Definition for Code SystemResearchStudyClassifiers

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

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="research-study-classifiers"/> 
  <meta> 
    <lastUpdated value="2023-12-18T15:12:07.602+11:00"/> 
    <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> 
  </meta> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p> This case-sensitive code system 
        <code> http://hl7.org/fhir/research-study-classifiers</code>  defines the following codes in a Is-A heirarchy:
      </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="trial-use"/> 
  </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-ballot1"/> 
  <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>