Union of http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research and http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research

This is the set of resources that conform to either of the profiles Adverse Event Clinical Research (http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research) and Adverse Event Clinical Research (http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research). E.g. what you have to deal with if you get resources conforming to one of them

Structure

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent	C	0..*		An event that may be related to unintended effects on a patient or research participant dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion.
meta	Σ	0..1	Meta	Metadata about the resource ele-1: All FHIR elements must have a @value or children
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
language		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language ele-1: All FHIR elements must have a @value or children
text		0..1	Narrative	Text summary of the resource, for human interpretation ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Extension ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
identifier	Σ	0..*	Identifier	Business identifier for the event ele-1: All FHIR elements must have a @value or children
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: ?? (required): Codes identifying the lifecycle stage of an event. ele-1: All FHIR elements must have a @value or children
actuality	?!Σ	1..1	code	actual Binding: ?? (required): Overall nature of the adverse event, e.g. real or potential. ele-1: All FHIR elements must have a @value or children
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. ele-1: All FHIR elements must have a @value or children
code	Σ	1..1	CodeableConcept	Event or incident that occurred or was averted Binding: ?? (example): Detailed type of event. ele-1: All FHIR elements must have a @value or children
subject	Σ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event ele-1: All FHIR elements must have a @value or children
encounter	Σ	0..1	Reference(Encounter)	The Encounter associated with the start of the AdverseEvent ele-1: All FHIR elements must have a @value or children
occurrence[x]	SΣ	0..1	Period	When the event occurred ele-1: All FHIR elements must have a @value or children
detected	Σ	0..1	dateTime	When the event was detected ele-1: All FHIR elements must have a @value or children
recordedDate	Σ	0..1	dateTime	When the event was recorded ele-1: All FHIR elements must have a @value or children
resultingEffect	Σ	0..*	Reference(Condition | Observation)	Effect on the subject due to this event ele-1: All FHIR elements must have a @value or children
location	Σ	0..1	Reference(Location)	Location where adverse event occurred ele-1: All FHIR elements must have a @value or children
seriousness	SΣ	1..1	CodeableConcept	Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: ?? (required) ele-1: All FHIR elements must have a @value or children
outcome	SΣ	1..1	CodeableConcept	Type of outcome from the adverse event Binding: ?? (required) ele-1: All FHIR elements must have a @value or children
recorder	Σ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Who recorded the adverse event ele-1: All FHIR elements must have a @value or children
participant	Σ	0..*	BackboneElement	Who was involved in the adverse event or the potential adverse event and what they did ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
function	Σ	0..1	CodeableConcept	Type of involvement Binding: ?? (example): Codes describing the type of involvement of the actor in the adverse event. ele-1: All FHIR elements must have a @value or children
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 ele-1: All FHIR elements must have a @value or children
study	SΣ	1..1	Reference(ResearchStudy)	Research study that the subject is enrolled in ele-1: All FHIR elements must have a @value or children
expectedInResearchStudy		0..1	boolean	Considered likely or probable or anticipated in the research study ele-1: All FHIR elements must have a @value or children
suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
instance[x]	Σ	1..1		Refers to the specific entity that caused the adverse event ele-1: All FHIR elements must have a @value or children
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 ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
entityRelatedness	Σ	0..1	CodeableConcept	Result of the assessment regarding the relatedness of the suspected entity to the event Binding: ?? (preferred) ele-1: All FHIR elements must have a @value or children
author	Σ	0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject)	Author of the information on the possible cause of the event ele-1: All FHIR elements must have a @value or children
contributingFactor	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
item[x]	Σ	1..1		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. ele-1: All FHIR elements must have a @value or children
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 ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
item[x]	Σ	1..1		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. ele-1: All FHIR elements must have a @value or children
itemReference			Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
itemCodeableConcept			CodeableConcept
supportingInfo	Σ	0..*	BackboneElement	Supporting information relevant to the event ele-1: All FHIR elements must have a @value or children
extension		0..*	Extension	Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
item[x]	Σ	1..1		Subject medical history or document relevant to this adverse event Binding: ?? (example): Codes describing the supporting information relevant to the event. ele-1: All FHIR elements must have a @value or children
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse)
itemCodeableConcept			CodeableConcept
note	Σ	0..*	Annotation	Comment on adverse event ele-1: All FHIR elements must have a @value or children
Documentation for this format