Fujitsu Healthy Living Implementation Guide
1.1.29 - release
Publication Build: This will be filled in by the publication tooling
<AdverseEvent xmlns="http://hl7.org/fhir">
<id value="clinical-research-ae-example-medwatch-patient-report"/>
<meta>
<profile
value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-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 "clinical-research-ae-example-medwatch-patient-report" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-fujitsu-adverseEvent-clinical-research.html">Fujitsu Adverse Event Clinical Research</a></p></div><blockquote><p><b>Fujitsu 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>Fujitsu 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><p><b>Fujitsu Resulting Effect</b>: <a href="Condition-janetReported-condition.html">Condition/janetReported-condition</a></p><blockquote><p><b>Fujitsu 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>Fujitsu 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://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-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</a> " CLINICAL TRIAL PATIENT"</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/5.5.0/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> " CLINICAL TRIAL PATIENT"</p><p><b>study</b>: <a href="ResearchStudy-BreastCancerTrial.html">ResearchStudy/BreastCancerTrial</a></p></div>
</text>
<extension
url="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-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://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-note">
<valueAnnotation>
<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."/>
</valueAnnotation>
</extension>
<extension
url="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resulting-effect">
<valueReference>🔗
<reference value="Condition/janetReported-condition"/>
</valueReference>
</extension>
<extension
url="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-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 Related"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="author">
<valueReference>🔗
<reference value="Patient/JanetPatient"/>
<display value="Janet"/>
</valueReference>
</extension>
</extension>
</extension>
<extension
url="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-supporting-info">
<extension url="item">
<valueReference>🔗
<reference value="MedicationStatement/example003"/>
</valueReference>
</extension>
</extension>
<modifierExtension
url="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-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"/>
</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"/>
<display value="Recovered/Resolved"/>
</coding>
</outcome>
<recorder>🔗
<reference value="Patient/JanetPatient"/>
</recorder>
<study>🔗
<reference value="ResearchStudy/BreastCancerTrial"/>
</study>
</AdverseEvent>