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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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:CodeSystem ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "419455"] ; #
fhir:meta [
fhir:versionId [ fhir:v "4" ] ;
fhir:lastUpdated [ fhir:v "2025-12-15T16:50:42.236Z"^^xsd:dateTime ]
] ; #
fhir:language [ fhir:v "en"] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ]
] ; #
fhir:extension ( [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as> ] ;
fhir:value [
a fhir:Markdown ;
fhir:v "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." ]
] ) ; #
fhir:url [
fhir:v "https://fevir.net/resources/CodeSystem/419455"^^xsd:anyURI ;
fhir:l <https://fevir.net/resources/CodeSystem/419455>
] ; #
fhir:identifier ( [
fhir:type [
( fhir:coding [
fhir:system [
fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ;
fhir:l <http://terminology.hl7.org/CodeSystem/v2-0203> ] ;
fhir:code [ fhir:v "ACSN" ] ;
fhir:display [ fhir:v "Accession ID" ] ] ) ;
fhir:text [ fhir:v "FEvIR Object Identifier" ] ] ;
fhir:system [
fhir:v "https://fevir.net/FOI"^^xsd:anyURI ;
fhir:l <https://fevir.net/FOI> ] ;
fhir:value [ fhir:v "419455" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ] ]
] [
fhir:system [
fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ;
fhir:l <urn:ietf:rfc:3986> ] ;
fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.44.16.8" ]
] ) ; #
fhir:version [ fhir:v "1.0.0-ballot3"] ; #
fhir:name [ fhir:v "ResearchStudyClassifierCodeSystem"] ; #
fhir:title [ fhir:v "ResearchStudy Classifier Code System"] ; #
fhir:status [ fhir:v "active"] ; #
fhir:date [ fhir:v "2025-12-18T14:27:29+00:00"^^xsd:dateTime] ; #
fhir:publisher [ fhir:v "HL7 International / Clinical Decision Support"] ; #
fhir:contact ( [
fhir:name [ fhir:v "HL7 International / Clinical Decision Support" ] ;
( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/dss" ] ] )
] ) ; #
fhir:description [ fhir:v "This CodeSystem is used for common values for the ResearchStudy.classifier element and will likely move to terminology.hl7.org when it is mature."] ; #
fhir:jurisdiction ( [
( fhir:coding [
fhir:system [
fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ;
fhir:l <http://unstats.un.org/unsd/methods/m49/m49.htm> ] ;
fhir:code [ fhir:v "001" ] ;
fhir:display [ fhir:v "World" ] ] )
] ) ; #
fhir:copyright [ fhir:v "https://creativecommons.org/licenses/by-nc-sa/4.0/"] ; #
fhir:author ( [
fhir:name [ fhir:v "Brian S. Alper, MD, MSPH" ]
] ) ; #
fhir:valueSet [
fhir:v "https://fevir.net/resources/ValueSet/419456"^^xsd:anyURI ;
fhir:l <https://fevir.net/resources/ValueSet/419456>
] ; #
fhir:content [ fhir:v "complete"] ; #
fhir:concept ( [
fhir:code [ fhir:v "fda-regulated-drug" ] ;
fhir:display [ fhir:v "FDA regulated drug" ] ;
fhir:definition [ fhir:v "A medication regulated by the U.S. Food and Drug Administration." ]
] [
fhir:code [ fhir:v "fda-regulated-device" ] ;
fhir:display [ fhir:v "FDA regulated device" ] ;
fhir:definition [ fhir:v "A medical device regulated by the U.S. Food and Drug Administration." ]
] [
fhir:code [ fhir:v "irb-exempt" ] ;
fhir:display [ fhir:v "IRB-exempt" ] ;
fhir:definition [ fhir:v "Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB)." ]
] [
fhir:code [ fhir:v "mpg-paragraph-23b" ] ;
fhir:display [ fhir:v "MPG Paragraph 23b" ] ;
fhir:definition [ fhir:v "Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b)." ]
] [
fhir:code [ fhir:v "includes-females" ] ;
fhir:display [ fhir:v "Includes female subjects" ] ;
fhir:definition [ fhir:v "Includes female subjects" ]
] [
fhir:code [ fhir:v "does-not-include-females" ] ;
fhir:display [ fhir:v "Does not include female subjects" ] ;
fhir:definition [ fhir:v "Does not include female subjects" ]
] [
fhir:code [ fhir:v "includes-males" ] ;
fhir:display [ fhir:v "Includes male subjects" ] ;
fhir:definition [ fhir:v "Includes male subjects" ]
] [
fhir:code [ fhir:v "does-not-include-males" ] ;
fhir:display [ fhir:v "Does not include male subjects" ] ;
fhir:definition [ fhir:v "Does not include male subjects" ]
] [
fhir:code [ fhir:v "includes-vulnerable-population" ] ;
fhir:display [ fhir:v "Includes vulnerable populations" ] ;
fhir:definition [ fhir:v "Includes vulnerable populations" ]
] [
fhir:code [ fhir:v "does-not-include-vulnerable-population" ] ;
fhir:display [ fhir:v "Does not include vulnerable populations" ] ;
fhir:definition [ fhir:v "Does not include vulnerable populations" ]
] [
fhir:code [ fhir:v "includes-healthy-volunteers" ] ;
fhir:display [ fhir:v "Includes healthy volunteers" ] ;
fhir:definition [ fhir:v "Includes healthy volunteers" ]
] [
fhir:code [ fhir:v "does-not-include-healthy-volunteers" ] ;
fhir:display [ fhir:v "Does not include healthy volunteers" ] ;
fhir:definition [ fhir:v "Does not include healthy volunteers" ]
] ) . #
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