Extensions for Using Data Elements from FHIR R4B in FHIR STU3
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Extensions for Using Data Elements from FHIR R4B in FHIR STU3 - Downloaded Version null See the Directory of published versions

: R4BResearchStudyPhaseForR3 - XML Representation

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="R4B-research-study-phase-for-R3"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet R4B-research-study-phase-for-R3</b></p><a name="R4B-research-study-phase-for-R3"> </a><a name="hcR4B-research-study-phase-for-R3"> </a><p>This value set expansion contains 8 concepts.</p><table class="codes"><tr><td><b>System</b></td><td><b>Version</b></td><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td><a name="R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-early-phase-1"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style="white-space:nowrap">  <a href="CodeSystem-research-study-phase.html#research-study-phase-early-phase-1">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><a name="R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-n-a"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style="white-space:nowrap">  <a href="CodeSystem-research-study-phase.html#research-study-phase-n-a">n-a</a></td><td>N/A</td><td>Trials without phases (for example, studies of devices or behavioral interventions).</td></tr><tr><td><a name="R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-phase-1"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style="white-space:nowrap">  <a href="CodeSystem-research-study-phase.html#research-study-phase-phase-1">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><a name="R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-phase-1-phase-2"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style="white-space:nowrap">  <a href="CodeSystem-research-study-phase.html#research-study-phase-phase-1-phase-2">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><a name="R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-phase-2"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style="white-space:nowrap">  <a href="CodeSystem-research-study-phase.html#research-study-phase-phase-2">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><a name="R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-phase-2-phase-3"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style="white-space:nowrap">  <a href="CodeSystem-research-study-phase.html#research-study-phase-phase-2-phase-3">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><a name="R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-phase-3"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style="white-space:nowrap">  <a href="CodeSystem-research-study-phase.html#research-study-phase-phase-3">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><a name="R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-phase-4"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style="white-space:nowrap">  <a href="CodeSystem-research-study-phase.html#research-study-phase-phase-4">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-fmm">
    <valueInteger value="1"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/package-source">
    <extension url="packageId">
      <valueId value="hl7.fhir.uv.xver-r4b.r3"/>
    </extension>
    <extension url="version">
      <valueString value="0.1.0"/>
    </extension>
    <extension url="uri">
      <valueUri
                value="http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r4b.r3"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueUri
                  value="http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r4b.r3"/>
      </extension>
    </valueCode>
  </extension>
  <url
       value="http://hl7.org/fhir/uv/xver/ValueSet/R4B-research-study-phase-for-R3"/>
  <version value="0.1.0"/>
  <name value="R4BResearchStudyPhaseForR3"/>
  <title
         value="Cross-version ValueSet R4B.ResearchStudyPhase for use in FHIR STU3"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2026-03-17T21:02:03.8104715+00:00"/>
  <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="This cross-version ValueSet represents content from `http://hl7.org/fhir/ValueSet/research-study-phase|4.3.0` for use in FHIR STU3."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <purpose
           value="This value set is part of the cross-version definitions generated to enable use of the
value set `http://hl7.org/fhir/ValueSet/research-study-phase|4.3.0` as defined in FHIR R4B
in FHIR STU3.

The source value set is bound to the following FHIR R4B elements:
* `ResearchStudy.phase` as Example

Across FHIR versions, the value set has been mapped as:
* `http://hl7.org/fhir/ValueSet/research-study-phase|4.3.0`
* `http://hl7.org/fhir/ValueSet/research-study-phase|4.0.1`

Note that all concepts are included in this cross-version definition because no concepts have compatible representations

Following are the generation technical comments:
All concepts in the comparison are listed as identical.
The source and target value sets have the same number of active concepts (8).
FHIR ValueSet `http://hl7.org/fhir/ValueSet/research-study-phase|4.3.0`, defined in FHIR R4B does not have any mapping to FHIR STU3"/>
  <compose>
    <include>
      <system
              value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
      <version value="4.3.0"/>
      <concept>
        <code value="early-phase-1"/>
        <display value="Early Phase 1"/>
      </concept>
      <concept>
        <code value="n-a"/>
        <display value="N/A"/>
      </concept>
      <concept>
        <code value="phase-1"/>
        <display value="Phase 1"/>
      </concept>
      <concept>
        <code value="phase-1-phase-2"/>
        <display value="Phase 1/Phase 2"/>
      </concept>
      <concept>
        <code value="phase-2"/>
        <display value="Phase 2"/>
      </concept>
      <concept>
        <code value="phase-2-phase-3"/>
        <display value="Phase 2/Phase 3"/>
      </concept>
      <concept>
        <code value="phase-3"/>
        <display value="Phase 3"/>
      </concept>
      <concept>
        <code value="phase-4"/>
        <display value="Phase 4"/>
      </concept>
    </include>
  </compose>
  <expansion>
    <timestamp value="2026-03-17T21:02:03.8104715+00:00"/>
    <contains>
      <system
              value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
      <version value="4.3.0"/>
      <code value="early-phase-1"/>
      <display value="Early Phase 1"/>
    </contains>
    <contains>
      <system
              value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
      <version value="4.3.0"/>
      <code value="n-a"/>
      <display value="N/A"/>
    </contains>
    <contains>
      <system
              value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
      <version value="4.3.0"/>
      <code value="phase-1"/>
      <display value="Phase 1"/>
    </contains>
    <contains>
      <system
              value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
      <version value="4.3.0"/>
      <code value="phase-1-phase-2"/>
      <display value="Phase 1/Phase 2"/>
    </contains>
    <contains>
      <system
              value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
      <version value="4.3.0"/>
      <code value="phase-2"/>
      <display value="Phase 2"/>
    </contains>
    <contains>
      <system
              value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
      <version value="4.3.0"/>
      <code value="phase-2-phase-3"/>
      <display value="Phase 2/Phase 3"/>
    </contains>
    <contains>
      <system
              value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
      <version value="4.3.0"/>
      <code value="phase-3"/>
      <display value="Phase 3"/>
    </contains>
    <contains>
      <system
              value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
      <version value="4.3.0"/>
      <code value="phase-4"/>
      <display value="Phase 4"/>
    </contains>
  </expansion>
</ValueSet>