Definition for Code SystemStudyDesign

<?xml version="1.0" encoding="UTF-8"?>

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="study-design"/> 
  <meta> 
    <lastUpdated value="2024-11-20T21:23:48.918+00:00"/> 
    <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> 
  </meta> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p class="res-header-id">
        <b> Generated Narrative: CodeSystem study-design</b> 
      </p> 
      <a name="study-design"> </a> 
      <a name="hcstudy-design"> </a> 
      <a name="study-design-en-US"> </a> 
      <p> This case-sensitive code system 
        <code> http://hl7.org/fhir/study-design</code>  defines the following codes in a Is-A hierarchy:
      </p> 
      <table class="codes">
        <tr> 
          <td> 
            <b> Lvl</b> 
          </td> 
          <td style="white-space:nowrap">
            <b> Code</b> 
          </td> 
          <td> 
            <b> Display</b> 
          </td> 
          <td> 
            <b> Definition</b> 
          </td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01001
            <a name="study-design-SEVCO.5801001"> </a> 
          </td> 
          <td> Interventional research</td> 
          <td> 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).</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01003
            <a name="study-design-SEVCO.5801003"> </a> 
          </td> 
          <td> randomized assignment</td> 
          <td> An interventional study design in which an independent variable (an exposure or
             intervention) is prospectively assigned or modified by random chance to separate
             groups.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01006
            <a name="study-design-SEVCO.5801006"> </a> 
          </td> 
          <td> simple randomization</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01007
            <a name="study-design-SEVCO.5801007"> </a> 
          </td> 
          <td> stratified randomization</td> 
          <td> A randomized assignment in which participants are stratified into groups based
             on prognostic variables and then randomized into balanced treatment groups</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01008
            <a name="study-design-SEVCO.5801008"> </a> 
          </td> 
          <td> block randomization</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01009
            <a name="study-design-SEVCO.5801009"> </a> 
          </td> 
          <td> adaptive randomization</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01005
            <a name="study-design-SEVCO.5801005"> </a> 
          </td> 
          <td> Non-randomized assignment</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01004
            <a name="study-design-SEVCO.5801004"> </a> 
          </td> 
          <td> Quasi-Randomized assignment</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01029
            <a name="study-design-SEVCO.5801029"> </a> 
          </td> 
          <td> Clinical trial</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01041
            <a name="study-design-SEVCO.5801041"> </a> 
          </td> 
          <td> Pragmatic clinical trial</td> 
          <td> A clinical trial conducted under conditions of routine clinical practice.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01038
            <a name="study-design-SEVCO.5801038"> </a> 
          </td> 
          <td> Expanded Access study</td> 
          <td> 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. </td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01030
            <a name="study-design-SEVCO.5801030"> </a> 
          </td> 
          <td> Phase 1 trial</td> 
          <td> A clinical trial to gather initial evidence in humans to support further investigation
             of an intervention.</td> 
        </tr> 
        <tr> 
          <td> 4</td> 
          <td style="white-space:nowrap">      SEVCO:01031
            <a name="study-design-SEVCO.5801031"> </a> 
          </td> 
          <td> Exploratory investigational new drug study</td> 
          <td> 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). </td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01032
            <a name="study-design-SEVCO.5801032"> </a> 
          </td> 
          <td> Phase 1/Phase 2 trial</td> 
          <td>  A clinical trial with a component meeting the definition of phase 1 trial and
             a component meeting the definition of phase 2 trial.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01033
            <a name="study-design-SEVCO.5801033"> </a> 
          </td> 
          <td> Phase 2 trial</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01034
            <a name="study-design-SEVCO.5801034"> </a> 
          </td> 
          <td> Phase 2/Phase 3 trial</td> 
          <td> A clinical trial with a component meeting the definition of phase 2 trial and a
             component meeting the definition of phase 3 trial.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01035
            <a name="study-design-SEVCO.5801035"> </a> 
          </td> 
          <td> Phase 3 Trial</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01036
            <a name="study-design-SEVCO.5801036"> </a> 
          </td> 
          <td> Post-marketing study</td> 
          <td> A clinical trial to gather additional evidence of effectiveness and safety of an
             intervention for an already approved clinical use.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01002
            <a name="study-design-SEVCO.5801002"> </a> 
          </td> 
          <td> Observational research</td> 
          <td> A study design in which the independent variables (exposures or interventions)
             are not prospectively assigned or modified by the investigator. </td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01037
            <a name="study-design-SEVCO.5801037"> </a> 
          </td> 
          <td> Post-Marketing Surveillance study</td> 
          <td> An observational study to identify adverse events related to the use of an approved
             clinical intervention.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01010
            <a name="study-design-SEVCO.5801010"> </a> 
          </td> 
          <td> Comparative study design</td> 
          <td> A study design in which two or more groups are compared.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01011
            <a name="study-design-SEVCO.5801011"> </a> 
          </td> 
          <td> Parallel cohort design</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01012
            <a name="study-design-SEVCO.5801012"> </a> 
          </td> 
          <td> Crossover cohort design</td> 
          <td> A comparative study design in which participants receive two or more alternative
             exposures during separate periods of time.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01024
            <a name="study-design-SEVCO.5801024"> </a> 
          </td> 
          <td> Controlled crossover cohort design</td> 
          <td> A crossover cohort design in which two or more cohorts have different orders of
             exposures.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01025
            <a name="study-design-SEVCO.5801025"> </a> 
          </td> 
          <td> Single-arm crossover design</td> 
          <td> A crossover cohort design in which all participants are in a single cohort with
             the same order of exposures.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01013
            <a name="study-design-SEVCO.5801013"> </a> 
          </td> 
          <td> Case control design</td> 
          <td> A comparative study design in which the groups being compared are defined by outcome
             presence (case) or absence (control).</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01014
            <a name="study-design-SEVCO.5801014"> </a> 
          </td> 
          <td> Matching for comparison</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01020
            <a name="study-design-SEVCO.5801020"> </a> 
          </td> 
          <td> Family study design</td> 
          <td> A matched study design in which related or non-related family members are compared.</td> 
        </tr> 
        <tr> 
          <td> 4</td> 
          <td style="white-space:nowrap">      SEVCO:01021
            <a name="study-design-SEVCO.5801021"> </a> 
          </td> 
          <td> Twin study design</td> 
          <td> A family study design in which twin siblings are compared.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01015
            <a name="study-design-SEVCO.5801015"> </a> 
          </td> 
          <td> Cluster as unit of allocation</td> 
          <td> A comparative study design in which participants are allocated to exposures (interventions)
             by their membership in groups (called clusters) rather than by individualized assignments.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01023
            <a name="study-design-SEVCO.5801023"> </a> 
          </td> 
          <td> Non-comparative study design</td> 
          <td> A study design with no comparisons between groups with different exposures and
             no comparisons between groups with different outcomes.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01016
            <a name="study-design-SEVCO.5801016"> </a> 
          </td> 
          <td> Uncontrolled cohort design</td> 
          <td> A non-comparative study design in which two or more participants are evaluated
             in a single group (or cohort).</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01017
            <a name="study-design-SEVCO.5801017"> </a> 
          </td> 
          <td> Case report</td> 
          <td> A non-comparative study design in which a single participant is evaluated.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01022
            <a name="study-design-SEVCO.5801022"> </a> 
          </td> 
          <td> Population-based design</td> 
          <td> A study design in which the unit of observation is a population or community. </td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01044
            <a name="study-design-SEVCO.5801044"> </a> 
          </td> 
          <td> Ecological design</td> 
          <td> A study design in which the unit of observation is a population or community defined
             by social relationships or physical surroundings. </td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01027
            <a name="study-design-SEVCO.5801027"> </a> 
          </td> 
          <td> Cross sectional data collection </td> 
          <td> A study design process in which data is collected at a single point in time.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01028
            <a name="study-design-SEVCO.5801028"> </a> 
          </td> 
          <td> Longitudinal data collection</td> 
          <td> A study design process in which data is collected at two or more points in time.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01018
            <a name="study-design-SEVCO.5801018"> </a> 
          </td> 
          <td> Time series design</td> 
          <td> A longitudinal data collection which includes a set of time-ordered observations.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01019
            <a name="study-design-SEVCO.5801019"> </a> 
          </td> 
          <td> Before and after comparison</td> 
          <td> A time series design which includes comparisons of observations before and after
             an event or exposure.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01045
            <a name="study-design-SEVCO.5801045"> </a> 
          </td> 
          <td> Primary data collection</td> 
          <td> A study design process in which the data are recorded and collected during the
             study for the purpose of the same study.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01026
            <a name="study-design-SEVCO.5801026"> </a> 
          </td> 
          <td> Real world data collection</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01039
            <a name="study-design-SEVCO.5801039"> </a> 
          </td> 
          <td> Real world data collection from healthcare records</td> 
          <td> Real world data collection from data obtained routinely for a purpose of recording
             healthcare delivery in a record controlled by a healthcare professional.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01050
            <a name="study-design-SEVCO.5801050"> </a> 
          </td> 
          <td> Real world data collection from personal health records</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01040
            <a name="study-design-SEVCO.5801040"> </a> 
          </td> 
          <td> Real world data collection from healthcare financing records</td> 
          <td> Real world data collection from data obtained routinely for a purpose of recording
             healthcare financing.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01048
            <a name="study-design-SEVCO.5801048"> </a> 
          </td> 
          <td> Real world data collection from testing procedures</td> 
          <td> Real world data collection from data obtained routinely for a purpose of testing,
             such as diagnostic testing or screening examination.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01046
            <a name="study-design-SEVCO.5801046"> </a> 
          </td> 
          <td> Real world data collection from monitoring procedures</td> 
          <td> Real world data collection from data obtained routinely for a purpose of repeated
             testing.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01049
            <a name="study-design-SEVCO.5801049"> </a> 
          </td> 
          <td> Secondary data collection from prior research</td> 
          <td> A study design process in which the data are collected from data obtained during
             a different study than the current study.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01042
            <a name="study-design-SEVCO.5801042"> </a> 
          </td> 
          <td> Secondary data collection from a registry</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01051
            <a name="study-design-SEVCO.5801051"> </a> 
          </td> 
          <td> Multisite data collection</td> 
          <td> A study design process in which data are collected from two or more geographic
             locations.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01086
            <a name="study-design-SEVCO.5801086"> </a> 
          </td> 
          <td> Quantitative analysis</td> 
          <td> A study design process in which data are analyzed with mathematical or statistical
             methods and formulas.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01087
            <a name="study-design-SEVCO.5801087"> </a> 
          </td> 
          <td> Qualitative analysis</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01060
            <a name="study-design-SEVCO.5801060"> </a> 
          </td> 
          <td> Blinding of study participants</td> 
          <td> A study design process in which study participants are not informed of their intervention
             assignment.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01061
            <a name="study-design-SEVCO.5801061"> </a> 
          </td> 
          <td> Blinding of intervention providers</td> 
          <td> A study design process in which the people administering the intervention are not
             informed of the intervention assignment.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01062
            <a name="study-design-SEVCO.5801062"> </a> 
          </td> 
          <td> Blinding of outcome assessors</td> 
          <td> A study design process in which the people determining the outcome are not informed
             of the intervention assignment.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01063
            <a name="study-design-SEVCO.5801063"> </a> 
          </td> 
          <td> Blinding of data analysts</td> 
          <td> A study design process in which the people managing or processing the data and
             statistical analysis are not informed of the intervention assignment.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01064
            <a name="study-design-SEVCO.5801064"> </a> 
          </td> 
          <td> Allocation concealment</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01043
            <a name="study-design-SEVCO.5801043"> </a> 
          </td> 
          <td> Multicentric</td> 
          <td> A study design feature in which two or more institutions are responsible for the
             conduct of the study.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01052
            <a name="study-design-SEVCO.5801052"> </a> 
          </td> 
          <td> Includes patient-reported outcome</td> 
          <td> A study design feature in which one or more outcomes are reported directly from
             the patient without interpretation by a clinician or researcher.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01053
            <a name="study-design-SEVCO.5801053"> </a> 
          </td> 
          <td> Includes patient-centered outcome</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01054
            <a name="study-design-SEVCO.5801054"> </a> 
          </td> 
          <td> Includes disease-oriented outcome</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01085
            <a name="study-design-SEVCO.5801085"> </a> 
          </td> 
          <td> Includes process measure</td> 
          <td> A study design feature in which one or more outcomes are actions or behaviors of
             a healthcare professional or care team.</td> 
        </tr> 
        <tr> 
          <td> 1</td> 
          <td style="white-space:nowrap">SEVCO:01089
            <a name="study-design-SEVCO.5801089"> </a> 
          </td> 
          <td> Study Goal</td> 
          <td> A study design feature specifying the intent of the study.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01096
            <a name="study-design-SEVCO.5801096"> </a> 
          </td> 
          <td> Evaluation Goal</td> 
          <td> A study goal to assess the efficiency, effectiveness, and impact of a given program,
             process, person or piece of equipment.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01097
            <a name="study-design-SEVCO.5801097"> </a> 
          </td> 
          <td> Derivation Goal</td> 
          <td> A study goal with the intent to generate a predictive algorithm.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01098
            <a name="study-design-SEVCO.5801098"> </a> 
          </td> 
          <td> Validation Goal</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  SEVCO:01088
            <a name="study-design-SEVCO.5801088"> </a> 
          </td> 
          <td> Comparison Goal</td> 
          <td> A study design feature in which the study intent is to compare two or more interventions
             or exposures.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01091
            <a name="study-design-SEVCO.5801091"> </a> 
          </td> 
          <td> Comparative Effectiveness Goal</td> 
          <td> A study design feature in which the study intent is to compare two or more interventions
             with respect to benefits and/or harms.</td> 
        </tr> 
        <tr> 
          <td> 4</td> 
          <td style="white-space:nowrap">      SEVCO:01090
            <a name="study-design-SEVCO.5801090"> </a> 
          </td> 
          <td> Comparative Efficacy Goal</td> 
          <td> A study design feature in which the study intent is to compare two or more interventions
             with respect to effectiveness in ideal conditions.</td> 
        </tr> 
        <tr> 
          <td> 4</td> 
          <td style="white-space:nowrap">      SEVCO:01092
            <a name="study-design-SEVCO.5801092"> </a> 
          </td> 
          <td> Comparative Safety Goal</td> 
          <td> A study design feature in which the study intent is to compare two or more interventions
             with respect to harms.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01093
            <a name="study-design-SEVCO.5801093"> </a> 
          </td> 
          <td> Equivalence Goal</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01094
            <a name="study-design-SEVCO.5801094"> </a> 
          </td> 
          <td> Non-inferiority Goal</td> 
          <td> 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.</td> 
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    SEVCO:01095
            <a name="study-design-SEVCO.5801095"> </a> 
          </td> 
          <td> Superiority Goal</td> 
          <td> A study goal with the intent to compare two or more interventions or exposures
             and detect a difference in effects.</td> 
        </tr> 
      </table> 
    </div> 
  </text> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="cds"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/> 
  </extension> 
  <url value="http://hl7.org/fhir/study-design"/> 
  <version value="6.0.0-ballot2"/> 
  <name value="StudyDesign"/> 
  <title value="Study Design"/> 
  <status value="active"/> 
  <experimental value="false"/> 
  <date value="2020-12-28T16:55:11+11:00"/> 
  <publisher value="HL7 (FHIR Project)"/> 
  <contact> 
    <telecom> 
      <system value="url"/> 
      <value value="http://hl7.org/fhir"/> 
    </telecom> 
    <telecom> 
      <system value="email"/> 
      <value value="fhir@lists.hl7.org"/> 
    </telecom> 
  </contact> 
  <description value="This is a set of terms for study design characteristics."/> 
  <jurisdiction> 
    <coding> 
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/> 
      <code value="001"/> 
      <display value="World"/> 
    </coding> 
  </jurisdiction> 
  <caseSensitive value="true"/> 
  <valueSet value="http://hl7.org/fhir/ValueSet/study-design"/> 
  <hierarchyMeaning value="is-a"/> 
  <content value="complete"/> 
  <concept> 
    <code value="SEVCO:01001"/> 
    <display value="Interventional research"/> 
    <definition value="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)."/> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Interventional study"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Interventional study design"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="interventional primary research"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="international method of research"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="experimental research"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="experimental study"/> 
    </designation> 
    <concept> 
      <code value="SEVCO:01003"/> 
      <display value="randomized assignment"/> 
      <definition value="An interventional study design in which an independent variable (an exposure or
       intervention) is prospectively assigned or modified by random chance to separate
       groups."/> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Interventional research with randomized assignment"/> 
      </designation> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Randomized trial"/> 
      </designation> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Randomized controlled trial"/> 
      </designation> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="RCT"/> 
      </designation> 
      <concept> 
        <code value="SEVCO:01006"/> 
        <display value="simple randomization"/> 
        <definition value="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."/> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Unrestricted Randomization"/> 
        </designation> 
      </concept> 
      <concept> 
        <code value="SEVCO:01007"/> 
        <display value="stratified randomization"/> 
        <definition value="A randomized assignment in which participants are stratified into groups based
         on prognostic variables and then randomized into balanced treatment groups"/> 
      </concept> 
      <concept> 
        <code value="SEVCO:01008"/> 
        <display value="block randomization"/> 
        <definition value="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."/> 
      </concept> 
      <concept> 
        <code value="SEVCO:01009"/> 
        <display value="adaptive randomization"/> 
        <definition value="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."/> 
      </concept> 
    </concept> 
    <concept> 
      <code value="SEVCO:01005"/> 
      <display value="Non-randomized assignment"/> 
      <definition value="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."/> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Interventional research with non-randomized assignment"/> 
      </designation> 
      <concept> 
        <code value="SEVCO:01004"/> 
        <display value="Quasi-Randomized assignment"/> 
        <definition value="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."/> 
      </concept> 
    </concept> 
    <concept> 
      <code value="SEVCO:01029"/> 
      <display value="Clinical trial"/> 
      <definition value="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."/> 
      <concept> 
        <code value="SEVCO:01041"/> 
        <display value="Pragmatic clinical trial"/> 
        <definition value="A clinical trial conducted under conditions of routine clinical practice."/> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Pragmatic trial"/> 
        </designation> 
      </concept> 
      <concept> 
        <code value="SEVCO:01038"/> 
        <display value="Expanded Access study"/> 
        <definition value="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. "/> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Compassionate use trial"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Compassionate use study"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Expanded access trial"/> 
        </designation> 
      </concept> 
      <concept> 
        <code value="SEVCO:01030"/> 
        <display value="Phase 1 trial"/> 
        <definition value="A clinical trial to gather initial evidence in humans to support further investigation
         of an intervention."/> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Phase I trial"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Phase 1 study"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="phase I clinical trial"/> 
        </designation> 
        <concept> 
          <code value="SEVCO:01031"/> 
          <display value="Exploratory investigational new drug study"/> 
          <definition value="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> 
              <display value="Alternative term"/> 
            </use> 
            <value value="Phase 0 study"/> 
          </designation> 
          <designation> 
            <use> 
              <display value="Alternative term"/> 
            </use> 
            <value value="Pre-clinical trial"/> 
          </designation> 
          <designation> 
            <use> 
              <display value="Alternative term"/> 
            </use> 
            <value value="Exploratory IND study"/> 
          </designation> 
        </concept> 
      </concept> 
      <concept> 
        <code value="SEVCO:01032"/> 
        <display value="Phase 1/Phase 2 trial"/> 
        <definition value=" 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> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Phase I/II trial"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Phase 1-2 trial"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Phase 1/2 trial"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Trial phase 1-2"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Trial phase 1/2"/> 
        </designation> 
      </concept> 
      <concept> 
        <code value="SEVCO:01033"/> 
        <display value="Phase 2 trial"/> 
        <definition value="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> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Phase II trial"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="phase 2 study"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Exploratory clinical study"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="phase II clinical trial"/> 
        </designation> 
      </concept> 
      <concept> 
        <code value="SEVCO:01034"/> 
        <display value="Phase 2/Phase 3 trial"/> 
        <definition value="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> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Phase II/III trial"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Phase 2-3 trial"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Phase 2/3 trial"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Trial phase 2-3"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Trial phase 2/3"/> 
        </designation> 
      </concept> 
      <concept> 
        <code value="SEVCO:01035"/> 
        <display value="Phase 3 Trial"/> 
        <definition value="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> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Phase III trial"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="phase 3 study"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Confirmatory clinical study"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="phase III clinical trial"/> 
        </designation> 
      </concept> 
      <concept> 
        <code value="SEVCO:01036"/> 
        <display value="Post-marketing study"/> 
        <definition value="A clinical trial to gather additional evidence of effectiveness and safety of an
         intervention for an already approved clinical use."/> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Phase IV trial"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Phase 4 trial"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Phase 4 study"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Trial phase 4"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Post-approval study"/> 
        </designation> 
      </concept> 
    </concept> 
  </concept> 
  <concept> 
    <code value="SEVCO:01002"/> 
    <display value="Observational research"/> 
    <definition value="A study design in which the independent variables (exposures or interventions)
     are not prospectively assigned or modified by the investigator. "/> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Observational Study"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Observational Study Design"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Observational primary research"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="observational method of research"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Non-interventional research"/> 
    </designation> 
    <concept> 
      <code value="SEVCO:01037"/> 
      <display value="Post-Marketing Surveillance study"/> 
      <definition value="An observational study to identify adverse events related to the use of an approved
       clinical intervention."/> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Postmarketing evaluation study"/> 
      </designation> 
    </concept> 
  </concept> 
  <concept> 
    <code value="SEVCO:01010"/> 
    <display value="Comparative study design"/> 
    <definition value="A study design in which two or more groups are compared."/> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Comparative research"/> 
    </designation> 
    <concept> 
      <code value="SEVCO:01011"/> 
      <display value="Parallel cohort design"/> 
      <definition value="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> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Concurrent cohort study"/> 
      </designation> 
    </concept> 
    <concept> 
      <code value="SEVCO:01012"/> 
      <display value="Crossover cohort design"/> 
      <definition value="A comparative study design in which participants receive two or more alternative
       exposures during separate periods of time."/> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Crossover study"/> 
      </designation> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Crossover trial"/> 
      </designation> 
      <concept> 
        <code value="SEVCO:01024"/> 
        <display value="Controlled crossover cohort design"/> 
        <definition value="A crossover cohort design in which two or more cohorts have different orders of
         exposures."/> 
      </concept> 
      <concept> 
        <code value="SEVCO:01025"/> 
        <display value="Single-arm crossover design"/> 
        <definition value="A crossover cohort design in which all participants are in a single cohort with
         the same order of exposures."/> 
      </concept> 
    </concept> 
    <concept> 
      <code value="SEVCO:01013"/> 
      <display value="Case control design"/> 
      <definition value="A comparative study design in which the groups being compared are defined by outcome
       presence (case) or absence (control)."/> 
    </concept> 
    <concept> 
      <code value="SEVCO:01014"/> 
      <display value="Matching for comparison"/> 
      <definition value="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> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Matched study design"/> 
      </designation> 
      <concept> 
        <code value="SEVCO:01020"/> 
        <display value="Family study design"/> 
        <definition value="A matched study design in which related or non-related family members are compared."/> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Familial study"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Family study"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Family based study"/> 
        </designation> 
        <concept> 
          <code value="SEVCO:01021"/> 
          <display value="Twin study design"/> 
          <definition value="A family study design in which twin siblings are compared."/> 
        </concept> 
      </concept> 
    </concept> 
    <concept> 
      <code value="SEVCO:01015"/> 
      <display value="Cluster as unit of allocation"/> 
      <definition value="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> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Clustering for comparison"/> 
      </designation> 
    </concept> 
  </concept> 
  <concept> 
    <code value="SEVCO:01023"/> 
    <display value="Non-comparative study design"/> 
    <definition value="A study design with no comparisons between groups with different exposures and
     no comparisons between groups with different outcomes."/> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Non-comparative research"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Descriptive study"/> 
    </designation> 
    <concept> 
      <code value="SEVCO:01016"/> 
      <display value="Uncontrolled cohort design"/> 
      <definition value="A non-comparative study design in which two or more participants are evaluated
       in a single group (or cohort)."/> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Single cohort design"/> 
      </designation> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Case series design"/> 
      </designation> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Non-controlled cohort design"/> 
      </designation> 
    </concept> 
    <concept> 
      <code value="SEVCO:01017"/> 
      <display value="Case report"/> 
      <definition value="A non-comparative study design in which a single participant is evaluated."/> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Case study"/> 
      </designation> 
    </concept> 
  </concept> 
  <concept> 
    <code value="SEVCO:01022"/> 
    <display value="Population-based design"/> 
    <definition value="A study design in which the unit of observation is a population or community. "/> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Population study"/> 
    </designation> 
    <concept> 
      <code value="SEVCO:01044"/> 
      <display value="Ecological design"/> 
      <definition value="A study design in which the unit of observation is a population or community defined
       by social relationships or physical surroundings. "/> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Ecologic study"/> 
      </designation> 
    </concept> 
  </concept> 
  <concept> 
    <code value="SEVCO:01027"/> 
    <display value="Cross sectional data collection "/> 
    <definition value="A study design process in which data is collected at a single point in time."/> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Cross-sectional study"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="SEVCO:01028"/> 
    <display value="Longitudinal data collection"/> 
    <definition value="A study design process in which data is collected at two or more points in time."/> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Longitudinal study"/> 
    </designation> 
    <concept> 
      <code value="SEVCO:01018"/> 
      <display value="Time series design"/> 
      <definition value="A longitudinal data collection which includes a set of time-ordered observations."/> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Multiple time point comparison"/> 
      </designation> 
      <concept> 
        <code value="SEVCO:01019"/> 
        <display value="Before and after comparison"/> 
        <definition value="A time series design which includes comparisons of observations before and after
         an event or exposure."/> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Before and After design"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Pre-Post Design"/> 
        </designation> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Before-After Comparison"/> 
        </designation> 
      </concept> 
    </concept> 
  </concept> 
  <concept> 
    <code value="SEVCO:01045"/> 
    <display value="Primary data collection"/> 
    <definition value="A study design process in which the data are recorded and collected during the
     study for the purpose of the same study."/> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Study-generated data collection"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="SEVCO:01026"/> 
    <display value="Real world data collection"/> 
    <definition value="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> 
        <display value="Alternative term"/> 
      </use> 
      <value value="RWD collection"/> 
    </designation> 
    <concept> 
      <code value="SEVCO:01039"/> 
      <display value="Real world data collection from healthcare records"/> 
      <definition value="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> 
          <display value="Alternative term"/> 
        </use> 
        <value value="RWD collection from clinical care records"/> 
      </designation> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="RWD from health care records"/> 
      </designation> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="RWD from healthcare delivery records"/> 
      </designation> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Real world data collection from medical records"/> 
      </designation> 
    </concept> 
    <concept> 
      <code value="SEVCO:01050"/> 
      <display value="Real world data collection from personal health records"/> 
      <definition value="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> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Real world data collection from personal care records"/> 
      </designation> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="RWD collection from personal medical records"/> 
      </designation> 
    </concept> 
    <concept> 
      <code value="SEVCO:01040"/> 
      <display value="Real world data collection from healthcare financing records"/> 
      <definition value="Real world data collection from data obtained routinely for a purpose of recording
       healthcare financing."/> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="RWD collection from healthcare financing records"/> 
      </designation> 
    </concept> 
    <concept> 
      <code value="SEVCO:01048"/> 
      <display value="Real world data collection from testing procedures"/> 
      <definition value="Real world data collection from data obtained routinely for a purpose of testing,
       such as diagnostic testing or screening examination."/> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="RWD collection from testing procedures"/> 
      </designation> 
      <concept> 
        <code value="SEVCO:01046"/> 
        <display value="Real world data collection from monitoring procedures"/> 
        <definition value="Real world data collection from data obtained routinely for a purpose of repeated
         testing."/> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="RWD collection from monitoring procedures"/> 
        </designation> 
      </concept> 
    </concept> 
  </concept> 
  <concept> 
    <code value="SEVCO:01049"/> 
    <display value="Secondary data collection from prior research"/> 
    <definition value="A study design process in which the data are collected from data obtained during
     a different study than the current study."/> 
  </concept> 
  <concept> 
    <code value="SEVCO:01042"/> 
    <display value="Secondary data collection from a registry"/> 
    <definition value="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."/> 
  </concept> 
  <concept> 
    <code value="SEVCO:01051"/> 
    <display value="Multisite data collection"/> 
    <definition value="A study design process in which data are collected from two or more geographic
     locations."/> 
  </concept> 
  <concept> 
    <code value="SEVCO:01086"/> 
    <display value="Quantitative analysis"/> 
    <definition value="A study design process in which data are analyzed with mathematical or statistical
     methods and formulas."/> 
  </concept> 
  <concept> 
    <code value="SEVCO:01087"/> 
    <display value="Qualitative analysis"/> 
    <definition value="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."/> 
  </concept> 
  <concept> 
    <code value="SEVCO:01060"/> 
    <display value="Blinding of study participants"/> 
    <definition value="A study design process in which study participants are not informed of their intervention
     assignment."/> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Masking of study participants"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="SEVCO:01061"/> 
    <display value="Blinding of intervention providers"/> 
    <definition value="A study design process in which the people administering the intervention are not
     informed of the intervention assignment."/> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Masking of intervention providers"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Blinding of intervention deliverers"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Masking of intervention deliverers"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="SEVCO:01062"/> 
    <display value="Blinding of outcome assessors"/> 
    <definition value="A study design process in which the people determining the outcome are not informed
     of the intervention assignment."/> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Masking of outcome assessors"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="SEVCO:01063"/> 
    <display value="Blinding of data analysts"/> 
    <definition value="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> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Masking of data analysts"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="SEVCO:01064"/> 
    <display value="Allocation concealment"/> 
    <definition value="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> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Blinding of randomization assignment"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Masking of randomization assignment"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="SEVCO:01043"/> 
    <display value="Multicentric"/> 
    <definition value="A study design feature in which two or more institutions are responsible for the
     conduct of the study."/> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Multi-institutional study"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Multicenter trial"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Multicenter study"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="SEVCO:01052"/> 
    <display value="Includes patient-reported outcome"/> 
    <definition value="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> 
        <display value="Alternative term"/> 
      </use> 
      <value value="PRO"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Includes patient-reported outcomes"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="SEVCO:01053"/> 
    <display value="Includes patient-centered outcome"/> 
    <definition value="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> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Includes patient-oriented outcome"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Includes patient-important outcome"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Includes patient-relevant outcome"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Includes clinical outcome"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Includes patient-centered outcome measure"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Includes clinical outcome measure"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="SEVCO:01054"/> 
    <display value="Includes disease-oriented outcome"/> 
    <definition value="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> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Includes disease-oriented outcome measure"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Includes surrogate outcome"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Includes surrogate outcome measure"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="SEVCO:01085"/> 
    <display value="Includes process measure"/> 
    <definition value="A study design feature in which one or more outcomes are actions or behaviors of
     a healthcare professional or care team."/> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Includes process outcome"/> 
    </designation> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Includes process outcome measure"/> 
    </designation> 
  </concept> 
  <concept> 
    <code value="SEVCO:01089"/> 
    <display value="Study Goal"/> 
    <definition value="A study design feature specifying the intent of the study."/> 
    <designation> 
      <use> 
        <display value="Alternative term"/> 
      </use> 
      <value value="Study Aim"/> 
    </designation> 
    <concept> 
      <code value="SEVCO:01096"/> 
      <display value="Evaluation Goal"/> 
      <definition value="A study goal to assess the efficiency, effectiveness, and impact of a given program,
       process, person or piece of equipment."/> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Evaluation Study Goal"/> 
      </designation> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Evaluation Aim"/> 
      </designation> 
    </concept> 
    <concept> 
      <code value="SEVCO:01097"/> 
      <display value="Derivation Goal"/> 
      <definition value="A study goal with the intent to generate a predictive algorithm."/> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Derivation Study Goal"/> 
      </designation> 
    </concept> 
    <concept> 
      <code value="SEVCO:01098"/> 
      <display value="Validation Goal"/> 
      <definition value="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> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Validation Study Goal"/> 
      </designation> 
    </concept> 
    <concept> 
      <code value="SEVCO:01088"/> 
      <display value="Comparison Goal"/> 
      <definition value="A study design feature in which the study intent is to compare two or more interventions
       or exposures."/> 
      <designation> 
        <use> 
          <display value="Alternative term"/> 
        </use> 
        <value value="Comparative Analysis Goal"/> 
      </designation> 
      <concept> 
        <code value="SEVCO:01091"/> 
        <display value="Comparative Effectiveness Goal"/> 
        <definition value="A study design feature in which the study intent is to compare two or more interventions
         with respect to benefits and/or harms."/> 
        <concept> 
          <code value="SEVCO:01090"/> 
          <display value="Comparative Efficacy Goal"/> 
          <definition value="A study design feature in which the study intent is to compare two or more interventions
           with respect to effectiveness in ideal conditions."/> 
        </concept> 
        <concept> 
          <code value="SEVCO:01092"/> 
          <display value="Comparative Safety Goal"/> 
          <definition value="A study design feature in which the study intent is to compare two or more interventions
           with respect to harms."/> 
        </concept> 
      </concept> 
      <concept> 
        <code value="SEVCO:01093"/> 
        <display value="Equivalence Goal"/> 
        <definition value="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."/> 
      </concept> 
      <concept> 
        <code value="SEVCO:01094"/> 
        <display value="Non-inferiority Goal"/> 
        <definition value="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."/> 
      </concept> 
      <concept> 
        <code value="SEVCO:01095"/> 
        <display value="Superiority Goal"/> 
        <definition value="A study goal with the intent to compare two or more interventions or exposures
         and detect a difference in effects."/> 
        <designation> 
          <use> 
            <display value="Alternative term"/> 
          </use> 
          <value value="Superiority study goal"/> 
        </designation> 
      </concept> 
    </concept> 
  </concept> 
</CodeSystem>