http://hl7.org/fhir/StructureDefinition/ResearchStudy|4.0.1

description: 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.
derivation: specialization
name: ResearchStudy
type: ResearchStudy
elements:
  description: {short: What this is study doing, index: 14}
  category: {short: Classifications for the study, array: true, isSummary: true, index: 7}
  enrollment: {short: Inclusion & exclusion criteria, array: true, isSummary: true, index: 15}
  arm:
    short: Defined path through the study for a subject
    array: true
    index: 22
    elements:
      name: {short: Label for study arm, index: 23}
      type: {short: Categorization of study arm, index: 24}
      description: {short: Short explanation of study path, index: 25}
    required: [name]
  site: {short: Facility where study activities are conducted, array: true, isSummary: true, index: 19}
  protocol: {short: Steps followed in executing study, array: true, isSummary: true, index: 2}
  principalInvestigator: {short: Researcher who oversees multiple aspects of the study, isSummary: true, index: 18}
  phase:
    short: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-phase'}
    isSummary: true
    index: 6
  reasonStopped:
    short: accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-reason-stopped'}
    isSummary: true
    index: 20
  title: {short: Name for this study, isSummary: true, index: 1}
  note: {short: Comments made about the study, array: true, index: 21}
  keyword: {short: Used to search for the study, array: true, isSummary: true, index: 12}
  status:
    isModifier: true
    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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-status|4.0.1'}
    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: 4
  condition:
    short: Condition being studied
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/condition-code'}
    isSummary: true
    index: 9
  identifier: {short: Business Identifier for study, array: true, isSummary: true, index: 0}
  primaryPurposeType:
    short: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
    binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-prim-purp-type'}
    isSummary: true
    index: 5
  focus: {short: 'Drugs, devices, etc. under study', array: true, isSummary: true, index: 8}
  objective:
    short: A goal for the study
    array: true
    index: 26
    elements:
      name: {short: Label for the objective, index: 27}
      type:
        short: primary | secondary | exploratory
        binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/ValueSet/research-study-objective-type'}
        index: 28
  period: {short: When the study began and ended, isSummary: true, index: 16}
  partOf: {short: Part of larger study, array: true, isSummary: true, index: 3}
  relatedArtifact: {short: References and dependencies, array: true, index: 11}
  location:
    short: Geographic region(s) for study
    array: true
    binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/ValueSet/jurisdiction'}
    isSummary: true
    index: 13
  contact: {short: Contact details for the study, array: true, isSummary: true, index: 10}
  sponsor: {short: Organization that initiates and is legally responsible for the study, isSummary: true, index: 17}
class: resource
kind: resource
url: http://hl7.org/fhir/StructureDefinition/ResearchStudy
base: http://hl7.org/fhir/StructureDefinition/DomainResource
version: 4.0.1
required: [status]