Adverse Event Clinical Research
1.0.1 - STU1

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

## Extension: Adverse event caused subject to discontinue the study

Official URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-study | Version: 1.0.1
Standards status: Trial-use | Maturity Level: 2 | Computable Name: CausedSubjectToDiscontinueStudy

Indicates if the subject discontinued the study due to the adverse event.

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 and AdverseEvent/SeriousAdverseEventResearchStudy

### 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: Indicates if the subject discontinued the study due to the adverse event.

Maturity: 2

This structure is derived from Extension

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Adverse event caused subject to discontinue the study
extension |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-study"
value[x] |  | 0..1 | boolean | Value of extension
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Adverse event caused subject to discontinue the study
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-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: Indicates if the subject discontinued the study due to the adverse event.

Maturity: 2

Differential View

This structure is derived from Extension

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Adverse event caused subject to discontinue the study
extension |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-study"
value[x] |  | 0..1 | boolean | Value of extension
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Adverse event caused subject to discontinue the study
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-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() |