FHIR Cross-Version Extensions package for FHIR R4 from FHIR R5
0.0.1-snapshot-2 - informative
FHIR Cross-Version Extensions package for FHIR R4 from FHIR R5
0.0.1-snapshot-2 - informative
FHIR Cross-Version Extensions package for FHIR R4 from FHIR R5 - Version 0.0.1-snapshot-2. See the Directory of published versions
| Page standards status: Informative | Maturity Level: 0 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="research-study-phase"/>
<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-standards-status">
<valueCode value="informative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
<valueInteger value="0"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/package-source">
<extension url="packageId">
<valueId value="hl7.fhir.uv.xver-r5.r4"/>
</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://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="2022-05-15T15:55:11.085+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|4.0.1"/>
<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>
IG © 2025+ FHIR Infrastructure. Package hl7.fhir.uv.xver-r5.r4#0.0.1-snapshot-2 based on FHIR 4.0.1. Generated 2025-09-13
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