Regulatory Correspondence
0.1.0 - ci-build

Regulatory Correspondence, published by Gravitate Health and HL7 Vulcan. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/rfi-ig/ and changes regularly. See the Directory of published versions

: RFICategoryAndSubcategory - TTL Representation

Draft as of 2025-06-19

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:ValueSet ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "rfi-category-subcategory"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet rfi-category-subcategory</b></p><a name=\"rfi-category-subcategory\"> </a><a name=\"hcrfi-category-subcategory\"> </a><p>This value set includes codes based on the following rules:</p><ul><li>Include these codes as defined in <code>http://hl7.org/fhir/rfi-category</code><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>Administrative</td><td>Administrative</td></tr><tr><td>Labeling</td><td>Labeling</td></tr><tr><td>CMC</td><td>CMC</td></tr><tr><td>Clinical</td><td>Clinical</td></tr><tr><td>Non-clinical</td><td>Non-clinical</td></tr></table></li><li>Include these codes as defined in <code>http://hl7.org/fhir/rfi-subcategory</code><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>ApplicationForm</td><td>Application Form</td></tr><tr><td>AdministrativeDetails</td><td>Administrative Details</td></tr><tr><td>ProposedLabeling</td><td>Proposed Labeling</td></tr><tr><td>RiskManagement</td><td>Risk Management</td></tr><tr><td>DrugSubstance</td><td>Drug Substance</td></tr><tr><td>Stability</td><td>Stability</td></tr><tr><td>Bioequivalence</td><td>Bioequivalence</td></tr><tr><td>ClinicalStudyReports</td><td>Clinical Study Reports</td></tr><tr><td>Toxicology</td><td>Toxicology</td></tr><tr><td>Pharmacology</td><td>Pharmacology</td></tr></table></li></ul></div>"^^rdf:XMLLiteral
  ] ; # 
  fhir:url [ fhir:v "http://hl7.org/fhir/ValueSet/rfi-category-subcategory"^^xsd:anyURI] ; # 
  fhir:version [ fhir:v "0.1.0"] ; # 
  fhir:name [ fhir:v "RFICategoryAndSubcategory"] ; # 
  fhir:status [ fhir:v "draft"] ; # 
  fhir:date [ fhir:v "2025-06-19T00:08:28+00:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "Gravitate Health and HL7 Vulcan"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "Gravitate Health and HL7 Vulcan" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "https://www.gravitatehealth.eu/" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Categories and sub-categories for RFI questions, aligned to ICH CTD headings."] ; # 
  fhir:compose [
    ( fhir:include [
fhir:system [ fhir:v "http://hl7.org/fhir/rfi-category"^^xsd:anyURI ] ;
      ( fhir:concept [
fhir:code [ fhir:v "Administrative" ] ;
fhir:display [ fhir:v "Administrative" ]       ] [
fhir:code [ fhir:v "Labeling" ] ;
fhir:display [ fhir:v "Labeling" ]       ] [
fhir:code [ fhir:v "CMC" ] ;
fhir:display [ fhir:v "CMC" ]       ] [
fhir:code [ fhir:v "Clinical" ] ;
fhir:display [ fhir:v "Clinical" ]       ] [
fhir:code [ fhir:v "Non-clinical" ] ;
fhir:display [ fhir:v "Non-clinical" ]       ] )     ] [
fhir:system [ fhir:v "http://hl7.org/fhir/rfi-subcategory"^^xsd:anyURI ] ;
      ( fhir:concept [
fhir:code [ fhir:v "ApplicationForm" ] ;
fhir:display [ fhir:v "Application Form" ]       ] [
fhir:code [ fhir:v "AdministrativeDetails" ] ;
fhir:display [ fhir:v "Administrative Details" ]       ] [
fhir:code [ fhir:v "ProposedLabeling" ] ;
fhir:display [ fhir:v "Proposed Labeling" ]       ] [
fhir:code [ fhir:v "RiskManagement" ] ;
fhir:display [ fhir:v "Risk Management" ]       ] [
fhir:code [ fhir:v "DrugSubstance" ] ;
fhir:display [ fhir:v "Drug Substance" ]       ] [
fhir:code [ fhir:v "Stability" ] ;
fhir:display [ fhir:v "Stability" ]       ] [
fhir:code [ fhir:v "Bioequivalence" ] ;
fhir:display [ fhir:v "Bioequivalence" ]       ] [
fhir:code [ fhir:v "ClinicalStudyReports" ] ;
fhir:display [ fhir:v "Clinical Study Reports" ]       ] [
fhir:code [ fhir:v "Toxicology" ] ;
fhir:display [ fhir:v "Toxicology" ]       ] [
fhir:code [ fhir:v "Pharmacology" ] ;
fhir:display [ fhir:v "Pharmacology" ]       ] )     ] )
  ] . #