HL7 Terminology
1.0.0 - Publication
HL7 Terminology
1.0.0 - Publication
This page is part of the HL7 Terminology (v1.0.0: 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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<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"> <h2>ResearchStudyPhase</h2> <div> <p>Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.</p> </div> <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> </text> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"> <valueCode value="brr"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="draft"/> </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="4.2.0"/> <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>
IG © 2020+ HL7 International - Vocabulary Work Group. Package hl7.terminology#1.0.0 based on FHIR 4.0.1. Generated 2020-05-09
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