{
  "resourceType": "CodeSystem",
  "id": "research-study-classifiers",
  "meta": {
    "lastUpdated": "2023-03-26T15:21:02.749+11:00",
    "profile": [
      "http://hl7.org/fhir/StructureDefinition/shareablecodesystem"
    ]
  },
  "text": {
    "status": "generated",
    "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This code system <code>http://hl7.org/fhir/research-study-classifiers</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=\"research-study-classifiers-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=\"research-study-classifiers-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\">mpg-paragraph-23b<a name=\"research-study-classifiers-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\">irb-exempt<a name=\"research-study-classifiers-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></table></div>"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "brr"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "trial-use"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 0
    }
  ],
  "url": "http://hl7.org/fhir/research-study-classifiers",
  "identifier": [
    {
      "system": "urn:ietf:rfc:3986",
      "value": "urn:oid:2.16.840.1.113883.4.642.4.1967"
    }
  ],
  "version": "5.0.0",
  "name": "ResearchStudyClassifiers",
  "title": "ResearchStudy Classifiers Code System",
  "status": "active",
  "experimental": false,
  "date": "2022-05-15T16:55:11.085+11:00",
  "publisher": "HL7 (FHIR Project)",
  "contact": [
    {
      "telecom": [
        {
          "system": "url",
          "value": "http://hl7.org/fhir"
        },
        {
          "system": "email",
          "value": "fhir@lists.hl7.org"
        }
      ]
    }
  ],
  "description": "Codes for use in ResearchStudy Resource. This resource (this entire set of content) is being used for active development of a ResearchStudyClassifiers CodeSystem for use for supporting multiple value sets in the FHIR ResearchStudy StructureDefinition.",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code": "001",
          "display": "World"
        }
      ]
    }
  ],
  "caseSensitive": true,
  "valueSet": "http://hl7.org/fhir/ValueSet/research-study-classifiers",
  "hierarchyMeaning": "is-a",
  "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": "mpg-paragraph-23b",
      "display": "MPG Paragraph 23b",
      "definition": "Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b)."
    },
    {
      "code": "irb-exempt",
      "display": "IRB-exempt",
      "definition": "Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB)."
    }
  ]
}