Adverse Event Clinical Research R4 Backport
1.0.1 - STU1

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:

- Use this Extension: Adverse Event Clinical Research
- Examples for this Extension: AdverseEvent/SeriousAdverseEventResearchStudy, AdverseEvent/adverse-event-compass-ex1, AdverseEvent/adverse-event-compass-ex1a, AdverseEvent/adverse-event-compass-ex1b... Show 2 more, AdverseEvent/adverse-event-compass-ex2 and AdverseEvent/clinical-research-ae-example-medwatch-patient-report

### Formal Views of Extension Content

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

- Text Summary
- Differential Table
- Snapshot Table
- All

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

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
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"
value[x] |  | 0..0 |  |
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
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.
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info"
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

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
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"
value[x] |  | 0..0 |  |
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
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.
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info"
Documentation for this format

Other representations of profile: CSV, Excel, Schematron

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Extension.extension:item.value[x]:valueCodeableConcept | example | AdverseEventSupportingInformation `http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-supporting-info` from this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |