View raw Markdown
type: codesystemcodesystem: research-study-classifiers

ResearchStudy Classifiers Code System

Concepts

CodeDisplayDefinition
fda-regulated-drugFDA regulated drugA medication regulated by the U.S. Food and Drug Administration.
fda-regulated-deviceFDA regulated deviceA medical device regulated by the U.S. Food and Drug Administration.
mpg-paragraph-23bMPG Paragraph 23bResearch regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b).
irb-exemptIRB-exemptHuman subjects research that is excempt from oversight and monitoring by an institutional review board (IRB).

CodeSystem XML

<?xml version="1.0" encoding="UTF-8"?>

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="research-study-classifiers"/>
  <meta>
    <lastUpdated value="2022-05-15T16:55:11.085+11:00"/>
  </meta>
  <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"/>
  <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."/>
  <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>