This page is part of the FHIR Specification (v4.4.0: R5 Preview #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4
Biomedical Research and Regulation Work Group | Maturity Level: 1 | Draft | Use Context: Any |
This is a value set defined by the FHIR project.
Summary
Defining URL: | http://hl7.org/fhir/ValueSet/research-study-phase |
Version: | 4.4.0 |
Name: | ResearchStudyPhase |
Title: | ResearchStudyPhase |
Definition: | Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. |
Committee: | Biomedical Research and Regulation Work Group |
OID: | 2.16.840.1.113883.4.642.3.821 (for OID based terminology systems) |
Source Resource | XML / JSON |
This value set is used in the following places:
http://terminology.hl7.org/CodeSystem/research-study-phase
This expansion generated 03 May 2020
This value set contains 8 concepts
Expansion based on ResearchStudyPhase v4.4.0 (CodeSystem)
All codes from system http://terminology.hl7.org/CodeSystem/research-study-phase
Code | Display | Logical Definition (CLD) |
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 Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies. Formerly called Phase 0. |
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. |
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 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 | 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 obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug. |
phase-4 | Phase 4 | Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use. |
See the full registry of value sets defined as part of FHIR.
Explanation of the columns that may appear on this page:
Lvl | A few code lists that FHIR defines are hierarchical - each code is assigned a level. For value sets, levels are mostly used to organize codes for user convenience, but may follow code system hierarchy - see Code System for further information |
Source | 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). If the code is in italics, this indicates that the code is not selectable ('Abstract') |
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 |