Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème
0.2.0 - trial-use France flag

This page is part of the Implementation Guide FHIR pour le projet ECLAIRE, base de données qui recense les essais cliniques en France (v0.2.0: Release) based on FHIR 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

ValueSet: Value Set type de phase de l'essai clinique

Official URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs Version: 0.2.0
Draft as of 2023-10-24 Computable Name: EclaireStudyPhaseVS

Value Set type de phase Eclaire de l’essai clinique.

References

Logical Definition (CLD)

This value set includes codes based on the following rules:

 

Expansion

This value set contains 9 concepts

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.

  phase-3-phase-4https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-phase-code-systemPhase 3 and phase 4

Trials that are a combination of phases 3 and 4.

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