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Codesystem-research-study-phase.xml

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: Informative

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Definition for Code System ResearchStudyPhase

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

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="research-study-phase"/> 
  <meta> 
    <lastUpdated value="2019-09-21T17:23:45.171+00:00"/> 
  </meta> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      <h2> ResearchStudyPhase</h2> 
      <div> 
        <p> Codes for the stage in the progression of a therapy from initial experimental use in humans
           in clinical trials to post-market evaluation.</p> 

      </div> 
      <p> This code system http://terminology.hl7.org/CodeSystem/research-study-phase defines the
         following codes:</p> 
      <table class="codes">
        <tr> 
          <td style="white-space:nowrap">
            <b> Code</b> 
          </td> 
          <td> 
            <b> Display</b> 
          </td> 
          <td> 
            <b> Definition</b> 
          </td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">n-a
            <a name="research-study-phase-n-a"> </a> 
          </td> 
          <td> N/A</td> 
          <td> Trials without phases (for example, studies of devices or behavioral interventions).</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">early-phase-1
            <a name="research-study-phase-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 style="white-space:nowrap">phase-1
            <a name="research-study-phase-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 style="white-space:nowrap">phase-1-phase-2
            <a name="research-study-phase-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 style="white-space:nowrap">phase-2
            <a name="research-study-phase-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 style="white-space:nowrap">phase-2-phase-3
            <a name="research-study-phase-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 style="white-space:nowrap">phase-3
            <a name="research-study-phase-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 style="white-space:nowrap">phase-4
            <a name="research-study-phase-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> 
      </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="draft"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/> 
  </extension> 
  <url value="http://terminology.hl7.org/CodeSystem/research-study-phase"/> 
  <identifier> 
    <system value="urn:ietf:rfc:3986"/> 
    <value value="urn:oid:2.16.840.1.113883.4.642.1.1247"/> 
  </identifier> 
  <version value="4.1.0"/> 
  <name value="ResearchStudyPhase"/> 
  <title value="ResearchStudyPhase"/> 
  <status value="draft"/> 
  <experimental value="false"/> 
  <date value="2019-09-21T17:23:45+00:00"/> 
  <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 the stage in the progression of a therapy from initial experimental use in humans
   in clinical trials to post-market evaluation."/> 
  <caseSensitive value="true"/> 
  <valueSet value="http://hl7.org/fhir/ValueSet/research-study-phase"/> 
  <content value="complete"/> 
  <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> 
</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.