Extensions for Using Data Elements from FHIR R4B in FHIR STU3
0.1.0 - STU International flag

Extensions for Using Data Elements from FHIR R4B in FHIR STU3 - Downloaded Version null See the Directory of published versions

ValueSet: R4BResearchStudyPhaseForR3

Official URL: http://hl7.org/fhir/uv/xver/ValueSet/R4B-research-study-phase-for-R3 Version: 0.1.0
Standards status: Trial-use Maturity Level: 1 Responsible: Biomedical Research and Regulation Computable Name: R4BResearchStudyPhaseForR3

This cross-version ValueSet represents content from http://hl7.org/fhir/ValueSet/research-study-phase|4.3.0 for use in FHIR STU3.

This value set is part of the cross-version definitions generated to enable use of the value set http://hl7.org/fhir/ValueSet/research-study-phase|4.3.0 as defined in FHIR R4B in FHIR STU3.

The source value set is bound to the following FHIR R4B elements:

  • ResearchStudy.phase as Example

Across FHIR versions, the value set has been mapped as:

  • http://hl7.org/fhir/ValueSet/research-study-phase|4.3.0
  • http://hl7.org/fhir/ValueSet/research-study-phase|4.0.1

Note that all concepts are included in this cross-version definition because no concepts have compatible representations

Following are the generation technical comments: All concepts in the comparison are listed as identical. The source and target value sets have the same number of active concepts (8). FHIR ValueSet http://hl7.org/fhir/ValueSet/research-study-phase|4.3.0, defined in FHIR R4B does not have any mapping to FHIR STU3

References

Logical Definition (CLD)

  • Include these codes as defined in http://terminology.hl7.org/CodeSystem/research-study-phase version 📍4.3.0
    CodeDisplayDefinition
    early-phase-1Early Phase 1Designation 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.
    n-aN/ATrials without phases (for example, studies of devices or behavioral interventions).
    phase-1Phase 1Includes 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-2Phase 1/Phase 2Trials that are a combination of phases 1 and 2.
    phase-2Phase 2Includes 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-3Phase 2/Phase 3Trials that are a combination of phases 2 and 3.
    phase-3Phase 3Includes 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-4Phase 4Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.

 

Expansion

This value set expansion contains 8 concepts.

SystemVersionCodeDisplayDefinitionJSONXML
http://terminology.hl7.org/CodeSystem/research-study-phase4.3.0  early-phase-1Early Phase 1Designation 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.
http://terminology.hl7.org/CodeSystem/research-study-phase4.3.0  n-aN/ATrials without phases (for example, studies of devices or behavioral interventions).
http://terminology.hl7.org/CodeSystem/research-study-phase4.3.0  phase-1Phase 1Includes 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.
http://terminology.hl7.org/CodeSystem/research-study-phase4.3.0  phase-1-phase-2Phase 1/Phase 2Trials that are a combination of phases 1 and 2.
http://terminology.hl7.org/CodeSystem/research-study-phase4.3.0  phase-2Phase 2Includes 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.
http://terminology.hl7.org/CodeSystem/research-study-phase4.3.0  phase-2-phase-3Phase 2/Phase 3Trials that are a combination of phases 2 and 3.
http://terminology.hl7.org/CodeSystem/research-study-phase4.3.0  phase-3Phase 3Includes 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.
http://terminology.hl7.org/CodeSystem/research-study-phase4.3.0  phase-4Phase 4Studies 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