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 - JSON Representation

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{
  "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://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>"
  },
  "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://terminology.hl7.org/CodeSystem/container-orientation",
            "code" : "horizontal",
            "display" : "horizontal"
          }
        ],
        "text" : "Horizontal"
      }
    }
  ],
  "identifier" : [
    {
      "system" : "https://eudract.europa.eu/example/identifier",
      "value" : "ABC1234"
    }
  ],
  "status" : "final",
  "code" : {
    "coding" : [
      {
        "system" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type",
        "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://terminology.hl7.org/CodeSystem/time-point-description",
              "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."
}