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Codesystem-research-study-classifiers.xml

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards 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="2022-08-09T15:51:58.790+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 http://hl7.org/fhir/research-study-classifiers 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-label-type
            <a name="research-study-classifiers-research-study-label-type"> </a> 
          </td> 
          <td> Research Study Label Type</td> 
          <td/>  
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  short
            <a name="research-study-classifiers-short"> </a> 
          </td> 
          <td> Short</td> 
          <td> A short form of the name - what is used in everyday conversation.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  public
            <a name="research-study-classifiers-public"> </a> 
          </td> 
          <td> Public</td> 
          <td> A name that is understandable to non-technical readers.</td> 
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  scientific
            <a name="research-study-classifiers-scientific"> </a> 
          </td> 
          <td> Scientific</td> 
          <td> A full name that is suitable for use in an academic or technical setting.</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">  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> 3</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> 3</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> 3</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> 3</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> 3</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> 3</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> 3</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> 3</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> 2</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> 3</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> 3</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> 3</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> 3</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> 3</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> 3</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> 3</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> 3</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> 2</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> 3</td> 
          <td style="white-space:nowrap">    medication
            <a name="research-study-classifiers-medication"> </a> 
          </td> 
          <td> Medication</td> 
          <td/>  
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    device
            <a name="research-study-classifiers-device"> </a> 
          </td> 
          <td> Device</td> 
          <td/>  
        </tr> 
        <tr> 
          <td> 3</td> 
          <td style="white-space:nowrap">    intervention
            <a name="research-study-classifiers-intervention"> </a> 
          </td> 
          <td> Intervention</td> 
          <td/>  
        </tr> 
        <tr> 
          <td> 3</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-classification-type
            <a name="research-study-classifiers-research-study-classification-type"> </a> 
          </td> 
          <td> Research Study Classification Type</td> 
          <td/>  
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  phase
            <a name="research-study-classifiers-phase"> </a> 
          </td> 
          <td> Phase</td> 
          <td/>  
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  category
            <a name="research-study-classifiers-category"> </a> 
          </td> 
          <td> Category</td> 
          <td/>  
        </tr> 
        <tr> 
          <td> 2</td> 
          <td style="white-space:nowrap">  keyword
            <a name="research-study-classifiers-keyword"> </a> 
          </td> 
          <td> Keyword</td> 
          <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> 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">  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> 
      </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:2.16.840.1.113883.4.642.1.1686"/> 
  </identifier> 
  <version value="4.6.0"/> 
  <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"/> 
  <content value="complete"/> 
  <concept> 
    <code value="research-study-label-type"/> 
    <display value="Research Study Label Type"/> 
    <concept> 
      <code value="short"/> 
      <display value="Short"/> 
      <definition value="A short form of the name - what is used in everyday conversation."/> 
    </concept> 
    <concept> 
      <code value="public"/> 
      <display value="Public"/> 
      <definition value="A name that is understandable to non-technical readers."/> 
    </concept> 
    <concept> 
      <code value="scientific"/> 
      <display value="Scientific"/> 
      <definition value="A full name that is suitable for use in an academic or technical setting."/> 
    </concept> 
  </concept> 
  <concept> 
    <code value="research-study-classifier"/> 
    <display value="Research Study Classifier"/> 
    <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> 
  <concept> 
    <code value="research-study-classification-type"/> 
    <display value="Research Study Classification Type"/> 
    <concept> 
      <code value="phase"/> 
      <display value="Phase"/> 
    </concept> 
    <concept> 
      <code value="category"/> 
      <display value="Category"/> 
    </concept> 
    <concept> 
      <code value="keyword"/> 
      <display value="Keyword"/> 
    </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> 
  <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="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> 
</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.