shorthome | work | temp | old | mobile - purpose of this contact point
                                              Comments

                                              Applications can assume that a contact is current unless it explicitly says that it is temporary or old.

                                              Control0..1
                                              BindingThe codes SHALL be taken from ContactPointUse
                                              (required to http://hl7.org/fhir/ValueSet/contact-point-use|5.0.0)

                                              Use of contact point.

                                              Typecode
                                              Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary or old contact etc.for a current/permanent one
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Summarytrue
                                              Requirements

                                              Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              134. Questionnaire.contact:sender.telecom:email.rank
                                              Definition

                                              Specifies a preferred order in which to use a set of contacts. ContactPoints with lower rank values are more preferred than those with higher rank values.

                                              ShortSpecify preferred order of use (1 = highest)
                                              Comments

                                              Note that rank does not necessarily follow the order in which the contacts are represented in the instance.

                                              Ranks need not be unique. E.g. it's possible to have multiple contacts with rank=1. If the ranks have different systems or uses, this would be interpreted to mean "X is my most preferred phone number, Y is my most preferred email address" or "X is my preferred home email and Y is my preferred work email". If the system and use for equally-ranked contacts are the same, then the level of preference is equivalent for both repetitions.

                                              Ranks need not be sequential and not all repetitions must have a rank. For example, it's possible to have 4 contacts with ranks of 2, 5 and two with no rank specified. That would be interpreted to mean the first is preferred over the second and no preference stated for the remaining contacts.

                                              Control0..1
                                              TypepositiveInt
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              136. Questionnaire.contact:sender.telecom:email.period
                                              Definition

                                              Time period when the contact point was/is in use.

                                              ShortTime period when the contact point was/is in use
                                              Control0..1
                                              TypePeriod
                                              Is Modifierfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              138. Questionnaire.contact:sender.telecom:phone
                                              Slice Namephone
                                              Definition

                                              Telephone number for the responsible regulatory contact.

                                              ShortTelephone number for the responsible regulatory contact
                                              Control0..1
                                              TypeContactPoint
                                              Is Modifierfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              140. Questionnaire.contact:sender.telecom:phone.id
                                              Definition

                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                              ShortUnique id for inter-element referencing
                                              Control0..1
                                              This element is affected by the following invariants: ele-1
                                              Typeid
                                              Is Modifierfalse
                                              XML FormatIn the XML format, this property is represented as an attribute.
                                              Summaryfalse
                                              142. Questionnaire.contact:sender.telecom:phone.extension
                                              Definition

                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                              ShortAdditional content defined by implementations
                                              Comments

                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                              Control0..*
                                              TypeExtension
                                              Is Modifierfalse
                                              Summaryfalse
                                              Alternate Namesextensions, user content
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                              SlicingThis element introduces a set of slices on Questionnaire.contact.telecom.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                              • value @ url
                                              • 144. Questionnaire.contact:sender.telecom:phone.system
                                                Definition

                                                Telecommunications form for contact point - what communications system is required to make use of the contact.

                                                Shortphone | fax | email | pager | url | sms | other
                                                Control1..1
                                                This element is affected by the following invariants: cpt-2
                                                BindingThe codes SHALL be taken from ContactPointSystem
                                                (required to http://hl7.org/fhir/ValueSet/contact-point-system|5.0.0)

                                                Telecommunications form for contact point.

                                                Typecode
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summarytrue
                                                Fixed Valuephone
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                146. Questionnaire.contact:sender.telecom:phone.value
                                                Definition

                                                The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).

                                                ShortThe actual contact point details
                                                Comments

                                                Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.

                                                Control1..1
                                                This element is affected by the following invariants: cpt-2
                                                Typestring
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summarytrue
                                                Requirements

                                                Need to support legacy numbers that are not in a tightly controlled format.

                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                148. Questionnaire.contact:sender.telecom:phone.use
                                                Definition

                                                Identifies the purpose for the contact point.

                                                Shorthome | work | temp | old | mobile - purpose of this contact point
                                                Comments

                                                Applications can assume that a contact is current unless it explicitly says that it is temporary or old.

                                                Control0..1
                                                BindingThe codes SHALL be taken from ContactPointUse
                                                (required to http://hl7.org/fhir/ValueSet/contact-point-use|5.0.0)

                                                Use of contact point.

                                                Typecode
                                                Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary or old contact etc.for a current/permanent one
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summarytrue
                                                Requirements

                                                Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.

                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                150. Questionnaire.contact:sender.telecom:phone.rank
                                                Definition

                                                Specifies a preferred order in which to use a set of contacts. ContactPoints with lower rank values are more preferred than those with higher rank values.

                                                ShortSpecify preferred order of use (1 = highest)
                                                Comments

                                                Note that rank does not necessarily follow the order in which the contacts are represented in the instance.

                                                Ranks need not be unique. E.g. it's possible to have multiple contacts with rank=1. If the ranks have different systems or uses, this would be interpreted to mean "X is my most preferred phone number, Y is my most preferred email address" or "X is my preferred home email and Y is my preferred work email". If the system and use for equally-ranked contacts are the same, then the level of preference is equivalent for both repetitions.

                                                Ranks need not be sequential and not all repetitions must have a rank. For example, it's possible to have 4 contacts with ranks of 2, 5 and two with no rank specified. That would be interpreted to mean the first is preferred over the second and no preference stated for the remaining contacts.

                                                Control0..1
                                                TypepositiveInt
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                152. Questionnaire.contact:sender.telecom:phone.period
                                                Definition

                                                Time period when the contact point was/is in use.

                                                ShortTime period when the contact point was/is in use
                                                Control0..1
                                                TypePeriod
                                                Is Modifierfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                154. Questionnaire.contact:receiver
                                                Slice Namereceiver
                                                Definition

                                                Identifies the pharmaceutical company, marketing authorisation holder, submitter or applicant that is the recipient of this Questionnaire and is obliged to provide the completed response.

                                                ShortContact details of the marketing authorisation holder/applicant
                                                Comments

                                                May be a web site, an email address, a telephone number, etc.

                                                See guidance around (not) making local changes to elements here.

                                                Control1..1
                                                TypeContactDetail
                                                Is Modifierfalse
                                                Must Supporttrue
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                156. Questionnaire.contact:receiver.id
                                                Definition

                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                ShortUnique id for inter-element referencing
                                                Control0..1
                                                This element is affected by the following invariants: ele-1
                                                Typeid
                                                Is Modifierfalse
                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                Summaryfalse
                                                158. Questionnaire.contact:receiver.extension
                                                Definition

                                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                ShortAdditional content defined by implementations
                                                Comments

                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                Control0..*
                                                TypeExtension
                                                Is Modifierfalse
                                                Summaryfalse
                                                Alternate Namesextensions, user content
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                SlicingThis element introduces a set of slices on Questionnaire.contact.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                • value @ url
                                                • 160. Questionnaire.contact:receiver.name
                                                  Definition

                                                  Full legal name of the marketing authorisation holder or applicant.

                                                  ShortLegal name of the MAH/applicant
                                                  Comments

                                                  If there is no named individual, the telecom information is for the organization as a whole.

                                                  Control1..1
                                                  Typestring
                                                  Is Modifierfalse
                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                  Must Supporttrue
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  162. Questionnaire.contact:receiver.telecom
                                                  Definition

                                                  The contact details for the individual (if a name was provided) or the organization.

                                                  ShortContact details for individual or organization
                                                  Control2..2
                                                  TypeContactPoint
                                                  Is Modifierfalse
                                                  Must Supporttrue
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  SlicingThis element introduces a set of slices on Questionnaire.contact.telecom. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                                  • value @ system
                                                  • 164. Questionnaire.contact:receiver.telecom:email
                                                    Slice Nameemail
                                                    Definition

                                                    Email address of the person or team at the MAH/applicant responsible for regulatory correspondence related to this regulatory activity.

                                                    ShortRegulatory contact email of the MAH/applicant
                                                    Control1..1
                                                    TypeContactPoint
                                                    Is Modifierfalse
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    166. Questionnaire.contact:receiver.telecom:email.id
                                                    Definition

                                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                    ShortUnique id for inter-element referencing
                                                    Control0..1
                                                    This element is affected by the following invariants: ele-1
                                                    Typeid
                                                    Is Modifierfalse
                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                    Summaryfalse
                                                    168. Questionnaire.contact:receiver.telecom:email.extension
                                                    Definition

                                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                    ShortAdditional content defined by implementations
                                                    Comments

                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                    Control0..*
                                                    TypeExtension
                                                    Is Modifierfalse
                                                    Summaryfalse
                                                    Alternate Namesextensions, user content
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                    SlicingThis element introduces a set of slices on Questionnaire.contact.telecom.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                    • value @ url
                                                    • 170. Questionnaire.contact:receiver.telecom:email.system
                                                      Definition

                                                      Telecommunications form for contact point - what communications system is required to make use of the contact.

                                                      Shortphone | fax | email | pager | url | sms | other
                                                      Control1..1
                                                      This element is affected by the following invariants: cpt-2
                                                      BindingThe codes SHALL be taken from ContactPointSystem
                                                      (required to http://hl7.org/fhir/ValueSet/contact-point-system|5.0.0)

                                                      Telecommunications form for contact point.

                                                      Typecode
                                                      Is Modifierfalse
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Summarytrue
                                                      Fixed Valueemail
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      172. Questionnaire.contact:receiver.telecom:email.value
                                                      Definition

                                                      The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).

                                                      ShortThe actual contact point details
                                                      Comments

                                                      Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.

                                                      Control1..1
                                                      This element is affected by the following invariants: cpt-2
                                                      Typestring
                                                      Is Modifierfalse
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Summarytrue
                                                      Requirements

                                                      Need to support legacy numbers that are not in a tightly controlled format.

                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      174. Questionnaire.contact:receiver.telecom:email.use
                                                      Definition

                                                      Identifies the purpose for the contact point.

                                                      Shorthome | work | temp | old | mobile - purpose of this contact point
                                                      Comments

                                                      Applications can assume that a contact is current unless it explicitly says that it is temporary or old.

                                                      Control0..1
                                                      BindingThe codes SHALL be taken from ContactPointUse
                                                      (required to http://hl7.org/fhir/ValueSet/contact-point-use|5.0.0)

                                                      Use of contact point.

                                                      Typecode
                                                      Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary or old contact etc.for a current/permanent one
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Summarytrue
                                                      Requirements

                                                      Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.

                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      176. Questionnaire.contact:receiver.telecom:email.rank
                                                      Definition

                                                      Specifies a preferred order in which to use a set of contacts. ContactPoints with lower rank values are more preferred than those with higher rank values.

                                                      ShortSpecify preferred order of use (1 = highest)
                                                      Comments

                                                      Note that rank does not necessarily follow the order in which the contacts are represented in the instance.

                                                      Ranks need not be unique. E.g. it's possible to have multiple contacts with rank=1. If the ranks have different systems or uses, this would be interpreted to mean "X is my most preferred phone number, Y is my most preferred email address" or "X is my preferred home email and Y is my preferred work email". If the system and use for equally-ranked contacts are the same, then the level of preference is equivalent for both repetitions.

                                                      Ranks need not be sequential and not all repetitions must have a rank. For example, it's possible to have 4 contacts with ranks of 2, 5 and two with no rank specified. That would be interpreted to mean the first is preferred over the second and no preference stated for the remaining contacts.

                                                      Control0..1
                                                      TypepositiveInt
                                                      Is Modifierfalse
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      178. Questionnaire.contact:receiver.telecom:email.period
                                                      Definition

                                                      Time period when the contact point was/is in use.

                                                      ShortTime period when the contact point was/is in use
                                                      Control0..1
                                                      TypePeriod
                                                      Is Modifierfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      180. Questionnaire.contact:receiver.telecom:phone
                                                      Slice Namephone
                                                      Definition

                                                      Direct telephone number (with country code) of the regulatory contact person at the receiving organisation.

                                                      ShortTelephone number of the regulatory contact at the MAH/applicant
                                                      Control1..1
                                                      TypeContactPoint
                                                      Is Modifierfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      182. Questionnaire.contact:receiver.telecom:phone.id
                                                      Definition

                                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                      ShortUnique id for inter-element referencing
                                                      Control0..1
                                                      This element is affected by the following invariants: ele-1
                                                      Typeid
                                                      Is Modifierfalse
                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                      Summaryfalse
                                                      184. Questionnaire.contact:receiver.telecom:phone.extension
                                                      Definition

                                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                      ShortAdditional content defined by implementations
                                                      Comments

                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                      Control0..*
                                                      TypeExtension
                                                      Is Modifierfalse
                                                      Summaryfalse
                                                      Alternate Namesextensions, user content
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                      SlicingThis element introduces a set of slices on Questionnaire.contact.telecom.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                      • value @ url
                                                      • 186. Questionnaire.contact:receiver.telecom:phone.system
                                                        Definition

                                                        Telecommunications form for contact point - what communications system is required to make use of the contact.

                                                        Shortphone | fax | email | pager | url | sms | other
                                                        Control1..1
                                                        This element is affected by the following invariants: cpt-2
                                                        BindingThe codes SHALL be taken from ContactPointSystem
                                                        (required to http://hl7.org/fhir/ValueSet/contact-point-system|5.0.0)

                                                        Telecommunications form for contact point.

                                                        Typecode
                                                        Is Modifierfalse
                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                        Summarytrue
                                                        Fixed Valuephone
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        188. Questionnaire.contact:receiver.telecom:phone.value
                                                        Definition

                                                        The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).

                                                        ShortThe actual contact point details
                                                        Comments

                                                        Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.

                                                        Control1..1
                                                        This element is affected by the following invariants: cpt-2
                                                        Typestring
                                                        Is Modifierfalse
                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                        Summarytrue
                                                        Requirements

                                                        Need to support legacy numbers that are not in a tightly controlled format.

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        190. Questionnaire.contact:receiver.telecom:phone.use
                                                        Definition

                                                        Identifies the purpose for the contact point.

                                                        Shorthome | work | temp | old | mobile - purpose of this contact point
                                                        Comments

                                                        Applications can assume that a contact is current unless it explicitly says that it is temporary or old.

                                                        Control0..1
                                                        BindingThe codes SHALL be taken from ContactPointUse
                                                        (required to http://hl7.org/fhir/ValueSet/contact-point-use|5.0.0)

                                                        Use of contact point.

                                                        Typecode
                                                        Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary or old contact etc.for a current/permanent one
                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                        Summarytrue
                                                        Requirements

                                                        Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        192. Questionnaire.contact:receiver.telecom:phone.rank
                                                        Definition

                                                        Specifies a preferred order in which to use a set of contacts. ContactPoints with lower rank values are more preferred than those with higher rank values.

                                                        ShortSpecify preferred order of use (1 = highest)
                                                        Comments

                                                        Note that rank does not necessarily follow the order in which the contacts are represented in the instance.

                                                        Ranks need not be unique. E.g. it's possible to have multiple contacts with rank=1. If the ranks have different systems or uses, this would be interpreted to mean "X is my most preferred phone number, Y is my most preferred email address" or "X is my preferred home email and Y is my preferred work email". If the system and use for equally-ranked contacts are the same, then the level of preference is equivalent for both repetitions.

                                                        Ranks need not be sequential and not all repetitions must have a rank. For example, it's possible to have 4 contacts with ranks of 2, 5 and two with no rank specified. That would be interpreted to mean the first is preferred over the second and no preference stated for the remaining contacts.

                                                        Control0..1
                                                        TypepositiveInt
                                                        Is Modifierfalse
                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                        Summarytrue
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        194. Questionnaire.contact:receiver.telecom:phone.period
                                                        Definition

                                                        Time period when the contact point was/is in use.

                                                        ShortTime period when the contact point was/is in use
                                                        Control0..1
                                                        TypePeriod
                                                        Is Modifierfalse
                                                        Summarytrue
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        196. Questionnaire.description
                                                        Definition

                                                        A free text natural language description of the questionnaire from a consumer's perspective.

                                                        ShortNatural language description of the questionnaire
                                                        Comments

                                                        This description can be used to capture details such as comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the questionnaire as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context. (E.g. the language of the questionnaire is presumed to be the predominant language in the place the questionnaire was created).

                                                        Control0..1
                                                        Typemarkdown
                                                        Is Modifierfalse
                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                        Must Supportfalse
                                                        Summarytrue
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        198. Questionnaire.useContext
                                                        Definition

                                                        The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate questionnaires.

                                                        ShortThe context that the content is intended to support
                                                        Comments

                                                        When multiple useContexts are specified, there is no expectation that all or even any of the contexts apply.

                                                        Control0..*
                                                        TypeUsageContext
                                                        Is Modifierfalse
                                                        Must Supportfalse
                                                        Summarytrue
                                                        Requirements

                                                        Assist in searching for appropriate content.

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        200. Questionnaire.jurisdiction
                                                        Definition

                                                        A legal or geographic region in which the questionnaire is intended to be used.

                                                        ShortIntended jurisdiction for questionnaire (if applicable)
                                                        Comments

                                                        It may be possible for the questionnaire to be used in jurisdictions other than those for which it was originally designed or intended.

                                                        DEPRECATION NOTE: For consistency, implementations are encouraged to migrate to using the new 'jurisdiction' code in the useContext element. (I.e. useContext.code indicating http://terminology.hl7.org/CodeSystem/usage-context-type#jurisdiction and useContext.valueCodeableConcept indicating the jurisdiction.)

                                                        Control0..*
                                                        BindingUnless not suitable, these codes SHALL be taken from JurisdictionValueSet
                                                        (extensible to http://hl7.org/fhir/ValueSet/jurisdiction|5.0.0)

                                                        Countries and regions within which this artifact is targeted for use.

                                                        TypeCodeableConcept
                                                        Is Modifierfalse
                                                        Must Supportfalse
                                                        Summarytrue
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        202. Questionnaire.purpose
                                                        Definition

                                                        Explanation of why this questionnaire is needed and why it has been designed as it has.

                                                        ShortWhy this questionnaire is defined
                                                        Comments

                                                        This element does not describe the usage of the questionnaire. Instead, it provides traceability of ''why'' the resource is either needed or ''why'' it is defined as it is. This may be used to point to source materials or specifications that drove the structure of this questionnaire.

                                                        Control0..1
                                                        Typemarkdown
                                                        Is Modifierfalse
                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                        Must Supportfalse
                                                        Summaryfalse
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        204. Questionnaire.copyright
                                                        Definition

                                                        A copyright statement relating to the questionnaire and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the questionnaire.

                                                        ShortUse and/or publishing restrictions
                                                        Control0..1
                                                        Typemarkdown
                                                        Is Modifierfalse
                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                        Must Supportfalse
                                                        Summaryfalse
                                                        Requirements

                                                        Consumers of the questionnaire must be able to determine any legal restrictions on the use of the artifact and/or its content.

                                                        Alternate NamesLicense, Restrictions
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        206. Questionnaire.copyrightLabel
                                                        Definition

                                                        A short string (<50 characters), suitable for inclusion in a page footer that identifies the copyright holder, effective period, and optionally whether rights are resctricted. (e.g. 'All rights reserved', 'Some rights reserved').

                                                        ShortCopyright holder and year(s)
                                                        Comments

                                                        The (c) symbol should NOT be included in this string. It will be added by software when rendering the notation. Full details about licensing, restrictions, warrantees, etc. goes in the more general 'copyright' element.

                                                        Control0..1
                                                        Typestring
                                                        Is Modifierfalse
                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                        Must Supportfalse
                                                        Summaryfalse
                                                        Requirements

                                                        Defines the content expected to be rendered in all representations of the artifact.

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        208. Questionnaire.approvalDate
                                                        Definition

                                                        The date on which the resource content was approved by the publisher. Approval happens once when the content is officially approved for usage.

                                                        ShortWhen the questionnaire was approved by publisher
                                                        Comments

                                                        The 'date' element may be more recent than the approval date because of minor changes or editorial corrections.

                                                        See guidance around (not) making local changes to elements here.

                                                        Control0..1
                                                        Typedate
                                                        Is Modifierfalse
                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                        Must Supportfalse
                                                        Summaryfalse
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        210. Questionnaire.lastReviewDate
                                                        Definition

                                                        The date on which the resource content was last reviewed. Review happens periodically after approval but does not change the original approval date.

                                                        ShortWhen the questionnaire was last reviewed by the publisher
                                                        Comments

                                                        If specified, this date follows the original approval date.

                                                        See guidance around (not) making local changes to elements here.

                                                        Control0..1
                                                        Typedate
                                                        Is Modifierfalse
                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                        Must Supportfalse
                                                        Summaryfalse
                                                        Requirements

                                                        Gives a sense of how "current" the content is. Resources that have not been reviewed in a long time may have a risk of being less appropriate/relevant.

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        212. Questionnaire.effectivePeriod
                                                        Definition

                                                        The period during which the questionnaire content was or is planned to be in active use.

                                                        ShortWhen the questionnaire is expected to be used
                                                        Comments

                                                        The effective period for a questionnaire determines when the content is applicable for usage and is independent of publication and review dates. For example, a questionnaire intended to be used for the year 2016 might be published in 2015.

                                                        See guidance around (not) making local changes to elements here.

                                                        Control0..1
                                                        TypePeriod
                                                        Is Modifierfalse
                                                        Must Supportfalse
                                                        Summarytrue
                                                        Requirements

                                                        Allows establishing a transition before a resource comes into effect and also allows for a sunsetting process when new versions of the questionnaire are or are expected to be used instead.

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        214. Questionnaire.code
                                                        Definition

                                                        An identifier for this collection of questions in a particular terminology such as LOINC.

                                                        ShortConcept that represents the overall questionnaire
                                                        Control0..*
                                                        BindingFor example codes, see QuestionnaireQuestionCodes
                                                        (example to http://hl7.org/fhir/ValueSet/questionnaire-questions|5.0.0)

                                                        Codes for questionnaires, groups and individual questions.

                                                        TypeCoding
                                                        Is Modifierfalse
                                                        Must Supportfalse
                                                        Summarytrue
                                                        Requirements

                                                        Allows linking of the complete Questionnaire resources to formal terminologies. It's common for "panels" of questions to be identified by a code.

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        216. Questionnaire.item
                                                        Definition

                                                        A particular question, question grouping or display text that is part of the questionnaire.

                                                        ShortQuestion in the regulatory questionnaire
                                                        Comments

                                                        The content of the questionnaire is constructed from an ordered, hierarchical collection of items.

                                                        Control0..*
                                                        TypeBackboneElement
                                                        Is Modifierfalse
                                                        Must Supporttrue
                                                        Summaryfalse
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        que-1a: Group items must have nested items when Questionanire is complete ((type='group' and %resource.status='complete') implies item.empty().not())
                                                        que-1b: Groups should have items (type='group' implies item.empty().not())
                                                        que-1c: Display items cannot have child items (type='display' implies item.empty())
                                                        que-3: Display items cannot have a "code" asserted (type!='display' or code.empty())
                                                        que-4: A question cannot have both answerOption and answerValueSet (answerOption.empty() or answerValueSet.empty())
                                                        que-5: 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: Required and repeat aren't permitted for display items (type!='display' or (required.empty() and repeats.empty()))
                                                        que-8: Initial values can't be specified for groups or display items ((type!='group' and type!='display') or initial.empty())
                                                        que-9: Read-only can't be specified for "display" items (type!='display' or readOnly.empty())
                                                        que-10: 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: If one or more answerOption is present, initial cannot be present. Use answerOption.initialSelected instead (answerOption.empty() or initial.empty())
                                                        que-12: If there are more than one enableWhen, enableBehavior must be specified (enableWhen.count() > 1 implies enableBehavior.exists())
                                                        que-13: Can only have multiple initial values for repeating items (repeats=true or initial.count() <= 1)
                                                        que-14: 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())
                                                        218. Questionnaire.item.id
                                                        Definition

                                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                        ShortUnique id for inter-element referencing
                                                        Control0..1
                                                        This element is affected by the following invariants: ele-1
                                                        Typestring
                                                        Is Modifierfalse
                                                        XML FormatIn the XML format, this property is represented as an attribute.
                                                        Summaryfalse
                                                        220. Questionnaire.item.extension
                                                        Definition

                                                        An Extension

                                                        ShortExtension
                                                        Control0..*
                                                        TypeExtension
                                                        Is Modifierfalse
                                                        Summaryfalse
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                        SlicingThis element introduces a set of slices on Questionnaire.item.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                        • value @ url
                                                        • 222. Questionnaire.item.extension:itemReference
                                                          Slice NameitemReference
                                                          Definition

                                                          An extension to allow referencing an RTQDocumentReference from a Questionnaire item (the question).

                                                          ShortSupporting document(s) for this question
                                                          Control0..*
                                                          TypeExtension(RTQ Item Reference Extension) (Extension Type: Reference(RTQ Document Reference))
                                                          Is Modifierfalse
                                                          Must Supporttrue
                                                          Summaryfalse
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                          224. Questionnaire.item.modifierExtension
                                                          Definition

                                                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                          ShortExtensions that cannot be ignored even if unrecognized
                                                          Comments

                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                          Control0..*
                                                          TypeExtension
                                                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                          Summarytrue
                                                          Requirements

                                                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                          Alternate Namesextensions, user content, modifiers
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                          226. Questionnaire.item.linkId
                                                          Definition

                                                          An identifier that is unique within the Questionnaire allowing linkage to the equivalent item in a QuestionnaireResponse resource.

                                                          ShortUnique id for item in questionnaire
                                                          Comments

                                                          This ''can'' be a meaningful identifier (e.g. a LOINC code) but is not intended to have any meaning. GUIDs or sequential numbers are appropriate here.

                                                          LinkIds can have whitespaces and slashes by design. Tooling should not rely on linkIds being valid XHTML element IDs, and should not directly embed them as such

                                                          Control1..1
                                                          This element is affected by the following invariants: que-2
                                                          Typestring
                                                          Is Modifierfalse
                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                          Must Supportfalse
                                                          Summaryfalse
                                                          Requirements

                                                          QuestionnaireResponse does not require omitted items to be included and may have some items that repeat, so linkage based on position alone is not sufficient.

                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          que-15: Link ids should be 255 characters or less ($this.length() <= 255)
                                                          228. Questionnaire.item.definition
                                                          Definition

                                                          This element is a URI that refers to an ElementDefinition or to an ObservationDefinition that provides information about this item, including information that might otherwise be included in the instance of the Questionnaire resource. A detailed description of the construction of the URI is shown in Comments, below.

                                                          ShortElementDefinition - details for the item
                                                          Comments

                                                          The uri refers to an ElementDefinition in a StructureDefinition or to an ObservationDefinition and always starts with the canonical URL for the target resource. When referring to a StructureDefinition, a fragment identifier is used to specify the element definition by its id Element.id. E.g. http://hl7.org/fhir/StructureDefinition/Observation#Observation.value[x]. In the absence of a fragment identifier, the first/root element definition in the target is the matching element definition.

                                                          Control0..1
                                                          Typeuri
                                                          Is Modifierfalse
                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                          Must Supportfalse
                                                          Summaryfalse
                                                          Requirements

                                                          A common pattern is to define a set of data elements and then build multiple questionnaires for different circumstances to gather the data. This element provides traceability to the common definition and allows the content for the question to come from the underlying definition.

                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          230. Questionnaire.item.code
                                                          Definition

                                                          A required code from the RTQ CTD Categories CodeSystem (or an allowed extension of it) that identifies which section, subsection, or specific regulatory topic within a medicinal product dossier this questionnaire item pertains to. This enables precise mapping and automated routing in regulatory processes.

                                                          ShortCTD-based category code that classifies the regulatory topic of this question/group
                                                          Comments

                                                          Examples: '2-3-s-4-2' = Nonclinical Overview, '3-2-p-5-3' = Microbiological quality control, etc.

                                                          Control1..*
                                                          This element is affected by the following invariants: que-3
                                                          BindingUnless not suitable, these codes SHALL be taken from http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full
                                                          (extensible to http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full)

                                                          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.

                                                          TypeCoding
                                                          Is Modifierfalse
                                                          Must Supporttrue
                                                          Summaryfalse
                                                          Requirements

                                                          Allows linking of groups of questions to formal terminologies.

                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          232. Questionnaire.item.code.id
                                                          Definition

                                                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                          ShortUnique id for inter-element referencing
                                                          Control0..1
                                                          This element is affected by the following invariants: ele-1
                                                          Typeid
                                                          Is Modifierfalse
                                                          XML FormatIn the XML format, this property is represented as an attribute.
                                                          Summaryfalse
                                                          234. Questionnaire.item.code.extension
                                                          Definition

                                                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                          ShortAdditional content defined by implementations
                                                          Comments

                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                          Control0..*
                                                          TypeExtension
                                                          Is Modifierfalse
                                                          Summaryfalse
                                                          Alternate Namesextensions, user content
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                          SlicingThis element introduces a set of slices on Questionnaire.item.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                          • value @ url
                                                          • 236. Questionnaire.item.code.system
                                                            Definition

                                                            The identification of the code system that defines the meaning of the symbol in the code.

                                                            ShortIdentity of the terminology system
                                                            Comments

                                                            The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

                                                            Control1..1
                                                            Typeuri
                                                            Is Modifierfalse
                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                            Must Supporttrue
                                                            Summarytrue
                                                            Requirements

                                                            Need to be unambiguous about the source of the definition of the symbol.

                                                            Fixed Valuehttp://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            238. Questionnaire.item.code.version
                                                            Definition

                                                            The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                                                            ShortVersion of the system - if relevant
                                                            Comments

                                                            Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                                                            NoteThis is a business version Id, not a resource version Id (see discussion)
                                                            Control0..1
                                                            Typestring
                                                            Is Modifierfalse
                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            240. Questionnaire.item.code.code
                                                            Definition

                                                            A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                                                            ShortCTD section/subsection code (e.g., 2-3-s-4-2-1)
                                                            Control1..1
                                                            This element is affected by the following invariants: cod-1
                                                            Typecode
                                                            Is Modifierfalse
                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                            Must Supporttrue
                                                            Summarytrue
                                                            Requirements

                                                            Need to refer to a particular code in the system.

                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            242. Questionnaire.item.code.display
                                                            Definition

                                                            A representation of the meaning of the code in the system, following the rules of the system.

                                                            ShortHuman-readable title of the CTD category
                                                            Control1..1
                                                            This element is affected by the following invariants: cod-1
                                                            Typestring
                                                            Is Modifierfalse
                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                            Must Supporttrue
                                                            Summarytrue
                                                            Requirements

                                                            Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            244. Questionnaire.item.code.userSelected
                                                            Definition

                                                            Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                                                            ShortIf this coding was chosen directly by the user
                                                            Comments

                                                            Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                                                            Control0..1
                                                            Typeboolean
                                                            Is Modifierfalse
                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                            Summarytrue
                                                            Requirements

                                                            This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            246. Questionnaire.item.prefix
                                                            Definition

                                                            A short label for a particular group, question or set of display text within the questionnaire used for reference by the individual completing the questionnaire.

                                                            ShortE.g. "1(a)", "2.5.3"
                                                            Comments

                                                            These are generally unique within a questionnaire, though this is not guaranteed. Some questionnaires may have multiple questions with the same label with logic to control which gets exposed. Typically, these won't be used for "display" items, though such use is not prohibited. Systems SHOULD NOT generate their own prefixes if prefixes are defined for any items within a Questionnaire.

                                                            Control0..1
                                                            Typestring
                                                            Is Modifierfalse
                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                            Must Supportfalse
                                                            Summaryfalse
                                                            Requirements

                                                            Separating the label from the question text allows improved rendering. Also, instructions will often refer to specific prefixes, so there's a need for the questionnaire design to have control over what labels are used.

                                                            Alternate Nameslabel
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            248. Questionnaire.item.text
                                                            Definition

                                                            The name of a section, the text of a question or text content for a display item.

                                                            ShortPrimary text for the item
                                                            Comments

                                                            When using this element to represent the name of a section, use group type item and also make sure to limit the text element to a short string suitable for display as a section heading. Group item instructions should be included as a display type item within the group.

                                                            Control1..1
                                                            Typestring
                                                            Is Modifierfalse
                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                            Must Supporttrue
                                                            Summaryfalse
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            250. Questionnaire.item.text.id
                                                            Definition

                                                            unique id for the element within a resource (for internal references)

                                                            Shortxml:id (or equivalent in JSON)
                                                            Control0..1
                                                            Typestring
                                                            Is Modifierfalse
                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                            Summaryfalse
                                                            252. Questionnaire.item.text.extension
                                                            Definition

                                                            An Extension

                                                            ShortExtension
                                                            Control1..*
                                                            TypeExtension
                                                            Is Modifierfalse
                                                            Summaryfalse
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                            SlicingThis element introduces a set of slices on Questionnaire.item.text.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                            • value @ url
                                                            • 254. Questionnaire.item.text.extension:rendering-xhtml
                                                              Slice Namerendering-xhtml
                                                              Definition

                                                              This is an equivalent of the string on which the extension is sent, but includes additional XHTML markup, such as bold, italics, styles, tables, etc. Existing restrictions on XHTML content apply. Note that using markdown allows for greater flexibility of display.

                                                              ShortString equivalent with html markup
                                                              Comments

                                                              For questionnaires, see additional guidance and examples in the SDC implementation guide.

                                                              Control1..1
                                                              TypeExtension(XHTML Representation) (Extension Type: string)
                                                              Is Modifierfalse
                                                              Must Supporttrue
                                                              Summaryfalse
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                              256. Questionnaire.item.text.value
                                                              Definition

                                                              The actual value

                                                              ShortPrimitive value for string
                                                              Control0..1
                                                              Typestring
                                                              Is Modifierfalse
                                                              XML FormatIn the XML format, this property is represented as an attribute.
                                                              Summaryfalse
                                                              Max Length:1048576
                                                              258. Questionnaire.item.type
                                                              Definition

                                                              The type of questionnaire item this is - whether text for display, a grouping of other items or a particular type of data to be captured (string, integer, Coding, etc.).

                                                              Shortgroup | display | boolean | decimal | integer | date | dateTime +
                                                              Comments

                                                              Additional constraints on the type of answer can be conveyed by extensions. The value may come from the ElementDefinition referred to by .definition.

                                                              Control1..1
                                                              This element is affected by the following invariants: que-9, que-8, que-6, que-5, que-3, que-10, que-1a, que-1b, que-1c
                                                              BindingThe codes SHALL be taken from QuestionnaireItemType
                                                              (required to http://hl7.org/fhir/ValueSet/item-type|5.0.0)

                                                              Distinguishes groups from questions and display text and indicates data type for questions.

                                                              Typecode
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Requirements

                                                              Defines the format in which the user is to be prompted for the answer.

                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              260. Questionnaire.item.enableWhen
                                                              Definition

                                                              A constraint indicating that this item should only be enabled (displayed/allow answers to be captured) when the specified condition is true.

                                                              ShortOnly allow data when
                                                              Comments

                                                              If multiple repetitions of this extension are present, the interpretation is driven by enableBehavior (either all repetitions must evaluate to true for this item to be enabled, or only one must evaluate to true for the item to be enabled). If the enableWhen.question has multiple answers, the condition evaluates to true if any of the answers for the referenced item match the enableWhen condition. This element is a modifier because if enableWhen is present for an item, "required" is ignored unless one of the enableWhen conditions is met. When an item is disabled, all of its descendants are disabled, regardless of what their own enableWhen logic might evaluate to. If enableWhen logic depends on an item that is disabled, the logic should proceed as though the item is not valued - even if a default value or other value might be retained in memory in the event of the item being re-enabled. In some cases, the comparison between the indicated answer and the specified value may differ only by precision. For example, the enableWhen might be Q1 > 1970, but the answer to Q1 is 1970-10-15. There is not a clear answer as to whether 1970-10-15 should be considered 'greater' than 1970, given that it is an imprecise value. In these indeterminate situations, the form filler has the option of refusing to render the form. If the form is displayed, items where enableWhen is indeterminate SHOULD be treated as enabled with a warning indicating that the questionnaire logic was faulty and it is possible that the item should not be enabled. Questionnaires SHOULD be designed to take into account challenges around varying precision to minimize non-deterministic situations by setting constraints around expected precision, etc.

                                                              Control0..*
                                                              This element is affected by the following invariants: que-12
                                                              TypeBackboneElement
                                                              Is Modifiertrue because If enableWhen is present and the condition evaluates to false, then the Questionnaire behaves as though the elements weren't actually present
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Requirements

                                                              Allows questionnaires to adapt based on answers to other questions. E.g. If physical gender is specified as a male, no need to capture pregnancy history. Also allows conditional display of instructions or groups of questions.

                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              que-7: If the operator is 'exists', the value must be a boolean (operator = 'exists' implies (answer is boolean))
                                                              262. Questionnaire.item.enableWhen.id
                                                              Definition

                                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                              ShortUnique id for inter-element referencing
                                                              Control0..1
                                                              This element is affected by the following invariants: ele-1
                                                              Typestring
                                                              Is Modifierfalse
                                                              XML FormatIn the XML format, this property is represented as an attribute.
                                                              Summaryfalse
                                                              264. Questionnaire.item.enableWhen.extension
                                                              Definition

                                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                              ShortAdditional content defined by implementations
                                                              Comments

                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                              Control0..*
                                                              TypeExtension
                                                              Is Modifierfalse
                                                              Summaryfalse
                                                              Alternate Namesextensions, user content
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                              266. Questionnaire.item.enableWhen.modifierExtension
                                                              Definition

                                                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                              ShortExtensions that cannot be ignored even if unrecognized
                                                              Comments

                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                              Control0..*
                                                              TypeExtension
                                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                              Summarytrue
                                                              Requirements

                                                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                              Alternate Namesextensions, user content, modifiers
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                              268. Questionnaire.item.enableWhen.question
                                                              Definition

                                                              The linkId for the question whose answer (or lack of answer) governs whether this item is enabled.

                                                              ShortThe linkId of question that determines whether item is enabled/disabled
                                                              Comments

                                                              If multiple question occurrences are present for the same question (same linkId), then this refers to the nearest question occurrence reachable by tracing first the "ancestor" axis and then the "preceding" axis and then the "following" axis. If there are multiple items with the same linkId and all are equadistant (e.g. a question references a question that appears in a separate repeating group), that is an error. (Consider using the enableWhenExpression extension to define logic to handle such a situation.)

                                                              Control1..1
                                                              Typestring
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              270. Questionnaire.item.enableWhen.operator
                                                              Definition

                                                              Specifies the criteria by which the question is enabled.

                                                              Shortexists | = | != | > | < | >= | <=
                                                              Control1..1
                                                              This element is affected by the following invariants: que-7
                                                              BindingThe codes SHALL be taken from QuestionnaireItemOperator
                                                              (required to http://hl7.org/fhir/ValueSet/questionnaire-enable-operator|5.0.0)

                                                              The criteria by which a question is enabled.

                                                              Typecode
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              272. Questionnaire.item.enableWhen.answer[x]
                                                              Definition

                                                              A value that the referenced question is tested using the specified operator in order for the item to be enabled. If there are multiple answers, a match on any of the answers suffices. If different behavior is desired (all must match, at least 2 must match, etc.), consider using the enableWhenExpression extension.

                                                              ShortValue for question comparison based on operator
                                                              Control1..1
                                                              This element is affected by the following invariants: que-7
                                                              BindingFor example codes, see QuestionnaireAnswerCodes
                                                              (example to http://hl7.org/fhir/ValueSet/questionnaire-answers|5.0.0)

                                                              Allowed values to answer questions.

                                                              TypeChoice of: boolean, decimal, integer, date, dateTime, time, string, Coding, Quantity, Reference(Resource)
                                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              274. Questionnaire.item.enableBehavior
                                                              Definition

                                                              Controls how multiple enableWhen values are interpreted - whether all or any must be true.

                                                              Shortall | any
                                                              Comments

                                                              This element must be specified if more than one enableWhen value is provided.

                                                              Control0..1
                                                              This element is affected by the following invariants: que-12
                                                              BindingThe codes SHALL be taken from EnableWhenBehavior
                                                              (required to http://hl7.org/fhir/ValueSet/questionnaire-enable-behavior|5.0.0)

                                                              Controls how multiple enableWhen values are interpreted - whether all or any must be true.

                                                              Typecode
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              276. Questionnaire.item.disabledDisplay
                                                              Definition

                                                              Indicates if and how items that are disabled (because enableWhen evaluates to 'false') should be displayed.

                                                              Shorthidden | protected
                                                              Comments

                                                              If not specified, rendering behavior is up to the client. This element is only meaningful if enableWhen or an equivalent extension is present

                                                              Control0..1
                                                              BindingThe codes SHALL be taken from QuestionnaireItemDisabledDisplay
                                                              (required to http://hl7.org/fhir/ValueSet/questionnaire-disabled-display|5.0.0)

                                                              Defines how disabled elements should be rendered

                                                              Typecode
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              278. Questionnaire.item.required
                                                              Definition

                                                              An indication, if true, that the item must be present in a "completed" QuestionnaireResponse. If false, the item may be skipped when answering the questionnaire.

                                                              ShortWhether the item must be included in data results
                                                              Comments

                                                              If the required item is a question, it must have a direct answer (i.e. an answer to the question itself, not merely answers to child questions) in order for the QuestionnaireResponse to be complete. If the required item is a group, it must have at least one descendant question which has an answer Questionnaire.item.required only has meaning for elements that are conditionally enabled with enableWhen if the condition evaluates to true. It also only has meaning if the parent element is present. If a non-required 'group' item contains a 'required' question item, it's completely fine to omit the group (because it's not required) despite it having a required child. Similarly, if an item that contains other items is marked as required, that does not automatically make the contained elements required (though required groups must contain at least one descendant item with a populated answer). The value for 'required' may come from the ElementDefinition referred to by .definition.

                                                              Control0..1
                                                              This element is affected by the following invariants: que-6
                                                              Typeboolean
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Meaning if MissingItems are assumed not to be required unless explicitly specified, though extensions may impose additional expectations
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              280. Questionnaire.item.repeats
                                                              Definition

                                                              An indication, if true, that a QuestionnaireResponse for this item may include multiple answers associated with a single instance of this item (for question-type items) or multiple repetitions of the item (for group-type items).

                                                              ShortWhether the item may repeat
                                                              Comments

                                                              If a question is marked as repeats=true, then multiple answers can be provided for the question in the corresponding QuestionnaireResponse. When rendering the questionnaire, it is up to the rendering software whether to render the question text for each answer repetition (i.e. "repeat the question") or to simply allow entry/selection of multiple answers for the question (repeat the answers). Which is most appropriate visually may depend on the type of answer as well as whether there are nested items.

                                                              The resulting QuestionnaireResponse will be populated the same way regardless of rendering - one 'question' item with multiple answer values.

                                                              The value may come from the ElementDefinition referred to by .definition. When repeats=true for a group, it'll be represented with multiple items with the same linkId in the QuestionnaireResponse. For a question, it'll be represented by a single item with that linkId with multiple answers.

                                                              Control0..1
                                                              This element is affected by the following invariants: que-6, que-13
                                                              Typeboolean
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Requirements

                                                              Items may be used to create set of (related) questions that can be repeated to give multiple answers to such a set.

                                                              Meaning if MissingItems are generally assumed not to repeat unless explicitly specified. Systems SHOULD always populate this value
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              282. Questionnaire.item.readOnly
                                                              Definition

                                                              An indication, when true, that the value cannot be changed by a human respondent to the Questionnaire.

                                                              ShortDon't allow human editing
                                                              Comments

                                                              If specified on a 'group', then all items beneath the specified group are read only. For questions, this only marks the answer associated with the specific item read only. Descendant questions are not impacted. The value of readOnly elements can be established by asserting extensions for defaultValues, linkages that support pre-population and/or extensions that support calculation based on other answers.

                                                              Control0..1
                                                              This element is affected by the following invariants: que-9
                                                              Typeboolean
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Requirements

                                                              Allows certain information to be phrased (and rendered) as a question and an answer, while keeping users from changing it. May also be useful for preventing changes to pre-populated portions of a questionnaire, for calculated values, etc.

                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              284. Questionnaire.item.maxLength
                                                              Definition

                                                              The maximum number of characters that are permitted in the answer to be considered a "valid" QuestionnaireResponse.

                                                              ShortNo more than these many characters
                                                              Comments

                                                              For base64binary, reflects the number of characters representing the encoded data, not the number of bytes of the binary data. The value may come from the ElementDefinition referred to by .definition.

                                                              Control0..1
                                                              This element is affected by the following invariants: que-10
                                                              Typeinteger
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              286. Questionnaire.item.answerConstraint
                                                              Definition

                                                              For items that have a defined set of allowed answers (via answerOption or answerValueSet), indicates whether values other than those specified can be selected.

                                                              ShortoptionsOnly | optionsOrType | optionsOrString
                                                              Control0..1
                                                              This element is affected by the following invariants: que-10, que-14
                                                              BindingThe codes SHALL be taken from QuestionnaireAnswerConstraint
                                                              (required to http://hl7.org/fhir/ValueSet/questionnaire-answer-constraint|5.0.0)

                                                              Indicates differnt modes for restricting values when options or valueset are specified

                                                              Typecode
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Requirements

                                                              Introduces the ability for questions to have 'other' answers

                                                              Meaning if MissingIf not specified, answerConstraint is presumed to be 'optionsOnly'
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              288. Questionnaire.item.answerValueSet
                                                              Definition

                                                              A reference to a value set containing a list of values representing permitted answers for a question.

                                                              ShortValueSet containing permitted answers
                                                              Comments

                                                              LOINC defines many useful value sets for questionnaire responses. See LOINC Answer Lists. The value may come from the ElementDefinition referred to by .definition.

                                                              Control0..1
                                                              This element is affected by the following invariants: que-5, que-4, que-14
                                                              Typecanonical(ValueSet)
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              290. Questionnaire.item.answerOption
                                                              Definition

                                                              One of the permitted answers for the question.

                                                              ShortPermitted answer
                                                              Comments

                                                              This element can be used when the value set machinery of answerValueSet is deemed too cumbersome or when there's a need to capture possible answers that are not codes.

                                                              Control0..*
                                                              This element is affected by the following invariants: que-5, que-4, que-11, que-14
                                                              TypeBackboneElement
                                                              Is Modifierfalse
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              292. Questionnaire.item.answerOption.id
                                                              Definition

                                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                              ShortUnique id for inter-element referencing
                                                              Control0..1
                                                              This element is affected by the following invariants: ele-1
                                                              Typestring
                                                              Is Modifierfalse
                                                              XML FormatIn the XML format, this property is represented as an attribute.
                                                              Summaryfalse
                                                              294. Questionnaire.item.answerOption.extension
                                                              Definition

                                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                              ShortAdditional content defined by implementations
                                                              Comments

                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                              Control0..*
                                                              TypeExtension
                                                              Is Modifierfalse
                                                              Summaryfalse
                                                              Alternate Namesextensions, user content
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                              296. Questionnaire.item.answerOption.modifierExtension
                                                              Definition

                                                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                              ShortExtensions that cannot be ignored even if unrecognized
                                                              Comments

                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                              Control0..*
                                                              TypeExtension
                                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                              Summarytrue
                                                              Requirements

                                                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                              Alternate Namesextensions, user content, modifiers
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                              298. Questionnaire.item.answerOption.value[x]
                                                              Definition

                                                              A potential answer that's allowed as the answer to this question.

                                                              ShortAnswer value
                                                              Comments

                                                              The data type of the value must agree with the item.type.

                                                              Control1..1
                                                              BindingFor example codes, see QuestionnaireAnswerCodes
                                                              (example to http://hl7.org/fhir/ValueSet/questionnaire-answers|5.0.0)

                                                              Allowed values to answer questions.

                                                              TypeChoice of: integer, date, time, string, Coding, Reference(Resource)
                                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              300. Questionnaire.item.answerOption.initialSelected
                                                              Definition

                                                              Indicates whether the answer value is selected when the list of possible answers is initially shown.

                                                              ShortWhether option is selected by default
                                                              Control0..1
                                                              Typeboolean
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Meaning if MissingOnly selected items explicitly marked to be selected
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              302. Questionnaire.item.initial
                                                              Definition

                                                              One or more values that should be pre-populated in the answer when initially rendering the questionnaire for user input.

                                                              ShortInitial value(s) when item is first rendered
                                                              Comments

                                                              The user is allowed to change the value and override the default (unless marked as read-only). If the user doesn't change the value, then this initial value will be persisted when the QuestionnaireResponse is initially created. Note that initial values can influence results. The data type of initial.answer[x] must agree with the item.type, and only repeating items can have more then one initial value.

                                                              Control0..*
                                                              This element is affected by the following invariants: que-8, que-13, que-11
                                                              TypeBackboneElement
                                                              Is Modifierfalse
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Requirements

                                                              In some workflows, having defaults saves time.

                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              304. Questionnaire.item.initial.id
                                                              Definition

                                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                              ShortUnique id for inter-element referencing
                                                              Control0..1
                                                              This element is affected by the following invariants: ele-1
                                                              Typestring
                                                              Is Modifierfalse
                                                              XML FormatIn the XML format, this property is represented as an attribute.
                                                              Summaryfalse
                                                              306. Questionnaire.item.initial.extension
                                                              Definition

                                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                              ShortAdditional content defined by implementations
                                                              Comments

                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                              Control0..*
                                                              TypeExtension
                                                              Is Modifierfalse
                                                              Summaryfalse
                                                              Alternate Namesextensions, user content
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                              308. Questionnaire.item.initial.modifierExtension
                                                              Definition

                                                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                              ShortExtensions that cannot be ignored even if unrecognized
                                                              Comments

                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                              Control0..*
                                                              TypeExtension
                                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                              Summarytrue
                                                              Requirements

                                                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                              Alternate Namesextensions, user content, modifiers
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                              310. Questionnaire.item.initial.value[x]
                                                              Definition

                                                              The actual value to for an initial answer.

                                                              ShortActual value for initializing the question
                                                              Comments

                                                              The type of the initial value must be consistent with the type of the item.

                                                              Control1..1
                                                              BindingFor example codes, see QuestionnaireAnswerCodes
                                                              (example to http://hl7.org/fhir/ValueSet/questionnaire-answers|5.0.0)

                                                              Allowed values to answer questions.

                                                              TypeChoice of: boolean, decimal, integer, date, dateTime, time, string, uri, Attachment, Coding, Quantity, Reference(Resource)
                                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              312. Questionnaire.item.item
                                                              Definition

                                                              Text, questions and other groups to be nested beneath a question or group.

                                                              ShortNested questionnaire items
                                                              Comments

                                                              There is no specified limit to the depth of nesting. However, Questionnaire authors are encouraged to consider the impact on the user and user interface of overly deep nesting.

                                                              Control0..*
                                                              TypeSeettp://hl7.org/fhir/StructureDefinition/Questionnaire#Questionnaire.item
                                                              Is Modifierfalse
                                                              Must Supportfalse
                                                              Summaryfalse
                                                              Requirements

                                                              Reports can consist of complex nested groups.

                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))