Adverse Event Clinical Research
1.0.1 - STU1

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

## : Patient reported AE during research study - XML Representation

Page standards status: Informative

Raw xml | Download

    <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-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><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.

    The 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.

    Any other types of seriousness are submitted within 15 calendar days. (By Patient/JanetPatient @2023-04-12)</p></div>
      </text>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionPresent">
          <valueBoolean value="true"/>
        </extension>
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C201939"/>
              <display
                       value="Required Intervention to Prevent Permanent Impairment/damage"/>
            </coding>
          </valueCodeableConcept>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria">
        <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 url="criterionPresent">
          <valueBoolean value="false"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-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-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="Death Related to Adverse Event"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="false"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-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-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-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>
      <status value="completed"/>
      <actuality value="actual"/>
      <code>
        <coding>
          <system value="http://snomed.info/sct"/>
          <code value="370901008"/>
          <display
                   value="Serious reportable event associated with product or device"/>
        </coding>
      </code>
      <subject>🔗
        <reference value="Patient/JanetPatient"/>
        <display value="Janet"/>
      </subject>
      <detected value="2023-04-10"/>
      <resultingEffect>🔗
        <reference value="Condition/janetReported-condition"/>
      </resultingEffect>
      <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"/>
          <display value="Recovered/Resolved"/>
        </coding>
      </outcome>
      <recorder>🔗
        <reference value="Patient/JanetPatient"/>
      </recorder>
      <study>🔗
        <reference value="ResearchStudy/BreastCancerTrial"/>
      </study>
      <suspectEntity>
        <instanceReference>🔗
          <reference value="Medication/bresentrik"/>
        </instanceReference>
        <causality>
          <entityRelatedness>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C53258"/>
              <display value="Possibly Related"/>
            </coding>
          </entityRelatedness>
          <author>🔗
            <reference value="Patient/JanetPatient"/>
            <display value="Janet"/>
          </author>
        </causality>
      </suspectEntity>
      <suspectEntity>
        <instanceReference>🔗
          <reference value="ResearchStudy/BreastCancerTrial"/>
        </instanceReference>
        <causality>
          <entityRelatedness>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C53258"/>
              <display value="Possibly Related"/>
            </coding>
          </entityRelatedness>
          <author>🔗
            <reference value="Patient/JanetPatient"/>
            <display value="Janet"/>
          </author>
        </causality>
      </suspectEntity>
      <supportingInfo>
        <itemReference>🔗
          <reference
                     value="MedicationAdministration/medicationAdministration-for-bresentrik"/>
        </itemReference>
      </supportingInfo>
      <supportingInfo>
        <itemReference>🔗
          <reference value="Observation/weight-janet"/>
        </itemReference>
      </supportingInfo>
      <supportingInfo>
        <itemReference>🔗
          <reference value="Observation/blood-pressure-janet"/>
        </itemReference>
      </supportingInfo>
      <supportingInfo>
        <itemReference>🔗
          <reference value="MedicationStatement/example001"/>
        </itemReference>
      </supportingInfo>
      <supportingInfo>
        <itemReference>🔗
          <reference value="MedicationStatement/example007"/>
        </itemReference>
      </supportingInfo>
      <supportingInfo>
        <itemReference>🔗
          <reference value="MedicationStatement/example003"/>
        </itemReference>
      </supportingInfo>
      <note>
        <authorReference>🔗
          <reference value="Patient/JanetPatient"/>
        </authorReference>
        <time value="2023-04-12"/>
        <text
              value="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.

    The 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.

    Any other types of seriousness are submitted within 15 calendar days."/>
      </note>
    </AdverseEvent>