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: Expected In Research Study

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

Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.

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/AdverseEventFromProcedureNotStudyDrug, AdverseEvent/NonSeriousAdverseEventResearchStudyMed, AdverseEvent/SeriousAdverseEventResearchStudy, AdverseEvent/adverse-event-compass-ex1... Show 4 more, 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

Simple Extension of type boolean: Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.

Maturity: 2

This structure is derived from Extension

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Expected In Research Study
extension |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study"
value[x] |  | 0..1 | boolean | Value of extension
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Expected In Research Study
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study"
value[x] |  | 0..1 | boolean | Value of extension
Documentation for this format

This structure is derived from Extension

Summary

Simple Extension of type boolean: Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.

Maturity: 2

Differential View

This structure is derived from Extension

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Expected In Research Study
extension |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study"
value[x] |  | 0..1 | boolean | Value of extension
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Expected In Research Study
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study"
value[x] |  | 0..1 | boolean | Value of extension
Documentation for this format

Other representations of profile: CSV, Excel, Schematron

#### 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() |