ResearchStudyPhase - HL7 Terminology (THO) v7.1.0

HL7 Terminology (THO)
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HL7 Terminology (THO), published by HL7 International - Vocabulary Work Group. This guide is not an authorized publication; it is the continuous build for version 7.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/UTG/ and changes regularly. See the Directory of published versions

ValueSet: ResearchStudyPhase

Official URL: http://terminology.hl7.org/ValueSet/research-study-phase		Version: 2.0.0	Highlight text changes?
	Maturity Level: 1	Responsible: Health Level Seven International	Computable Name: ResearchStudyPhase
Other Identifiers: OID:2.16.840.1.113883.4.642.3.821
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.html

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

References

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

Logical Definition (CLD)

Last updated: 2020-02-24 12:41:39+1100; Language: en

Profile: Shareable ValueSet

Include all codes defined in http://terminology.hl7.org/CodeSystem/research-study-phase version 📦1.0.0

Expansion

Expansion performed internally based on codesystem ResearchStudyPhase v1.0.0 (CodeSystem)

This value set contains 8 concepts

System	Code	Display (en)	Definition	JSON	XML
`http://terminology.hl7.org/CodeSystem/research-study-phase`	n-a	N/A	Trials without phases (for example, studies of devices or behavioral interventions).
`http://terminology.hl7.org/CodeSystem/research-study-phase`	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.
`http://terminology.hl7.org/CodeSystem/research-study-phase`	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.
`http://terminology.hl7.org/CodeSystem/research-study-phase`	phase-1-phase-2	Phase 1/Phase 2	Trials that are a combination of phases 1 and 2.
`http://terminology.hl7.org/CodeSystem/research-study-phase`	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.
`http://terminology.hl7.org/CodeSystem/research-study-phase`	phase-2-phase-3	Phase 2/Phase 3	Trials that are a combination of phases 2 and 3.
`http://terminology.hl7.org/CodeSystem/research-study-phase`	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.
`http://terminology.hl7.org/CodeSystem/research-study-phase`	phase-4	Phase 4	Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.