Data Model Libraries
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    ResearchStudy Class

    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.

    FHIR Specification

    • Short: Investigation to increase healthcare-related patient-independent knowledge
    • Definition: 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.
    • Comment: Need to make sure we encompass public health studies.
    • FHIR Version: 5.0.0

    Hierarchy (View Summary)

    Implements

    Index

    Constructors

    Properties

    Methods

    parse getUrlElement setUrlElement hasUrlElement getUrl setUrl hasUrl getIdentifier setIdentifier addIdentifier hasIdentifier getVersionElement setVersionElement hasVersionElement getVersion setVersion hasVersion getNameElement setNameElement hasNameElement getName setName hasName getTitleElement setTitleElement hasTitleElement getTitle setTitle hasTitle getLabel setLabel addLabel hasLabel getProtocol setProtocol addProtocol hasProtocol getPartOf setPartOf addPartOf hasPartOf getRelatedArtifact setRelatedArtifact addRelatedArtifact hasRelatedArtifact getDateElement setDateElement hasDateElement getDate setDate hasDate getStatusEnumType setStatusEnumType hasStatusEnumType getStatusElement setStatusElement hasStatusElement getStatus setStatus hasStatus getPrimaryPurposeType setPrimaryPurposeType hasPrimaryPurposeType getPhase setPhase hasPhase getStudyDesign setStudyDesign addStudyDesign hasStudyDesign getFocus setFocus addFocus hasFocus getCondition setCondition addCondition hasCondition getKeyword setKeyword addKeyword hasKeyword getRegion setRegion addRegion hasRegion getDescriptionSummaryElement setDescriptionSummaryElement hasDescriptionSummaryElement getDescriptionSummary setDescriptionSummary hasDescriptionSummary getDescriptionElement setDescriptionElement hasDescriptionElement getDescription setDescription hasDescription getPeriod setPeriod hasPeriod getSite setSite addSite hasSite getNote setNote addNote hasNote getClassifier setClassifier addClassifier hasClassifier getAssociatedParty setAssociatedParty addAssociatedParty hasAssociatedParty getProgressStatus setProgressStatus addProgressStatus hasProgressStatus getWhyStopped setWhyStopped hasWhyStopped getRecruitment setRecruitment hasRecruitment getComparisonGroup setComparisonGroup addComparisonGroup hasComparisonGroup getObjective setObjective addObjective hasObjective getOutcomeMeasure setOutcomeMeasure addOutcomeMeasure hasOutcomeMeasure getResult setResult addResult hasResult 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 initLabel initProtocol initPartOf initRelatedArtifact initStudyDesign initFocus initCondition initKeyword initRegion initSite initNote initClassifier initAssociatedParty initProgressStatus initComparisonGroup initObjective initOutcomeMeasure initResult

    Constructors

    Properties

    url?: UriType

    ResearchStudy.url Element

    FHIR Specification

    • Short: Canonical identifier for this study resource
    • Definition: Canonical identifier for this study resource, represented as a globally unique URI.
    • FHIR Type: uri
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: false
    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
    version?: StringType

    ResearchStudy.version Element

    FHIR Specification

    • Short: The business version for the study record
    • Definition: The business version for the study record.
    • FHIR Type: string
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: false
    name?: StringType

    FHIR Specification

    • Short: Name for this study (computer friendly)
    • Definition: Name for this study (computer friendly).
    • FHIR Type: string
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: false
    title?: StringType

    ResearchStudy.title Element

    FHIR Specification

    • Short: Human readable name of the study
    • Definition: The human readable name of the research study.
    • FHIR Type: string
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true

    ResearchStudy.label Element

    FHIR Specification

    • Short: Additional names for the study
    • Definition: Additional names for the study.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    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
    relatedArtifact?: RelatedArtifact[]

    ResearchStudy.relatedArtifact Element

    FHIR Specification

    • Short: References, URLs, and attachments
    • Definition: 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.
    • FHIR Type: RelatedArtifact
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false

    ResearchStudy.date Element

    FHIR Specification

    • Short: Date the resource last changed
    • Definition: 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.
    • FHIR Type: dateTime
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: false
    publicationStatusEnum: PublicationStatusEnum

    FHIR CodeSystem: PublicationStatus

    status: null | EnumCodeType

    ResearchStudy.status Element

    FHIR Specification

    • Short: draft | active | retired | unknown
    • Definition: The publication state of the resource (not 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: PublicationStatusEnum

    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 activities. A classification of the intent of the study.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true

    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
    studyDesign?: CodeableConcept[]

    ResearchStudy.studyDesign Element

    FHIR Specification

    • Short: Classifications of the study design characteristics
    • 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

    ResearchStudy.focus Element

    FHIR Specification

    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
    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
    region?: CodeableConcept[]

    ResearchStudy.region Element

    FHIR Specification

    • Short: Geographic area for the study
    • Definition: A country, state or other area where the study is taking place rather than its precise geographic location or address.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    descriptionSummary?: MarkdownType

    ResearchStudy.descriptionSummary Element

    FHIR Specification

    • Short: Brief text explaining the study
    • Definition: A brief text for explaining the study.
    • FHIR Type: markdown
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: false
    description?: MarkdownType

    ResearchStudy.description Element

    FHIR Specification

    • Short: Detailed narrative of the study
    • Definition: A detailed and human-readable narrative of the study. E.g., study abstract.
    • FHIR Type: markdown
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: false
    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
    site?: Reference[]

    ResearchStudy.site Element

    FHIR Specification

    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
    classifier?: CodeableConcept[]

    ResearchStudy.classifier Element

    FHIR Specification

    • Short: Classification for the study
    • Definition: 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.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false

    ResearchStudy.associatedParty Element

    FHIR Specification

    • Short: Sponsors, collaborators, and other parties
    • Definition: Sponsors, collaborators, and other parties.
    • Comment: For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.
    • Requirements: While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false

    ResearchStudy.progressStatus Element

    FHIR Specification

    • Short: Status of study with time for that status
    • Definition: Status of study with time for that status.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    whyStopped?: CodeableConcept

    ResearchStudy.whyStopped 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

    ResearchStudy.recruitment Element

    FHIR Specification

    • Short: Target or actual group of participants enrolled in study
    • Definition: Target or actual group of participants enrolled in study.
    • FHIR Type: BackboneElement
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true

    ResearchStudy.comparisonGroup Element

    FHIR Specification

    • Short: Defined path through the study for a subject
    • Definition: 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}.
    • Comment: 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.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false

    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

    ResearchStudy.outcomeMeasure Element

    FHIR Specification

    • Short: A variable measured during the study
    • Definition: 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.
    • Comment: 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
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    result?: Reference[]

    ResearchStudy.result Element

    FHIR Specification

    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 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