<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>

Generated Narrative: CodeSystem research-study-classifiers

Last updated: 2022-05-15T16:55:11.085+11:00

This case-sensitive code system http://hl7.org/fhir/research-study-classifiers defines the following codes in a Is-A hierarchy:

Code	Display	Definition
fda-regulated-drug	FDA regulated drug	A medication regulated by the U.S. Food and Drug Administration.
fda-regulated-device	FDA regulated device	A medical device regulated by the U.S. Food and Drug Administration.
mpg-paragraph-23b	MPG Paragraph 23b	Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b).
irb-exempt	IRB-exempt	Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB).