http://hl7.org/fhir/StructureDefinition/ResearchStudy|5.0.0

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.
Structure JSON Dependencies FHIRSchema Other Versions Dependant (0)Elements Summary
description: 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.
derivation: specialization
name: ResearchStudy
type: ResearchStudy
elements:
  description: {isModifier: false, short: Detailed narrative of the study, mustSupport: false, isSummary: false, index: 21}
  date: {isModifier: false, short: Date the resource last changed, mustSupport: false, isSummary: false, index: 11}
  site: {isModifier: false, short: Facility where study activities are conducted, mustSupport: false, array: true, isSummary: true, index: 23}
  protocol: {isModifier: false, short: Steps followed in executing study, mustSupport: false, array: true, isSummary: true, index: 8}
  name: {isModifier: false, short: Name for this study (computer friendly), mustSupport: false, isSummary: false, index: 3}
  classifier:
    isModifier: false
    short: Classification for the study
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-classifiers'}
    isSummary: false
    index: 25
  progressStatus:
    isModifier: false
    short: Status of study with time for that status
    mustSupport: false
    array: true
    isSummary: false
    index: 32
    elements:
      state:
        isModifier: false
        short: Label for status or state (e.g. recruitment status)
        mustSupport: false
        binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-status'}
        isSummary: false
        index: 33
      actual: {isModifier: false, short: Actual if true else anticipated, mustSupport: false, isSummary: false, index: 34}
      period: {isModifier: false, short: Date range, mustSupport: false, isSummary: false, index: 35}
    required: [state]
  phase:
    isModifier: false
    short: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
    mustSupport: false
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-phase'}
    isSummary: true
    index: 14
  whyStopped:
    isModifier: false
    short: accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
    mustSupport: false
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-reason-stopped'}
    isSummary: true
    index: 36
  title: {isModifier: false, short: Human readable name of the study, mustSupport: false, isSummary: true, index: 4}
  note: {isModifier: false, short: Comments made about the study, mustSupport: false, array: true, isSummary: false, index: 24}
  region:
    isModifier: false
    short: Geographic area for the study
    mustSupport: false
    array: true
    binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/ValueSet/jurisdiction'}
    isSummary: true
    index: 19
  descriptionSummary: {isModifier: false, short: Brief text explaining the study, mustSupport: false, isSummary: false, index: 20}
  outcomeMeasure:
    isModifier: false
    short: A variable measured during the study
    mustSupport: false
    array: true
    isSummary: false
    index: 53
    elements:
      name: {isModifier: false, short: Label for the outcome, mustSupport: false, isSummary: false, index: 54}
      type:
        isModifier: false
        short: primary | secondary | exploratory
        mustSupport: false
        array: true
        binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-objective-type'}
        isSummary: false
        index: 55
      description: {isModifier: false, short: Description of the outcome, mustSupport: false, isSummary: false, index: 56}
      reference: {isModifier: false, short: Structured outcome definition, mustSupport: false, isSummary: false, index: 57}
  keyword: {isModifier: false, short: Used to search for the study, mustSupport: false, array: true, isSummary: true, index: 18}
  status:
    isModifier: true
    short: draft | active | retired | unknown
    mustSupport: false
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/publication-status|5.0.0'}
    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
    index: 12
  result: {isModifier: false, short: Link to results generated during the study, mustSupport: false, array: true, isSummary: true, index: 58}
  label:
    isModifier: false
    short: Additional names for the study
    mustSupport: false
    array: true
    isSummary: false
    index: 5
    elements:
      type:
        isModifier: false
        short: primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
        mustSupport: false
        binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/ValueSet/title-type'}
        isSummary: false
        index: 6
      value: {isModifier: false, short: The name, mustSupport: false, isSummary: false, index: 7}
  condition:
    isModifier: false
    short: Condition being studied
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/condition-code'}
    isSummary: true
    index: 17
  url: {isModifier: false, short: Canonical identifier for this study resource, mustSupport: false, isSummary: false, index: 0}
  identifier: {isModifier: false, short: Business Identifier for study, mustSupport: false, array: true, isSummary: true, index: 1}
  primaryPurposeType:
    isModifier: false
    short: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
    mustSupport: false
    binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-prim-purp-type'}
    isSummary: true
    index: 13
  focus:
    isModifier: false
    short: Drugs, devices, etc. under study
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-focus-type'}
    isSummary: false
    index: 16
  objective:
    isModifier: false
    short: A goal for the study
    mustSupport: false
    array: true
    isSummary: false
    index: 49
    elements:
      name: {isModifier: false, short: Label for the objective, mustSupport: false, isSummary: false, index: 50}
      type:
        isModifier: false
        short: primary | secondary | exploratory
        mustSupport: false
        binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-objective-type'}
        isSummary: false
        index: 51
      description: {isModifier: false, short: Description of the objective, mustSupport: false, isSummary: false, index: 52}
  period: {isModifier: false, short: When the study began and ended, mustSupport: false, isSummary: true, index: 22}
  partOf: {isModifier: false, short: Part of larger study, mustSupport: false, array: true, isSummary: true, index: 9}
  version: {isModifier: false, short: The business version for the study record, mustSupport: false, isSummary: false, index: 2}
  relatedArtifact: {isModifier: false, short: 'References, URLs, and attachments', mustSupport: false, array: true, isSummary: false, index: 10}
  recruitment:
    isModifier: false
    short: Target or actual group of participants enrolled in study
    mustSupport: false
    isSummary: true
    index: 37
    elements:
      targetNumber: {isModifier: false, short: Estimated total number of participants to be enrolled, mustSupport: false, isSummary: false, index: 38}
      actualNumber: {isModifier: false, short: Actual total number of participants enrolled in study, mustSupport: false, isSummary: false, index: 39}
      eligibility: {isModifier: false, short: Inclusion and exclusion criteria, mustSupport: false, isSummary: false, index: 40}
      actualGroup: {isModifier: false, short: Group of participants who were enrolled in study, mustSupport: false, isSummary: true, index: 41}
  studyDesign:
    isModifier: false
    short: Classifications of the study design characteristics
    mustSupport: false
    array: true
    binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/ValueSet/study-design'}
    isSummary: true
    index: 15
  comparisonGroup:
    isModifier: false
    short: Defined path through the study for a subject
    mustSupport: false
    array: true
    isSummary: false
    index: 42
    elements:
      linkId: {isModifier: false, short: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily, mustSupport: false, isSummary: false, index: 43}
      name: {isModifier: false, short: Label for study comparisonGroup, mustSupport: false, isSummary: false, index: 44}
      type:
        isModifier: false
        short: Categorization of study comparisonGroup
        mustSupport: false
        binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-arm-type'}
        isSummary: false
        index: 45
      description: {isModifier: false, short: Short explanation of study path, mustSupport: false, isSummary: false, index: 46}
      intendedExposure: {isModifier: false, short: Interventions or exposures in this comparisonGroup or cohort, mustSupport: false, array: true, isSummary: false, index: 47}
      observedGroup: {isModifier: false, short: Group of participants who were enrolled in study comparisonGroup, mustSupport: false, isSummary: false, index: 48}
    required: [name]
  associatedParty:
    isModifier: false
    short: Sponsors, collaborators, and other parties
    mustSupport: false
    array: true
    isSummary: false
    index: 26
    elements:
      name: {isModifier: false, short: Name of associated party, mustSupport: false, isSummary: false, index: 27}
      role:
        isModifier: false
        short: sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair
        mustSupport: false
        binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-party-role'}
        isSummary: false
        index: 28
      period: {isModifier: false, short: When active in the role, mustSupport: false, array: true, isSummary: false, index: 29}
      classifier:
        isModifier: false
        short: nih | fda | government | nonprofit | academic | industry
        mustSupport: false
        array: true
        binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-party-organization-type'}
        isSummary: false
        index: 30
      party: {isModifier: false, short: Individual or organization associated with study (use practitionerRole to specify their organisation), mustSupport: false, isSummary: false, index: 31}
    required: [role]
class: resource
kind: resource
url: http://hl7.org/fhir/StructureDefinition/ResearchStudy
base: http://hl7.org/fhir/StructureDefinition/DomainResource
version: 5.0.0
required: [status]