description: 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: 5
  study: {mustSupport: true, index: 13}
  suspectEntity:
    elements:
      causality:
        mustSupport: true
        index: 14
        elements:
          assessmentMethod:
            short: Method of evaluating the relatedness of the suspected entity to the event.
            binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-causality-method'}
            index: 15
          entityRelatedness:
            binding: {strength: preferred, valueSet: 'http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness'}
            index: 16
    required: [causality]
  outcome:
    binding: {strength: required, valueSet: 'http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes'}
    mustSupport: true
    index: 12
  extension:
    index: 0
    slicing:
      rules: open
      ordered: false
      discriminator:
      - {path: url, type: value}
      min: null
      slices:
        caused-subject-to-discontinue-study:
          match: {url: null}
          schema: {type: Extension, url: 'http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-study', index: 1}
          min: 0
          max: 1
        seriousness-criteria:
          match: {url: null}
          schema: {type: Extension, url: 'http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria', index: 2}
          min: 0
        ae-severity:
          match: {url: null}
          schema: {type: Extension, short: The degree of something undesirable, url: 'http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity', index: 3}
          min: 0
          max: 1
        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-ig/StructureDefinition/ae-grade', index: 4}
          min: 0
          max: 1
  occurrencePeriod: {type: Period, mustSupport: true, choiceOf: occurrence, index: 9}
  seriousness:
    short: Investigator defined severity of the adverse event, in relation to the subject not the resulting condition
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-seriousness'}
    mustSupport: true
    index: 11
  code: {index: 6}
  resultingEffect: {index: 10}
  preventiveAction: {index: 17}
  occurrence:
    mustSupport: true
    choices: [occurrencePeriod]
    index: 8
package_version: research-ig-1.0.0
extensions:
  caused-subject-to-discontinue-study: {url: 'http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-study', min: 0, max: 1, type: Extension, index: 1}
  seriousness-criteria: {url: 'http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria', min: 0, type: Extension, index: 2}
  ae-severity: {url: 'http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity', min: 0, max: 1, type: Extension, short: The degree of something undesirable, index: 3}
  ae-grade: {url: 'http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade', min: 0, max: 1, type: Extension, short: 'The degree of something undesirable, used in oncology trials', index: 4}
class: profile
kind: resource
url: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research
base: http://hl7.org/fhir/StructureDefinition/AdverseEvent
version: 1.0.0
required: [seriousness, study, outcome, code]