HL7 Terminology (THO)
6.1.0 - Continuous Process Integration (ci build)
HL7 Terminology (THO)
6.1.0 - Continuous Process Integration (ci build)
HL7 Terminology (THO), published by HL7 International - Vocabulary Work Group. This guide is not an authorized publication; it is the continuous build for version 6.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/UTG/ and changes regularly. See the Directory of published versions
| Draft as of 2020-04-09 | Maturity Level: 1 |
<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 class="res-header-id"><b>Generated Narrative: CodeSystem research-study-phase</b></p><a name="research-study-phase"> </a><a name="hcresearch-study-phase"> </a><a name="research-study-phase-en-US"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Last updated: 2020-04-09 21:10:28+0000</p></div><p>This case-sensitive 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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
<valueInteger value="1"/>
</extension>
<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="1.0.0"/>
<name value="ResearchStudyPhase"/>
<title value="ResearchStudyPhase"/>
<status value="draft"/>
<experimental value="false"/>
<date value="2020-04-09T21:10:28+00:00"/>
<publisher value="Health Level Seven International"/>
<contact>
<telecom>
<system value="url"/>
<value value="http://hl7.org"/>
</telecom>
<telecom>
<system value="email"/>
<value value="hq@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."/>
<copyright
value="This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html"/>
<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>
IG © 2020+ HL7 International - Vocabulary Work Group. Package hl7.terminology#6.1.0 based on FHIR 5.0.0. Generated 2024-11-19
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