Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

: DiagnosticReport - Drug Analysis - example, stability - XML Representation

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<DiagnosticReport xmlns="http://hl7.org/fhir">
  <!--  stability results report  -->
  <!--  <id value="6f4a3311-92c5-2b4a-533e-76341e414c63"/> from bundle-drug-product-stability-pq-ex1 -->
  <id value="diagnosticreport-analysis-drug-pq-stability-prod"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><h2><span title="Codes: {http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type Stability Study Report - 18 months}">Stability Study Report - 18 months</span> </h2><table class="grid"><tr><td>When For</td><td>2020-12</td></tr><tr><td>Identifier:</td><td> <code>https://eudract.europa.eu/example/identifier</code>/ABC1234</td></tr></table><p><b>Report Details</b></p><table class="grid"><tr><td><b>Code</b></td><td><b>Value</b></td><td><b>When For</b></td></tr><tr><td><a href="Observation-observation-test-result-longterm25c-initial-1.html"><span title="Codes: ">Test Components - Long-term 25C etc - Initial (XYZ)</span></a></td><td/><td>2023-01-01 12:00:00+0000</td></tr></table><div><p>The samples have been assessed for initial period; no shelf life determined.</p>
</div></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
    <!--  this was new and was a broken link, reverted to last one  -->
    <!-- reference value="PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54"/ -->
    <valueReference>🔗 
      <reference
                 value="PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol"/>
    </valueReference>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq">
    <valueCodeableConcept>
      <!--  #223  -->
      <!--  Want to use studyDesign, but problem is that this is CodeableConcept, which allows text. However when you use text, you then
                            have no place to put a context. Ideally this would be a code/code pair.
                            Code says "statistical model", code (or text) then says what it is  -->
      <text
            value="information about statistical model utilized to interpret stability study results"/>
    </valueCodeableConcept>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq">
    <valueCodeableConcept>
      <coding>
        <system
                value="http://terminology.hl7.org/CodeSystem/container-orientation"/>
        <code value="horizontal"/>
        <display value="horizontal"/>
      </coding>
      <text value="Horizontal"/>
    </valueCodeableConcept>
  </extension>
  <identifier>
    <system value="https://eudract.europa.eu/example/identifier"/>
    <value value="ABC1234"/>
  </identifier>
  <status value="final"/>
  <code>
    <coding>
      <system
              value="http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type"/>
      <code value="Stability Study Report - 18 months"/>
      <display value="Stability Study Report - 18 months"/>
    </coding>
  </code>
  <effectiveDateTime value="2020-12">
    <!--  start of stability test  -->
    <extension
               url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq">
      <!--                <extension url="http://accumulus.org/fhir/extension/timePointDescription"> -->
      <valueCodeableConcept>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/time-point-description"/>
          <code value="Delayed Start Code"/>
          <display value="Delayed Start Code"/>
        </coding>
        <text value="Refrigerated delayed testing"/>
      </valueCodeableConcept>
    </extension>
  </effectiveDateTime>
  <performer>🔗 
    <reference value="Organization/organization-drug-pq-ex1"/>
  </performer>
  <!--    Abbreviated Results, showing only longterm25c-initial-1 of set of 3. Addotional groups of results would be added over time (18 mo., etc.). -->
  <result>🔗 
    <reference
               value="Observation/observation-test-result-longterm25c-initial-1"/>
  </result>
  <!--    <result>
      <reference value="Observation/observation-test-result-longterm25c-initial-2"/>
   </result>
   <result>
      <reference value="Observation/observation-test-result-longterm25c-initial-3"/>
   </result> -->
  <conclusion
              value="The samples have been assessed for initial period; no shelf life determined."/>
</DiagnosticReport>