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Packagehl7.fhir.uv.rwi-pharma
Resource TypeValueSet
IdValueSet-apix-ctd-module-vs.json
FHIR VersionR5
Sourcehttps://build.fhir.org/ig/HL7/reg-workflow-pharma/ValueSet-apix-ctd-module-vs.html
URLhttp://hl7.org/fhir/uv/rwi-pharma/ValueSet/apix-ctd-module-vs
Version0.1.0
Statusactive
Date2026-10-25T20:05:09+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

No resources found


Resources that this resource uses

CodeSystem
hl7.fhir.uv.rwi-pharma#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

  • Include these codes as defined in http://hl7.org/fhir/uv/rwi-pharma/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",
  "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/rwi-pharma/ImplementationGuide/hl7.fhir.uv.rwi-pharma"
          }
        ]
      }
    },
    {
      "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/rwi-pharma/ImplementationGuide/hl7.fhir.uv.rwi-pharma"
          }
        ]
      }
    }
  ],
  "url": "http://hl7.org/fhir/uv/rwi-pharma/ValueSet/apix-ctd-module-vs",
  "version": "0.1.0",
  "name": "APIXCTDModuleVS",
  "title": "APIX CTD/eCTD Module Value Set",
  "status": "active",
  "experimental": false,
  "date": "2026-10-25T20:05:09+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/rwi-pharma/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"
          }
        ]
      }
    ]
  }
}