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Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
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Definition for Code SystemResearchStudyClassifiers
{ "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)." }] }
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R5 hl7.fhir.core#5.0.0 generated on Sun, Mar 26, 2023 15:22+1100.
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