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

Left: | Adverse Event Clinical Research (http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research)
Right: | Adverse Event Clinical Research (http://hl7.org/fhir/uv/ae-research-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: '2024-04-15T17:39:57+00:00' vs '2024-04-30T19:42:09+00:00'

### Metadata

Name | Value | Comments
--- | --- | ---
abstract | false |
baseDefinition | http://hl7.org/fhir/StructureDefinition/AdverseEvent |
copyright |  |
date | 2024-04-15T17:39:57+00:00 | 2024-04-30T19:42:09+00:00 | Values Differ
description | Foundational profile of AdverseEvent for Clinical Research communications. |
experimental |  |
fhirVersion | 5.0.0 |
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-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 | An event that may be related to unintended effects on a patient or research participant aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion. | C | 0..* | AdverseEvent | An event that may be related to unintended effects on a patient or research participant 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: ?? (required): IETF language tag for a human language
Additional Bindings | Purpose
?? | Starter
|  | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
Additional Bindings | Purpose
?? | Starter
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 |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
identifier | Σ | 0..* | Identifier | Business identifier for the event | Σ | 0..* | Identifier | Business identifier for the event |
status | ?!Σ | 1..1 | code | in-progress | completed | entered-in-error | unknown Binding: ?? (required): Codes identifying the lifecycle stage of an event. | ?!Σ | 1..1 | code | in-progress | completed | entered-in-error | unknown Binding: ?? (required): Codes identifying the lifecycle stage of an 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 | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Binding: ?? (example): Overall categorization of the event, e.g. product-related or situational. | Σ | 0..* | CodeableConcept | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Binding: ?? (example): Overall categorization of the event, e.g. product-related or situational. |
code | 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 | ResearchSubject) | Subject impacted by event | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Subject impacted by event |
encounter | Σ | 0..1 | Reference(Encounter) | The Encounter associated with the start of the AdverseEvent | Σ | 0..1 | Reference(Encounter) | The Encounter associated with the start of the AdverseEvent |
occurrence[x] | S Σ | 0..1 | Period | When the event occurred | S Σ | 0..1 | Period | 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 |
resultingEffect | Σ | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event | Σ | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event |
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) |
outcome | S Σ | 1..1 | CodeableConcept | Type of outcome from the adverse event Binding: ?? (required) | S Σ | 1..1 | CodeableConcept | Type of outcome from the adverse event Binding: ?? (required) |
recorder | Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Who recorded the adverse event | Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Who recorded the adverse event |
participant | Σ | 0..* | BackboneElement | Who was involved in the adverse event or the potential adverse event and what they did | Σ | 0..* | BackboneElement | Who was involved in the adverse event or the potential adverse event and what they did |
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 |
function | Σ | 0..1 | CodeableConcept | Type of involvement Binding: ?? (example): Codes describing the type of involvement of the actor in the adverse event. | Σ | 0..1 | CodeableConcept | Type of involvement Binding: ?? (example): Codes describing the type of involvement of the actor in the adverse event. |
actor | Σ | 1..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | Who was involved in the adverse event or the potential adverse event | Σ | 1..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | Who was involved in the adverse event or the potential adverse event |
study | S Σ | 1..1 | Reference(ResearchStudy) | Research study that the subject is enrolled in | S Σ | 1..1 | Reference(ResearchStudy) | Research study that the subject is enrolled in |
expectedInResearchStudy |  | 0..1 | boolean | Considered likely or probable or anticipated in the research study |  | 0..1 | boolean | Considered likely or probable or anticipated in the research study |
suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event | Σ | 0..* | BackboneElement | The suspected agent causing the adverse 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 |
instance[x] | Σ | 1..1 | CodeableConcept, Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | Refers to the specific entity that caused the adverse event | Σ | 1..1 | CodeableConcept, Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | Refers to the specific entity that caused the adverse event |
causality | S Σ | 1..1 | BackboneElement | Information on the possible cause of the event | S Σ | 1..1 | 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 |
assessmentMethod | Σ | 0..1 | CodeableConcept | Method of evaluating the relatedness of the suspected entity to the event. Binding: ?? (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist. | Σ | 0..1 | CodeableConcept | Method of evaluating the relatedness of the suspected entity to the event. Binding: ?? (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist. |
entityRelatedness | Σ | 0..1 | CodeableConcept | Result of the assessment regarding the relatedness of the suspected entity to the event Binding: ?? (preferred) | Σ | 0..1 | CodeableConcept | Result of the assessment regarding the relatedness of the suspected entity to the event Binding: ?? (preferred) |
author | Σ | 0..1 | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject) | Author of the information on the possible cause of the event | Σ | 0..1 | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject) | Author of the information on the possible cause of the event |
contributingFactor | Σ | 0..* | BackboneElement | Contributing factors suspected to have increased the probability or severity of the adverse event | Σ | 0..* | BackboneElement | Contributing factors suspected to have increased the probability or severity of the adverse 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 |
item[x] | Σ | 1..1 | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement), CodeableConcept | Item suspected to have increased the probability or severity of the adverse event Binding: ?? (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event. | Σ | 1..1 | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement), CodeableConcept | Item suspected to have increased the probability or severity of the adverse event Binding: ?? (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event. |
preventiveAction | 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 |
item[x] | Σ | 1..1 | Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest), CodeableConcept | Action that contributed to avoiding the adverse event Binding: ?? (example): Codes describing the preventive actions that contributed to avoiding the adverse event. | Σ | 1..1 | Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest), CodeableConcept | Action that contributed to avoiding the adverse event Binding: ?? (example): Codes describing the preventive actions that contributed to avoiding the adverse event. |
mitigatingAction | Σ | 0..* | BackboneElement | Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm | Σ | 0..* | BackboneElement | Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm |
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 |
item[x] | Σ | 1..1 | Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest), CodeableConcept | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Binding: ?? (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm. | Σ | 1..1 | Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest), CodeableConcept | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Binding: ?? (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm. |
supportingInfo | Σ | 0..* | BackboneElement | Supporting information relevant to the event | Σ | 0..* | BackboneElement | Supporting information relevant to 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 |
item[x] | Σ | 1..1 | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse), CodeableConcept | Subject medical history or document relevant to this adverse event Binding: ?? (example): Codes describing the supporting information relevant to the event. | Σ | 1..1 | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse), CodeableConcept | Subject medical history or document relevant to this adverse event Binding: ?? (example): Codes describing the supporting information relevant to the event. |
note | Σ | 0..* | Annotation | Comment on adverse event | Σ | 0..* | Annotation | Comment on adverse event |
Documentation for this format