NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy TUDomainResourceInvestigation to increase healthcare-related patient-independent knowledge

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... url 0..1uriCanonical identifier for this study resource
... identifier Σ0..*IdentifierBusiness Identifier for study

... version 0..1stringThe business version for the study record
... name 0..1stringName for this study (computer friendly)
... title Σ0..1stringHuman readable name of the study
... label 0..*BackboneElementAdditional names for the study

.... type 0..1CodeableConceptprimary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
Binding: Title Type (Extensible)
.... value 0..1stringThe name
... protocol Σ0..*Reference(PlanDefinition)Steps followed in executing study

... partOf Σ0..*Reference(ResearchStudy)Part of larger study

... relatedArtifact 0..*RelatedArtifactReferences, URLs, and attachments

... date 0..1dateTimeDate the resource last changed
... status ?!Σ1..1codedraft | active | retired | unknown
Binding: PublicationStatus (Required)
... primaryPurposeType Σ0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: Research Study Primary Purpose Type (Preferred)
... phase Σ0..1CodeableConceptn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Binding: Research Study Phase (Example)
... studyDesign Σ0..*CodeableConceptClassifications of the study design characteristics
Binding: Study Design (Preferred)

... focus 0..*CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable)Drugs, devices, etc. under study
Binding: Research Study Focus Type (Example)

... condition Σ0..*CodeableConceptCondition being studied
Binding: Condition/Problem/Diagnosis Codes (Example)

... keyword Σ0..*CodeableConceptUsed to search for the study
Binding: ResearchStudyKeyword (Example)

... region Σ0..*CodeableConceptGeographic area for the study
Binding: Jurisdiction ValueSet (Extensible)

... descriptionSummary 0..1markdownBrief text explaining the study
... description 0..1markdownDetailed narrative of the study
... period Σ0..1PeriodWhen the study began and ended
... site Σ0..*Reference(Location | ResearchStudy | Organization)Facility where study activities are conducted

... note 0..*AnnotationComments made about the study

... classifier 0..*CodeableConceptClassification for the study
Binding: Research Study Classifiers (Example)

... associatedParty 0..*BackboneElementSponsors, collaborators, and other parties

.... name 0..1stringName of associated party
.... role 1..1CodeableConceptsponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair
Binding: Research Study Party Role (Extensible)
.... period 0..*PeriodWhen active in the role

.... classifier 0..*CodeableConceptnih | fda | government | nonprofit | academic | industry
Binding: Research Study Party Organization Type (Example)

.... party 0..1Reference(Practitioner | PractitionerRole | Organization)Individual or organization associated with study (use practitionerRole to specify their organisation)
... progressStatus 0..*BackboneElementStatus of study with time for that status

.... state 1..1CodeableConceptLabel for status or state (e.g. recruitment status)
Binding: Research Study Status (Extensible)
.... actual 0..1booleanActual if true else anticipated
.... period 0..1PeriodDate range
... whyStopped Σ0..1CodeableConceptaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Binding: Research Study Reason Stopped (Example)
... recruitment Σ0..1BackboneElementTarget or actual group of participants enrolled in study
.... targetNumber 0..1unsignedIntEstimated total number of participants to be enrolled
.... actualNumber 0..1unsignedIntActual total number of participants enrolled in study
.... eligibility 0..1Reference(Group | EvidenceVariable)Inclusion and exclusion criteria
.... actualGroup Σ0..1Reference(Group)Group of participants who were enrolled in study
... comparisonGroup 0..*BackboneElementDefined path through the study for a subject

.... linkId 0..1idAllows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
.... name 1..1stringLabel for study comparisonGroup
.... type 0..1CodeableConceptCategorization of study comparisonGroup
Binding: Research Study Arm Type (Extensible)
.... description 0..1markdownShort explanation of study path
.... intendedExposure 0..*Reference(EvidenceVariable)Interventions or exposures in this comparisonGroup or cohort

.... observedGroup 0..1Reference(Group)Group of participants who were enrolled in study comparisonGroup
... objective 0..*BackboneElementA goal for the study

.... name 0..1stringLabel for the objective
.... type 0..1CodeableConceptprimary | secondary | exploratory
Binding: Research Study Objective Type (Preferred)
.... description 0..1markdownDescription of the objective
... outcomeMeasure 0..*BackboneElementA variable measured during the study

.... name 0..1stringLabel for the outcome
.... type 0..*CodeableConceptprimary | secondary | exploratory
Binding: Research Study Objective Type (Preferred)

.... description 0..1markdownDescription of the outcome
.... reference 0..1Reference(EvidenceVariable)Structured outcome definition
... result Σ0..*Reference(EvidenceReport | Citation | DiagnosticReport)Link to results generated during the study


doco Documentation for this format