Definition for Code SystemResearchStudyPhase

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

  
  
    
    
  
  
    
    
      This code system 
         defines the following codes:
      
      
        
          
            
          
          
            
          
          
            
          
        
        
          n-a
            
          
          
          
        
        
          early-phase-1
            
          
          

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="research-study-phase"/> 
  <meta> 
    <lastUpdated value="2023-12-18T15:12:07.602+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 case-sensitive 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.
        
        
          phase-1
            
          
          

             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.
        
        
          phase-1-phase-2
            
          
          
          
        
        
          phase-2
            
          
          

             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.
        
        
          phase-2-phase-3
            
          
          
          
        
        
          phase-3
            
          
          

             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.
        
        
          phase-4
            
          
          

             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.
        
      
    
  
  
    
  
  
    
  
  
    
  
  
  
  
  
  
  
  
  
  
    
      
      
    
    
      
      
    
  

             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="6.0.0-ballot1"/> 
  <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.
  
    
      
      
      
    
  
  
  
  
  
    
    
    
  
  
    
    

   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.
  
  
    
    

     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.
  
  
    
    
    
  
  
    
    

     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.
  
  
    
    
    
  
  
    
    

     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.
  
  
    
    

     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.
  

     drug's risks, benefits, and optimal use."/> 
  </concept> 


</

CodeSystem

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