FHIR IG analytics

Resources that use this resource

Resources that this resource uses

No resources found

Narrative

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

Source1

{
  "resourceType": "CodeSystem",
  "id": "rtq-question-category",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "brr"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "informative",
      "_valueCode": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical": "http://hl7.org/fhir/uv/rtq/ImplementationGuide/hl7.fhir.uv.rtq-ig"
          }
        ]
      }
    }
  ],
  "url": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-question-category",
  "version": "0.2.0",
  "name": "RtqQuestionCategoryCS",
  "title": "RTQ Regulatory Significance Category Code System",
  "status": "draft",
  "experimental": true,
  "date": "2026-08-08",
  "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": "RTQ-defined category codes that classify the regulatory significance of a question (e.g., major objection, minor concern). This is one of several terminologies that can supply category codes on a question (see the RTQ Question Category Value Set); regulators are encouraged to adopt these as preferred terms to support international alignment.",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code": "001",
          "display": "World"
        }
      ]
    }
  ],
  "caseSensitive": true,
  "content": "complete",
  "count": 4,
  "concept": [
    {
      "code": "major-objection",
      "display": "Major Objection",
      "definition": "A significant deficiency that precludes approval unless satisfactorily resolved (e.g., EMA Major Objection, FDA deficiency requiring a complete response)."
    },
    {
      "code": "minor-concern",
      "display": "Minor Concern",
      "definition": "A point requiring clarification or minor supplementary information that does not by itself preclude approval (e.g., EMA Other Concern, clarification request)."
    },
    {
      "code": "other-consideration",
      "display": "Other Consideration",
      "definition": "An observation, recommendation, or administrative point that is not a deficiency but requires acknowledgement or action."
    },
    {
      "code": "commitment",
      "display": "Commitment",
      "definition": "A question or response item that establishes or relates to a post-approval commitment or follow-up measure to be fulfilled at a later date."
    }
  ]
}