FHIR Cross-Version Extensions package for FHIR R4 from FHIR R5
0.0.1-snapshot-2 - informative International flag

FHIR Cross-Version Extensions package for FHIR R4 from FHIR R5 - Version 0.0.1-snapshot-2. See the Directory of published versions

CodeSystem: ResearchStudy Phase Code System

Official URL: http://hl7.org/fhir/research-study-phase Version: 5.0.0
Standards status: Informative Maturity Level: 0 Responsible: Biomedical Research and Regulation Computable Name: ResearchStudyPhase

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

This Code system is referenced in the content logical definition of the following value sets:

  • This CodeSystem is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

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

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