Adverse Event Clinical Research R4 Backport
1.0.1 - STU1 International flag

Adverse Event Clinical Research R4 Backport, 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-backport-ig/ and changes regularly. See the Directory of published versions

Extension: Criteria reviewed in determining serious adverse event

Official URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria Version: 1.0.1
Standards status: Trial-use Maturity Level: 2 Computable Name: SeriousnessCriteria

Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.

Context of Use

This extension may be used on the following element(s):

  • Element ID AdverseEvent

Usage info

Usage:

Formal Views of Extension Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

This structure is derived from Extension

Summary

Complex Extension: Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.

  • criterionCode: CodeableConcept: An Extension
  • criterionPresent: boolean: An Extension

Maturity: 2

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Criteria reviewed in determining serious adverse event
... extension 2..* Extension Extension
... extension:criterionCode S 1..1 Extension Action criteria usually associated with events that pose a threat to a patient's life or functioning
.... extension 0..0
.... url 1..1 uri "criterionCode"
.... value[x] 1..1 CodeableConcept Value of extension
Binding: Adverse Event Clinical Research Seriousness Criteria (extensible)
... extension:criterionPresent 1..1 Extension Presence or absence of the specified criteria
.... extension 0..0
.... url 1..1 uri "criterionPresent"
.... value[x] 1..1 boolean Value of extension
... value[x] 0..0

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Criteria reviewed in determining serious adverse event
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
... extension:criterionCode S 1..1 Extension Action criteria usually associated with events that pose a threat to a patient's life or functioning
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..0
.... url 1..1 uri "criterionCode"
.... value[x] 1..1 CodeableConcept Value of extension
Binding: Adverse Event Clinical Research Seriousness Criteria (extensible)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..0
.... url 1..1 uri "criterionPresent"
.... value[x] 1..1 boolean Value of extension
... url 1..1 uri "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.

  • criterionCode: CodeableConcept: An Extension
  • criterionPresent: boolean: An Extension

Maturity: 2

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Criteria reviewed in determining serious adverse event
... extension 2..* Extension Extension
... extension:criterionCode S 1..1 Extension Action criteria usually associated with events that pose a threat to a patient's life or functioning
.... extension 0..0
.... url 1..1 uri "criterionCode"
.... value[x] 1..1 CodeableConcept Value of extension
Binding: Adverse Event Clinical Research Seriousness Criteria (extensible)
... extension:criterionPresent 1..1 Extension Presence or absence of the specified criteria
.... extension 0..0
.... url 1..1 uri "criterionPresent"
.... value[x] 1..1 boolean Value of extension
... value[x] 0..0

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Criteria reviewed in determining serious adverse event
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
... extension:criterionCode S 1..1 Extension Action criteria usually associated with events that pose a threat to a patient's life or functioning
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..0
.... url 1..1 uri "criterionCode"
.... value[x] 1..1 CodeableConcept Value of extension
Binding: Adverse Event Clinical Research Seriousness Criteria (extensible)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..0
.... url 1..1 uri "criterionPresent"
.... value[x] 1..1 boolean Value of extension
... url 1..1 uri "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSetURI
Extension.extension:criterionCode.value[x]extensibleAdverseEventCRSerCrit
http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-seriousness-criteria

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()