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. 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 ae-grade 0..1 CodeableConcept The degree of something undesirable, used in oncology trials URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade Binding: Adverse Event Clinical Research Grades (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 Binding: (unbound) (required): Codes identifying the lifecycle stage of an event. actuality 1..1 code actual Required Pattern: actual event 1..1 CodeableConcept Event or incident that occurred or was averted Binding: AdverseEvent Type (example): Detailed type of event. resultingCondition 0..0 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 resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: Adverse Event Clinical Research Outcomes (required) suspectEntity 0..0 subjectMedicalHistory 0..0 referenceDocument 0..0 study S 1..1 Reference(ResearchStudy) AdverseEvent.study Documentation for this format
HL7 International / Biomedical Research and Regulation
Convenience backport into R4 of FHIR R5 Foundational profile of AdverseEvent for Clinical Research communications.
Medical care, research study or other healthcare event causing physical injury
Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
not(parent::f:contained and f:contained)
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()
not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))
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()
not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
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() )
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
The base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Text summary of the resource, for human interpretation
A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
Communicates Research Subject related metadata.
exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
Adverse event caused subject to discontinue the study
Indicates if the subject discontinued the study due to the adverse event.
Criteria reviewed in determining serious adverse event
Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.
The degree of something undesirable, used in oncology trials
For cancer related trials, severity is represented as a grade. Describes the grade of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity, in oncology related trials this is reported as grade.
Considered likely or probable or anticipated in the research study
Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.
Comments made about the adverse event by the performer, subject or other participants.
The date the adverse event was resolved.
A suspected agent causing the adverse event
Describes an entity that is suspected to have caused the adverse event.
Contributing factors suspected to have increased the probability or severity of the adverse event
A contributing factors suspected to have increased the probability or severity of the adverse event.
Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm
The ameliorating action taken after the adverse event occurred in order to reduce the extent of harm.
Subject medical history or document relevant to this adverse event
Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.
Who was involved in the adverse event or the potential adverse event and what they did
Indicates who or what participated in the adverse event and how they were involved.
Information about the condition that occurred as a result of the adverse event.
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
in-progress | completed | entered-in-error | unknown
The current state of the adverse event or potential adverse event.
This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.
This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.
This is a business identifier, not a resource identifier (see [discussion](http://hl7.org/fhir/R4/resource.html#identifiers)). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.
Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.
Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.
This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
Overall nature of the adverse event, e.g. real or potential.
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
The overall type of event, intended for search and filtering purposes.
Overall categorization of the event, e.g. product-related or situational.
Event or incident that occurred or was averted
Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused.
This subject or group impacted by the event.
If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.
Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.
The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.
This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context.
The date (and perhaps time) when the adverse event occurred.
Estimated or actual date the AdverseEvent began, in the opinion of the reporter.
The date on which the existence of the AdverseEvent was first recorded.
The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata.
Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).
The information about where the adverse event occurred.
Investigator defined severity of the adverse event, in relation to the subject not the resulting condition
Assessment whether this event was of real importance.
Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is.
The severity of the adverse event itself, in direct relation to the subject.
resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Describes the type of outcome from the adverse event.
Information on who recorded the adverse event. May be the patient or a practitioner.
Who was involved in the adverse event or the potential adverse event
Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness).
The suspected agent causing the adverse event
Describes the entity that is suspected to have caused the adverse event.
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Extensions that cannot be ignored even if unrecognized
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Refers to the specific entity that caused the adverse event
Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.
Information on the possible cause of the event
Information on the possible cause of the event.
Assessment of if the entity caused the event
Assessment of if the entity caused the event.
Codes for the assessment of whether the entity caused the event.
ProbabilityScale | Bayesian | Checklist.
Codes identifying the lifecycle stage of an event.