HL7 Terminology (THO)
5.5.0 - Publication International flag

This page is part of the HL7 Terminology (v5.5.0: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

CodeSystem: ResearchStudyPhase

Official URL: http://terminology.hl7.org/CodeSystem/research-study-phase Version: 1.0.0
Draft as of 2020-04-09 Maturity Level: 1 Responsible: Health Level Seven International Computable Name: ResearchStudyPhase
Other Identifiers: urn:ietf:rfc:3986#Uniform Resource Identifier (URI)#urn:oid:2.16.840.1.113883.4.642.1.1247

Copyright/Legal: This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license

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

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

History

DateActionCustodianAuthorComment
2023-11-14reviseTSMGMarc DuteauAdd standard copyright and contact to internal content; up-476
2020-10-14reviseVocabulary WGGrahame GrieveReset Version after migration to UTG
2020-05-06reviseVocabulary WGTed KleinMigrated to the UTG maintenance environment and publishing tooling.