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: Participant

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

Indicates who or what participated in the adverse event and how they were involved.

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/adverse-event-compass-ex1, AdverseEvent/adverse-event-compass-ex1a, AdverseEvent/adverse-event-compass-ex1b, AdverseEvent/adverse-event-compass-ex2 and AdverseEvent/adverse-event-device-death

### 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: Indicates who or what participated in the adverse event and how they were involved.

- function: CodeableConcept: An Extension
- actor: Reference: An Extension

Maturity: 2

This structure is derived from Extension

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Participant
extension |  | 1..* | Extension | Extension
extension:function |  | 0..1 | Extension | Type of involvement
extension |  | 0..0 |  |
url |  | 1..1 | uri | "function"
Slices for value[x] |  | 0..1 | CodeableConcept | Value of extension Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | Value of extension Binding: Adverse Event Participant Functions (example)
extension:actor |  | 1..1 | Extension | Who was involved in the adverse event or the potential adverse event
extension |  | 0..0 |  |
url |  | 1..1 | uri | "actor"
Slices for value[x] |  | 0..1 | Reference() | Value of extension Slice: Unordered, Open by type:$this
value[x]:valueReference |  | 0..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | Value of extension
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant"
value[x] |  | 0..0 |  |
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Participant
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:function |  | 0..1 | Extension | Type of involvement
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "function"
Slices for value[x] |  | 0..1 | CodeableConcept | Value of extension Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | Value of extension Binding: Adverse Event Participant Functions (example)
extension:actor |  | 1..1 | Extension | Who was involved in the adverse event or the potential adverse event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "actor"
Slices for value[x] |  | 0..1 | Reference() | Value of extension Slice: Unordered, Closed by type:$this
value[x]:valueReference |  | 0..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | Value of extension
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant"
Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: Indicates who or what participated in the adverse event and how they were involved.

- function: CodeableConcept: An Extension
- actor: Reference: An Extension

Maturity: 2

Differential View

This structure is derived from Extension

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Participant
extension |  | 1..* | Extension | Extension
extension:function |  | 0..1 | Extension | Type of involvement
extension |  | 0..0 |  |
url |  | 1..1 | uri | "function"
Slices for value[x] |  | 0..1 | CodeableConcept | Value of extension Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | Value of extension Binding: Adverse Event Participant Functions (example)
extension:actor |  | 1..1 | Extension | Who was involved in the adverse event or the potential adverse event
extension |  | 0..0 |  |
url |  | 1..1 | uri | "actor"
Slices for value[x] |  | 0..1 | Reference() | Value of extension Slice: Unordered, Open by type:$this
value[x]:valueReference |  | 0..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | Value of extension
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant"
value[x] |  | 0..0 |  |
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Participant
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:function |  | 0..1 | Extension | Type of involvement
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "function"
Slices for value[x] |  | 0..1 | CodeableConcept | Value of extension Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | Value of extension Binding: Adverse Event Participant Functions (example)
extension:actor |  | 1..1 | Extension | Who was involved in the adverse event or the potential adverse event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "actor"
Slices for value[x] |  | 0..1 | Reference() | Value of extension Slice: Unordered, Closed by type:$this
value[x]:valueReference |  | 0..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | Value of extension
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant"
Documentation for this format

Other representations of profile: CSV, Excel, Schematron

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Extension.extension:function.value[x]:valueCodeableConcept | example | AdverseEventParticipantFunction `http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-participant-function-vs` 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() |