Definition for Code System ResearchStudyPhase SystemResearchStudyPhase

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        Codes for the stage in the progression of a therapy from initial experimental use in humans
           in clinical trials to post-market evaluation.

      
      This code system http://terminology.hl7.org/CodeSystem/research-study-phase defines the
         following codes:
      
        
          
            
          
          
            
          
          
            
          
        
        
          n-a
            
          
          
          
        
        
          early-phase-1
            
          
          
          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
            
          
          
          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
            
          
          
          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
            
          
          
          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
            
          
          
          Studies of FDA-approved drugs to delineate additional information including the drug's
             risks, benefits, and optimal use.
        
      
    
  
  
    
  
  
    
  
  
    
  
  
  
    
    
  
  
  
  
  
  
  
  
  
    
      
      
    
    
      
      
    
  
  Codes for the stage in the progression of a therapy from initial experimental use in humans
   in clinical trials to post-market evaluation.
  
  
  
  
    
    
    
  
  
    
    
    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.
  
  
    
    
    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.
  
  
    
    
    
  
  
    
    
    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.
  
  
    
    
    
  
  
    
    
    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.
  
  
    
    
    Studies of FDA-approved drugs to delineate additional information including the drug's
     risks, benefits, and optimal use.
  

<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

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