FHIR Cross-Version Extensions package for FHIR R4 from FHIR R5 - Version 0.0.1-snapshot-2. See the Directory of published versions
| Page standards status: Informative | Maturity Level: 0 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="research-study-classifiers"/>
<text>
<status value="generated"/>
<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>
</text>
<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>
<extension url="http://hl7.org/fhir/StructureDefinition/package-source">
<extension url="packageId">
<valueId value="hl7.fhir.uv.xver-r5.r4"/>
</extension>
<extension url="version">
<valueString value="0.0.1-snapshot-2"/>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<url value="http://hl7.org/fhir/research-study-classifiers"/>
<version value="5.0.0"/>
<name value="ResearchStudyClassifiers"/>
<title value="ResearchStudy Classifiers Code System"/>
<status value="active"/>
<experimental value="false"/>
<date value="2022-05-15T15:55:11.085+10:00"/>
<publisher value="Biomedical Research and Regulation"/>
<contact>
<name value="Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/rcrim"/>
</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>