Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème
0.2.1 - ci-build
Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème
0.2.1 - ci-build
Publication Build: This will be filled in by the publication tooling
| Official URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs | Version: 0.2.1 | |||
| Draft as of 2023-10-31 | Computable Name: EclaireStudyPhaseVS | |||
Value Set type de phase Eclaire de l’essai clinique.
References
This value set includes codes based on the following rules:
http://terminology.hl7.org/CodeSystem/research-study-phasehttps://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-phase-code-system
This value set contains 9 concepts
Expansion based on:
| Code | System | Display | Definition |
| n-a | http://terminology.hl7.org/CodeSystem/research-study-phase | N/A | Trials without phases (for example, studies of devices or behavioral interventions). |
| early-phase-1 | http://terminology.hl7.org/CodeSystem/research-study-phase | 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. |
| phase-1 | http://terminology.hl7.org/CodeSystem/research-study-phase | 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. |
| phase-1-phase-2 | http://terminology.hl7.org/CodeSystem/research-study-phase | Phase 1/Phase 2 | Trials that are a combination of phases 1 and 2. |
| phase-2 | http://terminology.hl7.org/CodeSystem/research-study-phase | 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. |
| phase-2-phase-3 | http://terminology.hl7.org/CodeSystem/research-study-phase | Phase 2/Phase 3 | Trials that are a combination of phases 2 and 3. |
| phase-3 | http://terminology.hl7.org/CodeSystem/research-study-phase | 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. |
| phase-4 | http://terminology.hl7.org/CodeSystem/research-study-phase | Phase 4 | Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use. |
| phase-3-phase-4 | https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-phase-code-system | Phase 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 |