HL7 Terminology (THO)
4.0.0 - Publication International flag

This page is part of the HL7 Terminology (v4.0.0: Release) based on FHIR R4. The current version which supercedes this version is 5.2.0. For a full list of available versions, see the Directory of published versions

ValueSet: ResearchStudyPhase

Official URL: http://terminology.hl7.org/ValueSet/research-study-phase Version: 0.1.0
Standards status: Draft Maturity Level: 1 Responsible: HL7 (FHIR Project) Computable Name: ResearchStudyPhase
Other Identifiers: : urn:oid:2.16.840.1.113883.4.642.3.821

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)

 

Expansion

This value set contains 8 concepts

Expansion based on ResearchStudyPhase v0.1.0 (CodeSystem)

CodeSystemDisplayDefinition
  n-ahttp://terminology.hl7.org/CodeSystem/research-study-phaseN/A

Trials without phases (for example, studies of devices or behavioral interventions).

  early-phase-1http://terminology.hl7.org/CodeSystem/research-study-phaseEarly 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-1http://terminology.hl7.org/CodeSystem/research-study-phasePhase 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-2http://terminology.hl7.org/CodeSystem/research-study-phasePhase 1/Phase 2

Trials that are a combination of phases 1 and 2.

  phase-2http://terminology.hl7.org/CodeSystem/research-study-phasePhase 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-3http://terminology.hl7.org/CodeSystem/research-study-phasePhase 2/Phase 3

Trials that are a combination of phases 2 and 3.

  phase-3http://terminology.hl7.org/CodeSystem/research-study-phasePhase 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-4http://terminology.hl7.org/CodeSystem/research-study-phasePhase 4

Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.

Explanation of the columns that may appear on this page:

Level A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies
System The source of the definition of the code (when the value set draws in codes defined elsewhere)
Code The code (used as the code in the resource instance)
Display The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
Definition An explanation of the meaning of the concept
Comments Additional notes about how to use the code

History

DateActionAuthorCustodianComment
2020-10-14reviseGrahame GrieveVocabulary WGReset Version after migration to UTG
2020-05-06reviseTed KleinVocabulary WGMigrated to the UTG maintenance environment and publishing tooling.