Adverse Event Clinical Research
1.0.1 - STU1 International flag

Adverse Event Clinical Research, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-ig/ and changes regularly. See the Directory of published versions

Resource Profile: AdverseEventClinicalResearch - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 2

Definitions for the AdverseEvent-clinical-research resource profile.

Guidance on how to interpret the contents of this table can be found here

0. AdverseEvent
InvariantsaeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion. ((seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria').exists().not() ))
2. AdverseEvent.extension
SlicingThis element introduces a set of slices on AdverseEvent.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 4. AdverseEvent.extension:caused-subject-to-discontinue-study
    Slice Namecaused-subject-to-discontinue-study
    Control0..1
    TypeExtension(Adverse event caused subject to discontinue the study) (Extension Type: boolean)
    6. AdverseEvent.extension:seriousness-criteria
    Slice Nameseriousness-criteria
    Control0..*
    TypeExtension(Criteria reviewed in determining serious adverse event) (Complex Extension)
    8. AdverseEvent.extension:ae-severity
    Slice Nameae-severity
    ShortThe degree of something undesirable
    Control0..1
    TypeExtension(Adverse Event Severity) (Extension Type: CodeableConcept)
    10. AdverseEvent.extension:ae-grade
    Slice Nameae-grade
    ShortThe degree of something undesirable, used in oncology trials
    Control0..1
    TypeExtension(Adverse Event Grade) (Extension Type: CodeableConcept)
    12. AdverseEvent.actuality
    Shortactual
    Pattern Valueactual
    14. AdverseEvent.code
    Control1..?
    16. AdverseEvent.occurrence[x]
    TypePeriod, dateTime, Timing
    [x] NoteSee Choice of Data Types for further information about how to use [x]
    Must Supporttrue
    18. AdverseEvent.resultingEffect
    Definition

    Information about the condition that occurred as a result of the adverse event.

    20. AdverseEvent.seriousness
    ShortInvestigator defined severity of the adverse event, in relation to the subject not the resulting condition
    Control1..?
    BindingThe codes SHALL be taken from AdverseEventSeriousness
    (required to http://hl7.org/fhir/ValueSet/adverse-event-seriousness)
    Must Supporttrue
    22. AdverseEvent.outcome
    Control1..1
    BindingThe codes SHALL be taken from Adverse Event Clinical Research Outcomes
    (required to http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes)
    Must Supporttrue
    24. AdverseEvent.study
    Control1..1
    Must Supporttrue
    26. AdverseEvent.suspectEntity
    28. AdverseEvent.suspectEntity.causality
    Control1..?
    Must Supporttrue
    30. AdverseEvent.suspectEntity.causality.assessmentMethod
    ShortMethod of evaluating the relatedness of the suspected entity to the event.
    BindingThe codes SHOULD be taken from AdverseEventCausalityMethod
    (preferred to http://hl7.org/fhir/ValueSet/adverse-event-causality-method)

    Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.

    32. AdverseEvent.suspectEntity.causality.entityRelatedness
    BindingThe codes SHOULD be taken from Adverse Event Clinical Research Causality Relatedness
    (preferred to http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness)
    34. AdverseEvent.preventiveAction
    Control0..0