| Package | hl7.fhir.uv.rfi-ig |
| Resource Type | ValueSet |
| Id | rfi-category-subcategory |
| FHIR Version | R5 |
| Source | http://hl7.org/fhir/uv/rfi-ig/https://build.fhir.org/ig/cander2/rfi-ig/ValueSet-rfi-category-subcategory.html |
| URL | http://hl7.org/fhir/ValueSet/rfi-category-subcategory |
| Version | 0.1.0 |
| Status | draft |
| Date | 2025-06-19T00:08:28+00:00 |
| Name | RFICategoryAndSubcategory |
| Realm | uv |
| Authority | hl7 |
| Description | Categories and sub-categories for RFI questions, aligned to ICH CTD headings. |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: ValueSet rfi-category-subcategory
This value set includes codes based on the following rules:
http://hl7.org/fhir/rfi-category| Code | Display |
| Administrative | Administrative |
| Labeling | Labeling |
| CMC | CMC |
| Clinical | Clinical |
| Non-clinical | Non-clinical |
http://hl7.org/fhir/rfi-subcategory| Code | Display |
| ApplicationForm | Application Form |
| AdministrativeDetails | Administrative Details |
| ProposedLabeling | Proposed Labeling |
| RiskManagement | Risk Management |
| DrugSubstance | Drug Substance |
| Stability | Stability |
| Bioequivalence | Bioequivalence |
| ClinicalStudyReports | Clinical Study Reports |
| Toxicology | Toxicology |
| Pharmacology | Pharmacology |
{
"resourceType": "ValueSet",
"id": "rfi-category-subcategory",
"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
"url": "http://hl7.org/fhir/ValueSet/rfi-category-subcategory",
"version": "0.1.0",
"name": "RFICategoryAndSubcategory",
"status": "draft",
"date": "2025-06-19T00:08:28+00:00",
"publisher": "Gravitate Health and HL7 Vulcan",
"contact": [
{
"name": "Gravitate Health and HL7 Vulcan",
"telecom": [
{
"system": "url",
"value": "https://www.gravitatehealth.eu/"
}
]
}
],
"description": "Categories and sub-categories for RFI questions, aligned to ICH CTD headings.",
"compose": {
"include": [
{
"system": "http://hl7.org/fhir/rfi-category",
"concept": [
{
"code": "Administrative",
"display": "Administrative"
},
{
"code": "Labeling",
"display": "Labeling"
},
{
"code": "CMC",
"display": "CMC"
},
{
"code": "Clinical",
"display": "Clinical"
},
{
"code": "Non-clinical",
"display": "Non-clinical"
}
]
},
{
"system": "http://hl7.org/fhir/rfi-subcategory",
"concept": [
{
"code": "ApplicationForm",
"display": "Application Form"
},
{
"code": "AdministrativeDetails",
"display": "Administrative Details"
},
{
"code": "ProposedLabeling",
"display": "Proposed Labeling"
},
{
"code": "RiskManagement",
"display": "Risk Management"
},
{
"code": "DrugSubstance",
"display": "Drug Substance"
},
{
"code": "Stability",
"display": "Stability"
},
{
"code": "Bioequivalence",
"display": "Bioequivalence"
},
{
"code": "ClinicalStudyReports",
"display": "Clinical Study Reports"
},
{
"code": "Toxicology",
"display": "Toxicology"
},
{
"code": "Pharmacology",
"display": "Pharmacology"
}
]
}
]
}
}