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Source1

{
  "resourceType": "CodeSystem",
  "id": "419455",
  "meta": {
    "versionId": "8",
    "lastUpdated": "2026-01-22T16:57:47.498Z"
  },
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as",
      "valueMarkdown": "ResearchStudy Classifier Code System [Database Entry: FHIR CodeSystem Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 419455. Revised 2026-01-22. Available at: https://fevir.net/resources/CodeSystem/419455. Computable resource at: https://fevir.net/resources/CodeSystem/419455#json."
    }
  ],
  "url": "https://fevir.net/resources/CodeSystem/419455",
  "identifier": [
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code": "ACSN",
            "display": "Accession ID"
          }
        ],
        "text": "FEvIR Object Identifier"
      },
      "system": "https://fevir.net/FOI",
      "value": "419455",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    },
    {
      "system": "urn:ietf:rfc:3986",
      "value": "urn:oid:2.16.840.1.113883.4.642.40.44.16.8"
    }
  ],
  "version": "1.0.0-ballot3",
  "name": "ResearchStudyClassifierCodeSystem",
  "title": "ResearchStudy Classifier Code System",
  "status": "active",
  "date": "2026-01-29T22:05:53+00:00",
  "publisher": "HL7 International / Clinical Decision Support",
  "contact": [
    {
      "name": "HL7 International / Clinical Decision Support",
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org/Special/committees/dss"
        }
      ]
    }
  ],
  "description": "This CodeSystem is used for common values for the ResearchStudy.classifier element and will likely move to terminology.hl7.org when it is mature.",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code": "001",
          "display": "World"
        }
      ]
    }
  ],
  "copyright": "https://creativecommons.org/licenses/by-nc-sa/4.0/",
  "author": [
    {
      "name": "Brian S. Alper, MD, MSPH"
    }
  ],
  "content": "complete",
  "concept": [
    {
      "code": "fda-regulated-drug",
      "display": "FDA regulated drug",
      "definition": "A medication regulated by the U.S. Food and Drug Administration."
    },
    {
      "code": "fda-regulated-device",
      "display": "FDA regulated device",
      "definition": "A medical device regulated by the U.S. Food and Drug Administration."
    },
    {
      "code": "irb-exempt",
      "display": "IRB-exempt",
      "definition": "Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB)."
    },
    {
      "code": "mpg-paragraph-23b",
      "display": "MPG Paragraph 23b",
      "definition": "Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b)."
    },
    {
      "code": "includes-females",
      "display": "Includes female subjects",
      "definition": "Includes female subjects"
    },
    {
      "code": "does-not-include-females",
      "display": "Does not include female subjects",
      "definition": "Does not include female subjects"
    },
    {
      "code": "includes-males",
      "display": "Includes male subjects",
      "definition": "Includes male subjects"
    },
    {
      "code": "does-not-include-males",
      "display": "Does not include male subjects",
      "definition": "Does not include male subjects"
    },
    {
      "code": "includes-vulnerable-population",
      "display": "Includes vulnerable populations",
      "definition": "Includes vulnerable populations"
    },
    {
      "code": "does-not-include-vulnerable-population",
      "display": "Does not include vulnerable populations",
      "definition": "Does not include vulnerable populations"
    },
    {
      "code": "includes-healthy-volunteers",
      "display": "Includes healthy volunteers",
      "definition": "Includes healthy volunteers"
    },
    {
      "code": "does-not-include-healthy-volunteers",
      "display": "Does not include healthy volunteers",
      "definition": "Does not include healthy volunteers"
    },
    {
      "code": "includes-ages-in-utero",
      "display": "Includes ages in utero",
      "definition": "Includes subjects who are not yet born"
    },
    {
      "code": "includes-ages-0-17",
      "display": "Includes ages 0-17 years",
      "definition": "Includes subjects between birth and 17 years of age (not yet 18 years old)"
    },
    {
      "code": "includes-ages-18-64",
      "display": "Includes ages 18-64 years",
      "definition": "Includes subjects between 18 and 64 years of age (not yet 65 years old)"
    },
    {
      "code": "includes-ages-65-and-older",
      "display": "Includes ages 65 and older",
      "definition": "Includes subjects aged 65 years and older"
    },
    {
      "code": "includes-preterm-newborns",
      "display": "Includes preterm newborns",
      "definition": "Includes subjects who are preterm newborns (up to gestational age < 37 weeks)"
    },
    {
      "code": "includes-neonates",
      "display": "Includes neonates",
      "definition": "Includes subjects between 0 and 27 days of age"
    },
    {
      "code": "includes-ages-28-day-23-month",
      "display": "Includes ages 28 days to 23 months",
      "definition": "Includes subjects between 28 days and 23 months of age"
    },
    {
      "code": "includes-ages-2-5",
      "display": "Includes ages 2-5 years",
      "definition": "Includes subjects between 2 and 5 years of age (not yet 6 years old)"
    },
    {
      "code": "includes-ages-6-11",
      "display": "Includes ages 6-11 years",
      "definition": "Includes subjects between  6 and 11 years of age (not yet 12 years old)"
    },
    {
      "code": "includes-ages-12-17",
      "display": "Includes ages 12-17 years",
      "definition": "Includes subjects between 12 and 17 years of age (not yet 18 years old)"
    },
    {
      "code": "includes-ages-65-84",
      "display": "Includes ages 65-84 years",
      "definition": "Includes subjects between 65 and 84 years of age (not yet 85 years old)"
    },
    {
      "code": "includes-ages-85-and-older",
      "display": "Includes ages 85 and older",
      "definition": "Includes subjects aged 85 years and older"
    },
    {
      "code": "includes-patients",
      "display": "Includes patients",
      "definition": "Includes patients"
    },
    {
      "code": "does-not-include-patients",
      "display": "Does not include patients",
      "definition": "Does not include patients"
    }
  ]
}