R6 Ballot (1st Draft)

This page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions

4.3.2.324 CodeSystem http://hl7.org/fhir/research-study-phase

Biomedical Research and Regulation icon Work Group Maturity Level: 0Trial Use Use Context: Country: World
Official URL: http://hl7.org/fhir/research-study-phase Version: 6.0.0-ballot1
active as of 2022-05-15 Computable Name: ResearchStudyPhase
Flags: CaseSensitive, Complete. All codes ValueSet: Research Study Phase OID: TBD

This Code system is used in the following value sets:

  • ValueSet: Research Study Phase (Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.)

4.3.2.324.1 Definition

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

4.3.2.324.2 Content

This case-sensitive code system http://hl7.org/fhir/research-study-phase defines the following codes:

CodeDisplayDefinitionCopy
n-a N/ATrials without phases (for example, studies of devices or behavioral interventions).btn btn
early-phase-1 Early Phase 1Designation 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.btn btn
phase-1 Phase 1Includes 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.btn btn
phase-1-phase-2 Phase 1/Phase 2Trials that are a combination of phases 1 and 2.btn btn
phase-2 Phase 2Includes 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.btn btn
phase-2-phase-3 Phase 2/Phase 3Trials that are a combination of phases 2 and 3.btn btn
phase-3 Phase 3Includes 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.btn btn
phase-4 Phase 4Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.btn btn

 

See the full registry of code systems defined as part of FHIR.

Explanation of the columns that may appear on this page:

LevelA few code lists that FHIR defines are hierarchical - each code is assigned a level. 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