FHIR IG analytics| Package | hl7.fhir.uv.rwi-pharma |
| Resource Type | Task |
| Id | Task-scenario3-05-cta-authorised.json |
| FHIR Version | R5 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Clinical trial authorised
| Task | Clinical Trial Application (clinical-trial-application) |
|---|---|
| Procedure number | CT-2026-000789 |
| Version | 3 |
| Status | completed |
| Business status | Authorised (authorised) |
| Requester | SynthPharma AG |
| Owner | Health Authority – Regulatory Review Division |
| Group identifier | urn:uuid:0a57b9f1-fc39-5bae-a93a-c86bd94484a5 |
| Authored | 2026-09-01T10:00:00+02:00 |
| Last modified | 2026-11-03T09:00:00+01:00 |
Inputs (from the requester)
cover-letterapplication-formprotocolOutputs (from the owner)
validation-reportauthorisation-decision{
"resourceType": "Task",
"id": "scenario3-05-cta-authorised",
"meta": {
"versionId": "3",
"lastUpdated": "2026-11-03T09:00:00+01:00",
"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:d572e793-2889-5b3d-bb51-7338eb4a3a07"
},
{
"use": "official",
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-demo",
"code": "apixregulatorprocedureno",
"display": "APIX Regulator Procedure Number"
}
]
},
"system": "http://example.org/health-authority/clinical-trial-number",
"value": "CT-2026-000789"
}
],
"groupIdentifier": {
"use": "official",
"system": "http://example.org/health-authority/work-flow-group-id",
"value": "urn:uuid:0a57b9f1-fc39-5bae-a93a-c86bd94484a5"
},
"status": "completed",
"businessStatus": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-business-status",
"code": "authorised",
"display": "Authorised"
}
]
},
"intent": "proposal",
"priority": "routine",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-code",
"code": "clinical-trial-application",
"display": "Clinical Trial Application"
}
]
},
"executionPeriod": {
"start": "2026-09-02T08:00:00+02:00",
"end": "2026-11-03T09:00:00+01:00"
},
"authoredOn": "2026-09-01T10:00:00+02:00",
"lastModified": "2026-11-03T09:00:00+01:00",
"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": "cover-letter",
"display": "Cover Letter"
}
]
},
"valueReference": {
"reference": "DocumentReference/docref-cta-cover-letter",
"display": "CTA cover letter"
}
},
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
"code": "application-form",
"display": "Application Form"
}
]
},
"valueReference": {
"reference": "DocumentReference/docref-cta-application-form",
"display": "CTA application form"
}
},
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
"code": "protocol",
"display": "Protocol"
}
]
},
"valueReference": {
"reference": "DocumentReference/docref-cta-protocol",
"display": "Protocol WD-201 v1.0"
}
}
],
"output": [
{
"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-cta-validation-report",
"display": "CTA validation report"
}
},
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
"code": "authorisation-decision",
"display": "Authorisation Decision"
}
]
},
"valueReference": {
"reference": "DocumentReference/docref-cta-decision",
"display": "Authorisation decision"
}
}
]
}