FHIR Cross-Version Extensions package for FHIR R4 from FHIR R5
0.0.1-snapshot-2 - informative
FHIR Cross-Version Extensions package for FHIR R4 from FHIR R5
0.0.1-snapshot-2 - informative
FHIR Cross-Version Extensions package for FHIR R4 from FHIR R5 - Version 0.0.1-snapshot-2. See the Directory of published versions
| Page standards status: Informative | Maturity Level: 1 |
<ValueSet xmlns="http://hl7.org/fhir">
<id value="R5-study-design-for-R4"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet R5-study-design-for-R4</b></p><a name="R5-study-design-for-R4"> </a><a name="hcR5-study-design-for-R4"> </a><p>This value set expansion contains 72 concepts.</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>System</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01001"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801001">SEVCO:01001</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01003"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801003">SEVCO:01003</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01006"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801006">SEVCO:01006</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01007"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801007">SEVCO:01007</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01008"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801008">SEVCO:01008</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01009"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801009">SEVCO:01009</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01005"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801005">SEVCO:01005</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01004"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801004">SEVCO:01004</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01029"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801029">SEVCO:01029</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01041"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801041">SEVCO:01041</a></td><td>http://hl7.org/fhir/study-design</td><td>Pragmatic clinical trial</td><td>A clinical trial conducted under conditions of routine clinical practice.</td></tr><tr><td style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01038"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801038">SEVCO:01038</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01030"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801030">SEVCO:01030</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01031"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801031">SEVCO:01031</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01032"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801032">SEVCO:01032</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01033"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801033">SEVCO:01033</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01034"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801034">SEVCO:01034</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01035"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801035">SEVCO:01035</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01036"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801036">SEVCO:01036</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01002"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801002">SEVCO:01002</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01037"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801037">SEVCO:01037</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01010"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801010">SEVCO:01010</a></td><td>http://hl7.org/fhir/study-design</td><td>Comparative study design</td><td>A study design in which two or more groups are compared.</td></tr><tr><td style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01011"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801011">SEVCO:01011</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01012"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801012">SEVCO:01012</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01024"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801024">SEVCO:01024</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01025"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801025">SEVCO:01025</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01013"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801013">SEVCO:01013</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01014"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801014">SEVCO:01014</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01020"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801020">SEVCO:01020</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01021"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801021">SEVCO:01021</a></td><td>http://hl7.org/fhir/study-design</td><td>Twin study design</td><td>A family study design in which twin siblings are compared.</td></tr><tr><td style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01015"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801015">SEVCO:01015</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01023"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801023">SEVCO:01023</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01016"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801016">SEVCO:01016</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01017"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801017">SEVCO:01017</a></td><td>http://hl7.org/fhir/study-design</td><td>Case report</td><td>A non-comparative study design in which a single participant is evaluated.</td></tr><tr><td style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01022"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801022">SEVCO:01022</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01044"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801044">SEVCO:01044</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01027"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801027">SEVCO:01027</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01028"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801028">SEVCO:01028</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01018"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801018">SEVCO:01018</a></td><td>http://hl7.org/fhir/study-design</td><td>Time series design</td><td>A longitudinal data collection which includes a set of time-ordered observations.</td></tr><tr><td style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01019"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801019">SEVCO:01019</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01045"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801045">SEVCO:01045</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01026"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801026">SEVCO:01026</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01039"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801039">SEVCO:01039</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01050"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801050">SEVCO:01050</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01040"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801040">SEVCO:01040</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01048"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801048">SEVCO:01048</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01046"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801046">SEVCO:01046</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01049"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801049">SEVCO:01049</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01042"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801042">SEVCO:01042</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01051"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801051">SEVCO:01051</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01086"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801086">SEVCO:01086</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01087"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801087">SEVCO:01087</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01060"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801060">SEVCO:01060</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01061"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801061">SEVCO:01061</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01062"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801062">SEVCO:01062</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01063"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801063">SEVCO:01063</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01064"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801064">SEVCO:01064</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01043"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801043">SEVCO:01043</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01052"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801052">SEVCO:01052</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01053"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801053">SEVCO:01053</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01054"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801054">SEVCO:01054</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01085"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801085">SEVCO:01085</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01089"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801089">SEVCO:01089</a></td><td>http://hl7.org/fhir/study-design</td><td>Study Goal</td><td>A study design feature specifying the intent of the study.</td></tr><tr><td style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01096"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801096">SEVCO:01096</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01097"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801097">SEVCO:01097</a></td><td>http://hl7.org/fhir/study-design</td><td>Derivation Goal</td><td>A study goal with the intent to generate a predictive algorithm.</td></tr><tr><td style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01098"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801098">SEVCO:01098</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01088"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801088">SEVCO:01088</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01091"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801091">SEVCO:01091</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01090"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801090">SEVCO:01090</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01092"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801092">SEVCO:01092</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01093"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801093">SEVCO:01093</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01094"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801094">SEVCO:01094</a></td><td>http://hl7.org/fhir/study-design</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 style="white-space:nowrap"><a name="R5-study-design-for-R4-http://hl7.org/fhir/study-design-SEVCO:01095"> </a> <a href="CodeSystem-study-design.html#study-design-SEVCO.5801095">SEVCO:01095</a></td><td>http://hl7.org/fhir/study-design</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-fmm">
<valueInteger value="1"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="cds"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/package-source">
<extension url="packageId">
<valueId value="hl7.fhir.uv.xver-r5.r4"/>
</extension>
<extension url="version">
<valueString value="0.0.1-snapshot-2"/>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="informative">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
<valueCanonical
value="http://hl7.org/fhir/5.0/ImplementationGuide/hl7.fhir.uv.xver-r5.r4"/>
</extension>
</valueCode>
</extension>
<url value="http://hl7.org/fhir/5.0/ValueSet/R5-study-design-for-R4"/>
<version value="0.0.1-snapshot-2"/>
<name value="R5_study_design_for_R4"/>
<title value="Cross-version VS for R5.StudyDesign for use in FHIR R4"/>
<status value="active"/>
<experimental value="false"/>
<date value="2025-09-01T22:37:03.437911+10:00"/>
<publisher value="Clinical Decision Support"/>
<contact>
<name value="Clinical Decision Support"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/dss"/>
</telecom>
</contact>
<description
value="This cross-version ValueSet represents concepts from http://hl7.org/fhir/ValueSet/study-design|5.0.0 for use in FHIR R4. Concepts not present here have direct `equivalent` mappings crossing all versions from R5 to R4."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<compose>
<include>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<concept>
<code value="SEVCO:01001"/>
<display value="Interventional research"/>
</concept>
<concept>
<code value="SEVCO:01003"/>
<display value="randomized assignment"/>
</concept>
<concept>
<code value="SEVCO:01006"/>
<display value="simple randomization"/>
</concept>
<concept>
<code value="SEVCO:01007"/>
<display value="stratified randomization"/>
</concept>
<concept>
<code value="SEVCO:01008"/>
<display value="block randomization"/>
</concept>
<concept>
<code value="SEVCO:01009"/>
<display value="adaptive randomization"/>
</concept>
<concept>
<code value="SEVCO:01005"/>
<display value="Non-randomized assignment"/>
</concept>
<concept>
<code value="SEVCO:01004"/>
<display value="Quasi-Randomized assignment"/>
</concept>
<concept>
<code value="SEVCO:01029"/>
<display value="Clinical trial"/>
</concept>
<concept>
<code value="SEVCO:01041"/>
<display value="Pragmatic clinical trial"/>
</concept>
<concept>
<code value="SEVCO:01038"/>
<display value="Expanded Access study"/>
</concept>
<concept>
<code value="SEVCO:01030"/>
<display value="Phase 1 trial"/>
</concept>
<concept>
<code value="SEVCO:01031"/>
<display value="Exploratory investigational new drug study"/>
</concept>
<concept>
<code value="SEVCO:01032"/>
<display value="Phase 1/Phase 2 trial"/>
</concept>
<concept>
<code value="SEVCO:01033"/>
<display value="Phase 2 trial"/>
</concept>
<concept>
<code value="SEVCO:01034"/>
<display value="Phase 2/Phase 3 trial"/>
</concept>
<concept>
<code value="SEVCO:01035"/>
<display value="Phase 3 Trial"/>
</concept>
<concept>
<code value="SEVCO:01036"/>
<display value="Post-marketing study"/>
</concept>
<concept>
<code value="SEVCO:01002"/>
<display value="Observational research"/>
</concept>
<concept>
<code value="SEVCO:01037"/>
<display value="Post-Marketing Surveillance study"/>
</concept>
<concept>
<code value="SEVCO:01010"/>
<display value="Comparative study design"/>
</concept>
<concept>
<code value="SEVCO:01011"/>
<display value="Parallel cohort design"/>
</concept>
<concept>
<code value="SEVCO:01012"/>
<display value="Crossover cohort design"/>
</concept>
<concept>
<code value="SEVCO:01024"/>
<display value="Controlled crossover cohort design"/>
</concept>
<concept>
<code value="SEVCO:01025"/>
<display value="Single-arm crossover design"/>
</concept>
<concept>
<code value="SEVCO:01013"/>
<display value="Case control design"/>
</concept>
<concept>
<code value="SEVCO:01014"/>
<display value="Matching for comparison"/>
</concept>
<concept>
<code value="SEVCO:01020"/>
<display value="Family study design"/>
</concept>
<concept>
<code value="SEVCO:01021"/>
<display value="Twin study design"/>
</concept>
<concept>
<code value="SEVCO:01015"/>
<display value="Cluster as unit of allocation"/>
</concept>
<concept>
<code value="SEVCO:01023"/>
<display value="Non-comparative study design"/>
</concept>
<concept>
<code value="SEVCO:01016"/>
<display value="Uncontrolled cohort design"/>
</concept>
<concept>
<code value="SEVCO:01017"/>
<display value="Case report"/>
</concept>
<concept>
<code value="SEVCO:01022"/>
<display value="Population-based design"/>
</concept>
<concept>
<code value="SEVCO:01044"/>
<display value="Ecological design"/>
</concept>
<concept>
<code value="SEVCO:01027"/>
<display value="Cross sectional data collection"/>
</concept>
<concept>
<code value="SEVCO:01028"/>
<display value="Longitudinal data collection"/>
</concept>
<concept>
<code value="SEVCO:01018"/>
<display value="Time series design"/>
</concept>
<concept>
<code value="SEVCO:01019"/>
<display value="Before and after comparison"/>
</concept>
<concept>
<code value="SEVCO:01045"/>
<display value="Primary data collection"/>
</concept>
<concept>
<code value="SEVCO:01026"/>
<display value="Real world data collection"/>
</concept>
<concept>
<code value="SEVCO:01039"/>
<display value="Real world data collection from healthcare records"/>
</concept>
<concept>
<code value="SEVCO:01050"/>
<display
value="Real world data collection from personal health records"/>
</concept>
<concept>
<code value="SEVCO:01040"/>
<display
value="Real world data collection from healthcare financing records"/>
</concept>
<concept>
<code value="SEVCO:01048"/>
<display value="Real world data collection from testing procedures"/>
</concept>
<concept>
<code value="SEVCO:01046"/>
<display
value="Real world data collection from monitoring procedures"/>
</concept>
<concept>
<code value="SEVCO:01049"/>
<display value="Secondary data collection from prior research"/>
</concept>
<concept>
<code value="SEVCO:01042"/>
<display value="Secondary data collection from a registry"/>
</concept>
<concept>
<code value="SEVCO:01051"/>
<display value="Multisite data collection"/>
</concept>
<concept>
<code value="SEVCO:01086"/>
<display value="Quantitative analysis"/>
</concept>
<concept>
<code value="SEVCO:01087"/>
<display value="Qualitative analysis"/>
</concept>
<concept>
<code value="SEVCO:01060"/>
<display value="Blinding of study participants"/>
</concept>
<concept>
<code value="SEVCO:01061"/>
<display value="Blinding of intervention providers"/>
</concept>
<concept>
<code value="SEVCO:01062"/>
<display value="Blinding of outcome assessors"/>
</concept>
<concept>
<code value="SEVCO:01063"/>
<display value="Blinding of data analysts"/>
</concept>
<concept>
<code value="SEVCO:01064"/>
<display value="Allocation concealment"/>
</concept>
<concept>
<code value="SEVCO:01043"/>
<display value="Multicentric"/>
</concept>
<concept>
<code value="SEVCO:01052"/>
<display value="Includes patient-reported outcome"/>
</concept>
<concept>
<code value="SEVCO:01053"/>
<display value="Includes patient-centered outcome"/>
</concept>
<concept>
<code value="SEVCO:01054"/>
<display value="Includes disease-oriented outcome"/>
</concept>
<concept>
<code value="SEVCO:01085"/>
<display value="Includes process measure"/>
</concept>
<concept>
<code value="SEVCO:01089"/>
<display value="Study Goal"/>
</concept>
<concept>
<code value="SEVCO:01096"/>
<display value="Evaluation Goal"/>
</concept>
<concept>
<code value="SEVCO:01097"/>
<display value="Derivation Goal"/>
</concept>
<concept>
<code value="SEVCO:01098"/>
<display value="Validation Goal"/>
</concept>
<concept>
<code value="SEVCO:01088"/>
<display value="Comparison Goal"/>
</concept>
<concept>
<code value="SEVCO:01091"/>
<display value="Comparative Effectiveness Goal"/>
</concept>
<concept>
<code value="SEVCO:01090"/>
<display value="Comparative Efficacy Goal"/>
</concept>
<concept>
<code value="SEVCO:01092"/>
<display value="Comparative Safety Goal"/>
</concept>
<concept>
<code value="SEVCO:01093"/>
<display value="Equivalence Goal"/>
</concept>
<concept>
<code value="SEVCO:01094"/>
<display value="Non-inferiority Goal"/>
</concept>
<concept>
<code value="SEVCO:01095"/>
<display value="Superiority Goal"/>
</concept>
</include>
</compose>
<expansion>
<timestamp value="2025-09-01T22:37:03.437896+10:00"/>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01001"/>
<display value="Interventional research"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01003"/>
<display value="randomized assignment"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01006"/>
<display value="simple randomization"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01007"/>
<display value="stratified randomization"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01008"/>
<display value="block randomization"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01009"/>
<display value="adaptive randomization"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01005"/>
<display value="Non-randomized assignment"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01004"/>
<display value="Quasi-Randomized assignment"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01029"/>
<display value="Clinical trial"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01041"/>
<display value="Pragmatic clinical trial"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01038"/>
<display value="Expanded Access study"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01030"/>
<display value="Phase 1 trial"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01031"/>
<display value="Exploratory investigational new drug study"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01032"/>
<display value="Phase 1/Phase 2 trial"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01033"/>
<display value="Phase 2 trial"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01034"/>
<display value="Phase 2/Phase 3 trial"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01035"/>
<display value="Phase 3 Trial"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01036"/>
<display value="Post-marketing study"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01002"/>
<display value="Observational research"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01037"/>
<display value="Post-Marketing Surveillance study"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01010"/>
<display value="Comparative study design"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01011"/>
<display value="Parallel cohort design"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01012"/>
<display value="Crossover cohort design"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01024"/>
<display value="Controlled crossover cohort design"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01025"/>
<display value="Single-arm crossover design"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01013"/>
<display value="Case control design"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01014"/>
<display value="Matching for comparison"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01020"/>
<display value="Family study design"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01021"/>
<display value="Twin study design"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01015"/>
<display value="Cluster as unit of allocation"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01023"/>
<display value="Non-comparative study design"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01016"/>
<display value="Uncontrolled cohort design"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01017"/>
<display value="Case report"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01022"/>
<display value="Population-based design"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01044"/>
<display value="Ecological design"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01027"/>
<display value="Cross sectional data collection"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01028"/>
<display value="Longitudinal data collection"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01018"/>
<display value="Time series design"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01019"/>
<display value="Before and after comparison"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01045"/>
<display value="Primary data collection"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01026"/>
<display value="Real world data collection"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01039"/>
<display value="Real world data collection from healthcare records"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01050"/>
<display
value="Real world data collection from personal health records"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01040"/>
<display
value="Real world data collection from healthcare financing records"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01048"/>
<display value="Real world data collection from testing procedures"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01046"/>
<display value="Real world data collection from monitoring procedures"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01049"/>
<display value="Secondary data collection from prior research"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01042"/>
<display value="Secondary data collection from a registry"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01051"/>
<display value="Multisite data collection"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01086"/>
<display value="Quantitative analysis"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01087"/>
<display value="Qualitative analysis"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01060"/>
<display value="Blinding of study participants"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01061"/>
<display value="Blinding of intervention providers"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01062"/>
<display value="Blinding of outcome assessors"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01063"/>
<display value="Blinding of data analysts"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01064"/>
<display value="Allocation concealment"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01043"/>
<display value="Multicentric"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01052"/>
<display value="Includes patient-reported outcome"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01053"/>
<display value="Includes patient-centered outcome"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01054"/>
<display value="Includes disease-oriented outcome"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01085"/>
<display value="Includes process measure"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01089"/>
<display value="Study Goal"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01096"/>
<display value="Evaluation Goal"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01097"/>
<display value="Derivation Goal"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01098"/>
<display value="Validation Goal"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01088"/>
<display value="Comparison Goal"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01091"/>
<display value="Comparative Effectiveness Goal"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01090"/>
<display value="Comparative Efficacy Goal"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01092"/>
<display value="Comparative Safety Goal"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01093"/>
<display value="Equivalence Goal"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01094"/>
<display value="Non-inferiority Goal"/>
</contains>
<contains>
<system value="http://hl7.org/fhir/study-design"/>
<version value="5.0.0"/>
<code value="SEVCO:01095"/>
<display value="Superiority Goal"/>
</contains>
</expansion>
</ValueSet>
IG © 2025+ FHIR Infrastructure. Package hl7.fhir.uv.xver-r5.r4#0.0.1-snapshot-2 based on FHIR 4.0.1. Generated 2025-09-13
Links: Table of Contents |
QA Report
| Version History |
|
History