HL7 Terminology
2.1.0 - Publication
HL7 Terminology
2.1.0 - Publication
This page is part of the HL7 Terminology (v2.1.0: 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 
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<id value="research-study-phase"/>
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<lastUpdated value="2020-04-09T15:10:28.568-06:00"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>This code system http://terminology.hl7.org/CodeSystem/research-study-phase 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>
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<url value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
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<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)"/>
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<value value="fhir@lists.hl7.org"/>
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<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."/>
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<concept>
<code value="n-a"/>
<display value="N/A"/>
<definition
value="Trials without phases (for example, studies of devices or behavioral interventions)."/>
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<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."/>
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<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."/>
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<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."/>
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<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."/>
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<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."/>
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IG © 2020+ HL7 International - Vocabulary Work Group. Package hl7.terminology#2.1.0 based on FHIR 4.0.1. Generated 2021-03-06
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