Release 5 Ballot

This page is part of the FHIR Specification (v5.0.0-ballot: FHIR R5 Ballot Preview). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4

4.4.1.549 ValueSet http://hl7.org/fhir/ValueSet/research-study-phase

Biomedical Research and Regulation Work Group Maturity Level: 1Draft Use Context: Not Intended for Production use, Not Intended for Production use

This is a value set defined by the FHIR project.

Summary

Defining URL:http://hl7.org/fhir/ValueSet/research-study-phase
Version:5.0.0-ballot
Name:ResearchStudyPhase
Title:ResearchStudyPhase
Status:draft
Definition:

Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

Committee:Biomedical Research and Regulation Work Group
OID:2.16.840.1.113883.4.642.3.821 (for OID based terminology systems)
Flags:Experimental, Immutable

This value set is used in the following places:

4.4.1.549.1 Content Logical Definition

 

4.4.1.549.2 Expansion

This expansion generated 07 Sep 2022

This value set contains 8 concepts

Expansion based on ResearchStudy Classifiers Code System v5.0.0-ballot (CodeSystem)

CodeSystemDisplayDefinition
  n-ahttp://hl7.org/fhir/research-study-classifiersN/A

Trials without phases (for example, studies of devices or behavioral interventions).

  early-phase-1http://hl7.org/fhir/research-study-classifiersEarly 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-1http://hl7.org/fhir/research-study-classifiersPhase 1

Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.

  phase-1-phase-2http://hl7.org/fhir/research-study-classifiersPhase 1/Phase 2

Trials that are a combination of phases 1 and 2.

  phase-2http://hl7.org/fhir/research-study-classifiersPhase 2

Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.

  phase-2-phase-3http://hl7.org/fhir/research-study-classifiersPhase 2/Phase 3

Trials that are a combination of phases 2 and 3.

  phase-3http://hl7.org/fhir/research-study-classifiersPhase 3

Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug.

  phase-4http://hl7.org/fhir/research-study-classifiersPhase 4

Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.

 

See the full registry of value sets defined as part of FHIR.

Explanation of the columns that may appear on this page:

LvlA few code lists that FHIR defines are hierarchical - each code is assigned a level. For value sets, levels are mostly used to organize codes for user convenience, but may follow code system hierarchy - see Code System for further information
SourceThe source of the definition of the code (when the value set draws in codes defined elsewhere)
CodeThe code (used as the code in the resource instance). If the code is in italics, this indicates that the code is not selectable ('Abstract')
DisplayThe display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
DefinitionAn explanation of the meaning of the concept
CommentsAdditional notes about how to use the code