IDEA4RC FHIR Implementation Guide
0.1.0 - CI Build 150

IDEA4RC FHIR Implementation Guide, published by IDEA4RC Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/idea4rc/ and changes regularly. See the Directory of published versions

Logical Model: AdverseEventI4RC - Detailed Descriptions

Draft as of 2025-07-25

Definitions for the AdverseEvent logical model.

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

0. AdverseEvent
Definition

Adverse Event Maturity Level: 0 Draft

ShortAdverse Event
Control0..*
Is Modifierfalse
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. AdverseEvent.treatmentReference[x]
Definition

Treatment element containing the data regarding the specific treatment. It can be SystemicTreatment, Surgery, Radiotherapy, Isolated Limb Perfusion or Regional Deep Hyperthemia OBSERVATION or CONDITION

ShortTreatment reference (M)
Control1..*
TypeChoice of: http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/SystemicTreatment, http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Radiotherapy, http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Surgery
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Obligations
    ObligationsActor
    SHALL:handleHead and Neck
    4. AdverseEvent.adverseEventType
    Definition

    the Common Terminology Criteria for Adverse Events (CTCAE) is used to identify the adverse events. It includes details of the adverse event type and grade OBSERVATION or CONDITION (check)

    ShortAdverse event type (CTCAE Term) (M)
    Control1..*
    TypeCodeableConcept
    Obligations
      ObligationsActor
      SHALL:handleHead and Neck
      6. AdverseEvent.adverseEventStartingDate
      Definition

      specifies when adverse events begins OBSERVATION or CONDITION (check)

      ShortAdverse event starting date (M)
      Control1..*
      Typedate
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Obligations
        ObligationsActor
        SHALL:handleHead and Neck
        8. AdverseEvent.adverseEventDuration
        Definition

        specifies the duration of the adverse event OBSERVATION or CONDITION (check)

        Adverse Events in OMOP ar standard conditions or observations and duration must be derived from that data

        https://forums.ohdsi.org/t/mapping-adverse-event-data-to-omop-and-to-fhir/15373

        ShortAdverse event duration (M)
        Comments

        Less than one week - 2000100050 More than one week but less than a month - 2000100051 More than a month but less than 3 months - 2000100052 More than 3 months - 2000100053

        Control1..*
        TypeCodeableConcept
        Obligations
          ObligationsActor
          SHALL:handleHead and Neck

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

          0. AdverseEvent
          Definition

          Adverse Event Maturity Level: 0 Draft

          ShortAdverse Event
          Logical ModelInstances of this logical model are not marked to be the target of a Reference
          2. AdverseEvent.treatmentReference[x]
          Definition

          Treatment element containing the data regarding the specific treatment. It can be SystemicTreatment, Surgery, Radiotherapy, Isolated Limb Perfusion or Regional Deep Hyperthemia OBSERVATION or CONDITION

          ShortTreatment reference (M)
          Control1..*
          TypeChoice of: http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/SystemicTreatment, http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Radiotherapy, http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Surgery
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Obligations
            ObligationsActor
            SHALL:handleHead and Neck
            4. AdverseEvent.adverseEventType
            Definition

            the Common Terminology Criteria for Adverse Events (CTCAE) is used to identify the adverse events. It includes details of the adverse event type and grade OBSERVATION or CONDITION (check)

            ShortAdverse event type (CTCAE Term) (M)
            Control1..*
            TypeCodeableConcept
            Obligations
              ObligationsActor
              SHALL:handleHead and Neck
              6. AdverseEvent.adverseEventStartingDate
              Definition

              specifies when adverse events begins OBSERVATION or CONDITION (check)

              ShortAdverse event starting date (M)
              Control1..*
              Typedate
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Obligations
                ObligationsActor
                SHALL:handleHead and Neck
                8. AdverseEvent.adverseEventDuration
                Definition

                specifies the duration of the adverse event OBSERVATION or CONDITION (check)

                Adverse Events in OMOP ar standard conditions or observations and duration must be derived from that data

                https://forums.ohdsi.org/t/mapping-adverse-event-data-to-omop-and-to-fhir/15373

                ShortAdverse event duration (M)
                Comments

                Less than one week - 2000100050 More than one week but less than a month - 2000100051 More than a month but less than 3 months - 2000100052 More than 3 months - 2000100053

                Control1..*
                TypeCodeableConcept
                Obligations
                  ObligationsActor
                  SHALL:handleHead and Neck

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

                  0. AdverseEvent
                  Definition

                  Adverse Event Maturity Level: 0 Draft

                  ShortAdverse Event
                  Control0..*
                  Is Modifierfalse
                  Logical ModelInstances of this logical model are not marked to be the target of a Reference
                  2. AdverseEvent.treatmentReference[x]
                  Definition

                  Treatment element containing the data regarding the specific treatment. It can be SystemicTreatment, Surgery, Radiotherapy, Isolated Limb Perfusion or Regional Deep Hyperthemia OBSERVATION or CONDITION

                  ShortTreatment reference (M)
                  Control1..*
                  TypeChoice of: http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/SystemicTreatment, http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Radiotherapy, http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Surgery
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Obligations
                    ObligationsActor
                    SHALL:handleHead and Neck
                    4. AdverseEvent.adverseEventType
                    Definition

                    the Common Terminology Criteria for Adverse Events (CTCAE) is used to identify the adverse events. It includes details of the adverse event type and grade OBSERVATION or CONDITION (check)

                    ShortAdverse event type (CTCAE Term) (M)
                    Control1..*
                    TypeCodeableConcept
                    Obligations
                      ObligationsActor
                      SHALL:handleHead and Neck
                      6. AdverseEvent.adverseEventStartingDate
                      Definition

                      specifies when adverse events begins OBSERVATION or CONDITION (check)

                      ShortAdverse event starting date (M)
                      Control1..*
                      Typedate
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Obligations
                        ObligationsActor
                        SHALL:handleHead and Neck
                        8. AdverseEvent.adverseEventDuration
                        Definition

                        specifies the duration of the adverse event OBSERVATION or CONDITION (check)

                        Adverse Events in OMOP ar standard conditions or observations and duration must be derived from that data

                        https://forums.ohdsi.org/t/mapping-adverse-event-data-to-omop-and-to-fhir/15373

                        ShortAdverse event duration (M)
                        Comments

                        Less than one week - 2000100050 More than one week but less than a month - 2000100051 More than a month but less than 3 months - 2000100052 More than 3 months - 2000100053

                        Control1..*
                        TypeCodeableConcept
                        Obligations
                          ObligationsActor
                          SHALL:handleHead and Neck