## Profile Comparison between http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research vs http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research

Left: | Adverse Event Clinical Research (http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research)
Right: | Adverse Event Clinical Research (http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research)

### Messages

Error | StructureDefinition.version | Values for version differ: '1.0.0' vs '1.0.1'
Information | StructureDefinition.date | Values for date differ: '2024-04-17T13:00:29+00:00' vs '2024-04-30T20:04:27+00:00'

### Metadata

Name | Value | Comments
--- | --- | ---
abstract | false |
baseDefinition | http://hl7.org/fhir/StructureDefinition/AdverseEvent |
copyright |  |
date | 2024-04-17T13:00:29+00:00 | 2024-04-30T20:04:27+00:00 | Values Differ
description | Convenience backport into R4 of FHIR R5 Foundational profile of AdverseEvent for Clinical Research communications. |
experimental |  |
fhirVersion | 4.0.1 |
jurisdiction |  |
jurisdiction[0] | http://unstats.un.org/unsd/methods/m49/m49.htm#001 |
kind | resource |
name | AdverseEventClinicalResearch |
publisher | HL7 International / Biomedical Research and Regulation |
purpose |  |
status | active |
title | Adverse Event Clinical Research |
type | AdverseEvent |
url | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research |
version | 1.0.0 | 1.0.1 | Values Differ

### Structure

Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments
--- | --- | --- | --- | --- | --- | --- | --- | --- | ---
AdverseEvent | C | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion. | C | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion. |
id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact |
meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
language |  | 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
Additional Bindings | Purpose
?? | Max Binding
|  | 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
Additional Bindings | Purpose
?? | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation |  | 0..1 | Narrative | Text summary of the resource, for human interpretation |
contained |  | 0..* | Resource | Contained, inline Resources |  | 0..* | Resource | Contained, inline Resources |
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url |
Slices for modifierExtension | ?! | 1..* | Extension | Extension Slice: Unordered, Open by value:url | ?! | 1..* | Extension | Extension Slice: Unordered, Open by value:url |
identifier | Σ | 0..1 | Identifier | Business identifier for the event | Σ | 0..1 | Identifier | Business identifier for the event |
actuality | ?!Σ | 1..1 | code | actual Binding: ?? (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual | ?!Σ | 1..1 | code | actual Binding: ?? (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual |
category | Σ | 0..* | CodeableConcept | product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: ?? (extensible): Overall categorization of the event, e.g. product-related or situational. | Σ | 0..* | CodeableConcept | product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: ?? (extensible): Overall categorization of the event, e.g. product-related or situational. |
event | Σ | 1..1 | CodeableConcept | Event or incident that occurred or was averted Binding: ?? (example): Detailed type of event. | Σ | 1..1 | CodeableConcept | Event or incident that occurred or was averted Binding: ?? (example): Detailed type of event. |
subject | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event |
encounter | Σ | 0..1 | Reference(Encounter) | Encounter created as part of | Σ | 0..1 | Reference(Encounter) | Encounter created as part of |
date | Σ | 0..1 | dateTime | When the event occurred | Σ | 0..1 | dateTime | When the event occurred |
detected | Σ | 0..1 | dateTime | When the event was detected | Σ | 0..1 | dateTime | When the event was detected |
recordedDate | Σ | 0..1 | dateTime | When the event was recorded | Σ | 0..1 | dateTime | When the event was recorded |
resultingCondition | Σ | 0..0 |  |  | Σ | 0..0 |  |  |
location | Σ | 0..1 | Reference(Location) | Location where adverse event occurred | Σ | 0..1 | Reference(Location) | Location where adverse event occurred |
seriousness | S Σ | 1..1 | CodeableConcept | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: ?? (required) | S Σ | 1..1 | CodeableConcept | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: ?? (required) |
severity | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: ?? (required): The severity of the adverse event itself, in direct relation to the subject. | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: ?? (required): The severity of the adverse event itself, in direct relation to the subject. |
outcome | S Σ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: ?? (required) | S Σ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: ?? (required) |
recorder | Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | Who recorded the adverse event | Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | Who recorded the adverse event |
contributor | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event |
suspectEntity | Σ | 0..0 |  |  | Σ | 0..0 |  |  |
id |  | 0..1 | string | Unique id for inter-element referencing |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
instance | Σ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event | Σ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event |
causality | Σ | 0..* | BackboneElement | Information on the possible cause of the event | Σ | 0..* | BackboneElement | Information on the possible cause of the event |
id |  | 0..1 | string | Unique id for inter-element referencing |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
assessment | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: ?? (example): Codes for the assessment of whether the entity caused the event. | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: ?? (example): Codes for the assessment of whether the entity caused the event. |
productRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness |
author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor |
method | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: ?? (example): TODO. | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: ?? (example): TODO. |
subjectMedicalHistory | Σ | 0..0 |  |  | Σ | 0..0 |  |  |
referenceDocument | Σ | 0..0 |  |  | Σ | 0..0 |  |  |
study | S Σ | 1..1 | Reference(ResearchStudy) | AdverseEvent.study | S Σ | 1..1 | Reference(ResearchStudy) | AdverseEvent.study |
Documentation for this format