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 - TTL Representation
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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:DiagnosticReport ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "diagnosticreport-analysis-drug-pq-stability-prod"] ; # stability results report , <id value="6f4a3311-92c5-2b4a-533e-76341e414c63"/> from bundle-drug-product-stability-pq-ex1
fhir:meta [
( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq> ] )
] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<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>\n</div></div>"
] ; #
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol" ] ] # this was new and was a broken link, reverted to last one , reference value=\"PlanDefinition\/c96cb248-1408-79fc-1f47-b17a6b2e4b54\"\/
] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "information about statistical model utilized to interpret stability study results" ] # #223 , Want to use studyDesign, but problem is that this is CodeableConcept, which allows text. However when you use text, you then\n have no place to put a context. Ideally this would be a code\/code pair.\n Code says \"statistical model\", code (or text) then says what it is ]
] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/container-orientation"^^xsd:anyURI ] ;
fhir:code [ fhir:v "horizontal" ] ;
fhir:display [ fhir:v "horizontal" ] ] ) ;
fhir:text [ fhir:v "Horizontal" ] ]
] ) ; #
fhir:identifier ( [
fhir:system [ fhir:v "https://eudract.europa.eu/example/identifier"^^xsd:anyURI ] ;
fhir:value [ fhir:v "ABC1234" ]
] ) ; #
fhir:status [ fhir:v "final"] ; #
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Stability Study Report - 18 months" ] ;
fhir:display [ fhir:v "Stability Study Report - 18 months" ] ] )
] ; #
fhir:effective [
fhir:v "2020-12"^^xsd:gYearMonth ;
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/time-point-description"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Delayed Start Code" ] ;
fhir:display [ fhir:v "Delayed Start Code" ] ] ) ;
fhir:text [ fhir:v "Refrigerated delayed testing" ] ] # <extension url=\"http:\/\/accumulus.org\/fhir\/extension\/timePointDescription\"> ] ) # start of stability test
] ; #
fhir:performer ( [
fhir:reference [ fhir:v "Organization/organization-drug-pq-ex1" ]
] ) ; #
fhir:result ( [
fhir:reference [ fhir:v "Observation/observation-test-result-longterm25c-initial-1" ]
] ) ; # Abbreviated Results, showing only longterm25c-initial-1 of set of 3. Addotional groups of results would be added over time (18 mo., etc.).
fhir:conclusion [ fhir:v "The samples have been assessed for initial period; no shelf life determined."] . # <result>
# <reference value="Observation/observation-test-result-longterm25c-initial-2"/>
# </result>
# <result>
# <reference value="Observation/observation-test-result-longterm25c-initial-3"/>
# </result>
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