Release 5 Ballot
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| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
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Definition for Code SystemResearchStudyClassifiers
<?xml version="1.0" encoding="UTF-8"?> <CodeSystem xmlns="http://hl7.org/fhir"> <id value="research-study-classifiers"/> <meta> <lastUpdated value="2022-09-07T11:58:29.429+11:00"/> <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> </meta> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"> <p> This code system <code> http://hl7.org/fhir/research-study-classifiers</code> defines the following codes: </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">research-study-prim-purp-type <a name="research-study-classifiers-research-study-prim-purp-type"> </a> </td> <td> Research Study Primary Purpose Type</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> treatment <a name="research-study-classifiers-treatment"> </a> </td> <td> Treatment</td> <td> One or more interventions are being evaluated for treating a disease, syndrome, or condition.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> prevention <a name="research-study-classifiers-prevention"> </a> </td> <td> Prevention</td> <td> One or more interventions are being assessed for preventing the development of a specific disease or health condition.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> diagnostic <a name="research-study-classifiers-diagnostic"> </a> </td> <td> Diagnostic</td> <td> One or more interventions are being evaluated for identifying a disease or health condition.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> supportive-care <a name="research-study-classifiers-supportive-care"> </a> </td> <td> Supportive Care</td> <td> One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> screening <a name="research-study-classifiers-screening"> </a> </td> <td> Screening</td> <td> One or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> health-services-research <a name="research-study-classifiers-health-services-research"> </a> </td> <td> Health Services Research</td> <td> One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> basic-science <a name="research-study-classifiers-basic-science"> </a> </td> <td> Basic Science</td> <td> One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention).</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> device-feasibility <a name="research-study-classifiers-device-feasibility"> </a> </td> <td> Device Feasibility</td> <td> An intervention of a device product is being evaluated to determine the feasibility of the product or to test a prototype device and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial.</td> </tr> <tr> <td> 1</td> <td style="white-space:nowrap">research-study-phase <a name="research-study-classifiers-research-study-phase"> </a> </td> <td> Research Study Phase</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> n-a <a name="research-study-classifiers-n-a"> </a> </td> <td> N/A</td> <td> Trials without phases (for example, studies of devices or behavioral interventions).</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> early-phase-1 <a name="research-study-classifiers-early-phase-1"> </a> </td> <td> Early Phase 1</td> <td> Designation for optional exploratory trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies. Formerly called Phase 0.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> phase-1 <a name="research-study-classifiers-phase-1"> </a> </td> <td> Phase 1</td> <td> Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> phase-1-phase-2 <a name="research-study-classifiers-phase-1-phase-2"> </a> </td> <td> Phase 1/Phase 2</td> <td> Trials that are a combination of phases 1 and 2.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> phase-2 <a name="research-study-classifiers-phase-2"> </a> </td> <td> Phase 2</td> <td> Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> phase-2-phase-3 <a name="research-study-classifiers-phase-2-phase-3"> </a> </td> <td> Phase 2/Phase 3</td> <td> Trials that are a combination of phases 2 and 3.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> phase-3 <a name="research-study-classifiers-phase-3"> </a> </td> <td> Phase 3</td> <td> Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> phase-4 <a name="research-study-classifiers-phase-4"> </a> </td> <td> Phase 4</td> <td> Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.</td> </tr> <tr> <td> 1</td> <td style="white-space:nowrap">research-study-focus-type <a name="research-study-classifiers-research-study-focus-type"> </a> </td> <td> Research Study Focus Type</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> medication <a name="research-study-classifiers-medication"> </a> </td> <td> Medication</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> device <a name="research-study-classifiers-device"> </a> </td> <td> Device</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> intervention <a name="research-study-classifiers-intervention"> </a> </td> <td> Intervention</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> factor <a name="research-study-classifiers-factor"> </a> </td> <td> Factor</td> <td/> </tr> <tr> <td> 1</td> <td style="white-space:nowrap">research-study-classifier <a name="research-study-classifiers-research-study-classifier"> </a> </td> <td> Research Study Classifier</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> fda-regulated-drug <a name="research-study-classifiers-fda-regulated-drug"> </a> </td> <td> FDA regulated drug</td> <td> A medication regulated by the U.S. Food and Drug Administration.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> fda-regulated-device <a name="research-study-classifiers-fda-regulated-device"> </a> </td> <td> FDA regulated device</td> <td> A medical device regulated by the U.S. Food and Drug Administration.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> mpg-paragraph-23b <a name="research-study-classifiers-mpg-paragraph-23b"> </a> </td> <td> MPG Paragraph 23b</td> <td> Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b).</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> irb-exempt <a name="research-study-classifiers-irb-exempt"> </a> </td> <td> IRB-exempt</td> <td> Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB).</td> </tr> <tr> <td> 1</td> <td style="white-space:nowrap">research-study-party-organization-type <a name="research-study-classifiers-research-study-party-organization-type"> </a> </td> <td> Research Study Party Organization Type</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> nih <a name="research-study-classifiers-nih"> </a> </td> <td> NIH</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> fda <a name="research-study-classifiers-fda"> </a> </td> <td> FDA</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> government <a name="research-study-classifiers-government"> </a> </td> <td> Government</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> nonprofit <a name="research-study-classifiers-nonprofit"> </a> </td> <td> Nonprofit</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> academic <a name="research-study-classifiers-academic"> </a> </td> <td> Academic</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> industry <a name="research-study-classifiers-industry"> </a> </td> <td> Industry</td> <td/> </tr> <tr> <td> 1</td> <td style="white-space:nowrap">research-study-party-role <a name="research-study-classifiers-research-study-party-role"> </a> </td> <td> Research Study Party Role</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> sponsor <a name="research-study-classifiers-sponsor"> </a> </td> <td> Sponsor</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> lead-sponsor <a name="research-study-classifiers-lead-sponsor"> </a> </td> <td> Lead Sponsor</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> sponsor-investigator <a name="research-study-classifiers-sponsor-investigator"> </a> </td> <td> Sponsor-Investigator</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> primary-investigator <a name="research-study-classifiers-primary-investigator"> </a> </td> <td> Primary Investigator</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> collaborator <a name="research-study-classifiers-collaborator"> </a> </td> <td> Collaborator</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> funding-source <a name="research-study-classifiers-funding-source"> </a> </td> <td> Funding Source</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> general-contact <a name="research-study-classifiers-general-contact"> </a> </td> <td> General Contact</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> recruitment-contact <a name="research-study-classifiers-recruitment-contact"> </a> </td> <td> Recruitment Contact</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> sub-investigator <a name="research-study-classifiers-sub-investigator"> </a> </td> <td> Sub-investigator</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> study-director <a name="research-study-classifiers-study-director"> </a> </td> <td> Study Director</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> study-chair <a name="research-study-classifiers-study-chair"> </a> </td> <td> Study Chair</td> <td/> </tr> <tr> <td> 1</td> <td style="white-space:nowrap">research-study-status <a name="research-study-classifiers-research-study-status"> </a> </td> <td> Research Study Status</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> overall-study <a name="research-study-classifiers-overall-study"> </a> </td> <td> Overall study</td> <td> Used for documenting the start and end of the overall study, distinct from progress states.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> active <a name="research-study-classifiers-active"> </a> </td> <td> Active</td> <td> Study is opened for accrual.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> active-but-not-recruiting <a name="research-study-classifiers-active-but-not-recruiting"> </a> </td> <td> Active, not recruiting</td> <td> The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> administratively-completed <a name="research-study-classifiers-administratively-completed"> </a> </td> <td> Administratively Completed</td> <td> Study is completed prematurely and will not resume; patients are no longer examined nor treated.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> approved <a name="research-study-classifiers-approved"> </a> </td> <td> Approved</td> <td> Protocol is approved by the review board.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> closed-to-accrual <a name="research-study-classifiers-closed-to-accrual"> </a> </td> <td> Closed to Accrual</td> <td> Study is closed for accrual; patients can be examined and treated.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> closed-to-accrual-and-intervention <a name="research-study-classifiers-closed-to-accrual-and-intervention"> </a> </td> <td> Closed to Accrual and Intervention</td> <td> Study is closed to accrual and intervention, i.e. the study is closed to enrollment, all study subjects have completed treatment or intervention but are still being followed according to the primary objective of the study.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> completed <a name="research-study-classifiers-completed"> </a> </td> <td> Completed</td> <td> The study closed according to the study plan. There will be no further treatments, interventions or data collection.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> disapproved <a name="research-study-classifiers-disapproved"> </a> </td> <td> Disapproved</td> <td> Protocol was disapproved by the review board.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> enrolling-by-invitation <a name="research-study-classifiers-enrolling-by-invitation"> </a> </td> <td> Enrolling by invitation</td> <td> The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> in-review <a name="research-study-classifiers-in-review"> </a> </td> <td> In Review</td> <td> Protocol is submitted to the review board for approval.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> not-yet-recruiting <a name="research-study-classifiers-not-yet-recruiting"> </a> </td> <td> Not yet recruiting</td> <td> The study has not started recruiting participants.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> recruiting <a name="research-study-classifiers-recruiting"> </a> </td> <td> Recruiting</td> <td> The study is currently recruiting participants.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> temporarily-closed-to-accrual <a name="research-study-classifiers-temporarily-closed-to-accrual"> </a> </td> <td> Temporarily Closed to Accrual</td> <td> Study is temporarily closed for accrual; can be potentially resumed in the future; patients can be examined and treated.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> temporarily-closed-to-accrual-and-intervention <a name="research-study-classifiers-temporarily-closed-to-accrual-and-intervention"> </a> </td> <td> Temporarily Closed to Accrual and Intervention</td> <td> Study is temporarily closed for accrual and intervention and potentially can be resumed in the future.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> terminated <a name="research-study-classifiers-terminated"> </a> </td> <td> Terminated</td> <td> The study has stopped early and will not start again. Participants are no longer being examined or treated.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> withdrawn <a name="research-study-classifiers-withdrawn"> </a> </td> <td> Withdrawn</td> <td> Protocol was withdrawn by the lead organization.</td> </tr> <tr> <td> 1</td> <td style="white-space:nowrap">research-study-registration-activity <a name="research-study-classifiers-research-study-registration-activity"> </a> </td> <td> Research Study Registration Activity</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> record-verification <a name="research-study-classifiers-record-verification"> </a> </td> <td> Record Verification</td> <td> Record has been verified.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> primary-outcome-data-collection <a name="research-study-classifiers-primary-outcome-data-collection"> </a> </td> <td> Primary outcome data collection</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> registration-submission <a name="research-study-classifiers-registration-submission"> </a> </td> <td> Registration submission</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> registration-submission-qc <a name="research-study-classifiers-registration-submission-qc"> </a> </td> <td> Registration submission Quality Check</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> registration-posting <a name="research-study-classifiers-registration-posting"> </a> </td> <td> Registration posting</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> results-submission <a name="research-study-classifiers-results-submission"> </a> </td> <td> Results submission</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> results-submission-qc <a name="research-study-classifiers-results-submission-qc"> </a> </td> <td> Results submission Quality Check</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> results-posting <a name="research-study-classifiers-results-posting"> </a> </td> <td> Results posting</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> disposition-submission <a name="research-study-classifiers-disposition-submission"> </a> </td> <td> Disposition submission</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> disposition-submission-qc <a name="research-study-classifiers-disposition-submission-qc"> </a> </td> <td> Disposition submission Quality Check</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> disposition-posting <a name="research-study-classifiers-disposition-posting"> </a> </td> <td> Disposition posting</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> update-submission <a name="research-study-classifiers-update-submission"> </a> </td> <td> Update submission </td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> update-posting <a name="research-study-classifiers-update-posting"> </a> </td> <td> Update posting</td> <td/> </tr> <tr> <td> 1</td> <td style="white-space:nowrap">research-study-reason-stopped <a name="research-study-classifiers-research-study-reason-stopped"> </a> </td> <td> Research Study Reason Stopped</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> accrual-goal-met <a name="research-study-classifiers-accrual-goal-met"> </a> </td> <td> Accrual Goal Met</td> <td> The study prematurely ended because the accrual goal was met.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> closed-due-to-toxicity <a name="research-study-classifiers-closed-due-to-toxicity"> </a> </td> <td> Closed due to toxicity</td> <td> The study prematurely ended due to toxicity.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> closed-due-to-lack-of-study-progress <a name="research-study-classifiers-closed-due-to-lack-of-study-progress"> </a> </td> <td> Closed due to lack of study progress</td> <td> The study prematurely ended due to lack of study progress.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> temporarily-closed-per-study-design <a name="research-study-classifiers-temporarily-closed-per-study-design"> </a> </td> <td> Temporarily closed per study design</td> <td> The study prematurely ended temporarily per study design.</td> </tr> <tr> <td> 1</td> <td style="white-space:nowrap">research-study-objective-type <a name="research-study-classifiers-research-study-objective-type"> </a> </td> <td> Research Study Objective Type</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> primary <a name="research-study-classifiers-primary"> </a> </td> <td> Primary</td> <td> The main question to be answered, and the one that drives any statistical planning for the study—e.g., calculation of the sample size to provide the appropriate power for statistical testing.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> secondary <a name="research-study-classifiers-secondary"> </a> </td> <td> Secondary</td> <td> Question to be answered in the study that is of lesser importance than the primary objective.</td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> exploratory <a name="research-study-classifiers-exploratory"> </a> </td> <td> Exploratory</td> <td> Exploratory questions to be answered in the study.</td> </tr> <tr> <td> 1</td> <td style="white-space:nowrap">research-study-arm-type <a name="research-study-classifiers-research-study-arm-type"> </a> </td> <td> Research Study Arm Type</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> active-comparator <a name="research-study-classifiers-active-comparator"> </a> </td> <td> Active Comparator</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> placebo-comparator <a name="research-study-classifiers-placebo-comparator"> </a> </td> <td> Placebo Comparator</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> sham-comparator <a name="research-study-classifiers-sham-comparator"> </a> </td> <td> Sham Comparator</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> no-intervention <a name="research-study-classifiers-no-intervention"> </a> </td> <td> No Intervention</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> experimental <a name="research-study-classifiers-experimental"> </a> </td> <td> Experimental</td> <td/> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> other-arm-type <a name="research-study-classifiers-other-arm-type"> </a> </td> <td> Other Arm Type</td> <td/> </tr> <tr> <td> 1</td> <td style="white-space:nowrap">SEVCO:01000 <a name="research-study-classifiers-SEVCO.5801000"> </a> </td> <td> Study Design</td> <td> A plan specification for how and what kinds of data will be gathered as part of an investigation which may produce testable explanations, conclusions and predictions or test a hypothesis. </td> </tr> <tr> <td> 2</td> <td style="white-space:nowrap"> SEVCO:01001 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01003 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01006 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01007 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01008 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01009 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01005 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01004 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01029 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01041 <a name="research-study-classifiers-SEVCO.5801041"> </a> </td> <td> Pragmatic clinical trial</td> <td> A clinical trial conducted under conditions of routine clinical practice.</td> </tr> <tr> <td> 4</td> <td style="white-space:nowrap"> SEVCO:01038 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01030 <a name="research-study-classifiers-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> 5</td> <td style="white-space:nowrap"> SEVCO:01031 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01032 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01033 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01034 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01035 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01036 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01002 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01037 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01010 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01011 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01012 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01024 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01025 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01013 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01014 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01020 <a name="research-study-classifiers-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> 5</td> <td style="white-space:nowrap"> SEVCO:01021 <a name="research-study-classifiers-SEVCO.5801021"> </a> </td> <td> Twin study design</td> <td> A family study design in which twin siblings are compared.</td> </tr> <tr> <td> 3</td> <td style="white-space:nowrap"> SEVCO:01015 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01023 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01016 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01017 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01022 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01044 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01027 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01028 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01018 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01019 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01045 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01026 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01039 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01050 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01040 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01048 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01046 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01049 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01042 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01051 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01086 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01087 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01060 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01061 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01062 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01063 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01064 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01043 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01052 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01053 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01054 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01085 <a name="research-study-classifiers-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> 2</td> <td style="white-space:nowrap"> SEVCO:01089 <a name="research-study-classifiers-SEVCO.5801089"> </a> </td> <td> Study Goal</td> <td> A study design feature specifying the intent of the study.</td> </tr> <tr> <td> 3</td> <td style="white-space:nowrap"> SEVCO:01096 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01097 <a name="research-study-classifiers-SEVCO.5801097"> </a> </td> <td> Derivation Goal</td> <td> A study goal with the intent to generate a predictive algorithm.</td> </tr> <tr> <td> 3</td> <td style="white-space:nowrap"> SEVCO:01098 <a name="research-study-classifiers-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> 3</td> <td style="white-space:nowrap"> SEVCO:01088 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01091 <a name="research-study-classifiers-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> 5</td> <td style="white-space:nowrap"> SEVCO:01090 <a name="research-study-classifiers-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> 5</td> <td style="white-space:nowrap"> SEVCO:01092 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01093 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01094 <a name="research-study-classifiers-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> 4</td> <td style="white-space:nowrap"> SEVCO:01095 <a name="research-study-classifiers-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="brr"/> </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="0"/> </extension> <url value="http://hl7.org/fhir/research-study-classifiers"/> <identifier> <system value="urn:ietf:rfc:3986"/> <value value="urn:oid:2.16.840.1.113883.4.642.4.1967"/> </identifier> <version value="5.0.0-ballot"/> <name value="ResearchStudyClassifiers"/> <title value="ResearchStudy Classifiers Code System"/> <status value="draft"/> <experimental value="false"/> <date value="2022-05-15T16:55:11.085+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="Codes for use in ResearchStudy Resource. This resource (this entire set of content) is being used for active development of a ResearchStudyClassifiers CodeSystem for use for supporting multiple value sets in the FHIR ResearchStudy StructureDefinition."/> <caseSensitive value="true"/> <valueSet value="http://hl7.org/fhir/ValueSet/research-study-classifiers"/> <hierarchyMeaning value="is-a"/> <content value="complete"/> <concept> <code value="research-study-prim-purp-type"/> <display value="Research Study Primary Purpose Type"/> <concept> <code value="treatment"/> <display value="Treatment"/> <definition value="One or more interventions are being evaluated for treating a disease, syndrome, or condition."/> </concept> <concept> <code value="prevention"/> <display value="Prevention"/> <definition value="One or more interventions are being assessed for preventing the development of a specific disease or health condition."/> </concept> <concept> <code value="diagnostic"/> <display value="Diagnostic"/> <definition value="One or more interventions are being evaluated for identifying a disease or health condition."/> </concept> <concept> <code value="supportive-care"/> <display value="Supportive Care"/> <definition value="One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function."/> </concept> <concept> <code value="screening"/> <display value="Screening"/> <definition value="One or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor."/> </concept> <concept> <code value="health-services-research"/> <display value="Health Services Research"/> <definition value="One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare."/> </concept> <concept> <code value="basic-science"/> <display value="Basic Science"/> <definition value="One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention)."/> </concept> <concept> <code value="device-feasibility"/> <display value="Device Feasibility"/> <definition value="An intervention of a device product is being evaluated to determine the feasibility of the product or to test a prototype device and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial."/> </concept> </concept> <concept> <code value="research-study-phase"/> <display value="Research Study Phase"/> <concept> <code value="n-a"/> <display value="N/A"/> <definition value="Trials without phases (for example, studies of devices or behavioral interventions)."/> </concept> <concept> <code value="early-phase-1"/> <display value="Early Phase 1"/> <definition value="Designation for optional exploratory trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies. Formerly called Phase 0."/> </concept> <concept> <code value="phase-1"/> <display value="Phase 1"/> <definition value="Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients."/> </concept> <concept> <code value="phase-1-phase-2"/> <display value="Phase 1/Phase 2"/> <definition value="Trials that are a combination of phases 1 and 2."/> </concept> <concept> <code value="phase-2"/> <display value="Phase 2"/> <definition value="Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks."/> </concept> <concept> <code value="phase-2-phase-3"/> <display value="Phase 2/Phase 3"/> <definition value="Trials that are a combination of phases 2 and 3."/> </concept> <concept> <code value="phase-3"/> <display value="Phase 3"/> <definition value="Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug."/> </concept> <concept> <code value="phase-4"/> <display value="Phase 4"/> <definition value="Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use."/> </concept> </concept> <concept> <code value="research-study-focus-type"/> <display value="Research Study Focus Type"/> <concept> <code value="medication"/> <display value="Medication"/> </concept> <concept> <code value="device"/> <display value="Device"/> </concept> <concept> <code value="intervention"/> <display value="Intervention"/> </concept> <concept> <code value="factor"/> <display value="Factor"/> </concept> </concept> <concept> <code value="research-study-classifier"/> <display value="Research Study Classifier"/> <concept> <code value="fda-regulated-drug"/> <display value="FDA regulated drug"/> <definition value="A medication regulated by the U.S. Food and Drug Administration."/> </concept> <concept> <code value="fda-regulated-device"/> <display value="FDA regulated device"/> <definition value="A medical device regulated by the U.S. Food and Drug Administration."/> </concept> <concept> <code value="mpg-paragraph-23b"/> <display value="MPG Paragraph 23b"/> <definition value="Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b)."/> </concept> <concept> <code value="irb-exempt"/> <display value="IRB-exempt"/> <definition value="Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB)."/> </concept> </concept> <concept> <code value="research-study-party-organization-type"/> <display value="Research Study Party Organization Type"/> <concept> <code value="nih"/> <display value="NIH"/> </concept> <concept> <code value="fda"/> <display value="FDA"/> </concept> <concept> <code value="government"/> <display value="Government"/> </concept> <concept> <code value="nonprofit"/> <display value="Nonprofit"/> </concept> <concept> <code value="academic"/> <display value="Academic"/> </concept> <concept> <code value="industry"/> <display value="Industry"/> </concept> </concept> <concept> <code value="research-study-party-role"/> <display value="Research Study Party Role"/> <concept> <code value="sponsor"/> <display value="Sponsor"/> </concept> <concept> <code value="lead-sponsor"/> <display value="Lead Sponsor"/> </concept> <concept> <code value="sponsor-investigator"/> <display value="Sponsor-Investigator"/> </concept> <concept> <code value="primary-investigator"/> <display value="Primary Investigator"/> </concept> <concept> <code value="collaborator"/> <display value="Collaborator"/> </concept> <concept> <code value="funding-source"/> <display value="Funding Source"/> </concept> <concept> <code value="general-contact"/> <display value="General Contact"/> </concept> <concept> <code value="recruitment-contact"/> <display value="Recruitment Contact"/> </concept> <concept> <code value="sub-investigator"/> <display value="Sub-investigator"/> </concept> <concept> <code value="study-director"/> <display value="Study Director"/> </concept> <concept> <code value="study-chair"/> <display value="Study Chair"/> </concept> </concept> <concept> <code value="research-study-status"/> <display value="Research Study Status"/> <concept> <code value="overall-study"/> <display value="Overall study"/> <definition value="Used for documenting the start and end of the overall study, distinct from progress states."/> </concept> <concept> <code value="active"/> <display value="Active"/> <definition value="Study is opened for accrual."/> </concept> <concept> <code value="active-but-not-recruiting"/> <display value="Active, not recruiting"/> <definition value="The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled."/> </concept> <concept> <code value="administratively-completed"/> <display value="Administratively Completed"/> <definition value="Study is completed prematurely and will not resume; patients are no longer examined nor treated."/> </concept> <concept> <code value="approved"/> <display value="Approved"/> <definition value="Protocol is approved by the review board."/> </concept> <concept> <code value="closed-to-accrual"/> <display value="Closed to Accrual"/> <definition value="Study is closed for accrual; patients can be examined and treated."/> </concept> <concept> <code value="closed-to-accrual-and-intervention"/> <display value="Closed to Accrual and Intervention"/> <definition value="Study is closed to accrual and intervention, i.e. the study is closed to enrollment, all study subjects have completed treatment or intervention but are still being followed according to the primary objective of the study."/> </concept> <concept> <code value="completed"/> <display value="Completed"/> <definition value="The study closed according to the study plan. There will be no further treatments, interventions or data collection."/> </concept> <concept> <code value="disapproved"/> <display value="Disapproved"/> <definition value="Protocol was disapproved by the review board."/> </concept> <concept> <code value="enrolling-by-invitation"/> <display value="Enrolling by invitation"/> <definition value="The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate."/> </concept> <concept> <code value="in-review"/> <display value="In Review"/> <definition value="Protocol is submitted to the review board for approval."/> </concept> <concept> <code value="not-yet-recruiting"/> <display value="Not yet recruiting"/> <definition value="The study has not started recruiting participants."/> </concept> <concept> <code value="recruiting"/> <display value="Recruiting"/> <definition value="The study is currently recruiting participants."/> </concept> <concept> <code value="temporarily-closed-to-accrual"/> <display value="Temporarily Closed to Accrual"/> <definition value="Study is temporarily closed for accrual; can be potentially resumed in the future; patients can be examined and treated."/> </concept> <concept> <code value="temporarily-closed-to-accrual-and-intervention"/> <display value="Temporarily Closed to Accrual and Intervention"/> <definition value="Study is temporarily closed for accrual and intervention and potentially can be resumed in the future."/> </concept> <concept> <code value="terminated"/> <display value="Terminated"/> <definition value="The study has stopped early and will not start again. Participants are no longer being examined or treated."/> </concept> <concept> <code value="withdrawn"/> <display value="Withdrawn"/> <definition value="Protocol was withdrawn by the lead organization."/> </concept> </concept> <concept> <code value="research-study-registration-activity"/> <display value="Research Study Registration Activity"/> <concept> <code value="record-verification"/> <display value="Record Verification"/> <definition value="Record has been verified."/> </concept> <concept> <code value="primary-outcome-data-collection"/> <display value="Primary outcome data collection"/> </concept> <concept> <code value="registration-submission"/> <display value="Registration submission"/> </concept> <concept> <code value="registration-submission-qc"/> <display value="Registration submission Quality Check"/> </concept> <concept> <code value="registration-posting"/> <display value="Registration posting"/> </concept> <concept> <code value="results-submission"/> <display value="Results submission"/> </concept> <concept> <code value="results-submission-qc"/> <display value="Results submission Quality Check"/> </concept> <concept> <code value="results-posting"/> <display value="Results posting"/> </concept> <concept> <code value="disposition-submission"/> <display value="Disposition submission"/> </concept> <concept> <code value="disposition-submission-qc"/> <display value="Disposition submission Quality Check"/> </concept> <concept> <code value="disposition-posting"/> <display value="Disposition posting"/> </concept> <concept> <code value="update-submission"/> <display value="Update submission "/> </concept> <concept> <code value="update-posting"/> <display value="Update posting"/> </concept> </concept> <concept> <code value="research-study-reason-stopped"/> <display value="Research Study Reason Stopped"/> <concept> <code value="accrual-goal-met"/> <display value="Accrual Goal Met"/> <definition value="The study prematurely ended because the accrual goal was met."/> </concept> <concept> <code value="closed-due-to-toxicity"/> <display value="Closed due to toxicity"/> <definition value="The study prematurely ended due to toxicity."/> </concept> <concept> <code value="closed-due-to-lack-of-study-progress"/> <display value="Closed due to lack of study progress"/> <definition value="The study prematurely ended due to lack of study progress."/> </concept> <concept> <code value="temporarily-closed-per-study-design"/> <display value="Temporarily closed per study design"/> <definition value="The study prematurely ended temporarily per study design."/> </concept> </concept> <concept> <code value="research-study-objective-type"/> <display value="Research Study Objective Type"/> <concept> <code value="primary"/> <display value="Primary"/> <definition value="The main question to be answered, and the one that drives any statistical planning for the study—e.g., calculation of the sample size to provide the appropriate power for statistical testing."/> </concept> <concept> <code value="secondary"/> <display value="Secondary"/> <definition value="Question to be answered in the study that is of lesser importance than the primary objective."/> </concept> <concept> <code value="exploratory"/> <display value="Exploratory"/> <definition value="Exploratory questions to be answered in the study."/> </concept> </concept> <concept> <code value="research-study-arm-type"/> <display value="Research Study Arm Type"/> <concept> <code value="active-comparator"/> <display value="Active Comparator"/> </concept> <concept> <code value="placebo-comparator"/> <display value="Placebo Comparator"/> </concept> <concept> <code value="sham-comparator"/> <display value="Sham Comparator"/> </concept> <concept> <code value="no-intervention"/> <display value="No Intervention"/> </concept> <concept> <code value="experimental"/> <display value="Experimental"/> </concept> <concept> <code value="other-arm-type"/> <display value="Other Arm Type"/> </concept> </concept> <concept> <code value="SEVCO:01000"/> <display value="Study Design"/> <definition value="A plan specification for how and what kinds of data will be gathered as part of an investigation which may produce testable explanations, conclusions and predictions or test a hypothesis. "/> <designation> <use> <display value="Alternative term"/> </use> <value value="research design"/> </designation> <designation> <use> <display value="Alternative term"/> </use> <value value="experimental design"/> </designation> <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> <designation> <use> <display value="Alternative term"/> </use> </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> </concept> </CodeSystem>
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R5 Ballot hl7.fhir.core#5.0.0-ballot generated on Wed, Sep 7, 2022 11:00+1000.
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