Adverse Event Clinical Research
1.0.1 - STU1 International flag

Adverse Event Clinical Research, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-ig/ and changes regularly. See the Directory of published versions

Extension: SeriousnessCriteria - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 2

Definitions for the seriousness-criteria extension.

Guidance on how to interpret the contents of this table can be found here

0. Extension
Definition

Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.

ShortCriteria reviewed in determining serious adverse event
2. Extension.extension
Control2..?
4. Extension.extension:criterionCode
Slice NamecriterionCode
ShortAction criteria usually associated with events that pose a threat to a patient's life or functioning
Control1..1
Must Supporttrue
6. Extension.extension:criterionCode.extension
Control0..0
8. Extension.extension:criterionCode.url
Fixed ValuecriterionCode
10. Extension.extension:criterionCode.value[x]
Control1..?
BindingUnless not suitable, these codes SHALL be taken from Adverse Event Clinical Research Seriousness Criteria
(extensible to http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-seriousness-criteria)
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
12. Extension.extension:criterionPresent
Slice NamecriterionPresent
ShortPresence or absence of the specified criteria
Control1..1
14. Extension.extension:criterionPresent.extension
Control0..0
16. Extension.extension:criterionPresent.url
Fixed ValuecriterionPresent
18. Extension.extension:criterionPresent.value[x]
Control1..?
Typeboolean
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
20. Extension.url
Fixed Valuehttp://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria
22. Extension.value[x]
Control0..0

Guidance on how to interpret the contents of this table can be found here

0. Extension
Definition

Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.


Optional Extension Element - found in all resources.

ShortCriteria reviewed in determining serious adverse eventOptional Extensions Element
Control0..*
Is Modifierfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2. Extension.extension
Definition

An Extension


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 managable, 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.

ShortExtensionAdditional content defined by implementations
Comments

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.

Control20..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 4. Extension.extension:criterionCode
    Slice NamecriterionCode
    Definition

    An Extension

    ShortAction criteria usually associated with events that pose a threat to a patient's life or functioningAdditional content defined by implementations
    Control10..1*
    TypeExtension
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    6. Extension.extension:criterionCode.extension
    Definition

    An Extension


    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 managable, 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.

    ShortExtensionAdditional content defined by implementations
    Comments

    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.

    Control0..0*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    SlicingThis element introduces a set of slices on Extension.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 8. Extension.extension:criterionCode.url
      Definition

      Source of the definition for the extension code - a logical name or a URL.

      Shortidentifies the meaning of the extension
      Comments

      The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

      Control1..1
      Typeuri
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      Fixed ValuecriterionCode
      10. Extension.extension:criterionCode.value[x]
      Definition

      Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

      ShortValue of extension
      Control10..1
      This element is affected by the following invariants: ext-1
      BindingUnless not suitable, these codes SHALL be taken from For codes, see Adverse Event Clinical Research Seriousness Criteria
      (extensible to http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-seriousness-criteria)
      TypeCodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      12. Extension.extension:criterionPresent
      Slice NamecriterionPresent
      Definition

      An Extension

      ShortPresence or absence of the specified criteriaAdditional content defined by implementations
      Control10..1*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      14. Extension.extension:criterionPresent.extension
      Definition

      An Extension


      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 managable, 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.

      ShortExtensionAdditional content defined by implementations
      Comments

      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.

      Control0..0*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on Extension.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 16. Extension.extension:criterionPresent.url
        Definition

        Source of the definition for the extension code - a logical name or a URL.

        Shortidentifies the meaning of the extension
        Comments

        The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

        Control1..1
        Typeuri
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        Fixed ValuecriterionPresent
        18. Extension.extension:criterionPresent.value[x]
        Definition

        Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

        ShortValue of extension
        Control10..1
        This element is affected by the following invariants: ext-1
        Typeboolean, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, Expression, CodeableReference, Signature, unsignedInt, time
        [x] NoteSee Choice of Data Types for further information about how to use [x]
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        20. Extension.url
        Definition

        Source of the definition for the extension code - a logical name or a URL.

        Shortidentifies the meaning of the extension
        Comments

        The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

        Control1..1
        Typeuri
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        Fixed Valuehttp://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria
        22. Extension.value[x]
        Definition

        Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

        ShortValue of extension
        Control0..01
        This element is affected by the following invariants: ext-1
        TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

        Guidance on how to interpret the contents of this table can be found here

        0. Extension
        Definition

        Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.

        ShortCriteria reviewed in determining serious adverse event
        Control0..*
        Is Modifierfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        2. Extension.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        ShortUnique id for inter-element referencing
        Control0..1
        This element is affected by the following invariants: ele-1
        Typeid
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        4. Extension.extension
        Definition

        An Extension

        ShortExtension
        Control2..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on Extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 6. Extension.extension:criterionCode
          Slice NamecriterionCode
          Definition

          An Extension

          ShortAction criteria usually associated with events that pose a threat to a patient's life or functioning
          Control1..1
          TypeExtension
          Is Modifierfalse
          Must Supporttrue
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          8. Extension.extension:criterionCode.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          This element is affected by the following invariants: ele-1
          Typeid
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          10. Extension.extension:criterionCode.extension
          Definition

          An Extension

          ShortExtension
          Control0..0
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on Extension.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 12. Extension.extension:criterionCode.url
            Definition

            Source of the definition for the extension code - a logical name or a URL.

            Shortidentifies the meaning of the extension
            Comments

            The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

            Control1..1
            Typeuri
            Is Modifierfalse
            XML FormatIn the XML format, this property is represented as an attribute.
            Summaryfalse
            Fixed ValuecriterionCode
            14. Extension.extension:criterionCode.value[x]
            Definition

            Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

            ShortValue of extension
            Control1..1
            This element is affected by the following invariants: ext-1
            BindingUnless not suitable, these codes SHALL be taken from Adverse Event Clinical Research Seriousness Criteria
            (extensible to http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-seriousness-criteria)
            TypeCodeableConcept
            [x] NoteSee Choice of Data Types for further information about how to use [x]
            Is Modifierfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            16. Extension.extension:criterionPresent
            Slice NamecriterionPresent
            Definition

            An Extension

            ShortPresence or absence of the specified criteria
            Control1..1
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            18. Extension.extension:criterionPresent.id
            Definition

            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

            ShortUnique id for inter-element referencing
            Control0..1
            This element is affected by the following invariants: ele-1
            Typeid
            Is Modifierfalse
            XML FormatIn the XML format, this property is represented as an attribute.
            Summaryfalse
            20. Extension.extension:criterionPresent.extension
            Definition

            An Extension

            ShortExtension
            Control0..0
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            SlicingThis element introduces a set of slices on Extension.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 22. Extension.extension:criterionPresent.url
              Definition

              Source of the definition for the extension code - a logical name or a URL.

              Shortidentifies the meaning of the extension
              Comments

              The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

              Control1..1
              Typeuri
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              Fixed ValuecriterionPresent
              24. Extension.extension:criterionPresent.value[x]
              Definition

              Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

              ShortValue of extension
              Control1..1
              This element is affected by the following invariants: ext-1
              Typeboolean
              [x] NoteSee Choice of Data Types for further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              26. Extension.url
              Definition

              Source of the definition for the extension code - a logical name or a URL.

              Shortidentifies the meaning of the extension
              Comments

              The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

              Control1..1
              Typeuri
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              Fixed Valuehttp://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria
              28. Extension.value[x]
              Definition

              Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

              ShortValue of extension
              Control0..0
              This element is affected by the following invariants: ext-1
              TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))