FHIR Cross-Version Extensions package for FHIR R4B from FHIR R4
0.0.1-snapshot-2 - informative International flag

FHIR Cross-Version Extensions package for FHIR R4B from FHIR R4 - Version 0.0.1-snapshot-2. See the Directory of published versions

: ResearchStudyPhase - XML Representation

Page standards status: Draft Maturity Level: 1

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="research-study-phase"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem research-study-phase</b></p><a name="research-study-phase"> </a><a name="hcresearch-study-phase"> </a><p>This case-sensitive code system <code>http://terminology.hl7.org/CodeSystem/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-standards-status">
    <valueCode value="draft"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/package-source">
    <extension url="packageId">
      <valueId value="hl7.fhir.uv.xver-r4.r4b"/>
    </extension>
    <extension url="version">
      <valueString value="0.0.1-snapshot-2"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <url value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
  <version value="4.0.1"/>
  <name value="ResearchStudyPhase"/>
  <title value="ResearchStudyPhase"/>
  <status value="draft"/>
  <experimental value="false"/>
  <date value="2019-11-01T08:29:23+10:00"/>
  <publisher value="Biomedical Research and Regulation"/>
  <contact>
    <name value="Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </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|4.3.0"/>
  <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>