Evidence Based Medicine on FHIR Implementation Guide
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Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

: ResearchStudy Classifier Code System

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{
  "resourceType" : "CodeSystem",
  "id" : "419455",
  "meta" : {
    "versionId" : "4",
    "lastUpdated" : "2025-12-15T16:50:42.236Z"
  },
  "language" : "en",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem 419455</b></p><a name=\"419455\"> </a><a name=\"hc419455\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 4; Last updated: 2025-12-15 16:50:42+0000</p></div><p>This  code system <code>https://fevir.net/resources/CodeSystem/419455</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style=\"white-space:nowrap\">fda-regulated-drug<a name=\"419455-fda-regulated-drug\"> </a></td><td>FDA regulated drug</td><td>A medication regulated by the U.S. Food and Drug Administration.</td></tr><tr><td style=\"white-space:nowrap\">fda-regulated-device<a name=\"419455-fda-regulated-device\"> </a></td><td>FDA regulated device</td><td>A medical device regulated by the U.S. Food and Drug Administration.</td></tr><tr><td style=\"white-space:nowrap\">irb-exempt<a name=\"419455-irb-exempt\"> </a></td><td>IRB-exempt</td><td>Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB).</td></tr><tr><td style=\"white-space:nowrap\">mpg-paragraph-23b<a name=\"419455-mpg-paragraph-23b\"> </a></td><td>MPG Paragraph 23b</td><td>Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b).</td></tr><tr><td style=\"white-space:nowrap\">includes-females<a name=\"419455-includes-females\"> </a></td><td>Includes female subjects</td><td>Includes female subjects</td></tr><tr><td style=\"white-space:nowrap\">does-not-include-females<a name=\"419455-does-not-include-females\"> </a></td><td>Does not include female subjects</td><td>Does not include female subjects</td></tr><tr><td style=\"white-space:nowrap\">includes-males<a name=\"419455-includes-males\"> </a></td><td>Includes male subjects</td><td>Includes male subjects</td></tr><tr><td style=\"white-space:nowrap\">does-not-include-males<a name=\"419455-does-not-include-males\"> </a></td><td>Does not include male subjects</td><td>Does not include male subjects</td></tr><tr><td style=\"white-space:nowrap\">includes-vulnerable-population<a name=\"419455-includes-vulnerable-population\"> </a></td><td>Includes vulnerable populations</td><td>Includes vulnerable populations</td></tr><tr><td style=\"white-space:nowrap\">does-not-include-vulnerable-population<a name=\"419455-does-not-include-vulnerable-population\"> </a></td><td>Does not include vulnerable populations</td><td>Does not include vulnerable populations</td></tr><tr><td style=\"white-space:nowrap\">includes-healthy-volunteers<a name=\"419455-includes-healthy-volunteers\"> </a></td><td>Includes healthy volunteers</td><td>Includes healthy volunteers</td></tr><tr><td style=\"white-space:nowrap\">does-not-include-healthy-volunteers<a name=\"419455-does-not-include-healthy-volunteers\"> </a></td><td>Does not include healthy volunteers</td><td>Does not include healthy volunteers</td></tr></table></div>"
  },
  "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 2025-12-15. 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" : "2025-12-22T15:35:23+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"
    }
  ],
  "valueSet" : "https://fevir.net/resources/ValueSet/419456",
  "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"
    }
  ]
}