Adverse Event Clinical Research R4 Backport
1.0.0-ballot - ballot
Adverse Event Clinical Research R4 Backport
1.0.0-ballot - ballot
This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions 
| Official URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research | Version: 1.0.0-ballot | |||
| Standards status: Trial-use | Maturity Level: 2 | Computable Name: AdverseEventClinicalResearch | ||
An example profile of AdverseEvent for Research reporting.
The Clinical Research adverse event profile of AdverseEvent, is for the clinical research setting. Adverse events are tracked and evaluated as part of the clinical research process in a research study, as the occurrence of an adverse event may surface a potential confounder or a potential side-effect of the study treatment. In the research setting an adverse event is the result of an intervention that caused unintentional harm to a specific subject or group of subjects, potential adverse events are not reported (this is surfaced in the profile as a constraint of ‘actual’ for the value of ‘actuality’). Examples of adverse events include the administration of an incorrect drug or an incorrect dose of a drug causing an adverse reaction, the use of an implanted device that causes an infection, or a biologic used during a research study that causes unanticipated renal failure. These events are characterized by the need to capture cause and effect (although they might not be known at the time of the event), severity, and outcome.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from AdverseEvent
| Path | Conformance | ValueSet |
| AdverseEvent.modifierExtension:status [CanonicalType[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]] | required | |
| AdverseEvent.event | example | AdverseEventType |
| AdverseEvent.seriousness | required | AdverseEventSeriousnessNonOnly |
| AdverseEvent.outcome | required | OutcomeAEClinRes |
| Id | Grade | Path(s) | Details | Requirements |
| aeClinRes-seriousness-1 | error | AdverseEvent | If seriousness is serious then must have at least one seriousness criterion. : (seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists().not() ) |
| Path | Conformance | ValueSet / Code |
| AdverseEvent.actuality | required | Pattern: actual |
| AdverseEvent.event | example | AdverseEventType |
| AdverseEvent.seriousness | required | AdverseEventSeriousnessNonOnly |
| AdverseEvent.outcome | required | OutcomeAEClinRes |
| Id | Grade | Path(s) | Details | Requirements |
| aeClinRes-seriousness-1 | error | AdverseEvent | If seriousness is serious then must have at least one seriousness criterion. : (seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists().not() ) | |
| dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | AdverseEvent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() | |
| 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() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
  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. | ||||
  id | Σ | 0..1 | id | Logical id of this artifact | ||||
 meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
 Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
 research-subject-ref | 0..1 | Reference(ResearchSubject) | Research Subject record of subject URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref | |||||
| caused-subject-to-discontinue-study | 0..1 | boolean | Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study | |||||
| seriousness-criteria | 0..* | (Complex) | Criteria reviewed in determining serious adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria | |||||
| severity-or-grade | 0..1 | CodeableConcept | The degree of something undesirable URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/severity-or-grade Binding: AdverseEvent Severity or Grade Value Set (preferred) | |||||
| expected-in-research-study | 0..1 | boolean | Considered likely or probable or anticipated in the research study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study | |||||
| note | 0..* | Annotation | Comment on adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note | |||||
| resolve-date | 0..1 | dateTime | Adverse Event resolution date URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date | |||||
| suspect-entity | Σ | 0..* | (Complex) | A suspected agent causing the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity | ||||
| contributing-factor | Σ | 0..* | (Complex) | Contributing factors suspected to have increased the probability or severity of the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor | ||||
| mitigating-action | Σ | 0..* | (Complex) | Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action | ||||
| supporting-info | Σ | 0..* | (Complex) | Subject medical history or document relevant to this adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info | ||||
| participant | 0..* | (Complex) | Who was involved in the adverse event or the potential adverse event and what they did URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant | |||||
| resultingEffect | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect | |||||
 Slices for modifierExtension | ?! | 1..* | Extension | Extension Slice: Unordered, Open by value:url | ||||
| modifierExtension:status | ?!Σ | 1..1 | Status | in-progress | completed | entered-in-error | unknown | ||||
| identifier | Σ | 0..1 | Identifier | Business identifier for the event | ||||
| actuality | ?!Σ | 1..1 | code | actual Binding: AdverseEventActuality (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: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational. | ||||
| event | Σ | 0..1 | CodeableConcept | Event or incident that occurred or was averted Binding: AdverseEvent Type (example): Detailed type of event. | ||||
 subject | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event | ||||
| encounter | Σ | 0..1 | Reference(Encounter) | Encounter created as part of | ||||
| date | Σ | 0..1 | dateTime | When the event occurred | ||||
| detected | Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate | Σ | 0..1 | dateTime | When the event was recorded | ||||
| location | Σ | 0..1 | Reference(Location) | Location where adverse event occurred | ||||
| seriousness | SΣ | 1..1 | CodeableConcept | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: AdverseEvent Seriousness Non-serious Codes Only (required) | ||||
| outcome | SΣ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: Adverse Event Clinical Research Outcomes (required) | ||||
| recorder | 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 | ||||
 study | SΣ | 1..1 | Reference(ResearchStudy) | AdverseEvent.study | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | ||||
| AdverseEvent.language | preferred | CommonLanguages
| ||||
| AdverseEvent.actuality | required | Pattern: actual | ||||
| AdverseEvent.category | extensible | AdverseEventCategory | ||||
| AdverseEvent.event | example | AdverseEventType | ||||
| AdverseEvent.seriousness | required | AdverseEventSeriousnessNonOnly | ||||
| AdverseEvent.outcome | required | OutcomeAEClinRes | ||||
| AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessment | ||||
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethod |
| 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() |
This structure is derived from AdverseEvent
Summary
Mandatory: 5 elements
Must-Support: 3 elements
Prohibited: 5 elements
Extensions
This structure refers to these extensions:
Maturity: 2
Differential View
This structure is derived from AdverseEvent
| Path | Conformance | ValueSet |
| AdverseEvent.modifierExtension:status [CanonicalType[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]] | required | |
| AdverseEvent.event | example | AdverseEventType |
| AdverseEvent.seriousness | required | AdverseEventSeriousnessNonOnly |
| AdverseEvent.outcome | required | OutcomeAEClinRes |
| Id | Grade | Path(s) | Details | Requirements |
| aeClinRes-seriousness-1 | error | AdverseEvent | If seriousness is serious then must have at least one seriousness criterion. : (seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists().not() ) |
Key Elements View
| Path | Conformance | ValueSet / Code |
| AdverseEvent.actuality | required | Pattern: actual |
| AdverseEvent.event | example | AdverseEventType |
| AdverseEvent.seriousness | required | AdverseEventSeriousnessNonOnly |
| AdverseEvent.outcome | required | OutcomeAEClinRes |
| Id | Grade | Path(s) | Details | Requirements |
| aeClinRes-seriousness-1 | error | AdverseEvent | If seriousness is serious then must have at least one seriousness criterion. : (seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists().not() ) | |
| dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | AdverseEvent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() | |
| 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() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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. | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| research-subject-ref | 0..1 | Reference(ResearchSubject) | Research Subject record of subject URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref | |||||
| caused-subject-to-discontinue-study | 0..1 | boolean | Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study | |||||
| seriousness-criteria | 0..* | (Complex) | Criteria reviewed in determining serious adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria | |||||
| severity-or-grade | 0..1 | CodeableConcept | The degree of something undesirable URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/severity-or-grade Binding: AdverseEvent Severity or Grade Value Set (preferred) | |||||
| expected-in-research-study | 0..1 | boolean | Considered likely or probable or anticipated in the research study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study | |||||
| note | 0..* | Annotation | Comment on adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note | |||||
| resolve-date | 0..1 | dateTime | Adverse Event resolution date URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date | |||||
| suspect-entity | Σ | 0..* | (Complex) | A suspected agent causing the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity | ||||
| contributing-factor | Σ | 0..* | (Complex) | Contributing factors suspected to have increased the probability or severity of the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor | ||||
| mitigating-action | Σ | 0..* | (Complex) | Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action | ||||
| supporting-info | Σ | 0..* | (Complex) | Subject medical history or document relevant to this adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info | ||||
| participant | 0..* | (Complex) | Who was involved in the adverse event or the potential adverse event and what they did URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant | |||||
| resultingEffect | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect | |||||
| Slices for modifierExtension | ?! | 1..* | Extension | Extension Slice: Unordered, Open by value:url | ||||
| modifierExtension:status | ?!Σ | 1..1 | Status | in-progress | completed | entered-in-error | unknown | ||||
| identifier | Σ | 0..1 | Identifier | Business identifier for the event | ||||
| actuality | ?!Σ | 1..1 | code | actual Binding: AdverseEventActuality (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: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational. | ||||
| event | Σ | 0..1 | CodeableConcept | Event or incident that occurred or was averted Binding: AdverseEvent Type (example): Detailed type of event. | ||||
| subject | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event | ||||
| encounter | Σ | 0..1 | Reference(Encounter) | Encounter created as part of | ||||
| date | Σ | 0..1 | dateTime | When the event occurred | ||||
| detected | Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate | Σ | 0..1 | dateTime | When the event was recorded | ||||
| location | Σ | 0..1 | Reference(Location) | Location where adverse event occurred | ||||
| seriousness | SΣ | 1..1 | CodeableConcept | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: AdverseEvent Seriousness Non-serious Codes Only (required) | ||||
| outcome | SΣ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: Adverse Event Clinical Research Outcomes (required) | ||||
| recorder | 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 | ||||
| study | SΣ | 1..1 | Reference(ResearchStudy) | AdverseEvent.study | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | ||||
| AdverseEvent.language | preferred | CommonLanguages
| ||||
| AdverseEvent.actuality | required | Pattern: actual | ||||
| AdverseEvent.category | extensible | AdverseEventCategory | ||||
| AdverseEvent.event | example | AdverseEventType | ||||
| AdverseEvent.seriousness | required | AdverseEventSeriousnessNonOnly | ||||
| AdverseEvent.outcome | required | OutcomeAEClinRes | ||||
| AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessment | ||||
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethod |
| 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() |
This structure is derived from AdverseEvent
Summary
Mandatory: 5 elements
Must-Support: 3 elements
Prohibited: 5 elements
Extensions
This structure refers to these extensions:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron
IG © 2020+ HL7 International - Biomedical Research and Regulation, Vulcan AdverseEvent groups. Package hl7.fhir.uv.ae-research-backport-ig#1.0.0-ballot based on FHIR 4.0.1. Generated 2023-07-28
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