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

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="research-study-phase"/>
  <meta>
    <lastUpdated value="2023-03-26T15:21:02.749+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-phase</code> 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="trial-use"/>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="0"/>
  </extension>
  <url value="http://hl7.org/fhir/research-study-phase"/>
  <version value="5.0.0"/>
  <name value="ResearchStudyPhase"/>
  <title value="ResearchStudy Phase Code System"/>
  <status value="active"/>
  <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 the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <caseSensitive value="true"/>
  <valueSet value="http://hl7.org/fhir/ValueSet/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>