study-design
type: ValueSet
node role: treeRoot
id:
  v: study-design
meta:
  last updated:
    v: 2026-03-21T18:47:02+00:00
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: ValueSet study-design Last updated: 2022-05-12T12:40:00Z 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-specified number of subjects is assi…
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: normative
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
identifier:
  system:
    v: urn:ietf:rfc:3986
    l: 3986
  value:
    v: urn:oid:2.16.840.1.113883.4.642.3.3045
version:
  v: 6.0.0-ballot4
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.
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 001
    display:
      v: World
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

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

code:
  v: SEVCO:01031
display:
  v: exploratory investigational new drug 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 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).
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 0 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: pre-clinical 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: 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
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: post-approval study

code:
  v: SEVCO:01002
display:
  v: observational research
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 in which the independent variables (exposures or interventions) are not prospectively assigned or modified by the investigator.
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: observational 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: observational study design
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: observational primary research
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: observational method of research
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: non-interventional research
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: observational 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: observational study design
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: observational primary research
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: non-interventional research

code:
  v: SEVCO:01037
display:
  v: post-marketing surveillance 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: An observational study to identify adverse events related to the use of an approved clinical intervention.
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: postmarketing evaluation 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: postmarketing evaluation study

code:
  v: SEVCO:01010
display:
  v: comparative study design
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 in which two or more groups are compared.
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: comparative research

code:
  v: SEVCO:01011
display:
  v: parallel cohort design
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 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.
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: concurrent cohort study

code:
  v: SEVCO:01012
display:
  v: crossover cohort design
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 comparative study design in which participants receive two or more alternative exposures during separate periods of time.
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: crossover 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: crossover trial

code:
  v: SEVCO:01024
display:
  v: controlled crossover cohort design
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 crossover cohort design in which two or more cohorts have different orders of exposures.

code:
  v: SEVCO:01025
display:
  v: single-arm crossover design
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 crossover cohort design in which all participants are in a single cohort with the same order of exposures.

code:
  v: SEVCO:01013
display:
  v: case control design
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 comparative study design in which the groups being compared are defined by outcome presence (case) or absence (control).

code:
  v: SEVCO:01014
display:
  v: matching for comparison
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 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.
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: matched study design

code:
  v: SEVCO:01020
display:
  v: family study design
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 matched study design in which related or non-related family members are compared.
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: familial 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: family 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: family based study

code:
  v: SEVCO:01021
display:
  v: twin study design
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 family study design in which twin siblings are compared.

code:
  v: SEVCO:01015
display:
  v: cluster as unit of allocation
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 comparative study design in which participants are allocated to exposures (interventions) by their membership in groups (called clusters) rather than by individualized assignments.
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: clustering for comparison

code:
  v: SEVCO:01023
display:
  v: non-comparative study design
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 with no comparisons between groups with different exposures and no comparisons between groups with different 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: non-comparative research
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: descriptive study

code:
  v: SEVCO:01016
display:
  v: uncontrolled cohort design
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 non-comparative study design in which two or more participants are evaluated in a single group (or cohort).
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: single cohort design
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: case series design
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: non-controlled cohort design

code:
  v: SEVCO:01017
display:
  v: case report
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 non-comparative study design in which a single participant is evaluated.
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: case study

code:
  v: SEVCO:01022
display:
  v: population-based design
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 in which the unit of observation is a population or community.
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: population study

code:
  v: SEVCO:01044
display:
  v: ecological design
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 in which the unit of observation is a population or community defined by social relationships or physical surroundings.
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: ecologic study

code:
  v: SEVCO:01027
display:
  v: cross sectional data collection
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 process in which data is collected at a single point in time.
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: cross-sectional study

code:
  v: SEVCO:01028
display:
  v: longitudinal data collection
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 process in which data is collected at two or more points in time.
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: longitudinal study

code:
  v: SEVCO:01018
display:
  v: time series design
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 longitudinal data collection which includes a set of time-ordered observations.
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: multiple time point comparison

code:
  v: SEVCO:01019
display:
  v: before and after comparison
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 time series design which includes comparisons of observations before and after an event or exposure.
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: before and after design
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: pre-post design
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: before-after comparison

code:
  v: SEVCO:01045
display:
  v: primary data collection
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 process in which the data are recorded and collected during the study for the purpose of the same 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: study-generated data collection

code:
  v: SEVCO:01026
display:
  v: real world data collection
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 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.
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

code:
  v: SEVCO:01039
display:
  v: real world data collection from healthcare records
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: Real world data collection from data obtained routinely for a purpose of recording healthcare delivery in a record controlled by a healthcare professional.
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 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
display:
  v: real world data collection from personal health records
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: 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
display:
  v: real world data collection from healthcare financing records
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: 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
display:
  v: real world data collection from testing procedures
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: 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
display:
  v: real world data collection from monitoring procedures
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: Real world data collection from data obtained routinely for a purpose of repeated testing.
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 monitoring procedures

code:
  v: SEVCO:01049
display:
  v: secondary data collection from prior research
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 process in which the data are collected from data obtained during a different study than the current study.

code:
  v: SEVCO:01042
display:
  v: secondary data collection from a registry
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 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:
  v: SEVCO:01051
display:
  v: multisite data collection
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 process in which data are collected from two or more geographic locations.

code:
  v: SEVCO:01086
display:
  v: quantitative analysis
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 process in which data are analyzed with mathematical or statistical methods and formulas.

code:
  v: SEVCO:01087
display:
  v: qualitative analysis
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 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:
  v: SEVCO:01060
display:
  v: blinding of study participants
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 process in which study participants are not informed of their intervention 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 study participants

code:
  v: SEVCO:01061
display:
  v: blinding of intervention providers
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 process in which the people administering the intervention are not informed of the intervention 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 intervention providers
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 intervention deliverers
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 intervention deliverers

code:
  v: SEVCO:01062
display:
  v: blinding of outcome assessors
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 process in which the people determining the outcome are not informed of the intervention 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 outcome assessors

code:
  v: SEVCO:01063
display:
  v: blinding of data analysts
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 process in which the people managing or processing the data and statistical analysis are not informed of the intervention 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 data analysts

code:
  v: SEVCO:01064
display:
  v: allocation concealment
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 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
display:
  v: multicentric
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 in which two or more institutions are responsible for the conduct of the 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: multi-institutional 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: multicenter 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: multicenter study

code:
  v: SEVCO:01052
display:
  v: includes patient-reported outcome
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 in which one or more outcomes are reported directly from the patient without interpretation by a clinician or researcher.
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 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
display:
  v: includes patient-centered outcome
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 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:
  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 patient-oriented 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 patient-important 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 patient-relevant 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 clinical 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 patient-centered 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 clinical outcome measure

code:
  v: SEVCO:01054
display:
  v: includes disease-oriented outcome
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 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:
  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 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:
  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 measure

code:
  v: SEVCO:01085
display:
  v: includes process measure
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 in which one or more outcomes are actions or behaviors of a healthcare professional or care team.
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
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
display:
  v: study goal
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 specifying the intent of the 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: study aim

code:
  v: SEVCO:01096
display:
  v: evaluation goal
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 goal to assess the efficiency, effectiveness, and impact of a given program, process, person or piece of equipment.
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: evaluation study goal
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: evaluation aim

code:
  v: SEVCO:01097
display:
  v: derivation goal
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 goal with the intent to generate a predictive algorithm.
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: derivation study goal

code:
  v: SEVCO:01098
display:
  v: validation goal
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 goal with the intent to determine the reliability and/or performance of a procedure for a specific predictive, classification, measurement, or communication purpose.
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: validation study goal

code:
  v: SEVCO:01088
display:
  v: comparison goal
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 in which the study intent is to compare two or more interventions or exposures.
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: comparative analysis goal

code:
  v: SEVCO:01091
display:
  v: comparative effectiveness goal
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 in which the study intent is to compare two or more interventions with respect to benefits and/or harms.

code:
  v: SEVCO:01090
display:
  v: comparative efficacy goal
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 in which the study intent is to compare two or more interventions with respect to effectiveness in ideal conditions.

code:
  v: SEVCO:01092
display:
  v: comparative safety goal
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 in which the study intent is to compare two or more interventions with respect to harms.

code:
  v: SEVCO:01093
display:
  v: equivalence goal
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 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
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 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
display:
  v: superiority goal
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 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.