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

## : Breast Cancer Trial - XML Representation

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    <ResearchStudy xmlns="http://hl7.org/fhir">
      <id value="BreastCancerTrial"/>
      <text>
        <status value="generated"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ResearchStudy</b><a name="BreastCancerTrial"> </a><a name="hcBreastCancerTrial"> </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 ResearchStudy &quot;BreastCancerTrial&quot; </p></div><p><b>identifier</b>: <code>http://clinicaltrials.gov/</code>/NCT01234567</p><p><b>title</b>: Breast Cancer Clinical Trial bresentrik study</p><p><b>protocol</b>: <span>: This would reference the PlanDefinition which would contain references to Bresentrik</span></p><p><b>status</b>: active</p><p><b>primaryPurposeType</b>: Treatment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-research-study-prim-purp-type.html">ResearchStudyPrimaryPurposeType</a>#treatment)</span></p><p><b>phase</b>: Phase 2/Phase 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-research-study-phase.html">ResearchStudyPhase</a>#phase-2-phase-3)</span></p><p><b>studyDesign</b>: Interventional research <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-study-design.html">Study Design</a>#SEVCO:01001)</span></p><p><b>condition</b>: Breast Cancer <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED CT</a>#254837009)</span></p><p><b>description</b>: Eligible participants will be those diagnosed with HER2-positive (IHC 3+ or ISH+), metastatic breast cancer, who have received no prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer. The study aims to evaluate the efficacy, and safety of bresentrik, alone or with pertuzumab, compared with the standard of care treatment (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab). This study aims to see if bresentrik allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.</p><p><b>period</b>: 2021-03-23 --&gt; 2029-03-23</p><p><b>site</b>: <span>: This would be a reference to a Location containing the facility where the trial is taking place</span></p><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Iam Recruitment Contact</p><p><b>role</b>: recruitment-contact <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-research-study-party-role.html">Research Study Party Role</a>#recruitment-contact)</span></p><p><b>classifier</b>: Contact <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>party</b>: <span>: This would be a reference which would provide phone number</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Alebund Pharmaceuticals</p><p><b>role</b>: sponsor <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-research-study-party-role.html">Research Study Party Role</a>#sponsor)</span></p><p><b>classifier</b>: INDUSTRY <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>party</b>: <span>: This would be a reference Organization and would be the body legally responsible for the trial</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Alebund Pty Ltd</p><p><b>role</b>: lead-sponsor <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-research-study-party-role.html">Research Study Party Role</a>#lead-sponsor)</span></p><p><b>classifier</b>: INDUSTRY <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>party</b>: <span>: This would be a reference Organization and would be the body legally responsible for the trial</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Sam Francis, Doctor</p><p><b>role</b>: Principal Investigator <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-research-study-party-role.html">Research Study Party Role</a>#primary-investigator &quot;primary-investigator&quot;)</span></p><p><b>party</b>: <span>: This would be a reference to a Practitioner or PractionerRole</span></p></blockquote><h3>Recruitments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Eligibility</b></td></tr><tr><td style="display: none">*</td><td><span>: This would be a reference to a Group, use Group.characteristic to define inclusion and exclusion criteria</span></td></tr></table><blockquote><p><b>comparisonGroup</b></p><p><b>name</b>: Arm A</p><p><b>type</b>: Experimental <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-research-study-arm-type.html">ResearchStudy Arm Type Code System</a>#experimental)</span></p><p><b>description</b>: Bresentrik (B) plus pertuzumab-matching placebo</p></blockquote><blockquote><p><b>comparisonGroup</b></p><p><b>name</b>: Arm B</p><p><b>type</b>: Experimental <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-research-study-arm-type.html">ResearchStudy Arm Type Code System</a>#experimental)</span></p><p><b>description</b>: Bresentrik (B) plus pertuzumab</p></blockquote><blockquote><p><b>comparisonGroup</b></p><p><b>name</b>: Arm C</p><p><b>type</b>: Active Comparator <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-research-study-arm-type.html">ResearchStudy Arm Type Code System</a>#active-comparator)</span></p><p><b>description</b>: Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)</p></blockquote></div>
      </text>
      <identifier>
        <system value="http://clinicaltrials.gov/"/>
        <value value="NCT01234567"/>
        <assigner>
          <display value="Allesgut Pharmaceuticals"/>
        </assigner>
      </identifier>
      <title value="Breast Cancer Clinical Trial bresentrik study"/>
      <protocol>
        <display
                 value="This would reference the PlanDefinition which would contain references to Bresentrik"/>
      </protocol>
      <status value="active"/>
      <primaryPurposeType>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type"/>
          <code value="treatment"/>
          <display value="Treatment"/>
        </coding>
      </primaryPurposeType>
      <phase>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
          <code value="phase-2-phase-3"/>
        </coding>
      </phase>
      <studyDesign>
        <coding>
          <system value="http://hl7.org/fhir/study-design"/>
          <code value="SEVCO:01001"/>
          <display value="Interventional research"/>
        </coding>
      </studyDesign>
      <condition>
        <coding>
          <system value="http://snomed.info/sct"/>
          <code value="254837009"/>
          <display value="Breast Cancer"/>
        </coding>
      </condition>
      <description
                   value="Eligible participants will be those diagnosed with HER2-positive (IHC 3+ or ISH+), metastatic breast cancer, who have received no prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer. The study aims to evaluate the efficacy, and safety of bresentrik, alone or with pertuzumab, compared with the standard of care treatment (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab). This study aims to see if bresentrik allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life."/>
      <period>
        <start value="2021-03-23"/>
        <end value="2029-03-23"/>
      </period>
      <site>
        <display
                 value="This would be a reference to a Location containing the facility where the trial is taking place"/>
      </site>
      <associatedParty>
        <name value="Iam Recruitment Contact"/>
        <role>
          <coding>
            <system value="http://hl7.org/fhir/research-study-party-role"/>
            <code value="recruitment-contact"/>
            <display value="recruitment-contact"/>
          </coding>
        </role>
        <classifier>
          <text value="Contact"/>
        </classifier>
        <party>
          <type value="Practitioner"/>
          <display
                   value="This would be a reference which would provide phone number"/>
        </party>
      </associatedParty>
      <associatedParty>
        <name value="Alebund Pharmaceuticals"/>
        <role>
          <coding>
            <system value="http://hl7.org/fhir/research-study-party-role"/>
            <code value="sponsor"/>
            <display value="sponsor"/>
          </coding>
        </role>
        <classifier>
          <text value="INDUSTRY"/>
        </classifier>
        <party>
          <display
                   value="This would be a reference Organization and would be the body legally responsible for the trial"/>
        </party>
      </associatedParty>
      <associatedParty>
        <name value="Alebund Pty Ltd"/>
        <role>
          <coding>
            <system value="http://hl7.org/fhir/research-study-party-role"/>
            <code value="lead-sponsor"/>
            <display value="lead-sponsor"/>
          </coding>
        </role>
        <classifier>
          <text value="INDUSTRY"/>
        </classifier>
        <party>
          <type value="Practitioner"/>
          <display
                   value="This would be a reference Organization and would be the body legally responsible for the trial"/>
        </party>
      </associatedParty>
      <associatedParty>
        <name value="Sam Francis, Doctor"/>
        <role>
          <coding>
            <system value="http://hl7.org/fhir/research-study-party-role"/>
            <code value="primary-investigator"/>
            <display value="primary-investigator"/>
          </coding>
          <text value="Principal Investigator"/>
        </role>
        <party>
          <display
                   value="This would be a reference to a Practitioner or PractionerRole"/>
        </party>
      </associatedParty>
      <recruitment>
        <eligibility>
          <display
                   value="This would be a reference to a Group, use Group.characteristic to define inclusion and exclusion criteria"/>
        </eligibility>
      </recruitment>
      <comparisonGroup>
        <name value="Arm A"/>
        <type>
          <coding>
            <system value="http://hl7.org/fhir/research-study-arm-type"/>
            <code value="experimental"/>
            <display value="Experimental"/>
          </coding>
        </type>
        <description value="Bresentrik (B) plus pertuzumab-matching placebo"/>
      </comparisonGroup>
      <comparisonGroup>
        <name value="Arm B"/>
        <type>
          <coding>
            <system value="http://hl7.org/fhir/research-study-arm-type"/>
            <code value="experimental"/>
            <display value="Experimental"/>
          </coding>
        </type>
        <description value="Bresentrik (B) plus pertuzumab"/>
      </comparisonGroup>
      <comparisonGroup>
        <name value="Arm C"/>
        <type>
          <coding>
            <system value="http://hl7.org/fhir/research-study-arm-type"/>
            <code value="active-comparator"/>
            <display value="Active Comparator"/>
          </coding>
        </type>
        <description
                     value="Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)"/>
      </comparisonGroup>
    </ResearchStudy>