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: Supporting information relevant to the event

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

Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject’s medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.

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: Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.

  • item: CodeableConcept, Reference: An Extension

Maturity: 2

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Supporting information relevant to the event
... extension 1..* Extension Extension
... extension:item 1..1 Extension Subject medical history or document relevant to this adverse event
.... extension 0..0
.... url 1..1 uri "item"
.... Slices for value[x] 0..1 CodeableConcept, Reference() Value of extension
Slice: Unordered, Open by type:$this
..... value[x]:valueReference 0..1 Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse) Value of extension
..... value[x]:valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: AdverseEvent Supporting Information (example): Codes describing the supporting information relevant to the event.

... url 1..1 uri "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info"

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Supporting information relevant to the event
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
... extension:item 1..1 Extension Subject medical history or document relevant to this adverse event
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..0
.... url 1..1 uri "item"
.... Slices for value[x] 0..1 Value of extension
Slice: Unordered, Closed by type:$this
..... valueCodeableConcept CodeableConcept
..... valueReference Reference(Any)
..... value[x]:valueReference 0..1 Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse) Value of extension
..... value[x]:valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: AdverseEvent Supporting Information (example): Codes describing the supporting information relevant to the event.


doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.

  • item: CodeableConcept, Reference: An Extension

Maturity: 2

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Supporting information relevant to the event
... extension 1..* Extension Extension
... extension:item 1..1 Extension Subject medical history or document relevant to this adverse event
.... extension 0..0
.... url 1..1 uri "item"
.... Slices for value[x] 0..1 CodeableConcept, Reference() Value of extension
Slice: Unordered, Open by type:$this
..... value[x]:valueReference 0..1 Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse) Value of extension
..... value[x]:valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: AdverseEvent Supporting Information (example): Codes describing the supporting information relevant to the event.

... url 1..1 uri "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info"

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Supporting information relevant to the event
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
... extension:item 1..1 Extension Subject medical history or document relevant to this adverse event
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..0
.... url 1..1 uri "item"
.... Slices for value[x] 0..1 Value of extension
Slice: Unordered, Closed by type:$this
..... valueCodeableConcept CodeableConcept
..... valueReference Reference(Any)
..... value[x]:valueReference 0..1 Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse) Value of extension
..... value[x]:valueCodeableConcept 0..1 CodeableConcept Value of extension
Binding: AdverseEvent Supporting Information (example): Codes describing the supporting information relevant to the event.


doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSetURI
Extension.extension:item.value[x]:valueCodeableConceptexampleAdverseEventSupportingInformation
http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-supporting-info
from this IG

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()