Data Model Libraries
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    Class ResearchStudy

    ResearchStudy Class

    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.

    FHIR Specification

    • Short: Investigation to increase healthcare-related patient-independent knowledge
    • Definition: 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.
    • Comment: Need to make sure we encompass public health studies.
    • FHIR Version: 4.0.1

    FHIR ResearchStudy

    Hierarchy (View Summary)

    Implements

    Index

    Constructors

    constructor

    Properties

    identifier? title? protocol? partOf? researchStudyStatusEnum status primaryPurposeType? phase? category? focus? condition? contact? relatedArtifact? keyword? location? description? enrollment? period? sponsor? principalInvestigator? site? reasonStopped? note? arm? objective?

    Methods

    parse getIdentifier setIdentifier addIdentifier hasIdentifier getTitleElement setTitleElement hasTitleElement getTitle setTitle hasTitle getProtocol setProtocol addProtocol hasProtocol getPartOf setPartOf addPartOf hasPartOf getStatusEnumType setStatusEnumType hasStatusEnumType getStatusElement setStatusElement hasStatusElement getStatus setStatus hasStatus getPrimaryPurposeType setPrimaryPurposeType hasPrimaryPurposeType getPhase setPhase hasPhase getCategory setCategory addCategory hasCategory getFocus setFocus addFocus hasFocus getCondition setCondition addCondition hasCondition getContact setContact addContact hasContact getRelatedArtifact setRelatedArtifact addRelatedArtifact hasRelatedArtifact getKeyword setKeyword addKeyword hasKeyword getLocation setLocation addLocation hasLocation getDescriptionElement setDescriptionElement hasDescriptionElement getDescription setDescription hasDescription getEnrollment setEnrollment addEnrollment hasEnrollment getPeriod setPeriod hasPeriod getSponsor setSponsor hasSponsor getPrincipalInvestigator setPrincipalInvestigator hasPrincipalInvestigator getSite setSite addSite hasSite getReasonStopped setReasonStopped hasReasonStopped getNote setNote addNote hasNote getArm setArm addArm hasArm getObjective setObjective addObjective hasObjective fhirType isEmpty isRequiredFieldsEmpty copy toJSON getText setText hasText getContained setContained addContained hasContained getExtension setExtension hasExtension getExtensionByUrl addExtension removeExtension getModifierExtension setModifierExtension hasModifierExtension getModifierExtensionByUrl addModifierExtension removeModifierExtension resourceType getIdElement setIdElement hasIdElement getId setId hasId getMeta setMeta hasMeta getImplicitRulesElement setImplicitRulesElement hasImplicitRulesElement getImplicitRules setImplicitRules hasImplicitRules getLanguageElement setLanguageElement hasLanguageElement getLanguage setLanguage hasLanguage isResource isDataType isComplexDataType isPrimitive isBooleanPrimitive isStringPrimitive isNumberPrimitive isBigIntPrimitive isDateTimePrimitive copyValues initIdentifier initProtocol initPartOf initCategory initFocus initCondition initContact initRelatedArtifact initKeyword initLocation initEnrollment initSite initNote initArm initObjective

    Constructors

    Properties

    identifier?: Identifier[]

    ResearchStudy.identifier Element

    FHIR Specification

    • Short: Business Identifier for study
    • Definition: Identifiers assigned to this research study by the sponsor or other systems.
    • Requirements: Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
    • FHIR Type: Identifier
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    title?: StringType

    ResearchStudy.title Element

    FHIR Specification

    • Short: Name for this study
    • Definition: A short, descriptive user-friendly label for the study.
    • FHIR Type: string
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    protocol?: Reference[]

    ResearchStudy.protocol Element

    FHIR Specification

    • Short: Steps followed in executing study
    • Definition: The set of steps expected to be performed as part of the execution of the study.
    • FHIR Type: Reference
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    partOf?: Reference[]

    ResearchStudy.partOf Element

    FHIR Specification

    • Short: Part of larger study
    • Definition: A larger research study of which this particular study is a component or step.
    • Requirements: Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.
    • FHIR Type: Reference
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    researchStudyStatusEnum: ResearchStudyStatusEnum

    FHIR CodeSystem: ResearchStudyStatus

    ResearchStudyStatusEnum

    status: null | EnumCodeType

    ResearchStudy.status Element

    FHIR Specification

    • Short: active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
    • Definition: The current state of the study.
    • FHIR Type: code
    • Cardinality: 1..1
    • isModifier: true
    • isModifierReason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
    • isSummary: true

    CodeSystem Enumeration: ResearchStudyStatusEnum

    primaryPurposeType?: CodeableConcept

    ResearchStudy.primaryPurposeType Element

    FHIR Specification

    • Short: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
    • Definition: The type of study based upon the intent of the study's activities. A classification of the intent of the study.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    phase?: CodeableConcept

    ResearchStudy.phase Element

    FHIR Specification

    • Short: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
    • Definition: The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    category?: CodeableConcept[]

    ResearchStudy.category Element

    FHIR Specification

    • Short: Classifications for the study
    • Definition: Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    focus?: CodeableConcept[]

    ResearchStudy.focus Element

    FHIR Specification

    • Short: Drugs, devices, etc. under study
    • Definition: The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    condition?: CodeableConcept[]

    ResearchStudy.condition Element

    FHIR Specification

    • Short: Condition being studied
    • Definition: 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.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    contact?: ContactDetail[]

    ResearchStudy.contact Element

    FHIR Specification

    • Short: Contact details for the study
    • Definition: Contact details to assist a user in learning more about or engaging with the study.
    • FHIR Type: ContactDetail
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    relatedArtifact?: RelatedArtifact[]

    ResearchStudy.relatedArtifact Element

    FHIR Specification

    • Short: References and dependencies
    • Definition: Citations, references and other related documents.
    • FHIR Type: RelatedArtifact
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    keyword?: CodeableConcept[]

    ResearchStudy.keyword Element

    FHIR Specification

    • Short: Used to search for the study
    • Definition: Key terms to aid in searching for or filtering the study.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    location?: CodeableConcept[]

    ResearchStudy.location Element

    FHIR Specification

    • Short: Geographic region(s) for study
    • Definition: Indicates a country, state or other region where the study is taking place.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    description?: MarkdownType

    ResearchStudy.description Element

    FHIR Specification

    • Short: What this is study doing
    • Definition: A full description of how the study is being conducted.
    • FHIR Type: markdown
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: false
    enrollment?: Reference[]

    ResearchStudy.enrollment Element

    FHIR Specification

    • Short: Inclusion & exclusion criteria
    • Definition: 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".
    • Comment: The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.
    • FHIR Type: Reference
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    period?: Period

    ResearchStudy.period Element

    FHIR Specification

    • Short: When the study began and ended
    • Definition: Identifies the start date and the expected (or actual, depending on status) end date for the study.
    • FHIR Type: Period
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    sponsor?: Reference

    ResearchStudy.sponsor Element

    FHIR Specification

    • Short: Organization that initiates and is legally responsible for the study
    • Definition: An organization that initiates the investigation and is legally responsible for the study.
    • FHIR Type: Reference
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    principalInvestigator?: Reference

    ResearchStudy.principalInvestigator Element

    FHIR Specification

    site?: Reference[]

    ResearchStudy.site Element

    FHIR Specification

    • Short: Facility where study activities are conducted
    • Definition: A facility in which study activities are conducted.
    • FHIR Type: Reference
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    reasonStopped?: CodeableConcept

    ResearchStudy.reasonStopped Element

    FHIR Specification

    • Short: accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
    • Definition: A description and/or code explaining the premature termination of the study.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    note?: Annotation[]

    ResearchStudy.note Element

    FHIR Specification

    • Short: Comments made about the study
    • Definition: Comments made about the study by the performer, subject or other participants.
    • FHIR Type: Annotation
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    arm?: ResearchStudyArmComponent[]

    ResearchStudy.arm Element

    FHIR Specification

    • Short: Defined path through the study for a subject
    • Definition: 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.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    objective?: ResearchStudyObjectiveComponent[]

    ResearchStudy.objective Element

    FHIR Specification

    • Short: A goal for the study
    • Definition: 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.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false

    Methods

    • Parse the provided ResearchStudy JSON to instantiate the ResearchStudy data model.

      Parameters

      • sourceJson: Value

        JSON representing FHIR ResearchStudy

      • OptionaloptSourceField: string

        Optional data source field (e.g. <complexTypeName>.<complexTypeFieldName>); defaults to ResearchStudy

      Returns undefined | ResearchStudy

      ResearchStudy data model or undefined for ResearchStudy

      JsonError if the provided JSON is not a valid JSON object

    • Assigns the provided PrincipalInvestigator object value to the principalInvestigator property.

      Parameters

      • value: undefined | Reference

        the principalInvestigator object value

      Returns this

      this

      @ReferenceTargets('ResearchStudy.principalInvestigator', ['Practitioner','PractitionerRole',])

      InvalidTypeError for invalid data type or reference value

    • Assigns the provided value to the text property.

      Parameters

      Returns this

      this

    • Returns boolean

      true if the text property exists and has a value; false otherwise

    • Assigns the provided Resource array value to the contained property.

      Parameters

      • value: undefined | IResource[]

        the contained array value

      Returns this

      this

    • Returns boolean

      true if the contained property exists and has a value; false otherwise

    • Assigns the provided array of Extension values to the extension property.

      Parameters

      • extension: undefined | IExtension[]

        array of Extensions

      Returns this

      this

    • Determines if the extension property exists.

      Parameters

      • Optionalurl: string

        the url that identifies a specific Extension

      Returns boolean

      true if an Extension has the provided url; false otherwise

      If the url is provided, determines if an Extension having the provided url exists. If the url is not provided, determines if the extension property exists and has any values.

      AssertionError for invalid url

    • Adds the provided Extension to the extension property array.

      Parameters

      • extension: undefined | IExtension

        the Extension value to add to the extension property array

      Returns this

      this

    • Removes the Extension having the provided url from the extension property array.

      Parameters

      • url: string

        the url that identifies a specific Extension to remove

      Returns void

      AssertionError for invalid url

    • Determines if the modifierExtension property exists.

      Parameters

      • Optionalurl: string

        the url that identifies a specific Extension

      Returns boolean

      true if an Extension has the provided url

      If the url is provided, determines if an Extension having the provided url exists. If the url is not provided, determines if the modifierExtension property exists and has any values.

      AssertionError for invalid url

    • Assigns the provided PrimitiveType value to the id property.

      Parameters

      • element: undefined | IdType

        the id value

      Returns this

      this

    • Returns undefined | string

      the id property value as a primitive value

    • Assigns the provided primitive value to the id property.

      Parameters

      • value: undefined | string

        the id value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns boolean

      true if the id property exists and has a value; false otherwise

    • Assigns the provided value to the meta property.

      Parameters

      • value: undefined | Meta

        the meta value

      Returns this

      this

    • Returns boolean

      true if the meta property exists and has a value; false otherwise

    • Assigns the provided primitive value to the implicitRules property.

      Parameters

      • value: undefined | string

        the implicitRules value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns undefined | string

      the language property value as a primitive value

    • Assigns the provided primitive value to the language property.

      Parameters

      • value: undefined | string

        the language value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns boolean

      true if the language property exists and has a value; false otherwise

    • Returns boolean

      true if the instance is a FHIR complex or primitive datatype; false otherwise

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