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Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
Raw XML (canonical form + also see XML Format Specification)
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="2024-11-08T08:55:24.528+11:00"/> <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> </meta> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"> <p class="res-header-id"> <b> Generated Narrative: CodeSystem research-study-classifiers</b> </p> <a name="research-study-classifiers"> </a> <a name="hcresearch-study-classifiers"> </a> <a name="research-study-classifiers-en-US"> </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">Last updated: 2022-05-15T16:55:11.085+11:00</p> <p style="margin-bottom: 0px">Profile: <a href="shareablecodesystem.html">Shareable CodeSystem</a> </p> </div> <p> This case-sensitive code system <code> http://hl7.org/fhir/research-study-classifiers</code> defines the following codes in a Is-A hierarchy: </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-ballot2"/> <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>
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 R6 hl7.fhir.core#6.0.0-ballot2 generated on Thu, Nov 7, 2024 22:21+0000.
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