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Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
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Definition for Code SystemResearchStudyPhase
<?xml version="1.0" encoding="UTF-8"?> <CodeSystem xmlns="http://hl7.org/fhir"> <id value="research-study-phase"/> <meta> <lastUpdated value="2024-10-15T01:31:19.573+11:00"/> <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> </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: 2022-05-15T16:55:11.085+11:00</p> <p style="margin-bottom: 0px">Profile: <a href="shareablecodesystem.html">Shareable CodeSystem</a> </p> </div> <p> This case-sensitive 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-wg"> <valueCode value="brr"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="trial-use"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"> <valueInteger value="0"/> </extension> <url value="http://hl7.org/fhir/research-study-phase"/> <version value="6.0.0-ballot2"/> <name value="ResearchStudyPhase"/> <title value="ResearchStudy Phase Code System"/> <status value="active"/> <experimental value="false"/> <date value="2022-05-15T16:55:11.085+11:00"/> <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."/> <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"/> <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>
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot2 generated on Mon, Oct 14, 2024 15:00+0000.
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