Generated Narrative: StructureDefinition RegulatoryQuestionnaire Name Flags Card. Type Description & Constraints Questionnaire 0..* Questionnaire Regulatory Q&A Questionnaire #xD; meta #xD; profile 1..* canonical(StructureDefinition) Profiles this resource claims to conform to Fixed Value: http://hl7.org/fhir/uv/src-ig/StructureDefinition/RegulatoryQuestionnaire #xD; identifier 2..* Identifier Business identifier for questionnaire #xD; system 1..1 uri The namespace for the identifier value #xD; value 1..1 string The value that is unique #xD; version 1..1 string Business version of the questionnaire #xD; status 1..1 code draft | active | retired | unknown Fixed Value: active #xD; subjectType 1..* code Resource that can be subject of QuestionnaireResponse Fixed Value: MedicinalProductDefinition #xD; date 1..1 dateTime Date last changed #xD; contact 1..1 ContactDetail Contact details for the publisher #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:contact-signature 0..1 ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/src-ig/StructureDefinition/contact-signature]] Extension URL: http://hl7.org/fhir/uv/src-ig/StructureDefinition/contact-signature #xD; effectivePeriod 1..1 Period When the questionnaire is expected to be used #xD; item 1..* BackboneElement Questions and sections within the Questionnaire #xD; linkId 1..1 string Unique id for item in questionnaire #xD; code 3..3 Coding Corresponding concept for this item in a terminology Binding: http://hl7.org/fhir/uv/src-ig/ValueSet/ctd-categories-full (required) #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full #xD; text 1..1 string Primary text for the item #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:richText 1..1 ?gen-e1? [CanonicalType[http://hl7.org/fhir/uv/src-ig/StructureDefinition/questionnaire-itemRichText]] Extension URL: http://hl7.org/fhir/uv/src-ig/StructureDefinition/questionnaire-itemRichText #xD; type 1..1 code group | display | boolean | decimal | integer | date | dateTime + Fixed Value: string #xD; Documentation for this format
Regulatory Questionnaire (LOQ / LOI / RFI)
Gravitate Health and HL7 Biomedical Research & Regulation (BR&R)
A Questionnaire used by a health authority to issue a List of Questions (LOQ), List of Issues (LOI), or Request for Information (RFI) to a Market Authorization Holder. Supports rich-text questions, hierarchical CTD coding, and full contact signature.
Structured regulatory correspondence from a health authority.
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}$')
The link ids for groups and questions must be unique within the questionnaire
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
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.
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.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
Additional content defined by implementations
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.
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.
Must have either extensions or value[x], not both
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.
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.
When the resource last changed - e.g. when the version changed.
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](http://hl7.org/fhir/R5/http.html#read) interaction.
Identifies where the resource comes from
A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](http://hl7.org/fhir/R5/provenance.html#) 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.
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.
Profiles this resource claims to conform to
A list of profiles (references to [StructureDefinition](http://hl7.org/fhir/R5/structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](http://hl7.org/fhir/R5/structuredefinition-definitions.html#StructureDefinition.url).
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.
Security Labels applied to this resource
Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.
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.
Security Labels from the Healthcare Privacy and Security Classification System.
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.
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.
Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
A set of rules under which this content was created
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.
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.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
The base language in which the resource is written.
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).
Text summary of the resource, for human interpretation
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.
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.
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.
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.
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.
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).
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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Canonical identifier for this questionnaire, represented as an absolute URI (globally unique)
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.
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](http://hl7.org/fhir/R5/resource.html#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](http://hl7.org/fhir/R5/resource.html#meta) 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.
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.
URL should not contain | or # - these characters make processing canonical references problematic
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.
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.
Allows externally provided and/or usable business identifiers to be easily associated with the questionnaire.
usual | official | temp | secondary | old (If known)
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Identifies the purpose for this identifier, if known .
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
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.
Allows users to make use of identifiers when the identifier system is not known.
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Identifier.system is always case sensitive.
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.
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
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](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). 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.
II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
Time period when id is/was valid for use
Time period during which identifier is/was valid for use.
Role.effectiveTime or implied by context
Organization that issued id (may be just text)
Organization that issued/manages the identifier.
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.
II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
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.
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](http://hl7.org/fhir/R5/resource.html#bv-format).
Indicates the mechanism used to compare versions to determine which is more current.
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.
Name for this questionnaire (computer friendly)
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.
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.
Name for this questionnaire (human friendly)
A short, descriptive, user-friendly title for the questionnaire.
This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc.
The URL of a Questionnaire that this Questionnaire is based on.
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](http://hl7.org/fhir/extensions/StructureDefinition-questionnaire-derivationType.html).
Allows a Questionnaire to be created based on another Questionnaire.
.outboundRelationship[typeCode=DRIV].target[classCode=OBS, moodCode=DEFN]
The current state of this questionnaire.
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](http://hl7.org/fhir/R5/canonicalresource.html#localization).
Enables tracking the lifecycle of the content and filtering of questionnaires that are appropriate for use versus not.
This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
A Boolean value to indicate that this questionnaire is authored for testing purposes (or education/evaluation/marketing) and is not intended for genuine usage.
Allows filtering of questionnaires that are appropriate for use versus not.
Enables experimental content to be developed following the same lifecycle that would be used for a production-level questionnaire.
If absent, this resource is treated as though it is not experimental.
Resource that can be subject of QuestionnaireResponse
The types of subjects that can be the subject of responses created for the questionnaire.
If none are specified, then the subject is unlimited.
Allows enforcing that a QuestionnaireResponse only has a .subject element of the appropriate type.
One of the resource types defined as part of this version of FHIR.
.outboundRelationship[typeCode=META].target[classCode=OBS, moodCode=DEFN, isCriterion=true].participation.role.classCode
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.
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](http://hl7.org/fhir/R5/canonicalresource.html#localization).
Name of the publisher/steward (organization or individual)
The name of the organization or individual responsible for the release and ongoing maintenance of the questionnaire.
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.
Helps establish the "authority/credibility" of the questionnaire. May also allow for contact.
Contact details to assist a user in finding and communicating with the publisher.
May be a web site, an email address, a telephone number, etc. See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization).
If there is no named individual, the telecom information is for the organization as a whole.
Contact details for individual or organization
The contact details for the individual (if a name was provided) or the organization.
Natural language description of the questionnaire
A free text natural language description of the questionnaire from a consumer's perspective.
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).
The context that the content is intended to support
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.
When multiple useContexts are specified, there is no expectation that all or even any of the contexts apply.
Assist in searching for appropriate content.
Intended jurisdiction for questionnaire (if applicable)
A legal or geographic region in which the questionnaire is intended to be used.
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.)
Countries and regions within which this artifact is targeted for use.
Explanation of why this questionnaire is needed and why it has been designed as it has.
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.
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.
Consumers of the questionnaire must be able to determine any legal restrictions on the use of the artifact and/or its content.
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').
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.
Defines the content expected to be rendered in all representations of the artifact.
When the questionnaire was approved by publisher
The date on which the resource content was approved by the publisher. Approval happens once when the content is officially approved for usage.
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](http://hl7.org/fhir/R5/canonicalresource.html#localization).
When the questionnaire was last reviewed by the publisher
The date on which the resource content was last reviewed. Review happens periodically after approval but does not change the original approval date.
If specified, this date follows the original approval date. See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization).
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.
.outboundRelationship[typeCode="SUBJ"; subsetCode="RECENT"].act[classCode=CACT;moodCode=EVN;code="review"].effectiveTime
When the questionnaire is expected to be used
The period during which the questionnaire content was or is planned to be in active use.
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](http://hl7.org/fhir/R5/canonicalresource.html#localization).
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.
Concept that represents the overall questionnaire
An identifier for this collection of questions in a particular terminology such as LOINC.
Allows linking of the complete Questionnaire resources to formal terminologies. It's common for "panels" of questions to be identified by a code.
Codes for questionnaires, groups and individual questions.
Questions and sections within the Questionnaire
A particular question, question grouping or display text that is part of the questionnaire.
The content of the questionnaire is constructed from an ordered, hierarchical collection of items.
Group items must have nested items when Questionanire is complete
(type='group' and %resource.status='complete') implies item.empty().not()
Display items cannot have a "code" asserted
A question cannot have both answerOption and answerValueSet
answerOption.empty() or answerValueSet.empty()
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())
Required and repeat aren't permitted for display items
type!='display' or (required.empty() and repeats.empty())
Initial values can't be specified for groups or display items
(type!='group' and type!='display') or initial.empty()
Read-only can't be specified for "display" items
Maximum length can only be declared for simple question types
(type in ('boolean' | 'decimal' | 'integer' | 'string' | 'text' | 'url')) or answerConstraint='optionOrString' or maxLength.empty()
If one or more answerOption is present, initial cannot be present. Use answerOption.initialSelected instead
If there are more than one enableWhen, enableBehavior must be specified
enableWhen.count() > 1 implies enableBehavior.exists()
Can only have multiple initial values for repeating items
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()
.outboundRelationship[typeCode=COMP].target[classCode=OBS, moodCode=DEF]
Extensions that cannot be ignored even if unrecognized
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).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
An identifier that is unique within the Questionnaire allowing linkage to the equivalent item in a QuestionnaireResponse resource.
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
[QuestionnaireResponse](http://hl7.org/fhir/R5/questionnaireresponse.html#) does not require omitted items to be included and may have some items that repeat, so linkage based on position alone is not sufficient.
Link ids should be 255 characters or less
ElementDefinition - details for the item
This element is a URI that refers to an [ElementDefinition](http://hl7.org/fhir/R5/elementdefinition.html) or to an [ObservationDefinition](http://hl7.org/fhir/R5/observationdefinition.html) 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](http://hl7.org/fhir/R5/questionnaire.html#definition), below.
The uri refers to an ElementDefinition in a [StructureDefinition](http://hl7.org/fhir/R5/structuredefinition.html#) or to an [ObservationDefinition](http://hl7.org/fhir/R5/observationdefinition.html) and always starts with the [canonical URL](http://hl7.org/fhir/R5/references.html#canonical) for the target resource. When referring to a StructureDefinition, a fragment identifier is used to specify the element definition by its id [Element.id](http://hl7.org/fhir/R5/types-definitions.html#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.
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.
.outboundRelationship[typeCode=INST].target[classCode=OBS, moodCode=DEF]
Corresponding concept for this item in a terminology
A terminology code that corresponds to this group or question (e.g. a code from LOINC, which defines many questions and answers).
The value may come from the ElementDefinition referred to by .definition.
Allows linking of groups of questions to formal terminologies.
The identification of the code system that defines the meaning of the symbol in the code.
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.
Need to be unambiguous about the source of the definition of the symbol.
fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
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.
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.
fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
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).
Need to refer to a particular code in the system.
fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
A representation of the meaning of the code in the system, following the rules of the system.
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
C*E.2 - but note this is not well followed
fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
If this coding was chosen directly by the user
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
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.
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.
fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
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.
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.
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.
The name of a section, the text of a question or text content for a display item.
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.
unique id for the element within a resource (for internal references)
group | display | boolean | decimal | integer | date | dateTime +
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.).
Additional constraints on the type of answer can be conveyed by extensions. The value may come from the ElementDefinition referred to by .definition.
Defines the format in which the user is to be prompted for the answer.
Distinguishes groups from questions and display text and indicates data type for questions.
A constraint indicating that this item should only be enabled (displayed/allow answers to be captured) when the specified condition is true.
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.
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.
If the operator is 'exists', the value must be a boolean
operator = 'exists' implies (answer is boolean)
If enableWhen is present and the condition evaluates to false, then the Questionnaire behaves as though the elements weren't actually present
The linkId of question that determines whether item is enabled/disabled
The linkId for the question whose answer (or lack of answer) governs whether this item is enabled.
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.)
Specifies the criteria by which the question is enabled.
The criteria by which a question is enabled.
Value for question comparison based on operator
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.
Controls how multiple enableWhen values are interpreted - whether all or any must be true.
This element must be specified if more than one enableWhen value is provided.
Indicates if and how items that are disabled (because enableWhen evaluates to 'false') should be displayed.
If not specified, rendering behavior is up to the client. This element is only meaningful if enableWhen or an equivalent extension is present
Defines how disabled elements should be rendered
Whether the item must be included in data results
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.
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.
Items are assumed not to be required unless explicitly specified, though extensions may impose additional expectations
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).
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.
Items may be used to create set of (related) questions that can be repeated to give multiple answers to such a set.
Items are generally assumed not to repeat unless explicitly specified. Systems SHOULD always populate this value
An indication, when true, that the value cannot be changed by a human respondent to the Questionnaire.
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.
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.
The maximum number of characters that are permitted in the answer to be considered a "valid" QuestionnaireResponse.
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.
optionsOnly | optionsOrType | optionsOrString
For items that have a defined set of allowed answers (via answerOption or answerValueSet), indicates whether values *other* than those specified can be selected.
Introduces the ability for questions to have 'other' answers
If not specified, answerConstraint is presumed to be 'optionsOnly'
Indicates differnt modes for restricting values when options or valueset are specified
A reference to a value set containing a list of values representing permitted answers for a question.
LOINC defines many useful value sets for questionnaire responses. See [LOINC Answer Lists](https://terminology.hl7.org/LOINC.html). The value may come from the ElementDefinition referred to by .definition.
One of the permitted answers for the question.
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.
A potential answer that's allowed as the answer to this question.
The data type of the value must agree with the item.type.
Indicates whether the answer value is selected when the list of possible answers is initially shown.
Only selected items explicitly marked to be selected
Initial value(s) when item is first rendered
One or more values that should be pre-populated in the answer when initially rendering the questionnaire for user input.
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.
In some workflows, having defaults saves time.
Actual value for initializing the question
The actual value to for an initial answer.
The type of the initial value must be consistent with the type of the item.
Text, questions and other groups to be nested beneath a question or group.
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.
Reports can consist of complex nested groups.