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
| Draft as of 2025-06-19 |
{
"resourceType" : "ValueSet",
"id" : "rfi-category-subcategory",
"text" : {
"status" : "generated",
"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>"
},
"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"
}
]
}
]
}
}