Adverse Event Clinical Research
1.0.1 - STU1 International flag

This page is part of the Adverse Event Clinical Research (v1.0.1: STU 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

: Patient reported AE during research study - TTL Representation

Page standards status: Informative

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix sct: <http://snomed.info/id/> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:AdverseEvent ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "clinical-research-ae-example-medwatch-patient-report"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: AdverseEvent</b><a name=\"clinical-research-ae-example-medwatch-patient-report\"> </a><a name=\"hcclinical-research-ae-example-medwatch-patient-report\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource AdverseEvent &quot;clinical-research-ae-example-medwatch-patient-report&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Required Intervention to Prevent Permanent Impairment/damage <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C201939)</span></p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Results In Persistent Or Significant Disability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C11338)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Requires Inpatient Hospitalization <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C83052)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Death Related to Adverse Event <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C48275)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Is Life Threatening <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C84266)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Congenital Anomaly or Birth Defect <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C83117)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Other Medically Important Condition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C82521)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</b>: Serious reportable event associated with product or device <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#370901008)</span></p><p><b>subject</b>: <a href=\"Patient-JanetPatient.html\">Patient/JanetPatient: Janet</a> &quot; CLINICAL TRIAL PATIENT&quot;</p><p><b>detected</b>: 2023-04-10</p><p><b>resultingEffect</b>: <a href=\"Condition-janetReported-condition.html\">Condition/janetReported-condition</a></p><p><b>seriousness</b>: Serious <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-adverse-event-seriousness.html\">AdverseEventSeriousness</a>#serious)</span></p><p><b>outcome</b>: Recovered/Resolved <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C49498)</span></p><p><b>recorder</b>: <a href=\"Patient-JanetPatient.html\">Patient/JanetPatient</a> &quot; CLINICAL TRIAL PATIENT&quot;</p><p><b>study</b>: <a href=\"ResearchStudy-BreastCancerTrial.html\">ResearchStudy/BreastCancerTrial</a></p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"Medication-bresentrik.html\">Medication/bresentrik</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>EntityRelatedness</b></td><td><b>Author</b></td></tr><tr><td style=\"display: none\">*</td><td>Possibly Related <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C53258)</span></td><td><a href=\"Patient-JanetPatient.html\">Patient/JanetPatient: Janet</a> &quot; CLINICAL TRIAL PATIENT&quot;</td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"ResearchStudy-BreastCancerTrial.html\">ResearchStudy/BreastCancerTrial</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>EntityRelatedness</b></td><td><b>Author</b></td></tr><tr><td style=\"display: none\">*</td><td>Possibly Related <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C53258)</span></td><td><a href=\"Patient-JanetPatient.html\">Patient/JanetPatient: Janet</a> &quot; CLINICAL TRIAL PATIENT&quot;</td></tr></table></blockquote><blockquote><p><b>supportingInfo</b></p><p><b>item</b>: <a href=\"MedicationAdministration-medicationAdministration-for-bresentrik.html\">MedicationAdministration/medicationAdministration-for-bresentrik</a></p></blockquote><blockquote><p><b>supportingInfo</b></p><p><b>item</b>: <a href=\"Observation-weight-janet.html\">Observation/weight-janet</a></p></blockquote><blockquote><p><b>supportingInfo</b></p><p><b>item</b>: <a href=\"Observation-blood-pressure-janet.html\">Observation/blood-pressure-janet</a></p></blockquote><blockquote><p><b>supportingInfo</b></p><p><b>item</b>: <a href=\"MedicationStatement-example001.html\">MedicationStatement/example001</a></p></blockquote><blockquote><p><b>supportingInfo</b></p><p><b>item</b>: <a href=\"MedicationStatement-example007.html\">MedicationStatement/example007</a></p></blockquote><blockquote><p><b>supportingInfo</b></p><p><b>item</b>: <a href=\"MedicationStatement-example003.html\">MedicationStatement/example003</a></p></blockquote><p><b>note</b>: A 64-year-old woman (Janet) is participating in a breast cancer clinical trial and taking an investigational drug. As part of her participation in the study, she was instructed to use a patient reported outcomes (ePRO) application to report an adverse event that resulted in any of the following: hospitalization, required help to prevent permanent harm, disability or health problem, birth defect, life-threatening, death, other serious/important medical incident (this list identifies the event as being serious events). The application is designed to capture data elements found on the 3500A Form. \n\nThe Clinical Investigator (CI) receives a notification that Janet has an adverse event and reviews the event in Janet’s EHR system. The adverse event form is pre-populated from EHR data for the clinical investigator. The CI assesses causality for Janet’s adverse event and submits the serious adverse event to the sponsor. The sponsor reviews the received adverse event and performs its own causality assessment. Since this event is a Suspected Unexpected Serious Adverse Reaction (SUSAR) within FDA’s regulation. If the Suspected Unexpected Serious Adverse Reaction (SUSAR) was life threatening or death, it is submitted within 7 calendar days.\n\nAny other types of seriousness are submitted within 15 calendar days. (By Patient/JanetPatient @2023-04-12)</p></div>"
  ] ; # 
  fhir:extension ( [
    ( fhir:extension [
fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "true"^^xsd:boolean ]     ] [
fhir:url [ fhir:v "criterionCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C201939" ] ;
fhir:display [ fhir:v "Required Intervention to Prevent Permanent Impairment/damage" ]         ] )       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "criterionCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C11338" ] ;
fhir:display [ fhir:v "Results In Persistent Or Significant Disability" ]         ] )       ]     ] [
fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "criterionCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C83052" ] ;
fhir:display [ fhir:v "Requires Inpatient Hospitalization" ]         ] )       ]     ] [
fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "criterionCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48275" ] ;
fhir:display [ fhir:v "Death Related to Adverse Event" ]         ] )       ]     ] [
fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "criterionCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C84266" ] ;
fhir:display [ fhir:v "Is Life Threatening" ]         ] )       ]     ] [
fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "criterionCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C83117" ] ;
fhir:display [ fhir:v "Congenital Anomaly or Birth Defect" ]         ] )       ]     ] [
fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "criterionCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C82521" ] ;
fhir:display [ fhir:v "Other Medically Important Condition" ]         ] )       ]     ] [
fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
  ] ) ; # 
  fhir:status [ fhir:v "completed"] ; # 
  fhir:actuality [ fhir:v "actual"] ; # 
  fhir:code [
    ( fhir:coding [
a sct:370901008 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "370901008" ] ;
fhir:display [ fhir:v "Serious reportable event associated with product or device" ]     ] )
  ] ; # 
  fhir:subject [
fhir:reference [ fhir:v "Patient/JanetPatient" ] ;
fhir:display [ fhir:v "Janet" ]
  ] ; # 
  fhir:detected [ fhir:v "2023-04-10"^^xsd:date] ; # 
  fhir:resultingEffect ( [
fhir:reference [ fhir:v "Condition/janetReported-condition" ]
  ] ) ; # 
  fhir:seriousness [
    ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"^^xsd:anyURI ] ;
fhir:code [ fhir:v "serious" ]     ] )
  ] ; # 
  fhir:outcome ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C49498" ] ;
fhir:display [ fhir:v "Recovered/Resolved" ]     ] )
  ] ) ; # 
  fhir:recorder [
fhir:reference [ fhir:v "Patient/JanetPatient" ]
  ] ; # 
  fhir:study ( [
fhir:reference [ fhir:v "ResearchStudy/BreastCancerTrial" ]
  ] ) ; # 
  fhir:suspectEntity ( [
fhir:instance [
a fhir:Reference ;
fhir:reference [ fhir:v "Medication/bresentrik" ]     ] ;
fhir:causality [
fhir:entityRelatedness [
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C53258" ] ;
fhir:display [ fhir:v "Possibly Related" ]         ] )       ] ;
fhir:author [
fhir:reference [ fhir:v "Patient/JanetPatient" ] ;
fhir:display [ fhir:v "Janet" ]       ]     ]
  ] [
fhir:instance [
a fhir:Reference ;
fhir:reference [ fhir:v "ResearchStudy/BreastCancerTrial" ]     ] ;
fhir:causality [
fhir:entityRelatedness [
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C53258" ] ;
fhir:display [ fhir:v "Possibly Related" ]         ] )       ] ;
fhir:author [
fhir:reference [ fhir:v "Patient/JanetPatient" ] ;
fhir:display [ fhir:v "Janet" ]       ]     ]
  ] ) ; # 
  fhir:supportingInfo ( [
fhir:item [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicationAdministration/medicationAdministration-for-bresentrik" ]     ]
  ] [
fhir:item [
a fhir:Reference ;
fhir:reference [ fhir:v "Observation/weight-janet" ]     ]
  ] [
fhir:item [
a fhir:Reference ;
fhir:reference [ fhir:v "Observation/blood-pressure-janet" ]     ]
  ] [
fhir:item [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicationStatement/example001" ]     ]
  ] [
fhir:item [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicationStatement/example007" ]     ]
  ] [
fhir:item [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicationStatement/example003" ]     ]
  ] ) ; # 
  fhir:note ( [
fhir:author [
a fhir:Reference ;
fhir:reference [ fhir:v "Patient/JanetPatient" ]     ] ;
fhir:time [ fhir:v "2023-04-12"^^xsd:date ] ;
fhir:text [ fhir:v "A 64-year-old woman (Janet) is participating in a breast cancer clinical trial and taking an investigational drug. As part of her participation in the study, she was instructed to use a patient reported outcomes (ePRO) application to report an adverse event that resulted in any of the following: hospitalization, required help to prevent permanent harm, disability or health problem, birth defect, life-threatening, death, other serious/important medical incident (this list identifies the event as being serious events). The application is designed to capture data elements found on the 3500A Form. \n\nThe Clinical Investigator (CI) receives a notification that Janet has an adverse event and reviews the event in Janet’s EHR system. The adverse event form is pre-populated from EHR data for the clinical investigator. The CI assesses causality for Janet’s adverse event and submits the serious adverse event to the sponsor. The sponsor reviews the received adverse event and performs its own causality assessment. Since this event is a Suspected Unexpected Serious Adverse Reaction (SUSAR) within FDA’s regulation. If the Suspected Unexpected Serious Adverse Reaction (SUSAR) was life threatening or death, it is submitted within 7 calendar days.\n\nAny other types of seriousness are submitted within 15 calendar days." ]
  ] ) . #