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
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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" } ] } ] } }