FHIR IG analytics| Package | hl7.fhir.uv.rtq-ig |
| Resource Type | Questionnaire |
| Id | Questionnaire-questionnaire-ID001.json |
| FHIR Version | R5 |
| Source | https://build.fhir.org/ig/HL7/rtq-ig/Questionnaire-questionnaire-ID001.html |
| URL | https://build.fhir.org/ig/HL7/rtq-ig/Questionnaire/questionnaire-ID001 |
| Version | 0.1.0 |
| Status | active |
| Date | 2025-11-11 |
| Name | BRRRegulatoryQAQuestionnaire |
| Title | Question Set ID001 |
| Realm | uv |
| Authority | hl7 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: Questionnaire questionnaire-ID001
version: 1; Last updated: 2025-11-11 22:30:00+0000
Profile: Questionnaire
| LinkID | Text | Cardinality | Type | Description & Constraints |
|---|---|---|---|---|
  BRRRegulatoryQAQuestionnaire | Questionnaire | https://build.fhir.org/ig/HL7/rtq-ig/Questionnaire/questionnaire-ID001#0.1.0 | ||
  admin-1 | Is the fee for the Type II variation fully paid and documented? | 0..1 | question | |
 admin-2 | Are all required metadata fields in the application form complete? | 0..1 | group | |
| product-1 | Do the updated storage conditions (2–8°C for 36 months) require additional patient guidance? | 0..1 | question | |
| product-2 | Is the patient leaflet revised to clarify the extended shelf life? | 0..1 | question | |
| product-3 | Is the updated ePI text sufficiently clear for all EU languages? | 0..1 | question | |
| quality-1 | Are there any new stability studies conducted, or does the submission include only data from additional timepoints from previously submitted studies? | 0..1 | question | |
| quality-2 | Does the data support all intended climatic zones? | 0..1 | question | |
| quality-3 | Are the test methods used the same as in the previously submitted stability information? | 0..1 | question | |
| quality-4 | Are there any new degradation products identified within the newly submitted data? | 0..1 | question | |
 quality-5 | Any changes in the packaging configuration and/or storage of the samples during stability? | 0..1 | question | |
| Documentation for this format | ||||
FHIR
FHIRsmith{
"resourceType": "Questionnaire",
"id": "questionnaire-ID001",
"meta": {
"versionId": "1",
"lastUpdated": "2025-11-11T22:30:00Z",
"profile": [
"http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaire"
]
},
"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
"url": "https://build.fhir.org/ig/HL7/rtq-ig/Questionnaire/questionnaire-ID001",
"identifier": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type",
"code": "regulator-id",
"display": "Regulator-issued Identifier"
}
]
},
"system": "http://hl7.org/fhir/uv/brr/identifier/qa-request",
"value": "ID001"
},
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type",
"code": "regulator-id",
"display": "Regulator-issued Identifier"
}
]
},
"system": "https://ema.europa.eu/procedure-number",
"value": "EMEA/H/C/005432/II/0023"
}
],
"version": "0.1.0",
"name": "BRRRegulatoryQAQuestionnaire",
"title": "Question Set ID001",
"status": "active",
"subjectType": [
"MedicinalProductDefinition"
],
"date": "2025-11-11",
"publisher": "HL7 International",
"contact": [
{
"name": "HL7 International",
"telecom": [
{
"system": "url",
"value": "http://www.hl7.org"
}
]
}
],
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId": "admin-1",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "1.0",
"display": "1.0 Administrative Information"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "1.1",
"display": "1.1 Application Form"
}
],
"text": "Is the fee for the Type II variation fully paid and documented?",
"type": "question"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId": "admin-2",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "1.0",
"display": "Administrative Information"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "1.1",
"display": "Application Form"
}
],
"text": "Are all required metadata fields in the application form complete?",
"type": "group"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId": "product-1",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "1.3",
"display": "1.3 Product Information"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "1.3.1",
"display": "SmPC, Labelling and Package Leaflet"
}
],
"text": "Do the updated storage conditions (2–8°C for 36 months) require additional patient guidance?",
"type": "question"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId": "product-2",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "1.3",
"display": "Product Information"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "1.3.1",
"display": "SmPC, Labelling and Package Leaflet"
}
],
"text": "Is the patient leaflet revised to clarify the extended shelf life?",
"type": "question"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId": "product-3",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "1.3",
"display": "Product Information"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "1.3.1",
"display": "SmPC, Labelling and Package Leaflet"
}
],
"text": "Is the updated ePI text sufficiently clear for all EU languages?",
"type": "question"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId": "quality-1",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.8",
"display": "Stability"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.8.1",
"display": "Stability Summary and Conclusion"
}
],
"text": "Are there any new stability studies conducted, or does the submission include only data from additional timepoints from previously submitted studies?",
"type": "question"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId": "quality-2",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.8",
"display": "Stability"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.8.1",
"display": "Stability Summary and Conclusion"
}
],
"text": "Does the data support all intended climatic zones?",
"type": "question"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId": "quality-3",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.5",
"display": "Control of Drug Product"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.5.2",
"display": "Analytical Procedures"
}
],
"text": "Are the test methods used the same as in the previously submitted stability information?",
"type": "question"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId": "quality-4",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.5",
"display": "Control of Drug Product"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.5.4",
"display": "Impurities"
}
],
"text": "Are there any new degradation products identified within the newly submitted data?",
"type": "question"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId": "quality-5",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.7",
"display": "Container Closure System"
}
],
"text": "Any changes in the packaging configuration and/or storage of the samples during stability?",
"type": "question"
}
]
}