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Narrative

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Source1

{
  "resourceType": "Task",
  "id": "scenario2b-02-icsr-rejected",
  "meta": {
    "versionId": "2",
    "lastUpdated": "2026-10-14T11:12:30+02:00",
    "profile": [
      "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"
    ]
  },
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "identifier": [
    {
      "use": "official",
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-demo",
            "code": "apixtaskinstance",
            "display": "APIX Task Instance ID"
          }
        ]
      },
      "system": "http://example.org/health-authority/task-id",
      "value": "urn:uuid:b2f7cb95-4ab9-5dc5-b889-83f284126d52"
    }
  ],
  "groupIdentifier": {
    "use": "official",
    "system": "http://example.org/health-authority/work-flow-group-id",
    "value": "urn:uuid:6575f2a4-b372-557c-a74d-0b0f039d0546"
  },
  "status": "rejected",
  "statusReason": {
    "concept": {
      "text": "The ICSR failed validation (rule R2-0214: MedDRA version missing in B.2.i.1a) and was not loaded. See the acknowledgment log and validation report."
    }
  },
  "businessStatus": {
    "coding": [
      {
        "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-business-status",
        "code": "rejected",
        "display": "Rejected"
      }
    ]
  },
  "intent": "proposal",
  "priority": "routine",
  "code": {
    "coding": [
      {
        "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-code",
        "code": "icsr",
        "display": "Individual Case Safety Report"
      }
    ]
  },
  "executionPeriod": {
    "start": "2026-10-14T11:00:04+02:00",
    "end": "2026-10-14T11:12:30+02:00"
  },
  "authoredOn": "2026-10-14T11:00:00+02:00",
  "lastModified": "2026-10-14T11:12:30+02:00",
  "requester": {
    "reference": "Organization/org-synthpharma-ag",
    "display": "SynthPharma AG"
  },
  "owner": {
    "reference": "Organization/org-ema-srm-hmed",
    "display": "Health Authority – Regulatory Review Division"
  },
  "input": [
    {
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
            "code": "icsr-e2b-r2",
            "display": "ICSR (E2B(R2))"
          }
        ]
      },
      "valueReference": {
        "reference": "DocumentReference/docref-icsr-2b",
        "display": "ICSR — case CH-SYNTHPHARMA-2026-000512"
      }
    }
  ],
  "output": [
    {
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
            "code": "icsr-e2b-r2-acklog",
            "display": "ICSR E2B(R2) Acknowledgment Log"
          }
        ]
      },
      "valueReference": {
        "reference": "DocumentReference/docref-icsr-2b-acklog",
        "display": "ICSR acknowledgment log (rejected)"
      }
    },
    {
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
            "code": "validation-report",
            "display": "Validation Report"
          }
        ]
      },
      "valueReference": {
        "reference": "DocumentReference/docref-icsr-2b-validation-report",
        "display": "ICSR validation report"
      }
    }
  ]
}