<status value="active"/> <experimental value="false"/> <date value="2025-09-01T22:36:17.026093+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="This cross-version ValueSet represents concepts from http://hl7.org/fhir/ValueSet/research-study-phase|4.0.1 for use in FHIR R4B. Concepts not present here have direct `equivalent` mappings crossing all versions from R4 to R4B."/> <jurisdiction> <coding> <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/> <code value="001"/> <display value="World"/> </coding> </jurisdiction> <compose> <include> <system value="http://terminology.hl7.org/CodeSystem/research-study-phase"/> <version value="4.0.1"/> <concept> <code value="early-phase-1"/> <display value="Early Phase 1"/> </concept> <concept> <code value="phase-1-phase-2"/> <display value="Phase 1/Phase 2"/> </concept> <concept> <code value="phase-2-phase-3"/> <display value="Phase 2/Phase 3"/> </concept> <concept> <code value="phase-4"/> <display value="Phase 4"/> </concept> </include> </compose> <expansion> <timestamp value="2025-09-01T22:36:17.026097+10:00"/> <contains> <system value="http://terminology.hl7.org/CodeSystem/research-study-phase"/> <version value="4.0.1"/> <code value="early-phase-1"/> <display value="Early Phase 1"/> </contains> <contains> <system value="http://terminology.hl7.org/CodeSystem/research-study-phase"/> <version value="4.0.1"/> <code value="phase-1-phase-2"/> <display value="Phase 1/Phase 2"/> </contains> <contains> <system value="http://terminology.hl7.org/CodeSystem/research-study-phase"/> <version value="4.0.1"/> <code value="phase-2-phase-3"/> <display value="Phase 2/Phase 3"/> </contains> <contains> <system value="http://terminology.hl7.org/CodeSystem/research-study-phase"/> <version value="4.0.1"/> <code value="phase-4"/> <display value="Phase 4"/> </contains> </expansion> </ValueSet>

Generated Narrative: ValueSet R4-research-study-phase-for-R4B

This value set expansion contains 4 concepts.

Code	System	Display	Definition
early-phase-1	http://terminology.hl7.org/CodeSystem/research-study-phase	Early Phase 1	Designation for optional exploratory trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies. Formerly called Phase 0.
phase-1-phase-2	http://terminology.hl7.org/CodeSystem/research-study-phase	Phase 1/Phase 2	Trials that are a combination of phases 1 and 2.
phase-2-phase-3	http://terminology.hl7.org/CodeSystem/research-study-phase	Phase 2/Phase 3	Trials that are a combination of phases 2 and 3.
phase-4	http://terminology.hl7.org/CodeSystem/research-study-phase	Phase 4	Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.