R5-study-design-for-R4
type: ValueSet
node role: treeRoot
id:
  v: R5-study-design-for-R4
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ValueSet R5-study-design-for-R4 This value set expansion contains 72 concepts. System Version Code Display Definition http://hl7.org/fhir/study-design 5.0.0 SEVCO:01001 Interventional research A study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by the investigator to evaluate a response in the dependent variable (an effect or outcome). http://hl7.org/fhir/study-design 5.0.0 SEVCO:01002 Observational research A study design in which the independent variables (exposures or interventions) are not prospectively assigned or modified by the investigator. http://hl7.org/fhir/study-design 5.0.0 SEVCO:01003 randomized assignment An interventional study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by random chance to separate groups. http://hl7.org/fhir/study-design 5.0.0 SEVCO:01004 Quasi-Randomized assignment An interventional study design with a method of allocation that is not limited to random chance but is intended to produce similar baseline groups for experimentation. http://hl7.org/fhir/study-design 5.0.0 SEVCO:01005 Non-randomized assignment An interventional study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by methods other than random chance to separate groups. http://hl7.org/fhir/study-design 5.0.0 SEVCO:01006 simple randomization A randomized assignment in which each participant has the same prespecified likelihood of being assigned to a group as all other participants, independent of the assignment of any other participant. http://hl7.org/fhir/study-design 5.0.0 SEVCO:01007 stratified randomization A randomized assignment in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups http://hl7.org/fhir/study-design 5.0.0 SEVCO:01008 block randomization A randomized assignment in which a…
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm
    l: structuredefinition-fmm
  value: Integer
    v: 1
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
    l: structuredefinition-wg
  value: Code
    v: cds
extension:
  extension:
    url:
      v: packageId
      l: packageId
    value: Id
      v: hl7.fhir.uv.xver-r5.r4
  extension:
    url:
      v: version
      l: version
    value: String
      v: 0.1.0
  extension:
    url:
      v: uri
      l: uri
    value: Uri
      v: http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r5.r4
      l: hl7.fhir.uv.xver-r5.r4
  url:
    v: http://hl7.org/fhir/StructureDefinition/package-source
    l: package-source
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
    l: structuredefinition-standards-status
  value: Code
    v: trial-use
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom
        l: structuredefinition-conformance-derivedFrom
      value: Canonical
        v: http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r5.r4
        l: hl7.fhir.uv.xver-r5.r4
url:
  v: http://hl7.org/fhir/uv/xver/ValueSet/R5-study-design-for-R4
  l: R5-study-design-for-R4
version:
  v: 0.1.0
name:
  v: R5StudyDesignForR4
title:
  v: Cross-version ValueSet R5.StudyDesign for use in FHIR R4
status:
  v: active
experimental:
  v: false
date:
  v: 2026-03-17T21:02:03.8104715+00:00
publisher:
  v: Clinical Decision Support
contact:
  name:
    v: Clinical Decision Support
  telecom:
    system:
      v: url
    value:
      v: http://www.hl7.org/Special/committees/dss
description:
  v: This cross-version ValueSet represents content from `http://hl7.org/fhir/ValueSet/study-design|5.0.0` for use in FHIR R4.
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 001
    display:
      v: World
purpose:
  v: This value set is part of the cross-version definitions generated to enable use of the value set `http://hl7.org/fhir/ValueSet/study-design|5.0.0` as defined in FHIR R5 in FHIR R4. The source value set is bound to the following FHIR R5 elements: * `Evidence.studyDesign` * `ResearchStudy.studyDesign` Note that all concepts are included in this cross-version definition because no concepts have compatible representations Following are the generation technical comments: FHIR ValueSet `http://hl7.org/fhir/ValueSet/study-design|5.0.0`, defined in FHIR R5 does not have any mapping to FHIR R4
compose:
  include:
    system:
      v: http://hl7.org/fhir/study-design
      l: study-design
    version:
      v: 5.0.0
    concept:
      code:
        v: SEVCO:01001
      display:
        v: Interventional research
    concept:
      code:
        v: SEVCO:01002
      display:
        v: Observational research
    concept:
      code:
        v: SEVCO:01003
      display:
        v: randomized assignment
    concept:
      code:
        v: SEVCO:01004
      display:
        v: Quasi-Randomized assignment
    concept:
      code:
        v: SEVCO:01005
      display:
        v: Non-randomized assignment
    concept:
      code:
        v: SEVCO:01006
      display:
        v: simple randomization
    concept:
      code:
        v: SEVCO:01007
      display:
        v: stratified randomization
    concept:
      code:
        v: SEVCO:01008
      display:
        v: block randomization
    concept:
      code:
        v: SEVCO:01009
      display:
        v: adaptive randomization
    concept:
      code:
        v: SEVCO:01010
      display:
        v: Comparative study design
    concept:
      code:
        v: SEVCO:01011
      display:
        v: Parallel cohort design
    concept:
      code:
        v: SEVCO:01012
      display:
        v: Crossover cohort design
    concept:
      code:
        v: SEVCO:01013
      display:
        v: Case control design
    concept:
      code:
        v: SEVCO:01014
      display:
        v: Matching for comparison
    concept:
      code:
        v: SEVCO:01015
      display:
        v: Cluster as unit of allocation
    concept:
      code:
        v: SEVCO:01016
      display:
        v: Uncontrolled cohort design
    concept:
      code:
        v: SEVCO:01017
      display:
        v: Case report
    concept:
      code:
        v: SEVCO:01018
      display:
        v: Time series design
    concept:
      code:
        v: SEVCO:01019
      display:
        v: Before and after comparison
    concept:
      code:
        v: SEVCO:01020
      display:
        v: Family study design

code:
  v: SEVCO:01021
display:
  v: Twin study design

code:
  v: SEVCO:01022
display:
  v: Population-based design

code:
  v: SEVCO:01023
display:
  v: Non-comparative study design

code:
  v: SEVCO:01024
display:
  v: Controlled crossover cohort design

code:
  v: SEVCO:01025
display:
  v: Single-arm crossover design

code:
  v: SEVCO:01026
display:
  v: Real world data collection

code:
  v: SEVCO:01027
display:
  v: Cross sectional data collection

code:
  v: SEVCO:01028
display:
  v: Longitudinal data collection

code:
  v: SEVCO:01029
display:
  v: Clinical trial

code:
  v: SEVCO:01030
display:
  v: Phase 1 trial

code:
  v: SEVCO:01031
display:
  v: Exploratory investigational new drug study

code:
  v: SEVCO:01032
display:
  v: Phase 1/Phase 2 trial

code:
  v: SEVCO:01033
display:
  v: Phase 2 trial

code:
  v: SEVCO:01034
display:
  v: Phase 2/Phase 3 trial

code:
  v: SEVCO:01035
display:
  v: Phase 3 Trial

code:
  v: SEVCO:01036
display:
  v: Post-marketing study

code:
  v: SEVCO:01037
display:
  v: Post-Marketing Surveillance study

code:
  v: SEVCO:01038
display:
  v: Expanded Access study

code:
  v: SEVCO:01039
display:
  v: Real world data collection from healthcare records

code:
  v: SEVCO:01040
display:
  v: Real world data collection from healthcare financing records

code:
  v: SEVCO:01041
display:
  v: Pragmatic clinical trial

code:
  v: SEVCO:01042
display:
  v: Secondary data collection from a registry

code:
  v: SEVCO:01043
display:
  v: Multicentric

code:
  v: SEVCO:01044
display:
  v: Ecological design

code:
  v: SEVCO:01045
display:
  v: Primary data collection

code:
  v: SEVCO:01046
display:
  v: Real world data collection from monitoring procedures

code:
  v: SEVCO:01048
display:
  v: Real world data collection from testing procedures

code:
  v: SEVCO:01049
display:
  v: Secondary data collection from prior research

code:
  v: SEVCO:01050
display:
  v: Real world data collection from personal health records

code:
  v: SEVCO:01051
display:
  v: Multisite data collection

code:
  v: SEVCO:01052
display:
  v: Includes patient-reported outcome

code:
  v: SEVCO:01053
display:
  v: Includes patient-centered outcome

code:
  v: SEVCO:01054
display:
  v: Includes disease-oriented outcome

code:
  v: SEVCO:01060
display:
  v: Blinding of study participants

code:
  v: SEVCO:01061
display:
  v: Blinding of intervention providers

code:
  v: SEVCO:01062
display:
  v: Blinding of outcome assessors

code:
  v: SEVCO:01063
display:
  v: Blinding of data analysts

code:
  v: SEVCO:01064
display:
  v: Allocation concealment

code:
  v: SEVCO:01085
display:
  v: Includes process measure

code:
  v: SEVCO:01086
display:
  v: Quantitative analysis

code:
  v: SEVCO:01087
display:
  v: Qualitative analysis

code:
  v: SEVCO:01088
display:
  v: Comparison Goal

code:
  v: SEVCO:01089
display:
  v: Study Goal

code:
  v: SEVCO:01090
display:
  v: Comparative Efficacy Goal

code:
  v: SEVCO:01091
display:
  v: Comparative Effectiveness Goal

code:
  v: SEVCO:01092
display:
  v: Comparative Safety Goal

code:
  v: SEVCO:01093
display:
  v: Equivalence Goal

code:
  v: SEVCO:01094
display:
  v: Non-inferiority Goal

code:
  v: SEVCO:01095
display:
  v: Superiority Goal

code:
  v: SEVCO:01096
display:
  v: Evaluation Goal

code:
  v: SEVCO:01097
display:
  v: Derivation Goal

code:
  v: SEVCO:01098
display:
  v: Validation Goal

timestamp:
  v: 2026-03-17T21:02:03.8104715+00:00
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01001
  display:
    v: Interventional research
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01002
  display:
    v: Observational research
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01003
  display:
    v: randomized assignment
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01004
  display:
    v: Quasi-Randomized assignment
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01005
  display:
    v: Non-randomized assignment
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01006
  display:
    v: simple randomization
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01007
  display:
    v: stratified randomization
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01008
  display:
    v: block randomization
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01009
  display:
    v: adaptive randomization
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01010
  display:
    v: Comparative study design
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01011
  display:
    v: Parallel cohort design
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01012
  display:
    v: Crossover cohort design
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01013
  display:
    v: Case control design
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01014
  display:
    v: Matching for comparison
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01015
  display:
    v: Cluster as unit of allocation
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01016
  display:
    v: Uncontrolled cohort design
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01017
  display:
    v: Case report
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01018
  display:
    v: Time series design
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01019
  display:
    v: Before and after comparison
contains:
  system:
    v: http://hl7.org/fhir/study-design
    l: study-design
  version:
    v: 5.0.0
  code:
    v: SEVCO:01020
  display:
    v: Family study design

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01021
display:
  v: Twin study design

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01022
display:
  v: Population-based design

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01023
display:
  v: Non-comparative study design

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01024
display:
  v: Controlled crossover cohort design

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01025
display:
  v: Single-arm crossover design

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01026
display:
  v: Real world data collection

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01027
display:
  v: Cross sectional data collection

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01028
display:
  v: Longitudinal data collection

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01029
display:
  v: Clinical trial

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01030
display:
  v: Phase 1 trial

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01031
display:
  v: Exploratory investigational new drug study

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01032
display:
  v: Phase 1/Phase 2 trial

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01033
display:
  v: Phase 2 trial

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01034
display:
  v: Phase 2/Phase 3 trial

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01035
display:
  v: Phase 3 Trial

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01036
display:
  v: Post-marketing study

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01037
display:
  v: Post-Marketing Surveillance study

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01038
display:
  v: Expanded Access study

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01039
display:
  v: Real world data collection from healthcare records

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01040
display:
  v: Real world data collection from healthcare financing records

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01041
display:
  v: Pragmatic clinical trial

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01042
display:
  v: Secondary data collection from a registry

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01043
display:
  v: Multicentric

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01044
display:
  v: Ecological design

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01045
display:
  v: Primary data collection

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01046
display:
  v: Real world data collection from monitoring procedures

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01048
display:
  v: Real world data collection from testing procedures

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01049
display:
  v: Secondary data collection from prior research

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01050
display:
  v: Real world data collection from personal health records

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01051
display:
  v: Multisite data collection

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01052
display:
  v: Includes patient-reported outcome

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01053
display:
  v: Includes patient-centered outcome

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01054
display:
  v: Includes disease-oriented outcome

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01060
display:
  v: Blinding of study participants

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01061
display:
  v: Blinding of intervention providers

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01062
display:
  v: Blinding of outcome assessors

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01063
display:
  v: Blinding of data analysts

system:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
code:
  v: SEVCO:01064
display:
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system:
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system:
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system:
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code:
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code:
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