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
{
"resourceType" : "DiagnosticReport",
"id" : "diagnosticreport-analysis-drug-pq-stability-prod",
"meta" : // stability results report
// <id value="6f4a3311-92c5-2b4a-533e-76341e414c63"/> from bundle-drug-product-stability-pq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<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:\u00a0ABC1234</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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : // this was new and was a broken link, reverted to last one
// reference value="PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54"/
{
🔗 "reference" : "PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq",
"valueCodeableConcept" : {
"text" : "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
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
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-containerOrientation-local-pq",
"code" : "horizontal",
"display" : "horizontal"
}
],
"text" : "Horizontal"
}
}
],
"identifier" : [
{
"system" : "https://eudract.europa.eu/example/identifier",
"value" : "ABC1234"
}
],
"status" : "final",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq",
"code" : "Stability Study Report - 18 months",
"display" : "Stability Study Report - 18 months"
}
]
},
"effectiveDateTime" : "2020-12",
"_effectiveDateTime" : {
"extension" : [
// start of stability test
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq",
"valueCodeableConcept" : // <extension url="http://accumulus.org/fhir/extension/timePointDescription">
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-timePointDescription-local-pq",
"code" : "Delayed Start Code",
"display" : "Delayed Start Code"
}
],
"text" : "Refrigerated delayed testing"
}
}
]
},
"performer" : [
{
🔗 "reference" : "Organization/organization-drug-pq-ex1"
}
],
"result" : [
// Abbreviated Results, showing only longterm25c-initial-1 of set of 3. Addotional groups of results would be added over time (18 mo., etc.).
{
🔗 "reference" : "Observation/observation-test-result-longterm25c-initial-1"
}
],
"conclusion" : "The samples have been assessed for initial period; no shelf life determined."
}
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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