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.

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.

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 interaction.

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

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.

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 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).

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.

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.

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.

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.

The purpose of this identifier.

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

Identifies the purpose for this identifier, if known .

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

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.

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

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

A reference to a code defined by a terminology system.

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.

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

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.

The purpose of this identifier.

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

Identifies the purpose for this identifier, if known .

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

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.

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

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

A reference to a code defined by a terminology system.

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.

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

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.

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.

The lifecycle status of an artifact.

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

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.

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.

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.

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

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

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

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

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

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.

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

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

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.

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).

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.

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.

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

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.

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

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.

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.

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.

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.

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.

An Extension

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.

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

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.

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

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

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.

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).

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.

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.

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.

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.

Allowed values to answer questions.

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.

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

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

Introduces the ability for questions to have 'other' answers

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. 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.

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).

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.

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.

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

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

Allowed values to answer questions.

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.

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).

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.

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.

The actual value to for an initial answer.

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

Allowed values to answer questions.

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.

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

The regulatory agency (e.g., EMA, national competent authority) responsible for issuing Questionnaire.

Official identifier of the issuing competent authority.

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

Complete official address of the regulatory authority that issued the Questionnaire.

Complete address of the competent authority as a single human-readable string (for display and verification purposes).

Street address (including building, floor, department, P.O. Box, etc.) of the regulatory authority.

City or municipality where the regulatory authority is located.

District or borough within the city (if applicable).

State, province, canton or equivalent administrative region of the regulatory authority (required when applicable, e.g., for national agencies in federal countries).

Postal or ZIP code of the regulatory authority’s address.

ISO 3166-1 alpha-2 country code of the country in which the regulatory authority is established (e.g., 'NL' for Netherlands, 'GB' for United Kingdom).

Designated contact person or role within the regulatory authority responsible for this Questionnaire and for receiving the completed response.

Official email for the designated regulatory contact

Telephone number for the responsible regulatory contact.

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.

The legal entity (MAH or applicant) to whom the Questionnaire is addressed.

Official identifier of the receiving organisation as registered in an authoritative system.

Full legal name of the marketing authorisation holder or applicant.

Complete official registered address of the MAH or sponsor organisation to whom the Questionnaire is addressed.

Complete address of the marketing authorisation holder or sponsor as a single formatted string for display, verification, and correspondence purposes.

One or more lines containing the street address, building name/number, floor, department, P.O. Box, etc., of the marketing authorisation holder or sponsor as registered in OMS or equivalent authoritative source.

City or municipality in which the marketing authorisation holder or sponsor is legally registered.

District, borough or sub-division of the city in which the MAH/sponsor is located (used when relevant, e.g., in large metropolitan areas).

State, province, canton, or equivalent administrative region of the MAH/sponsor’s registered address (required when the country has such subdivisions).

Postal code or ZIP code of the marketing authorisation holder or sponsor’s registered address.

ISO 3166-1 alpha-2 country code of the country in which the marketing authorisation holder or sponsor is legally established (e.g., 'DE' for Germany, 'US' for United States).

Individual or role within the MAH/applicant responsible for completing and returning the response.

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

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

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.

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

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.

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.

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.

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

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.

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 interaction.

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.

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.

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

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).

IETF language tag for a human language

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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

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.

The purpose of this identifier.

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

Identifies the purpose for this identifier, if known .

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

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.

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

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

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

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.

A reference to a code defined by a terminology system.

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.

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

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.

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

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.

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). 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.

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

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.

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.

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

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.

The purpose of this identifier.

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

Identifies the purpose for this identifier, if known .

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

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.

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

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

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

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.

A reference to a code defined by a terminology system.

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.

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

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.

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

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.

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). 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.

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

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.

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.

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.

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.

Supports code generation.

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.

Allows a Questionnaire to be created based on another Questionnaire.

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.

The lifecycle status of an artifact.

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

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.

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.

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.

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.

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.

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

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

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

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

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

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

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.

The name of an individual to contact.

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