Adverse Event Clinical Research R4 Backport
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This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

: Use case 6B - patient reported AE during research study - XML Representation

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<AdverseEvent xmlns="http://hl7.org/fhir">
  <id value="clinical-research-ae-example-medwatch-patient-report"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"/>
  </meta>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: AdverseEvent</b><a name="clinical-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>: false</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/5.0.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C11338)</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>: Requires Inpatient Hospitalization <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/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>: Results In Death <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/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/5.0.0/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/5.0.0/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/5.0.0/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>Note</b>: Use case for MedWatch Form FDA 3500B being used during a clinical trial%:  
A 64-year old woman %(Janet%) is participating in a breast cancer clinical trial. As part of her participation in the study, she was instructed to use a specific consumer facing FHIR 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 serious events.%)  

Janet created an account in the consumer facing FHIR application and imported her health records from her three %(3%) health systems. The data from her health systems were aggregated to allow her a single view of all her medical information. Janet was able to add more information that was not included in her imported data %(OTC drugs, vitamins, etc.%).  

After receiving the study drug %(bresentrik%) during a study visit, Janet went home and began vomiting uncontrollably. Her husband called an ambulance and Janet was taken to the hospital where she was treated in the ER and released.  

The following morning, Janet opened the study designated consumer facing FHIR application and completed the MedWatch Form FDA 3500B as earlier directed. The form provides her the opportunity to choose to auto fill several of the areas to allow for faster/easier completion of the form %(demographics, meds, allergies, conditions, labs%). She is given the option to display and choose the relevant items from each category %(example%: only current meds she is taking, current labs, etc. which might be a subset of her full PHR%).  

When Janet clicked “Submit” on the electronic form, the data automatically flowed to the investigator %(or to whomever was designated to receive the data%). The data is then absorbed within the receiver’s system to auto populate a MedWatch Form FDA 3500B for submission to the FDA within 24 hours. (By Patient/JanetPatient @2023-04-12)</p><p><b>Resulting Effect</b>: <a href="Condition-janetReported-condition.html">Condition/janetReported-condition</a></p><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href="Medication-bresentrik.html">Medication/bresentrik</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><blockquote><p><b>Supporting information relevant to the event</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href="MedicationAdministration-medicationAdministration-for-bresentrik.html">MedicationAdministration/medicationAdministration-for-bresentrik</a></p></blockquote><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href="ResearchStudy-BreastCancerTrial.html">ResearchStudy/BreastCancerTrial</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><blockquote><p><b>Supporting information relevant to the event</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href="Observation-weight-janet.html">Observation/weight-janet</a></p></blockquote><blockquote><p><b>Supporting information relevant to the event</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href="Observation-blood-pressure-janet.html">Observation/blood-pressure-janet</a></p></blockquote><blockquote><p><b>Supporting information relevant to the event</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href="MedicationStatement-example001.html">MedicationStatement/example001</a></p></blockquote><blockquote><p><b>Supporting information relevant to the event</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href="MedicationStatement-example007.html">MedicationStatement/example007</a></p></blockquote><blockquote><p><b>Supporting information relevant to the event</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href="MedicationStatement-example003.html">MedicationStatement/example003</a></p></blockquote><blockquote><p><b>modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]</b></p></blockquote><p><b>actuality</b>: actual</p><p><b>event</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>date</b>: 2023-04-10</p><p><b>seriousness</b>: Serious <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-adverse-event-seriousness.html">AdverseEventSeriousness</a>#serious)</span></p><p><b>outcome</b>: C49498&quot;Recovered/Resolved&quot; <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C49498&quot;Recovered/Resolved&quot;)</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></div>
  </text>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
    <extension url="criterionPresent">
      <valueBoolean value="false"/>
    </extension>
    <extension url="criterionCode">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C11338"/>
          <display value="Results In Persistent Or Significant Disability"/>
        </coding>
      </valueCodeableConcept>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
    <extension url="criterionCode">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C83052"/>
          <display value="Requires Inpatient Hospitalization"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="criterionPresent">
      <valueBoolean value="false"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
    <extension url="criterionCode">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C48275"/>
          <display value="Results In Death"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="criterionPresent">
      <valueBoolean value="false"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
    <extension url="criterionCode">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C84266"/>
          <display value="Is Life Threatening"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="criterionPresent">
      <valueBoolean value="false"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
    <extension url="criterionCode">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C83117"/>
          <display value="Congenital Anomaly or Birth Defect"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="criterionPresent">
      <valueBoolean value="false"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
    <extension url="criterionCode">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C82521"/>
          <display value="Other Medically Important Condition"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="criterionPresent">
      <valueBoolean value="false"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note">
    <valueAnnotation>
      <authorReference>
        <reference value="Patient/JanetPatient"/>
      </authorReference>
      <time value="2023-04-12"/>
      <text
            value="Use case for MedWatch Form FDA 3500B being used during a clinical trial%:  
A 64-year old woman %(Janet%) is participating in a breast cancer clinical trial. As part of her participation in the study, she was instructed to use a specific consumer facing FHIR 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 serious events.%)  

Janet created an account in the consumer facing FHIR application and imported her health records from her three %(3%) health systems. The data from her health systems were aggregated to allow her a single view of all her medical information. Janet was able to add more information that was not included in her imported data %(OTC drugs, vitamins, etc.%).  

After receiving the study drug %(bresentrik%) during a study visit, Janet went home and began vomiting uncontrollably. Her husband called an ambulance and Janet was taken to the hospital where she was treated in the ER and released.  

The following morning, Janet opened the study designated consumer facing FHIR application and completed the MedWatch Form FDA 3500B as earlier directed. The form provides her the opportunity to choose to auto fill several of the areas to allow for faster/easier completion of the form %(demographics, meds, allergies, conditions, labs%). She is given the option to display and choose the relevant items from each category %(example%: only current meds she is taking, current labs, etc. which might be a subset of her full PHR%).  

When Janet clicked “Submit” on the electronic form, the data automatically flowed to the investigator %(or to whomever was designated to receive the data%). The data is then absorbed within the receiver’s system to auto populate a MedWatch Form FDA 3500B for submission to the FDA within 24 hours."/>
    </valueAnnotation>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect">
    <valueReference>
      <reference value="Condition/janetReported-condition"/>
    </valueReference>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity">
    <extension url="instance">
      <valueReference>
        <reference value="Medication/bresentrik"/>
      </valueReference>
    </extension>
    <extension url="causality">
      <extension url="entityRelatedness">
        <valueCodeableConcept>
          <coding>
            <system
                    value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
            <code value="C53258"/>
            <display value="Possibly"/>
          </coding>
        </valueCodeableConcept>
      </extension>
      <extension url="author">
        <valueReference>
          <reference value="Patient/JanetPatient"/>
          <display value="Janet"/>
        </valueReference>
      </extension>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info">
    <extension url="item">
      <valueReference>
        <reference
                   value="MedicationAdministration/medicationAdministration-for-bresentrik"/>
      </valueReference>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity">
    <extension url="instance">
      <valueReference>
        <reference value="ResearchStudy/BreastCancerTrial"/>
      </valueReference>
    </extension>
    <extension url="causality">
      <extension url="entityRelatedness">
        <valueCodeableConcept>
          <coding>
            <system
                    value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
            <code value="C53258"/>
            <display value="Possibly"/>
          </coding>
        </valueCodeableConcept>
      </extension>
      <extension url="author">
        <valueReference>
          <reference value="Patient/JanetPatient"/>
          <display value="Janet"/>
        </valueReference>
      </extension>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info">
    <extension url="item">
      <valueReference>
        <reference value="Observation/weight-janet"/>
      </valueReference>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info">
    <extension url="item">
      <valueReference>
        <reference value="Observation/blood-pressure-janet"/>
      </valueReference>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info">
    <extension url="item">
      <valueReference>
        <reference value="MedicationStatement/example001"/>
      </valueReference>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info">
    <extension url="item">
      <valueReference>
        <reference value="MedicationStatement/example007"/>
      </valueReference>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info">
    <extension url="item">
      <valueReference>
        <reference value="MedicationStatement/example003"/>
      </valueReference>
    </extension>
  </extension>
  <modifierExtension
                     url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status">
    <valueCode value="completed"/>
  </modifierExtension>
  <actuality value="actual"/>
  <event>
    <coding>
      <system value="http://snomed.info/sct"/>
      <code value="370901008"/>
      <display
               value="Serious reportable event associated with product or device"/>
    </coding>
  </event>
  <subject>
    <reference value="Patient/JanetPatient"/>
    <display value="Janet"/>
  </subject>
  <date value="2023-04-10"/>
  <seriousness>
    <coding>
      <system
              value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
      <code value="serious"/>
    </coding>
  </seriousness>
  <outcome>
    <coding>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C49498&quot;Recovered/Resolved&quot;"/>
    </coding>
  </outcome>
  <recorder>
    <reference value="Patient/JanetPatient"/>
  </recorder>
  <study>
    <reference value="ResearchStudy/BreastCancerTrial"/>
  </study>
</AdverseEvent>