This page is part of the HL7 Terminology (v5.1.0: Release) based on FHIR R4. The current version which supercedes this version is 5.2.0. For a full list of available versions, see the Directory of published versions 
: ResearchStudyPhase - XML Representation
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<CodeSystem xmlns="http://hl7.org/fhir">
<id value="research-study-phase"/>
<meta>
<lastUpdated value="2020-04-09T21:10:28.568+00:00"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>This 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>
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url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
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<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
<valueInteger value="1"/>
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<url value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.1.1247"/>
</identifier>
<version value="0.1.0"/>
<name value="ResearchStudyPhase"/>
<title value="ResearchStudyPhase"/>
<status value="draft"/>
<experimental value="false"/>
<date value="2020-04-09T21:10:28+00:00"/>
<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."/>
<caseSensitive value="true"/>
<valueSet value="http://terminology.hl7.org/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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