## 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] | S Σ | 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 | S Σ | 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 | S Σ | 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 | S Σ | 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 | S Σ | 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