description: Convenience backport into R4 of FHIR R5 Foundational profile of AdverseEvent for Clinical Research communications.
package_name: hl7.fhir.uv.ae
derivation: constraint
name: AdverseEventClinicalResearch
type: AdverseEvent
elements:
  actuality:
    short: actual
    pattern: {type: Code, value: actual}
    index: 16
  study: {mustSupport: true, index: 24}
  suspectEntity: {index: 21}
  referenceDocument: {index: 23}
  outcome:
    binding: {strength: required, valueSet: 'http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes'}
    mustSupport: true
    index: 20
  extension:
    index: 0
    slicing:
      rules: open
      ordered: false
      discriminator:
      - {path: url, type: value}
      min: null
      slices:
        suspect-entity:
          match: {url: null}
          schema: {short: A suspected agent causing the adverse event, type: Extension, url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity', isSummary: true, index: 8}
          min: 0
        resolve-date:
          match: {url: null}
          schema: {type: Extension, short: Adverse Event resolution date, url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date', index: 7}
          min: 0
          max: 1
        participant:
          match: {url: null}
          schema: {type: Extension, short: Who was involved in the adverse event or the potential adverse event and what they did, url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant', index: 12}
          min: 0
        caused-subject-to-discontinue-study:
          match: {url: null}
          schema: {type: Extension, url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study', index: 2}
          min: 0
          max: 1
        note:
          match: {url: null}
          schema: {type: Extension, short: Comment on adverse event, url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note', index: 6}
          min: 0
        seriousness-criteria:
          match: {url: null}
          schema: {type: Extension, url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria', index: 3}
          min: 0
        contributing-factor:
          match: {url: null}
          schema: {short: Contributing factors suspected to have increased the probability or severity of the adverse event, type: Extension, url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor', isSummary: true, index: 9}
          min: 0
        expected-in-research-study:
          match: {url: null}
          schema: {type: Extension, short: Considered likely or probable or anticipated in the research study, url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study', index: 5}
          min: 0
          max: 1
        research-subject-ref:
          match: {url: null}
          schema: {type: Extension, short: Research Subject record of subject, url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref', index: 1}
          min: 0
          max: 1
        resultingEffect:
          match: {url: null}
          schema: {type: Extension, short: Effect on the subject due to this event, url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect', index: 13}
          min: 0
        ae-grade:
          match: {url: null}
          schema: {type: Extension, short: 'The degree of something undesirable, used in oncology trials', url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade', index: 4}
          min: 0
          max: 1
        mitigating-action:
          match: {url: null}
          schema: {short: Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm, type: Extension, url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action', isSummary: true, index: 10}
          min: 0
        supporting-info:
          match: {url: null}
          schema: {type: Extension, short: Subject medical history or document relevant to this adverse event, isSummary: true, url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info', index: 11}
          min: 0
  event:
    short: Event or incident that occurred or was averted
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs'}
    index: 17
  subjectMedicalHistory: {index: 22}
  seriousness:
    short: Investigator defined severity of the adverse event, in relation to the subject not the resulting condition
    binding: {strength: required, valueSet: 'http://terminology.hl7.org/ValueSet/adverse-event-seriousness'}
    mustSupport: true
    index: 19
  modifierExtension:
    index: 14
    slicing:
      rules: open
      ordered: false
      discriminator:
      - {path: url, type: value}
      min: 1
      slices:
        status:
          match: {url: null}
          schema: {short: in-progress | completed | entered-in-error | unknown, type: Extension, url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status', 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: 15}
          min: 1
          max: 1
  resultingCondition: {index: 18}
package_version: research-backport-ig-1.0.1
extensions:
  suspect-entity: {url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity', min: 0, short: A suspected agent causing the adverse event, type: Extension, isSummary: true, index: 8}
  resolve-date: {url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date', min: 0, max: 1, type: Extension, short: Adverse Event resolution date, index: 7}
  participant: {url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant', min: 0, type: Extension, short: Who was involved in the adverse event or the potential adverse event and what they did, index: 12}
  caused-subject-to-discontinue-study: {url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study', min: 0, max: 1, type: Extension, index: 2}
  note: {url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note', min: 0, type: Extension, short: Comment on adverse event, index: 6}
  seriousness-criteria: {url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria', min: 0, type: Extension, index: 3}
  contributing-factor: {url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor', min: 0, short: Contributing factors suspected to have increased the probability or severity of the adverse event, type: Extension, isSummary: true, index: 9}
  expected-in-research-study: {url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study', min: 0, max: 1, type: Extension, short: Considered likely or probable or anticipated in the research study, index: 5}
  research-subject-ref: {url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref', min: 0, max: 1, type: Extension, short: Research Subject record of subject, index: 1}
  resultingEffect: {url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect', min: 0, type: Extension, short: Effect on the subject due to this event, index: 13}
  ae-grade: {url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade', min: 0, max: 1, type: Extension, short: 'The degree of something undesirable, used in oncology trials', index: 4}
  mitigating-action: {url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action', min: 0, short: Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm, type: Extension, isSummary: true, index: 10}
  supporting-info: {url: 'http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info', min: 0, type: Extension, short: Subject medical history or document relevant to this adverse event, isSummary: true, index: 11}
class: profile
kind: resource
url: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research
base: http://hl7.org/fhir/StructureDefinition/AdverseEvent
version: 1.0.1
required: [modifierExtension, event, seriousness, study, outcome]