http://hl7.org/fhir/research-study-phase|5.0.0
name
ResearchStudyPhase
ResearchStudyPhase
package
hl7.fhir.r5.core@5.0.0
hl7.fhir.r5.core@5.0.0
content
complete
complete
status
active
active
date
2022-05-15 05:55:11.085
2022-05-15 05:55:11.085
ResearchStudy Phase Code System
Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
| code | display | definition | hierarchy |
|---|---|---|---|
| n-a | N/A | Trials without phases (for example, studies of devices or behavioral interventions).... | |
| early-phase-1 | Early Phase 1 | Designation for optional exploratory trials conducted in accordance with the United States Food and ... | |
| phase-1 | Phase 1 | Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, t... | |
| phase-1-phase-2 | Phase 1/Phase 2 | Trials that are a combination of phases 1 and 2.... | |
| phase-2 | Phase 2 | Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a parti... | |
| phase-2-phase-3 | Phase 2/Phase 3 | Trials that are a combination of phases 2 and 3.... | |
| phase-3 | Phase 3 | Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been o... | |
| phase-4 | Phase 4 | Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefi... |