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Packagehl7.fhir.uv.apix
Resource TypeValueSet
IdValueSet-apix-ctd-module-vs.json
FHIR VersionR5
Sourcehttps://build.fhir.org/ig/HL7/APIX---API-Exchange-for-Medicinal-Products/ValueSet-apix-ctd-module-vs.html
URLhttp://hl7.org/fhir/uv/apix/ValueSet/apix-ctd-module-vs
Version0.1.0
Statusactive
Date2026-03-27T01:59:45+00:00
NameAPIXCTDModuleVS
TitleAPIX CTD/eCTD Module Value Set
Realmuv
Authorityhl7
DescriptionValue set for CTD module codes used in APIX regulatory submissions

Resources that use this resource

StructureDefinition
hl7.fhir.uv.apix#currentapix-documentreferenceAPIX Regulatory DocumentReference

Resources that this resource uses

CodeSystem
hl7.fhir.uv.apix#currentctd-sectionAPIX CTD/eCTD Section Code System

Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: ValueSet apix-ctd-module-vs

Language: en

  • Include these codes as defined in http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section version 📦0.1.0
    CodeDisplayDefinition
    m1Module 1Module 1: Administrative Information
    m2Module 2Module 2: Overviews and Summaries
    m3Module 3Module 3: Quality (CMC)
    m4Module 4Module 4: Nonclinical Study Reports
    m5Module 5Module 5: Clinical Study Reports

Source1

{
  "resourceType": "ValueSet",
  "id": "apix-ctd-module-vs",
  "language": "en",
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "brr"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 1,
      "_valueInteger": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical": "http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "trial-use",
      "_valueCode": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical": "http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix"
          }
        ]
      }
    }
  ],
  "url": "http://hl7.org/fhir/uv/apix/ValueSet/apix-ctd-module-vs",
  "version": "0.1.0",
  "name": "APIXCTDModuleVS",
  "title": "APIX CTD/eCTD Module Value Set",
  "status": "active",
  "experimental": false,
  "date": "2026-03-27T01:59:45+00:00",
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "contact": [
    {
      "name": "HL7 International / Biomedical Research and Regulation",
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org/Special/committees/rcrim"
        }
      ]
    }
  ],
  "description": "Value set for CTD module codes used in APIX regulatory submissions",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code": "001",
          "display": "World"
        }
      ]
    }
  ],
  "compose": {
    "include": [
      {
        "system": "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
        "concept": [
          {
            "code": "m1",
            "display": "Module 1"
          },
          {
            "code": "m2",
            "display": "Module 2"
          },
          {
            "code": "m3",
            "display": "Module 3"
          },
          {
            "code": "m4",
            "display": "Module 4"
          },
          {
            "code": "m5",
            "display": "Module 5"
          }
        ]
      }
    ]
  }
}