Release 5
AdministrationThis page is part of the FHIR Specification (v5.0.0: R5 - STU). This is a downloaded copy of the specification. For a full list of available versions, see the Directory of published versions 
. Page versions: R5 R4B R4 R3
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: No defined compartments |
Raw XML (canonical form + also see XML Format Specification)
Generated Questionnaire for ResearchStudy
<?xml version="1.0" encoding="UTF-8"?>
<Questionnaire xmlns="http://hl7.org/fhir">
<id value="qgen-ResearchStudy1"/>
<url value="http://hl7.org/fhir/Questionnaire/qgen-ResearchStudy1"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
</identifier>
<version value="5.0.0"/>
<status value="draft"/>
<experimental value="false"/>
<date value="2023-03-26T15:21:02+11:00"/>
<publisher value="Health Level Seven International (Biomedical Research and Regulation)"/>
<item>
<linkId value="ResearchStudy"/>
<text value="Investigation to increase healthcare-related patient-independent knowledge"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<linkId value="ResearchStudy-display"/>
<text value="Need to make sure we encompass public health studies."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy-flyover"/>
<text value="A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.id"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.id-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.id.value"/>
<text value="Logical id of this artifact"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<linkId value="ResearchStudy.meta"/>
<text value="Metadata about the resource"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.meta-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="uri"/>
</extension>
<linkId value="ResearchStudy.implicitRules"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.implicitRules-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.implicitRules.value"/>
<text value="A set of rules under which this content was created"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="code"/>
</extension>
<linkId value="ResearchStudy.language"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.language-flyover"/>
<text value="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)."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.language.value"/>
<text value="language"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOrType"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<linkId value="ResearchStudy.text"/>
<text value="Text summary of the resource, for human interpretation"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.text-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.contained"/>
<text value="Contained, inline Resources"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.contained-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.extension"/>
<text value="Additional content defined by implementations"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.extension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.modifierExtension"/>
<text value="Extensions that cannot be ignored"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.modifierExtension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="uri"/>
</extension>
<linkId value="ResearchStudy.url"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.url-flyover"/>
<text value="Canonical identifier for this study resource, represented as a globally unique URI."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.url.value"/>
<text value="Canonical identifier for this study resource"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Identifier"/>
</extension>
<linkId value="ResearchStudy.identifier"/>
<text value="Business Identifier for study"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.identifier-flyover"/>
<text value="Identifiers assigned to this research study by the sponsor or other systems."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.identifier.label"/>
<text value="label:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
<item>
<linkId value="ResearchStudy.identifier.system"/>
<text value="system:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
<item>
<linkId value="ResearchStudy.identifier.value"/>
<text value="value:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.version"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.version-flyover"/>
<text value="The business version for the study record."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.version.value"/>
<text value="The business version for the study record"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.name"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.name-flyover"/>
<text value="Name for this study (computer friendly)."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.name.value"/>
<text value="Name for this study (computer friendly)"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.title"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.title-flyover"/>
<text value="The human readable name of the research study."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.title.value"/>
<text value="Human readable name of the study"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.label"/>
<text value="Additional names for the study"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.label-flyover"/>
<text value="Additional names for the study."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.label.id"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.label.id-flyover"/>
<text value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.label.id.value"/>
<text value="Unique id for inter-element referencing"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.label.extension"/>
<text value="Additional content defined by implementations"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.label.extension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.label.modifierExtension"/>
<text value="Extensions that cannot be ignored even if unrecognized"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.label.modifierExtension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.label.type"/>
<text value="primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.label.type-flyover"/>
<text value="Kind of name."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.label.type.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.label.type.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.label.value"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.label.value-flyover"/>
<text value="The name."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.label.value.value"/>
<text value="The name"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Reference"/>
</extension>
<linkId value="ResearchStudy.protocol"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.protocol-flyover"/>
<text value="The set of steps expected to be performed as part of the execution of the study."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceResource">
<valueCode value="PlanDefinition"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter">
<valueString value="subject=$subj&patient=$subj&encounter=$encounter"/>
</extension>
<linkId value="ResearchStudy.protocol.value"/>
<text value="Steps followed in executing study"/>
<type value="reference"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Reference"/>
</extension>
<linkId value="ResearchStudy.partOf"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.partOf-flyover"/>
<text value="A larger research study of which this particular study is a component or step."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceResource">
<valueCode value="ResearchStudy"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter">
<valueString value="subject=$subj&patient=$subj&encounter=$encounter"/>
</extension>
<linkId value="ResearchStudy.partOf.value"/>
<text value="Part of larger study"/>
<type value="reference"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.relatedArtifact"/>
<text value="References, URLs, and attachments"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.relatedArtifact-flyover"/>
<text value="Citations, references, URLs and other related documents. When using relatedArtifact to share URLs, the relatedArtifact.type will often be set to one of "documentation" or "supported-with" and the URL value will often be in relatedArtifact.document.url but another possible location is relatedArtifact.resource when it is a canonical URL."/>
<type value="display"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="datetime"/>
</extension>
<linkId value="ResearchStudy.date"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.date-flyover"/>
<text value="The date (and optionally time) when the ResearchStudy Resource 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 ResearchStudy Resource changes."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.date.value"/>
<text value="Date the resource last changed"/>
<type value="dateTime"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-minOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="code"/>
</extension>
<linkId value="ResearchStudy.status"/>
<type value="group"/>
<required value="true"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.status-flyover"/>
<text value="The publication state of the resource (not of the study)."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.status.value"/>
<text value="status"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOrType"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.primaryPurposeType"/>
<text value="treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.primaryPurposeType-flyover"/>
<text value="The type of study based upon the intent of the study activities. A classification of the intent of the study."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.primaryPurposeType.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.primaryPurposeType.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.phase"/>
<text value="n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.phase-flyover"/>
<text value="The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.phase.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.phase.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.studyDesign"/>
<text value="Classifications of the study design characteristics"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.studyDesign-flyover"/>
<text value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.studyDesign.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.studyDesign.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.focus"/>
<text value="Drugs, devices, etc. under study"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.focus-flyover"/>
<text value="The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about."/>
<type value="display"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.condition"/>
<text value="Condition being studied"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.condition-flyover"/>
<text value="The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.condition.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.condition.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.keyword"/>
<text value="Used to search for the study"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.keyword-flyover"/>
<text value="Key terms to aid in searching for or filtering the study."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.keyword.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.keyword.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.region"/>
<text value="Geographic area for the study"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.region-flyover"/>
<text value="A country, state or other area where the study is taking place rather than its precise geographic location or address."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.region.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.region.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.descriptionSummary"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.descriptionSummary-flyover"/>
<text value="A brief text for explaining the study."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.descriptionSummary.value"/>
<text value="Brief text explaining the study"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.description"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.description-flyover"/>
<text value="A detailed and human-readable narrative of the study. E.g., study abstract."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.description.value"/>
<text value="Detailed narrative of the study"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Period"/>
</extension>
<linkId value="ResearchStudy.period"/>
<text value="When the study began and ended"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.period-flyover"/>
<text value="Identifies the start date and the expected (or actual, depending on status) end date for the study."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.period.low"/>
<text value="start:"/>
<type value="dateTime"/>
<required value="false"/>
<repeats value="false"/>
</item>
<item>
<linkId value="ResearchStudy.period.end"/>
<text value="end:"/>
<type value="dateTime"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Reference"/>
</extension>
<linkId value="ResearchStudy.site"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.site-flyover"/>
<text value="A facility in which study activities are conducted."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceResource">
<valueCode value="Location, ResearchStudy, Organization"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter">
<valueString value="subject=$subj&patient=$subj&encounter=$encounter"/>
</extension>
<linkId value="ResearchStudy.site.value"/>
<text value="Facility where study activities are conducted"/>
<type value="reference"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Annotation"/>
</extension>
<linkId value="ResearchStudy.note"/>
<text value="Comments made about the study"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.note-flyover"/>
<text value="Comments made about the study by the performer, subject or other participants."/>
<type value="display"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.classifier"/>
<text value="Classification for the study"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.classifier-flyover"/>
<text value="Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.classifier.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.classifier.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.associatedParty"/>
<text value="Sponsors, collaborators, and other parties"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<linkId value="ResearchStudy.associatedParty-display"/>
<text value="For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.associatedParty-flyover"/>
<text value="Sponsors, collaborators, and other parties."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.associatedParty.id"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.associatedParty.id-flyover"/>
<text value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.associatedParty.id.value"/>
<text value="Unique id for inter-element referencing"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.associatedParty.extension"/>
<text value="Additional content defined by implementations"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.associatedParty.extension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.associatedParty.modifierExtension"/>
<text value="Extensions that cannot be ignored even if unrecognized"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.associatedParty.modifierExtension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.associatedParty.name"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.associatedParty.name-flyover"/>
<text value="Name of associated party."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.associatedParty.name.value"/>
<text value="Name of associated party"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-minOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.associatedParty.role"/>
<text value="sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair"/>
<type value="group"/>
<required value="true"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.associatedParty.role-flyover"/>
<text value="Type of association."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.associatedParty.role.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.associatedParty.role.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Period"/>
</extension>
<linkId value="ResearchStudy.associatedParty.period"/>
<text value="When active in the role"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.associatedParty.period-flyover"/>
<text value="Identifies the start date and the end date of the associated party in the role. The cardinality is 0..* due to the fact that an associated party may be intermittently active in a given role over multiple time periods."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.associatedParty.period.low"/>
<text value="start:"/>
<type value="dateTime"/>
<required value="false"/>
<repeats value="false"/>
</item>
<item>
<linkId value="ResearchStudy.associatedParty.period.end"/>
<text value="end:"/>
<type value="dateTime"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.associatedParty.classifier"/>
<text value="nih | fda | government | nonprofit | academic | industry"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.associatedParty.classifier-flyover"/>
<text value="A categorization other than role for the associated party."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.associatedParty.classifier.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.associatedParty.classifier.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Reference"/>
</extension>
<linkId value="ResearchStudy.associatedParty.party"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.associatedParty.party-flyover"/>
<text value="Individual or organization associated with study (use practitionerRole to specify their organisation). Suggestions of a better attribute name are appreciated"/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceResource">
<valueCode value="Practitioner, PractitionerRole, Organization"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter">
<valueString value="subject=$subj&patient=$subj&encounter=$encounter"/>
</extension>
<linkId value="ResearchStudy.associatedParty.party.value"/>
<text value="Individual or organization associated with study (use practitionerRole to specify their organisation)"/>
<type value="reference"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
</item>
<item>
<linkId value="ResearchStudy.progressStatus"/>
<text value="Status of study with time for that status"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.progressStatus-flyover"/>
<text value="Status of study with time for that status."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.progressStatus.id"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.progressStatus.id-flyover"/>
<text value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.progressStatus.id.value"/>
<text value="Unique id for inter-element referencing"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.progressStatus.extension"/>
<text value="Additional content defined by implementations"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.progressStatus.extension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.progressStatus.modifierExtension"/>
<text value="Extensions that cannot be ignored even if unrecognized"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.progressStatus.modifierExtension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-minOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.progressStatus.state"/>
<text value="Label for status or state (e.g. recruitment status)"/>
<type value="group"/>
<required value="true"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.progressStatus.state-flyover"/>
<text value="Label for status or state (e.g. recruitment status)."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.progressStatus.state.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.progressStatus.state.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="boolean"/>
</extension>
<linkId value="ResearchStudy.progressStatus.actual"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.progressStatus.actual-flyover"/>
<text value="An indication of whether or not the date is a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated date."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.progressStatus.actual.value"/>
<text value="Actual if true else anticipated"/>
<type value="boolean"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Period"/>
</extension>
<linkId value="ResearchStudy.progressStatus.period"/>
<text value="Date range"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.progressStatus.period-flyover"/>
<text value="Date range."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.progressStatus.period.low"/>
<text value="start:"/>
<type value="dateTime"/>
<required value="false"/>
<repeats value="false"/>
</item>
<item>
<linkId value="ResearchStudy.progressStatus.period.end"/>
<text value="end:"/>
<type value="dateTime"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.whyStopped"/>
<text value="accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.whyStopped-flyover"/>
<text value="A description and/or code explaining the premature termination of the study."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.whyStopped.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.whyStopped.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<linkId value="ResearchStudy.recruitment"/>
<text value="Target or actual group of participants enrolled in study"/>
<type value="group"/>
<required value="false"/>
<repeats value="false"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.recruitment-flyover"/>
<text value="Target or actual group of participants enrolled in study."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.recruitment.id"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.recruitment.id-flyover"/>
<text value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.recruitment.id.value"/>
<text value="Unique id for inter-element referencing"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.recruitment.extension"/>
<text value="Additional content defined by implementations"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.recruitment.extension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.recruitment.modifierExtension"/>
<text value="Extensions that cannot be ignored even if unrecognized"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.recruitment.modifierExtension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="integer"/>
</extension>
<linkId value="ResearchStudy.recruitment.targetNumber"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.recruitment.targetNumber-flyover"/>
<text value="Estimated total number of participants to be enrolled."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.recruitment.targetNumber.value"/>
<text value="Estimated total number of participants to be enrolled"/>
<type value="integer"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="integer"/>
</extension>
<linkId value="ResearchStudy.recruitment.actualNumber"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.recruitment.actualNumber-flyover"/>
<text value="Actual total number of participants enrolled in study."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.recruitment.actualNumber.value"/>
<text value="Actual total number of participants enrolled in study"/>
<type value="integer"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Reference"/>
</extension>
<linkId value="ResearchStudy.recruitment.eligibility"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.recruitment.eligibility-flyover"/>
<text value="Inclusion and exclusion criteria."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceResource">
<valueCode value="Group, EvidenceVariable"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter">
<valueString value="subject=$subj&patient=$subj&encounter=$encounter"/>
</extension>
<linkId value="ResearchStudy.recruitment.eligibility.value"/>
<text value="Inclusion and exclusion criteria"/>
<type value="reference"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Reference"/>
</extension>
<linkId value="ResearchStudy.recruitment.actualGroup"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.recruitment.actualGroup-flyover"/>
<text value="Group of participants who were enrolled in study."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceResource">
<valueCode value="Group"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter">
<valueString value="subject=$subj&patient=$subj&encounter=$encounter"/>
</extension>
<linkId value="ResearchStudy.recruitment.actualGroup.value"/>
<text value="Group of participants who were enrolled in study"/>
<type value="reference"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
</item>
<item>
<linkId value="ResearchStudy.comparisonGroup"/>
<text value="Defined path through the study for a subject"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<linkId value="ResearchStudy.comparisonGroup-display"/>
<text value="In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.comparisonGroup-flyover"/>
<text value="Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.comparisonGroup.id"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.comparisonGroup.id-flyover"/>
<text value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.comparisonGroup.id.value"/>
<text value="Unique id for inter-element referencing"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.comparisonGroup.extension"/>
<text value="Additional content defined by implementations"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.comparisonGroup.extension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.comparisonGroup.modifierExtension"/>
<text value="Extensions that cannot be ignored even if unrecognized"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.comparisonGroup.modifierExtension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.comparisonGroup.linkId"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.comparisonGroup.linkId-flyover"/>
<text value="Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.comparisonGroup.linkId.value"/>
<text value="Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-minOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.comparisonGroup.name"/>
<type value="group"/>
<required value="true"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.comparisonGroup.name-flyover"/>
<text value="Unique, human-readable label for this comparisonGroup of the study."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.comparisonGroup.name.value"/>
<text value="Label for study comparisonGroup"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.comparisonGroup.type"/>
<text value="Categorization of study comparisonGroup"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.comparisonGroup.type-flyover"/>
<text value="Categorization of study comparisonGroup, e.g. experimental, active comparator, placebo comparater."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.comparisonGroup.type.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.comparisonGroup.type.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.comparisonGroup.description"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.comparisonGroup.description-flyover"/>
<text value="A succinct description of the path through the study that would be followed by a subject adhering to this comparisonGroup."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.comparisonGroup.description.value"/>
<text value="Short explanation of study path"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Reference"/>
</extension>
<linkId value="ResearchStudy.comparisonGroup.intendedExposure"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.comparisonGroup.intendedExposure-flyover"/>
<text value="Interventions or exposures in this comparisonGroup or cohort."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceResource">
<valueCode value="EvidenceVariable"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter">
<valueString value="subject=$subj&patient=$subj&encounter=$encounter"/>
</extension>
<linkId value="ResearchStudy.comparisonGroup.intendedExposure.value"/>
<text value="Interventions or exposures in this comparisonGroup or cohort"/>
<type value="reference"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Reference"/>
</extension>
<linkId value="ResearchStudy.comparisonGroup.observedGroup"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.comparisonGroup.observedGroup-flyover"/>
<text value="Group of participants who were enrolled in study comparisonGroup."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceResource">
<valueCode value="Group"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter">
<valueString value="subject=$subj&patient=$subj&encounter=$encounter"/>
</extension>
<linkId value="ResearchStudy.comparisonGroup.observedGroup.value"/>
<text value="Group of participants who were enrolled in study comparisonGroup"/>
<type value="reference"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
</item>
<item>
<linkId value="ResearchStudy.objective"/>
<text value="A goal for the study"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.objective-flyover"/>
<text value="A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.objective.id"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.objective.id-flyover"/>
<text value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.objective.id.value"/>
<text value="Unique id for inter-element referencing"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.objective.extension"/>
<text value="Additional content defined by implementations"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.objective.extension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.objective.modifierExtension"/>
<text value="Extensions that cannot be ignored even if unrecognized"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.objective.modifierExtension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.objective.name"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.objective.name-flyover"/>
<text value="Unique, human-readable label for this objective of the study."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.objective.name.value"/>
<text value="Label for the objective"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.objective.type"/>
<text value="primary | secondary | exploratory"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.objective.type-flyover"/>
<text value="The kind of study objective."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.objective.type.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.objective.type.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.objective.description"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.objective.description-flyover"/>
<text value="Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description)."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.objective.description.value"/>
<text value="Description of the objective"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
</item>
<item>
<linkId value="ResearchStudy.outcomeMeasure"/>
<text value="A variable measured during the study"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<linkId value="ResearchStudy.outcomeMeasure-display"/>
<text value="A study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP"/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.outcomeMeasure-flyover"/>
<text value="An "outcome measure", "endpoint", "effect measure" or "measure of effect" is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.outcomeMeasure.id"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.outcomeMeasure.id-flyover"/>
<text value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.outcomeMeasure.id.value"/>
<text value="Unique id for inter-element referencing"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.outcomeMeasure.extension"/>
<text value="Additional content defined by implementations"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.outcomeMeasure.extension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<linkId value="ResearchStudy.outcomeMeasure.modifierExtension"/>
<text value="Extensions that cannot be ignored even if unrecognized"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.outcomeMeasure.modifierExtension-flyover"/>
<text value="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."/>
<type value="display"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.outcomeMeasure.name"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.outcomeMeasure.name-flyover"/>
<text value="Label for the outcome."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.outcomeMeasure.name.value"/>
<text value="Label for the outcome"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="CodeableConcept"/>
</extension>
<linkId value="ResearchStudy.outcomeMeasure.type"/>
<text value="primary | secondary | exploratory"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.outcomeMeasure.type-flyover"/>
<text value="The parameter or characteristic being assessed as one of the values by which the study is assessed."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.outcomeMeasure.type.coding"/>
<text value="code:"/>
<type value="coding"/>
<required value="false"/>
<repeats value="false"/>
<answerConstraint value="optionsOnly"/>
</item>
<item>
<linkId value="ResearchStudy.outcomeMeasure.type.text"/>
<text value="text:"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="string"/>
</extension>
<linkId value="ResearchStudy.outcomeMeasure.description"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.outcomeMeasure.description-flyover"/>
<text value="Description of the outcome."/>
<type value="display"/>
</item>
<item>
<linkId value="ResearchStudy.outcomeMeasure.description.value"/>
<text value="Description of the outcome"/>
<type value="string"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-maxOccurs">
<valueInteger value="1"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Reference"/>
</extension>
<linkId value="ResearchStudy.outcomeMeasure.reference"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.outcomeMeasure.reference-flyover"/>
<text value="Structured outcome definition."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceResource">
<valueCode value="EvidenceVariable"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter">
<valueString value="subject=$subj&patient=$subj&encounter=$encounter"/>
</extension>
<linkId value="ResearchStudy.outcomeMeasure.reference.value"/>
<text value="Structured outcome definition"/>
<type value="reference"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType">
<valueString value="Reference"/>
</extension>
<linkId value="ResearchStudy.result"/>
<type value="group"/>
<required value="false"/>
<repeats value="true"/>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/questionnaire-item-control"/>
<code value="flyover"/>
<display value="Fly-over"/>
</coding>
</valueCodeableConcept>
</extension>
<linkId value="ResearchStudy.result-flyover"/>
<text value="Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov."/>
<type value="display"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceResource">
<valueCode value="EvidenceReport, Citation, DiagnosticReport"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter">
<valueString value="subject=$subj&patient=$subj&encounter=$encounter"/>
</extension>
<linkId value="ResearchStudy.result.value"/>
<text value="Link to results generated during the study"/>
<type value="reference"/>
<required value="false"/>
<repeats value="false"/>
</item>
</item>
</item>
</Questionnaire>
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R5 hl7.fhir.core#5.0.0 generated on Sun, Mar 26, 2023 15:25+1100.
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