ResearchStudyPhase

ResearchStudy Phase Code System

activeExtensions for Using Data Elements from FHIR R5 in FHIR R40.1.0complete8 concepts

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

Metadata

hl7.org/fhir
Canonical URL
http://hl7.org/fhir/research-study-phase
ID
research-study-phase
Version
5.0.0
Publisher
Biomedical Research and Regulation
Case Sensitive
Yes

Concepts (8)

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