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Resource ValueSet/FHIR Server from package hl7.fhir.uv.rfi-ig#current (16 ms)

Package hl7.fhir.uv.rfi-ig
Type ValueSet
Id Id
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 2025-05-28T19:43:55+00:00
Name RFICategoryAndSubcategory
Experimental False
Realm uv
Authority hl7
Description Categories and sub-categories for RFI questions, aligned to ICH CTD headings.

Resources that use this resource

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Resources that this resource uses

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Narrative

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:

  • Include these codes as defined in http://hl7.org/fhir/rfi-category
    CodeDisplay
    AdministrativeAdministrative
    LabelingLabeling
    CMCCMC
    ClinicalClinical
    Non-clinicalNon-clinical
  • Include these codes as defined in http://hl7.org/fhir/rfi-subcategory
    CodeDisplay
    ApplicationFormApplication Form
    AdministrativeDetailsAdministrative Details
    ProposedLabelingProposed Labeling
    RiskManagementRisk Management
    DrugSubstanceDrug Substance
    StabilityStability
    BioequivalenceBioequivalence
    ClinicalStudyReportsClinical Study Reports
    ToxicologyToxicology
    PharmacologyPharmacology

Source

{
  "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><a name=\"rfi-category-subcategory-en-US\"> </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" : "2025-05-28T19:43:55+00:00",
  "publisher" : "Gravitate Health Project",
  "contact" : [
    {
      "name" : "Gravitate Health Project",
      "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"
          }
        ]
      }
    ]
  }
}

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