<?xml version="1.0" encoding="UTF-8"?><CodeSystem xmlns="http://hl7.org/fhir"><id value="research-study-classifiers"/><meta><lastUpdated value="2026-04-02T04:59:15.240+11:00"/></meta><text><status value="generated"/><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></text><extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"><valueCode value="brr"/></extension><extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"><valueCode value="informative"/></extension><extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"><valueInteger value="0"/></extension><url value="http://hl7.org/fhir/research-study-classifiers"/><identifier><system value="urn:ietf:rfc:3986"/><value value="urn:oid:2.16.840.1.113883.4.642.4.1967"/></identifier><version value="6.0.0-ballot4"/><name value="ResearchStudyClassifiers"/><title value="ResearchStudy Classifiers Code System"/><status value="active"/><experimental value="false"/><date value="2022-05-15T16:55:11.085+11:00"/><publisher value="HL7 (FHIR Project)"/><contact><telecom><system value="url"/><value value="http://hl7.org/fhir"/></telecom><telecom><system value="email"/><value value="fhir@lists.hl7.org"/></telecom></contact><description value="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 value="http://unstats.un.org/unsd/methods/m49/m49.htm"/><code value="001"/><display value="World"/></coding></jurisdiction><caseSensitive value="true"/><valueSet value="http://hl7.org/fhir/ValueSet/research-study-classifiers"/><hierarchyMeaning value="is-a"/><content value="complete"/><concept><code value="fda-regulated-drug"/><display value="FDA regulated drug"/><definition value="A medication regulated by the U.S. Food and Drug Administration."/></concept><concept><code value="fda-regulated-device"/><display value="FDA regulated device"/><definition value="A medical device regulated by the U.S. Food and Drug Administration."/></concept><concept><code value="mpg-paragraph-23b"/><display value="MPG Paragraph 23b"/><definition value="Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b)."/></concept><concept><code value="irb-exempt"/><display value="IRB-exempt"/><definition value="Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB)."/></concept></CodeSystem>