This page is part of the FHIR Specification (v3.0.2: STU 3). The current version which supercedes this version is 4.0.1. For a full list of available versions, see the Directory of published versions
Regulated Clinical Research Information Management Work Group | Maturity Level: N/A | Ballot Status: Informative | Compartments: Practitioner |
Generated Questionnaire for ResearchStudy
<?xml version="1.0" encoding="UTF-8"?> <Questionnaire xmlns="http://hl7.org/fhir"> <id value="qs1"/> <identifier> <system value="urn:ietf:rfc:3986"/> </identifier> <status value="draft"/> <date value="2019-10-24T11:53:00+11:00"/> <publisher value="Health Level Seven International (Regulated Clinical Research Information Management)"/> <item> <linkId value="ResearchStudy"/> <text value="Investigation to increase healthcare-related patient-independent knowledge"/> <type value="group"/> <required value="false"/> <repeats value="true"/> <item> <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> <text value="A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects."/> <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> <text value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/> <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> <text value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may 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> <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. 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. 

This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation."/> <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> <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="choice"/> <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.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> <text value="A human-readable narrative that contains a summary of the resource, and may 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 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 in formation 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> <text value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. 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."/> <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> <text value="May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, 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. 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> <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. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, 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. 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-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> <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.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> <text value="A short, descriptive user-friendly label for the study."/> <type value="display"/> </item> <item> <linkId value="ResearchStudy.title.value"/> <text value="Name for this study"/> <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.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> <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-allowedResource"> <valueCode value="PlanDefinition"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter"> <valueString value="subject=$subj&patient=$subj&encounter=$encounter"/> </extension> <linkId value="ResearchStudy.protocol.value"/> <text value="Steps followed in executing study"/> <type value="reference"/> <required value="false"/> <repeats value="false"/> </item> </item> <item> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType"> <valueString value="Reference"/> </extension> <linkId value="ResearchStudy.partOf"/> <type value="group"/> <required value="false"/> <repeats value="true"/> <item> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl"> <valueCodeableConcept> <coding> <system value="http://hl7.org/fhir/questionnaire-item-control"/> <code value="flyover"/> <display value="Fly-over"/> </coding> </valueCodeableConcept> </extension> <text value="A larger research study of which this particular study is a component or step."/> <type value="display"/> </item> <item> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-allowedResource"> <valueCode value="ResearchStudy"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter"> <valueString value="subject=$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> <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> <text value="The current state of the study. This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid."/> <type value="display"/> </item> <item> <linkId value="ResearchStudy.status.value"/> <text value="status"/> <type value="choice"/> <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.category"/> <text value="Classifications 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> <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.category.coding"/> <text value="code:"/> <type value="open-choice"/> <required value="false"/> <repeats value="false"/> </item> <item> <linkId value="ResearchStudy.category.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.focus"/> <text value="Drugs, devices, conditions, 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> <text value="The condition(s), 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> <linkId value="ResearchStudy.focus.coding"/> <text value="code:"/> <type value="open-choice"/> <required value="false"/> <repeats value="false"/> </item> <item> <linkId value="ResearchStudy.focus.text"/> <text value="text:"/> <type value="string"/> <required value="false"/> <repeats value="false"/> </item> </item> <item> <linkId value="ResearchStudy.contact"/> <text value="Contact details 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> <text value="Contact details to assist a user in learning more about or engaging with the study."/> <type value="display"/> </item> </item> <item> <linkId value="ResearchStudy.relatedArtifact"/> <text value="References and dependencies"/> <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> <text value="Citations, references and other related documents."/> <type value="display"/> </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> <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="open-choice"/> <required value="false"/> <repeats value="false"/> </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.jurisdiction"/> <text value="Geographic region(s) 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> <text value="Indicates a country, state or other region where the study is taking place."/> <type value="display"/> </item> <item> <linkId value="ResearchStudy.jurisdiction.coding"/> <text value="code:"/> <type value="open-choice"/> <required value="false"/> <repeats value="false"/> </item> <item> <linkId value="ResearchStudy.jurisdiction.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.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> <text value="A full description of how the study is being conducted."/> <type value="display"/> </item> <item> <linkId value="ResearchStudy.description.value"/> <text value="What this is study doing"/> <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.enrollment"/> <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> <text value="Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes". The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource."/> <type value="display"/> </item> <item> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-allowedResource"> <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.enrollment.value"/> <text value="Inclusion & 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="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> <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-maxOccurs"> <valueInteger value="1"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType"> <valueString value="Reference"/> </extension> <linkId value="ResearchStudy.sponsor"/> <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> <text value="The organization responsible for the execution of the study."/> <type value="display"/> </item> <item> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-allowedResource"> <valueCode value="Organization"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter"> <valueString value="subject=$subj&patient=$subj&encounter=$encounter"/> </extension> <linkId value="ResearchStudy.sponsor.value"/> <text value="Organization responsible for the study"/> <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.principalInvestigator"/> <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> <text value="Indicates the individual who has primary oversite of the execution of the study."/> <type value="display"/> </item> <item> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-allowedResource"> <valueCode value="Practitioner"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter"> <valueString value="subject=$subj&patient=$subj&encounter=$encounter"/> </extension> <linkId value="ResearchStudy.principalInvestigator.value"/> <text value="The individual responsible for the study"/> <type value="reference"/> <required value="false"/> <repeats value="false"/> </item> </item> <item> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-fhirType"> <valueString value="Reference"/> </extension> <linkId value="ResearchStudy.site"/> <type value="group"/> <required value="false"/> <repeats value="true"/> <item> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl"> <valueCodeableConcept> <coding> <system value="http://hl7.org/fhir/questionnaire-item-control"/> <code value="flyover"/> <display value="Fly-over"/> </coding> </valueCodeableConcept> </extension> <text value="Clinic, hospital or other healthcare location that is participating in the study."/> <type value="display"/> </item> <item> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-allowedResource"> <valueCode value="Location"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/questionnaire-referenceFilter"> <valueString value="subject=$subj&patient=$subj&encounter=$encounter"/> </extension> <linkId value="ResearchStudy.site.value"/> <text value="Location involved in study execution"/> <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="CodeableConcept"/> </extension> <linkId value="ResearchStudy.reasonStopped"/> <text value="Reason for terminating study early"/> <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> <text value="A description and/or code explaining the premature termination of the study."/> <type value="display"/> </item> <item> <linkId value="ResearchStudy.reasonStopped.coding"/> <text value="code:"/> <type value="open-choice"/> <required value="false"/> <repeats value="false"/> </item> <item> <linkId value="ResearchStudy.reasonStopped.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="Annotation"/> </extension> <linkId value="ResearchStudy.note"/> <text value="Comments made about the event"/> <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> <text value="Comments made about the event by the performer, subject or other participants."/> <type value="display"/> </item> </item> <item> <linkId value="ResearchStudy.arm"/> <text value="Defined path through the study for a subject"/> <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> <text value="Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up."/> <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.arm.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> <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.arm.id.value"/> <text value="xml:id (or equivalent in JSON)"/> <type value="string"/> <required value="false"/> <repeats value="false"/> </item> </item> <item> <linkId value="ResearchStudy.arm.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> <text value="May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, 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. 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.arm.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> <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 that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, 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. 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="string"/> </extension> <linkId value="ResearchStudy.arm.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> <text value="Unique, human-readable label for this arm of the study."/> <type value="display"/> </item> <item> <linkId value="ResearchStudy.arm.name.value"/> <text value="Label for study arm"/> <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.arm.code"/> <text value="Categorization of study arm"/> <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> <text value="Categorization of study arm, e.g. experimental, active comparator, placebo comparater."/> <type value="display"/> </item> <item> <linkId value="ResearchStudy.arm.code.coding"/> <text value="code:"/> <type value="open-choice"/> <required value="false"/> <repeats value="false"/> </item> <item> <linkId value="ResearchStudy.arm.code.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.arm.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> <text value="A succinct description of the path through the study that would be followed by a subject adhering to this arm."/> <type value="display"/> </item> <item> <linkId value="ResearchStudy.arm.description.value"/> <text value="Short explanation of study path"/> <type value="string"/> <required value="false"/> <repeats value="false"/> </item> </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.