{"caseSensitive":true,"concept":[{"code":"fda-regulated-drug","definition":"A medication regulated by the U.S. Food and Drug Administration.","display":"FDA regulated drug"},{"code":"fda-regulated-device","definition":"A medical device regulated by the U.S. Food and Drug Administration.","display":"FDA regulated device"},{"code":"mpg-paragraph-23b","definition":"Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b).","display":"MPG Paragraph 23b"},{"code":"irb-exempt","definition":"Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB).","display":"IRB-exempt"}],"contact":[{"telecom":[{"system":"url","value":"http://hl7.org/fhir"},{"system":"email","value":"fhir@lists.hl7.org"}]}],"content":"complete","date":"2022-05-15T16:55:11.085+11:00","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.","experimental":false,"extension":[{"url":"http://hl7.org/fhir/StructureDefinition/structuredefinition-wg","valueCode":"brr"},{"url":"http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status","valueCode":"informative"},{"url":"http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm","valueInteger":0}],"hierarchyMeaning":"is-a","id":"research-study-classifiers","identifier":[{"system":"urn:ietf:rfc:3986","value":"urn:oid:2.16.840.1.113883.4.642.4.1967"}],"jurisdiction":[{"coding":[{"code":"001","display":"World","system":"http://unstats.un.org/unsd/methods/m49/m49.htm"}]}],"meta":{"lastUpdated":"2026-04-01T22:29:14.669+11:00"},"name":"ResearchStudyClassifiers","publisher":"HL7 (FHIR Project)","resourceType":"CodeSystem","status":"active","text":{"div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem research-study-classifiers</b></p><a name=\"research-study-classifiers\"> </a><a name=\"hcresearch-study-classifiers\"> </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\">Last updated: 2022-05-15T16:55:11.085+11:00</p></div><p>This case-sensitive code system <code>http://hl7.org/fhir/research-study-classifiers</code> defines the following codes in a Is-A hierarchy:</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>","status":"generated"},"title":"ResearchStudy Classifiers Code System","url":"http://hl7.org/fhir/research-study-classifiers","valueSet":"http://hl7.org/fhir/ValueSet/research-study-classifiers","version":"6.0.0-ballot4"}