Scope and Usage

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.

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints
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.
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
caused-subject-to-discontinue-study		0..1	boolean	Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-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-ig/StructureDefinition/seriousness-criteria
severity-or-grade		0..1	CodeableConcept	The degree of something undesirable URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/severity-or-grade Binding: AdverseEvent Severity or Grade Value Set (preferred)
actuality		1..1	code	actual Required Pattern: actual
occurrence[x]	S	0..1	Period	When the event occurred
resultingEffect		0..*	Reference(Condition | Observation)	Effect on the subject due to this event
seriousness	S	1..1	CodeableConcept	Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: AdverseEventSeriousness (required)
outcome	S	1..1	CodeableConcept	Type of outcome from the adverse event Binding: Adverse Event Clinical Research Outcomes (required)
study	S	1..1	Reference(ResearchStudy)	Research study that the subject is enrolled in
suspectEntity
causality	S	1..1	BackboneElement	Information on the possible cause of the event
assessmentMethod		0..1	CodeableConcept	Method of evaluating the relatedness of the suspected entity to the event. Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.
entityRelatedness		0..1	CodeableConcept	Result of the assessment regarding the relatedness of the suspected entity to the event Binding: Causality Relatedness values (preferred)
preventiveAction		0..0
supportingInfo
item[x]		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: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event.
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
AdverseEvent.seriousness	required	AdverseEventSeriousness
AdverseEvent.outcome	required	OutcomeAEClinRes
AdverseEvent.suspectEntity.causality.assessmentMethod	preferred	AdverseEventCausalityMethod
AdverseEvent.suspectEntity.causality.entityRelatedness	preferred	CausalityRelatedness
AdverseEvent.supportingInfo.item[x]	example	AdverseEventSupportingInforation

Constraints

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-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-ig/StructureDefinition/seriousness-criteria').exists().not() )

This structure is derived from AdverseEvent

Differential View

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints
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.
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
caused-subject-to-discontinue-study		0..1	boolean	Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-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-ig/StructureDefinition/seriousness-criteria
severity-or-grade		0..1	CodeableConcept	The degree of something undesirable URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/severity-or-grade Binding: AdverseEvent Severity or Grade Value Set (preferred)
actuality		1..1	code	actual Required Pattern: actual
occurrence[x]	S	0..1	Period	When the event occurred
resultingEffect		0..*	Reference(Condition | Observation)	Effect on the subject due to this event
seriousness	S	1..1	CodeableConcept	Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: AdverseEventSeriousness (required)
outcome	S	1..1	CodeableConcept	Type of outcome from the adverse event Binding: Adverse Event Clinical Research Outcomes (required)
study	S	1..1	Reference(ResearchStudy)	Research study that the subject is enrolled in
suspectEntity
causality	S	1..1	BackboneElement	Information on the possible cause of the event
assessmentMethod		0..1	CodeableConcept	Method of evaluating the relatedness of the suspected entity to the event. Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.
entityRelatedness		0..1	CodeableConcept	Result of the assessment regarding the relatedness of the suspected entity to the event Binding: Causality Relatedness values (preferred)
preventiveAction		0..0
supportingInfo
item[x]		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: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event.
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
AdverseEvent.seriousness	required	AdverseEventSeriousness
AdverseEvent.outcome	required	OutcomeAEClinRes
AdverseEvent.suspectEntity.causality.assessmentMethod	preferred	AdverseEventCausalityMethod
AdverseEvent.suspectEntity.causality.entityRelatedness	preferred	CausalityRelatedness
AdverseEvent.supportingInfo.item[x]	example	AdverseEventSupportingInforation

Constraints

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-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-ig/StructureDefinition/seriousness-criteria').exists().not() )

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
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.
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
caused-subject-to-discontinue-study		0..1	boolean	Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-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-ig/StructureDefinition/seriousness-criteria
severity-or-grade		0..1	CodeableConcept	The degree of something undesirable URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/severity-or-grade Binding: AdverseEvent Severity or Grade Value Set (preferred)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.
actuality	?!Σ	1..1	code	actual Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual
subject	Σ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
occurrence[x]	SΣ	0..1	Period	When the event occurred
resultingEffect	Σ	0..*	Reference(Condition | Observation)	Effect on the subject due to this event
seriousness	SΣ	1..1	CodeableConcept	Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: AdverseEventSeriousness (required)
outcome	SΣ	1..1	CodeableConcept	Type of outcome from the adverse event Binding: Adverse Event Clinical Research Outcomes (required)
study	SΣ	1..1	Reference(ResearchStudy)	Research study that the subject is enrolled in
suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
causality	SΣ	1..1	BackboneElement	Information on the possible cause of the event
modifierExtension	?!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: AdverseEventCausalityMethod (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: Causality Relatedness values (preferred)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
AdverseEvent.status	required	AdverseEventStatus
AdverseEvent.actuality	required	Pattern: actual
AdverseEvent.seriousness	required	AdverseEventSeriousness
AdverseEvent.outcome	required	OutcomeAEClinRes
AdverseEvent.suspectEntity.causality.assessmentMethod	preferred	AdverseEventCausalityMethod
AdverseEvent.suspectEntity.causality.entityRelatedness	preferred	CausalityRelatedness
AdverseEvent.preventiveAction.item[x]	example	AdverseEventPreventiveAction

Constraints

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-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-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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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	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
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: AllLanguages (required): IETF language tag for 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
caused-subject-to-discontinue-study		0..1	boolean	Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-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-ig/StructureDefinition/seriousness-criteria
severity-or-grade		0..1	CodeableConcept	The degree of something undesirable URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/severity-or-grade Binding: AdverseEvent Severity or Grade Value Set (preferred)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business identifier for the event
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an 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	wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Binding: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational.
code	Σ	0..1	CodeableConcept	Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event.
subject	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
occurrence[x]	SΣ	0..1	Period	When the event occurred
detected	Σ	0..1	dateTime	When the event was detected
recordedDate	Σ	0..1	dateTime	When the event was recorded
resultingEffect	Σ	0..*	Reference(Condition | Observation)	Effect on the subject due to this event
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: AdverseEventSeriousness (required)
outcome	SΣ	1..1	CodeableConcept	Type of outcome from the adverse event Binding: Adverse Event Clinical Research Outcomes (required)
recorder	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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
function	Σ	0..1	CodeableConcept	Type of involvement Binding: AdverseEventParticipantFunction (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
study	SΣ	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
suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event
instanceCodeableConcept			CodeableConcept
instanceReference			Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
causality	SΣ	1..1	BackboneElement	Information on the possible cause of the event
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!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: AdverseEventCausalityMethod (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: Causality Relatedness values (preferred)
author	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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
itemCodeableConcept			CodeableConcept
mitigatingAction	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
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
item[x]	Σ	1..1		Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Binding: AdverseEventMitigatingAction (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm.
itemReference			Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
itemCodeableConcept			CodeableConcept
supportingInfo	Σ	0..*	BackboneElement	Supporting information relevant to the event
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
item[x]	Σ	1..1		Subject medical history or document relevant to this adverse event Binding: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse)
itemCodeableConcept			CodeableConcept
note	Σ	0..*	Annotation	Comment on adverse event
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
AdverseEvent.language	required	AllLanguages
AdverseEvent.status	required	AdverseEventStatus
AdverseEvent.actuality	required	Pattern: actual
AdverseEvent.category	example	AdverseEventCategory
AdverseEvent.code	example	AdverseEventType
AdverseEvent.seriousness	required	AdverseEventSeriousness
AdverseEvent.outcome	required	OutcomeAEClinRes
AdverseEvent.participant.function	example	AdverseEventParticipantFunction
AdverseEvent.suspectEntity.causality.assessmentMethod	preferred	AdverseEventCausalityMethod
AdverseEvent.suspectEntity.causality.entityRelatedness	preferred	CausalityRelatedness
AdverseEvent.contributingFactor.item[x]	example	AdverseEventContributingFactor
AdverseEvent.preventiveAction.item[x]	example	AdverseEventPreventiveAction
AdverseEvent.mitigatingAction.item[x]	example	AdverseEventMitigatingAction
AdverseEvent.supportingInfo.item[x]	example	AdverseEventSupportingInforation

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()

This structure is derived from AdverseEvent