abstractbaseDefinitioncopyrightdate- Values Differ
descriptionexperimentalfhirVersionjurisdiction
jurisdiction[0]kindnamepublisherpurposestatus- Values Differ
titletypeurlversion- Values Differ
| Left: | ICSR Adverse Event (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-adverseevent) |
| Right: | ICSR Adverse Event (http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-adverseevent) |
| Error | StructureDefinition.version | Values for version differ: '1.0.0' vs '1.0.1' |
| Information | StructureDefinition.status | Values for status differ: 'active' vs 'draft' |
| Information | StructureDefinition.date | Values for date differ: '2022-01-19T13:49:57+00:00' vs '2023-08-29T21:40:08+00:00' |
| Name | Value | Comments | |
|---|---|---|---|
| abstract | true | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/AdverseEvent | ||
| copyright | |||
| date | 2022-01-19T13:49:57+00:00 | 2023-08-29T21:40:08+00:00 |
|
| description | The fields needed to submit an AdverseEvent for a ICSR Report. | ||
| experimental | |||
| fhirVersion | 4.0.1 | ||
| jurisdiction | |||
| jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | ICSRAdverseEvent | ||
| publisher | Biomedical Research & Regulation WG | ||
| purpose | |||
| status | active | draft |
|
| title | ICSR Adverse Event | ||
| type | AdverseEvent | ||
| url | http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-adverseevent | ||
| version | 1.0.0 | 1.0.1 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | L Type | L Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 AdverseEvent | 0..* | AdverseEvent | This is an abstract profile. Child profiles: AdverseEvent, AdverseEvent Medical care, research study or other healthcare event causing physical injury | 0..* | AdverseEvent | This is an abstract profile. Child profiles: AdverseEvent, AdverseEvent Medical care, research study or other healthcare event causing physical injury | |||||||||||
 id | Σ | 0..1 | string | 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: ?? (preferred): A human language.
| 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| |||||||||||
| 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 | ?! | 0..* | Extension | Extensions that cannot be ignored | ?! | 0..* | Extension | Extensions that cannot be ignored | |||||||||
| identifier | SΣ | 0..1 | Identifier | Business identifier for the event | SΣ | 0..1 | Identifier | Business identifier for the event | |||||||||
| actuality | ?!SΣ | 1..1 | code | actual | potential Binding: ?? (required): Overall nature of the adverse event, e.g. real or potential. Fixed Value: actual | ?!SΣ | 1..1 | code | actual | potential Binding: ?? (required): Overall nature of the adverse event, e.g. real or potential. Fixed Value: actual | |||||||||
| category | SΣ | 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: ?? (extensible): Overall categorization of the event, e.g. product-related or situational. | SΣ | 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: ?? (extensible): Overall categorization of the event, e.g. product-related or situational. | |||||||||
 event | SΣ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: ?? (example): Detailed type of event. | SΣ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: ?? (example): Detailed type of event. | |||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | Σ | 0..* | Coding | Code defined by a terminology system | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| system | Σ | 0..1 | uri | Identity of the terminology system Fixed Value: http://meddra.org | Σ | 0..1 | uri | Identity of the terminology system Fixed Value: http://meddra.org | |||||||||
| version | Σ | 0..1 | string | Version of the system - if relevant | Σ | 0..1 | string | Version of the system - if relevant | |||||||||
| code | Σ | 0..1 | code | Symbol in syntax defined by the system | Σ | 0..1 | code | Symbol in syntax defined by the system | |||||||||
| display | Σ | 0..1 | string | Representation defined by the system | Σ | 0..1 | string | Representation defined by the system | |||||||||
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user | Σ | 0..1 | boolean | If this coding was chosen directly by the user | |||||||||
| text | Σ | 0..1 | string | Plain text representation of the concept | Σ | 0..1 | string | Plain text representation of the concept | |||||||||
| subject | SΣ | 1..1 | Reference(ICSR Patient) | Subject impacted by event | SΣ | 1..1 | Reference(ICSR Patient) | Subject impacted by event | |||||||||
| encounter | SΣ | 0..1 | Reference(US Core Encounter Profile) | Encounter created as part of | SΣ | 0..1 | Reference(US Core Encounter Profile) | Encounter created as part of | |||||||||
| date | SΣ | 0..1 | dateTime | When the event occurred | SΣ | 0..1 | dateTime | When the event occurred | |||||||||
| id | 0..1 | string | xml:id (or equivalent in JSON) | 0..1 | string | xml:id (or equivalent in JSON) | |||||||||||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||||||
| value | 0..1 | dateTime | Primitive value for dateTime | 0..1 | dateTime | Primitive value for dateTime | |||||||||||
| 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 | |||||||||
| resultingCondition | Σ | 0..* | Reference(Condition) | Effect on the subject due to this event | Σ | 0..* | Reference(Condition) | Effect on the subject due to this event | |||||||||
| location | SΣ | 0..1 | Reference(US Core Location Profile) | Location where adverse event occurred | SΣ | 0..1 | Reference(US Core Location Profile) | Location where adverse event occurred | |||||||||
| seriousness | SΣ | 1..1 | CodeableConcept | Seriousness of the event Binding: ?? (required) | SΣ | 1..1 | CodeableConcept | Seriousness of the event Binding: ?? (required) | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | Σ | 0..* | Coding | Code defined by a terminology system | |||||||||
| text | Σ | 0..1 | string | Plain text representation of the concept | Σ | 0..1 | string | Plain text representation of the concept | |||||||||
| severity | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: ?? (required): The severity of the adverse event itself, in direct relation to the subject. | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: ?? (required): The severity of the adverse event itself, in direct relation to the subject. | |||||||||
| outcome | SΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: ?? (required): TODO (and should this be required?). | SΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: ?? (required): TODO (and should this be required?). | |||||||||
| recorder | SΣ | 0..1 | Reference(Practitioner Author) | Who recorded the adverse event | SΣ | 0..1 | Reference(Practitioner Author) | Who recorded the adverse event | |||||||||
| contributor | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event | |||||||||
| suspectEntity | SΣ | 1..* | BackboneElement | The suspected agent causing the adverse event | SΣ | 1..* | 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 | SΣ | 1..1 | Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion) | Refers to the specific entity that caused the adverse event | SΣ | 1..1 | Reference(ICSR Immunization | ICSR MedicationAdministration | ICSR Transfusion) | Refers to the specific entity that caused the adverse event | |||||||||
 causality | SΣ | 1..1 | BackboneElement | Information on the possible cause of the event | SΣ | 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 | |||||||||
| assessment | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: ?? (example): Codes for the assessment of whether the entity caused the event. | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: ?? (example): Codes for the assessment of whether the entity caused the event. | |||||||||
| productRelatedness | SΣ | 1..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | SΣ | 1..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | |||||||||
| author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | |||||||||
| method | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: ?? (example): TODO. | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: ?? (example): TODO. | |||||||||
| subjectMedicalHistory | Σ | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory | Σ | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory | |||||||||
| referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | |||||||||
| study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | |||||||||
| Documentation for this format | |||||||||||||||||