study-design
type: ValueSet
node role: treeRoot
id:
  v: study-design
meta:
  last updated:
    v: 2022-05-12T12:40:00+00:00
  profile:
    v: http://hl7.org/fhir/StructureDefinition/shareablevalueset
    l: shareablevalueset
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: ValueSet study-design Last updated: 2022-05-12 12:40:00+0000 Profile: Shareable ValueSet Include these codes as defined in https://fevir.net/sevco version ?2.0 Code Display Definition Definition (core metadata concept) Synonym (core metadata concept) 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). 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). experimental study 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. An interventional study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by random chance to separate groups. RCT 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. 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. unrestricted randomization 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 A randomized assignment in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups SEVCO:01008 block randomization A randomized assignment in which a pre-spec…
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
    l: structuredefinition-wg
  value: Code
    v: cds
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-fmm
    l: structuredefinition-fmm
  value: Integer
    v: 2
url:
  v: http://hl7.org/fhir/ValueSet/study-design
  l: study-design
version:
  v: 1.0.0
name:
  v: StudyDesign
title:
  v: Study Design
status:
  v: active
experimental:
  v: false
date:
  v: 2022-08-24T12:40:00+00:00
publisher:
  v: HL7 (FHIR Project)
contact:
  telecom:
    system:
      v: url
    value:
      v: http://hl7.org/fhir
  telecom:
    system:
      v: email
description:
  v: This is a set of terms for study design characteristics.
immutable:
  v: true
compose:
  include:
    system:
      v: https://fevir.net/sevco
      l: sevco
    version:
      v: 2.0
    concept:
      code:
        v: SEVCO:01001
      display:
        v: interventional research
      designation:
        use: http://snomed.info/id/900000000000550004
      designation:
        use: http://snomed.info/id/900000000000013009
      designation:
        use: http://snomed.info/id/900000000000013009
      designation:
        use: http://snomed.info/id/900000000000013009
      designation:
        use: http://snomed.info/id/900000000000013009
      designation:
        use: http://snomed.info/id/900000000000013009
      designation:
        use: http://snomed.info/id/900000000000013009
    concept:
      code:
        v: SEVCO:01003
      display:
        v: randomized assignment
      designation:
        use: http://snomed.info/id/900000000000550004
      designation:
        use: http://snomed.info/id/900000000000013009
      designation:
        use: http://snomed.info/id/900000000000013009
      designation:
        use: http://snomed.info/id/900000000000013009
      designation:
        use: http://snomed.info/id/900000000000013009
    concept:
      code:
        v: SEVCO:01006
      display:
        v: simple randomization
      designation:
        use: http://snomed.info/id/900000000000550004
      designation:
        use: http://snomed.info/id/900000000000013009
    concept:
      code:
        v: SEVCO:01007
      display:
        v: stratified randomization
      designation:
        use: http://snomed.info/id/900000000000550004
    concept:
      code:
        v: SEVCO:01008
      display:
        v: block randomization
      designation:
        use: http://snomed.info/id/900000000000550004
    concept:
      code:
        v: SEVCO:01009
      display:
        v: adaptive randomization
      designation:
        use: http://snomed.info/id/900000000000550004
    concept:
      code:
        v: SEVCO:01005
      display:
        v: non-randomized assignment
      designation:
        use: http://snomed.info/id/900000000000550004
      designation:
        use: http://snomed.info/id/900000000000013009
    concept:
      code:
        v: SEVCO:01004
      display:
        v: quasi-randomized assignment
      designation:
        use: http://snomed.info/id/900000000000550004
    concept:
      code:
        v: SEVCO:01029
      display:
        v: clinical trial
      designation:
        use: http://snomed.info/id/900000000000550004
    concept:
      code:
        v: SEVCO:01041
      display:
        v: pragmatic clinical trial
      designation:
        use: http://snomed.info/id/900000000000550004
      designation:
        use: http://snomed.info/id/900000000000013009
    concept:
      code:
        v: SEVCO:01038
      display:
        v: expanded access study
      designation:
        use: http://snomed.info/id/900000000000550004
      designation:
        use: http://snomed.info/id/900000000000013009
      designation:
        use: http://snomed.info/id/900000000000013009
      designation:
        use: http://snomed.info/id/900000000000013009
    concept:
      code:
        v: SEVCO:01030
      display:
        v: phase 1 trial
      designation:
        use: http://snomed.info/id/900000000000550004
      designation:
        use: http://snomed.info/id/900000000000013009
      designation:
        use: http://snomed.info/id/900000000000013009
      designation:
        use: http://snomed.info/id/900000000000013009
    concept:
      code:
        v: SEVCO:01031
      display:
        v: exploratory investigational new drug study
      designation:
        use: http://snomed.info/id/900000000000550004
      designation:
        use: http://snomed.info/id/900000000000013009
      designation:
        use: http://snomed.info/id/900000000000013009

http://snomed.info/id/900000000000550004
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000550004
display:
  v: Definition (core metadata concept)

v: 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://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: interventional study

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: interventional study design

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: interventional primary research

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: international method of research

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: experimental research

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: experimental study

http://snomed.info/id/900000000000550004
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000550004
display:
  v: Definition (core metadata concept)

v: 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://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: interventional research with randomized assignment

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: randomized trial

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: randomized controlled trial

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: RCT

http://snomed.info/id/900000000000550004
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000550004
display:
  v: Definition (core metadata concept)

v: 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://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: unrestricted randomization

http://snomed.info/id/900000000000550004
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000550004
display:
  v: Definition (core metadata concept)

v: A randomized assignment in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups

http://snomed.info/id/900000000000550004
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000550004
display:
  v: Definition (core metadata concept)

v: A randomized assignment in which a pre-specified number of subjects is assigned to a block containing the same pre-specified ratio of group assignments in random order.

http://snomed.info/id/900000000000550004
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000550004
display:
  v: Definition (core metadata concept)

v: A randomized assignment in which a participant’s group assignment probability is adjusted based on any factor such that the likelihood of assignment is not the same for all participants.

http://snomed.info/id/900000000000550004
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000550004
display:
  v: Definition (core metadata concept)

v: 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://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: interventional research with non-randomized assignment

http://snomed.info/id/900000000000550004
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000550004
display:
  v: Definition (core metadata concept)

v: 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://snomed.info/id/900000000000550004
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000550004
display:
  v: Definition (core metadata concept)

v: Interventional research in which one or more healthcare-related actions (i.e., a diagnostic, prognostic, therapeutic, preventive or screening method or intervention) is evaluated for effects on health-related biomedical or behavioral processes and/or outcomes.

http://snomed.info/id/900000000000550004
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000550004
display:
  v: Definition (core metadata concept)

v: A clinical trial conducted under conditions of routine clinical practice.

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: pragmatic trial

http://snomed.info/id/900000000000550004
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000550004
display:
  v: Definition (core metadata concept)

v: A clinical trial that provides a means for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in another clinical study.

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: compassionate use trial

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: compassionate use study

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: expanded access trial

http://snomed.info/id/900000000000550004
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000550004
display:
  v: Definition (core metadata concept)

v: A clinical trial to gather initial evidence in humans to support further investigation of an intervention.

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: phase I trial

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: phase 1 study

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: phase I clinical trial

http://snomed.info/id/900000000000550004
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000550004
display:
  v: Definition (core metadata concept)

v: A clinical trial that is conducted early in phase 1, involves very limited human exposure, and has no therapeutic or diagnostic intent (e.g., screening studies, microdose studies).

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: phase 0 study

http://snomed.info/id/900000000000013009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 900000000000013009
display:
  v: Synonym (core metadata concept)

v: pre-clinical trial

use: http://snomed.info/id/900000000000013009
  system:
    v: http://snomed.info/sct
    l: sct
  code:
    v: 900000000000013009
  display:
    v: Synonym (core metadata concept)
value:
  v: exploratory ind study

code:
  v: SEVCO:01032
display:
  v: phase 1/phase 2 trial
designation:
  use: http://snomed.info/id/900000000000550004
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A clinical trial with a component meeting the definition of phase 1 trial and a component meeting the definition of phase 2 trial.
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase I/II trial
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase 1-2 trial
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase 1/2 trial
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: trial phase 1-2
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: trial phase 1/2

code:
  v: SEVCO:01033
display:
  v: phase 2 trial
designation:
  use: http://snomed.info/id/900000000000550004
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A clinical trial to gather evidence of effectiveness and safety for an intervention in patients with the disease or condition under study, but not intended to provide an adequate basis for regulatory approval for clinical use.
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase II trial
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase 2 study
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: exploratory clinical study
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase II clinical trial

code:
  v: SEVCO:01034
display:
  v: phase 2/phase 3 trial
designation:
  use: http://snomed.info/id/900000000000550004
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A clinical trial with a component meeting the definition of phase 2 trial and a component meeting the definition of phase 3 trial.
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase II/III trial
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase 2-3 trial
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase 2/3 trial
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: trial phase 2-3
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: trial phase 2/3

code:
  v: SEVCO:01035
display:
  v: phase 3 trial
designation:
  use: http://snomed.info/id/900000000000550004
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A clinical trial to gather the evidence of effectiveness and safety of an intervention, intended to provide an adequate basis for regulatory approval for clinical use.
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase III trial
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase 3 study
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: confirmatory clinical study
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase III clinical trial

code:
  v: SEVCO:01036
display:
  v: post-marketing study
designation:
  use: http://snomed.info/id/900000000000550004
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A clinical trial to gather additional evidence of effectiveness and safety of an intervention for an already approved clinical use.
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase IV trial
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase 4 trial
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: phase 4 study
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: trial phase 4
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    v: observational method of research
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      v: Synonym (core metadata concept)
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      v: Synonym (core metadata concept)
  value:
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      v: Synonym (core metadata concept)
  value:
    v: observational study design
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      v: 900000000000013009
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      v: Synonym (core metadata concept)
  value:
    v: observational primary research
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      v: 900000000000013009
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      v: Synonym (core metadata concept)
  value:
    v: non-interventional research

code:
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    code:
      v: 900000000000550004
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      v: Definition (core metadata concept)
  value:
    v: An observational study to identify adverse events related to the use of an approved clinical intervention.
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      v: 900000000000013009
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      v: Synonym (core metadata concept)
  value:
    v: postmarketing evaluation study
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    code:
      v: 900000000000013009
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      v: Synonym (core metadata concept)
  value:
    v: postmarketing evaluation study

code:
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design in which two or more groups are compared.
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    code:
      v: 900000000000013009
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      v: Synonym (core metadata concept)
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    v: comparative research

code:
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  v: parallel cohort design
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A comparative study design in which the groups are compared concurrently and participants are expected to remain in the groups being compared for the entire duration of participation in the study.
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: concurrent cohort study

code:
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  v: crossover cohort design
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A comparative study design in which participants receive two or more alternative exposures during separate periods of time.
designation:
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: crossover study
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    system:
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: crossover trial

code:
  v: SEVCO:01024
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  v: controlled crossover cohort design
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A crossover cohort design in which two or more cohorts have different orders of exposures.

code:
  v: SEVCO:01025
display:
  v: single-arm crossover design
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A crossover cohort design in which all participants are in a single cohort with the same order of exposures.

code:
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display:
  v: case control design
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A comparative study design in which the groups being compared are defined by outcome presence (case) or absence (control).

code:
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  v: matching for comparison
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A comparative study design in which individual participants in different groups being compared are paired or matched into sets based on selected attributes for within-set analysis.
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: matched study design

code:
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  v: family study design
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      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A matched study design in which related or non-related family members are compared.
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    code:
      v: 900000000000013009
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      v: Synonym (core metadata concept)
  value:
    v: familial study
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    system:
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    code:
      v: 900000000000013009
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      v: Synonym (core metadata concept)
  value:
    v: family study
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    code:
      v: 900000000000013009
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      v: Synonym (core metadata concept)
  value:
    v: family based study

code:
  v: SEVCO:01021
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  v: twin study design
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A family study design in which twin siblings are compared.

code:
  v: SEVCO:01015
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  v: cluster as unit of allocation
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A comparative study design in which participants are allocated to exposures (interventions) by their membership in groups (called clusters) rather than by individualized assignments.
designation:
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: clustering for comparison

code:
  v: SEVCO:01023
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  v: non-comparative study design
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      v: http://snomed.info/sct
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design with no comparisons between groups with different exposures and no comparisons between groups with different outcomes.
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      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: non-comparative research
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: descriptive study

code:
  v: SEVCO:01016
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  v: uncontrolled cohort design
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    system:
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A non-comparative study design in which two or more participants are evaluated in a single group (or cohort).
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      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: single cohort design
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: case series design
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    system:
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: non-controlled cohort design

code:
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  v: case report
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A non-comparative study design in which a single participant is evaluated.
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    system:
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: case study

code:
  v: SEVCO:01022
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  v: population-based design
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design in which the unit of observation is a population or community.
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      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
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      v: Synonym (core metadata concept)
  value:
    v: population study

code:
  v: SEVCO:01044
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  v: ecological design
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      v: http://snomed.info/sct
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design in which the unit of observation is a population or community defined by social relationships or physical surroundings.
designation:
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: ecologic study

code:
  v: SEVCO:01027
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  v: cross sectional data collection
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design process in which data is collected at a single point in time.
designation:
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      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
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      v: Synonym (core metadata concept)
  value:
    v: cross-sectional study

code:
  v: SEVCO:01028
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  v: longitudinal data collection
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      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design process in which data is collected at two or more points in time.
designation:
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: longitudinal study

code:
  v: SEVCO:01018
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  v: time series design
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      v: http://snomed.info/sct
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A longitudinal data collection which includes a set of time-ordered observations.
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: multiple time point comparison

code:
  v: SEVCO:01019
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  v: before and after comparison
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A time series design which includes comparisons of observations before and after an event or exposure.
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: before and after design
designation:
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: pre-post design
designation:
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: before-after comparison

code:
  v: SEVCO:01045
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  v: primary data collection
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design process in which the data are recorded and collected during the study for the purpose of the same study.
designation:
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: study-generated data collection

code:
  v: SEVCO:01026
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  v: real world data collection
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design process in which the study data are obtained from a source of data collected during a routine process in the natural environment rather than using a process designed or controlled by the researcher.
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: RWD collection

code:
  v: SEVCO:01039
display:
  v: real world data collection from healthcare records
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: Real world data collection from data obtained routinely for a purpose of recording healthcare delivery in a record controlled by a healthcare professional.
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: RWD collection from clinical care records
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: RWD from health care records
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: RWD from healthcare delivery records
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: real world data collection from medical records

code:
  v: SEVCO:01050
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  v: real world data collection from personal health records
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: Real world data collection from data obtained routinely for a purpose of recording data related to personal health in a record controlled by the person, guardian, or caretaker.
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: real world data collection from personal care records
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: RWD collection from personal medical records

code:
  v: SEVCO:01040
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  v: real world data collection from healthcare financing records
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: Real world data collection from data obtained routinely for a purpose of recording healthcare financing.
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: RWD collection from healthcare financing records

code:
  v: SEVCO:01048
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  v: real world data collection from testing procedures
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: Real world data collection from data obtained routinely for a purpose of testing, such as diagnostic testing or screening examination.
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: RWD collection from testing procedures

code:
  v: SEVCO:01046
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  v: real world data collection from monitoring procedures
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  use: http://snomed.info/id/900000000000550004
    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: Real world data collection from data obtained routinely for a purpose of repeated testing.
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: RWD collection from monitoring procedures

code:
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  v: secondary data collection from prior research
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    system:
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design process in which the data are collected from data obtained during a different study than the current study.

code:
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display:
  v: secondary data collection from a registry
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    system:
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design process in which the data are collected from a system organized to obtain and maintain uniform data for discovery and analysis, and this system is organized prior to the current study.

code:
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  v: multisite data collection
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    system:
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design process in which data are collected from two or more geographic locations.

code:
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display:
  v: quantitative analysis
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design process in which data are analyzed with mathematical or statistical methods and formulas.

code:
  v: SEVCO:01087
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  v: qualitative analysis
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design process in which data are analyzed, without primary reliance on mathematical or statistical techniques, by coding and organizing data to provide interpretation or understanding of experiences or hypotheses.

code:
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display:
  v: blinding of study participants
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    system:
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design process in which study participants are not informed of their intervention assignment.
designation:
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: masking of study participants

code:
  v: SEVCO:01061
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  v: blinding of intervention providers
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design process in which the people administering the intervention are not informed of the intervention assignment.
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: masking of intervention providers
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: blinding of intervention deliverers
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: masking of intervention deliverers

code:
  v: SEVCO:01062
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  v: blinding of outcome assessors
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design process in which the people determining the outcome are not informed of the intervention assignment.
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: masking of outcome assessors

code:
  v: SEVCO:01063
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  v: blinding of data analysts
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design process in which the people managing or processing the data and statistical analysis are not informed of the intervention assignment.
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: masking of data analysts

code:
  v: SEVCO:01064
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  v: allocation concealment
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design process in which all parties influencing study enrollment and allocation to study groups are unaware of the group assignment for the study participant at the time of enrollment and allocation.
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: blinding of randomization assignment
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: masking of randomization assignment

code:
  v: SEVCO:01043
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  v: multicentric
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    system:
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      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design feature in which two or more institutions are responsible for the conduct of the study.
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: multi-institutional study
designation:
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    system:
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: multicenter trial
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: multicenter study

code:
  v: SEVCO:01052
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  v: includes patient-reported outcome
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      v: http://snomed.info/sct
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design feature in which one or more outcomes are reported directly from the patient without interpretation by a clinician or researcher.
designation:
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: includes patient-reported outcomes
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: PRO

code:
  v: SEVCO:01053
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  v: includes patient-centered outcome
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      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design feature in which one or more measures are outcomes that patients directly care about, i.e. outcomes that are directly related to patients' experience of their life.
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: includes patient-oriented outcome
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: includes patient-important outcome
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: includes patient-relevant outcome
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: includes clinical outcome
designation:
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    system:
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: includes patient-centered outcome measure
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: includes clinical outcome measure

code:
  v: SEVCO:01054
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  v: includes disease-oriented outcome
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design feature in which one or more measures are outcomes that relate to a health or illness condition but are not outcomes which patients directly care about.
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: includes disease-oriented outcome measure
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: includes surrogate outcome
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: includes surrogate outcome measure

code:
  v: SEVCO:01085
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  v: includes process measure
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design feature in which one or more outcomes are actions or behaviors of a healthcare professional or care team.
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: includes process outcome
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: includes process outcome measure

code:
  v: SEVCO:01089
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  v: study goal
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    system:
      v: http://snomed.info/sct
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    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design feature specifying the intent of the study.
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
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      v: Synonym (core metadata concept)
  value:
    v: study aim

code:
  v: SEVCO:01096
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  v: evaluation goal
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study goal to assess the efficiency, effectiveness, and impact of a given program, process, person or piece of equipment.
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      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: evaluation study goal
designation:
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      v: http://snomed.info/sct
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    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: evaluation aim

code:
  v: SEVCO:01097
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  v: derivation goal
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study goal with the intent to generate a predictive algorithm.
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: derivation study goal

code:
  v: SEVCO:01098
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  v: validation goal
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study goal with the intent to determine the reliability and/or performance of a procedure for a specific predictive, classification, measurement, or communication purpose.
designation:
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: validation study goal

code:
  v: SEVCO:01088
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  v: comparison goal
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design feature in which the study intent is to compare two or more interventions or exposures.
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: comparative analysis goal

code:
  v: SEVCO:01091
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  v: comparative effectiveness goal
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design feature in which the study intent is to compare two or more interventions with respect to benefits and/or harms.

code:
  v: SEVCO:01090
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  v: comparative efficacy goal
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  use: http://snomed.info/id/900000000000550004
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design feature in which the study intent is to compare two or more interventions with respect to effectiveness in ideal conditions.

code:
  v: SEVCO:01092
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  v: comparative safety goal
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design feature in which the study intent is to compare two or more interventions with respect to harms.

code:
  v: SEVCO:01093
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  v: equivalence goal
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  use: http://snomed.info/id/900000000000550004
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study goal with the intent to compare two or more interventions or exposures and determine that any difference in effects is within a prespecified range representing absence of a meaningful difference.

code:
  v: SEVCO:01094
display:
  v: non-inferiority goal
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    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study goal with the intent to compare two or more interventions or exposures and determine that any difference in effects is below a prespecified value representing a threshold between a meaningful difference and absence of a meaningful difference.

code:
  v: SEVCO:01095
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  v: superiority goal
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  use: http://snomed.info/id/900000000000550004
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study goal with the intent to compare two or more interventions or exposures and detect a difference in effects.
designation:
  use: http://snomed.info/id/900000000000013009
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000013009
    display:
      v: Synonym (core metadata concept)
  value:
    v: superiority study goal

code:
  v: SEVCO:01100
display:
  v: allocation ratio
designation:
  use: http://snomed.info/id/900000000000550004
    system:
      v: http://snomed.info/sct
      l: sct
    code:
      v: 900000000000550004
    display:
      v: Definition (core metadata concept)
  value:
    v: A study design feature describing the intended relative proportion of assignment across groups.