This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq 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> id: 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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-containerOrientation-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-timePointDescription-local-pq"/>
<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>
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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