FHIR IG analytics| Package | hl7.fhir.uv.rtq-ig |
| Resource Type | QuestionnaireResponse |
| Id | QuestionnaireResponse-questionnaireresponse-ID001.json |
| FHIR Version | R5 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: QuestionnaireResponse questionnaireresponse-ID001
version: 1; Last updated: 2025-11-20 22:30:00+0000
Profile: http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaireresponse
| LinkID | Text | Definition | Answer |
|---|---|---|---|
  questionnaireresponse-ID001 | Questionnaire:Questionnaire/questionnaire-ID001 | ||
  admin-1 | |||
| admin-2 | See extension | ||
| product-1 | See extension | ||
| product-2 | See extension | ||
| product-3 | See extension | ||
| quality-1 | See extension | ||
| quality-2 | See extension | ||
| quality-3 | See extension | ||
| quality-4 | See extension | ||
 quality-5 | See extension | ||
| Documentation for this format | |||
FHIR
FHIRsmith{
"resourceType": "QuestionnaireResponse",
"id": "questionnaireresponse-ID001",
"meta": {
"versionId": "1",
"lastUpdated": "2025-11-20T22:30:00Z",
"profile": [
"http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaireresponse"
]
},
"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
"contained": [
{
"resourceType": "Organization",
"id": "org-regulator",
"identifier": [
{
"system": "https://example-nra.example.org/organization-id",
"value": "NRA"
}
],
"name": "National Regulatory Authority",
"contact": [
{
"telecom": [
{
"system": "email",
"value": "regulatory.contact@example-nra.example.org"
}
],
"address": {
"text": "1 Regulatory Plaza, Capital City",
"line": [
"1 Regulatory Plaza"
],
"city": "Capital City",
"postalCode": "00001",
"country": "XX"
}
}
]
},
{
"resourceType": "Organization",
"id": "org-mah",
"identifier": [
{
"system": "https://www.zefix.ch/en/SwissCompanyRegistry/UID",
"value": "CHE-123.456.789"
}
],
"name": "SynthPharma AG",
"contact": [
{
"telecom": [
{
"system": "email",
"value": "john.doe@synthpharma.ch"
}
],
"address": {
"text": "Industriestrasse 12, 4056 Basel, CH",
"line": [
"Industriestrasse 12"
],
"city": "Basel",
"postalCode": "4056",
"country": "CH"
}
}
]
},
{
"resourceType": "DocumentReference",
"id": "example-docref",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-documentreference"
]
},
"identifier": [
{
"system": "urn:ietf:rfc:3986",
"value": "urn:oid:1.2.3.4.5"
}
],
"version": "1.0",
"status": "current",
"docStatus": "final",
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code": "3-2-P-5-3",
"display": "3.2.P.5.3 Validation of Analytical Procedures"
}
]
},
"category": [
{
"coding": [
{
"system": "http://hl7.org/fhir/document-reference-status",
"code": "current",
"display": "Current"
}
]
}
],
"date": "2025-11-20T10:00:00Z",
"description": "Comprehensive validation of analytical procedures for the WonderDrug 10mg product lifecycle.",
"content": [
{
"attachment": {
"contentType": "application/pdf",
"title": "Validation Report for HPLC Method",
"creation": "2025-11-19T15:00:00Z"
}
}
]
}
],
"identifier": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/rtq/CodeSystem/rtq-identifier-type",
"code": "regulator",
"display": "Regulatory Authority Identifier"
}
]
},
"system": "http://hl7.org/fhir/uv/brr/identifier/qa-request",
"value": "ID001"
}
],
"questionnaire": "Questionnaire/questionnaire-ID001",
"status": "completed",
"subject": {
"reference": "MedicinalProductDefinition/MedicinalProduct-ExampleDrug",
"display": "ExampleDrug 10 mg Tablets"
},
"authored": "2025-06-25T14:00:00+02:00",
"author": {
"reference": "#org-regulator",
"type": "Organization",
"display": "National Regulatory Authority"
},
"source": {
"reference": "#org-mah",
"type": "Organization",
"display": "SynthPharma AG"
},
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Is the fee for the Type II variation fully paid and documented?</p></div>"
}
],
"linkId": "admin-1",
"answer": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Yes, the fee was paid on <b>June 25, 2025</b>. Payment confirmation and receipt are included in the application form (see Section 1.1).</p></div>"
}
],
"valueString": "See extension"
},
{
"valueReference": {
"reference": "#example-docref",
"display": "Fee Payment Receipt"
}
}
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Are all required metadata fields in the application form complete?</p></div>"
}
],
"linkId": "admin-2",
"answer": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Yes, all required metadata fields are complete:</p><ul><li><strong>MAH:</strong> SynthPharma AG</li><li><strong>Product:</strong> ExampleDrug 10 mg Tablets</li><li><strong>Procedure:</strong> NRA/H/C/005432/II/0023</li><li><strong>Submission Date:</strong> 2025-06-25</li></ul></div>"
}
],
"valueString": "See extension"
}
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do the updated storage conditions (2–8°C for 36 months) require additional patient guidance?</p></div>"
}
],
"linkId": "product-1",
"answer": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>No additional patient guidance is required. The ePI clearly states: 'Store in a refrigerator (2°C – 8°C). Do not freeze.' The 36-month shelf life is supported by stability data and does not alter patient handling instructions.</p></div>"
}
],
"valueString": "See extension"
}
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Is the patient leaflet revised to clarify the extended shelf life?</p></div>"
}
],
"linkId": "product-2",
"answer": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Yes, the patient leaflet has been updated to state: 'Shelf life after first opening: 36 months when stored at 2–8°C'. The revised leaflet is included in the submission.</p></div>"
}
],
"valueString": "See extension"
}
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Is the updated ePI text sufficiently clear for all applicable languages?</p></div>"
}
],
"linkId": "product-3",
"answer": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Yes, the ePI text has been translated into all applicable languages and reviewed for clarity. All versions are linguistically validated. Status: English (Approved), French (Approved), German (Approved), others (Final review completed).</p></div>"
}
],
"valueString": "See extension"
}
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Are there any new stability studies conducted, or does the submission include only data from additional timepoints from previously submitted studies?</p></div>"
}
],
"linkId": "quality-1",
"answer": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The submission includes both:</p><ul><li><strong>Additional timepoints:</strong> Long-term data extended to 36 months for primary batches A-001, A-002, A-003.</li><li><strong>New stability studies:</strong> Two pilot-scale batches (B-001, B-002) in new Alu/Alu packaging, with 6-month accelerated (40°C/75% RH) and long-term (25°C/60% RH) data.</li></ul><p>No protocol deviations occurred. All studies follow ICH Q1A(R2).</p></div>"
}
],
"valueString": "See extension"
}
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Does the data support all intended climatic zones?</p></div>"
}
],
"linkId": "quality-2",
"answer": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Yes, the data supports all ICH climatic zones, including Zone IVb:</p><ul><li><strong>Zone I/II:</strong> 25°C/60% RH (long-term), 40°C/75% RH (accelerated)</li><li><strong>Zone IVb:</strong> 30°C/75% RH (long-term) — data confirms compliance per WHO TRS 1010.</li></ul><p>All batches remain within specification.</p></div>"
}
],
"valueString": "See extension"
}
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Are the test methods used the same as in the previously submitted stability information?</p></div>"
}
],
"linkId": "quality-3",
"answer": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Yes, all test methods are identical to those validated in the original MAA. No changes were made. Methods remain stability-indicating for assay, impurities, and dissolution.</p></div>"
}
],
"valueString": "See extension"
}
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Are there any new degradation products identified within the newly submitted data?</p></div>"
}
],
"linkId": "quality-4",
"answer": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>No new degradation products were identified. All observed impurities correspond to previously qualified degradants. Levels remain below 0.10% (ICH Q3B(R2) threshold). No peaks above reporting threshold detected.</p></div>"
}
],
"valueString": "See extension"
}
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Any changes in the packaging configuration and/or storage of the samples during stability?</p></div>"
}
],
"linkId": "quality-5",
"answer": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Yes, a change in packaging configuration was implemented:</p><ul><li><strong>Original:</strong> PVC/PVDC blister pack</li><li><strong>New:</strong> Aluminum/aluminum (Alu/Alu) blister pack</li></ul><p>New stability studies (B-001, B-002) were initiated in the Alu/Alu system. Storage conditions remain unchanged: 25°C/60% RH (long-term), 40°C/75% RH (accelerated).</p><div style=\"background:#e5e5ea;border:1px dashed #999;padding:10px;text-align:center;color:#666;\">[Figure 1: Cross-section of new Alu/Alu blister pack]</div><p style=\"font-size:0.9em;color:#555\"><b>Figure 1:</b> Cross-section of new Alu/Alu blister showing foil thickness and sealing layer.</p><table><tr><th>Parameter</th><th>Original</th><th>New</th></tr><tr><td>Material</td><td>PVC/PVDC</td><td>Alu/Alu</td></tr><tr><td>Storage Condition</td><td>25°C/60% RH</td><td>Unchanged</td></tr></table></div>"
}
],
"valueString": "See extension"
}
]
}
]
}