HL7 Terminology
1.0.0 - Publication

This page is part of the HL7 Terminology (v1.0.0: Release) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions

ResearchStudyPhase

Summary

Defining URL:http://terminology.hl7.org/CodeSystem/research-study-phase
Version:4.2.0
Name:ResearchStudyPhase
Title:ResearchStudyPhase
Status:draft
Content:All the concepts defined by the code system are included in the code system resource
Definition:

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

Publisher:HL7 (FHIR Project)
Committee:Biomedical Research and Regulation
OID:2.16.840.1.113883.4.642.1.1247 (for OID based terminology systems)
Content Mode:Complete
Value Set:http://terminology.hl7.org/ValueSet/research-study-phase ( is the value set for all codes in this code system)
Maturity:1
Source Resource:XML / JSON / Turtle

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

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 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
2020-05-06reviseVocabulary WGTed KleinMigrated to the UTG maintenance environment and publishing tooling.