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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
{ "resourceType" : "CodeSystem", "id" : "research-study-phase", "meta" : { "lastUpdated" : "2024-10-03T04:31:51.554+11:00", "profile" : ["http://hl7.org/fhir/StructureDefinition/shareablecodesystem"] }, "text" : { "status" : "generated", "div" : "<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>" }, "extension" : [{ "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode" : "brr" }, { "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode" : "trial-use" }, { "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger" : 0 }], "url" : "http://hl7.org/fhir/research-study-phase", "version" : "6.0.0-ballot2", "name" : "ResearchStudyPhase", "title" : "ResearchStudy Phase Code System", "status" : "active", "experimental" : false, "date" : "2022-05-15T16:55:11.085+11:00", "publisher" : "HL7 (FHIR Project)", "contact" : [{ "telecom" : [{ "system" : "url", "value" : "http://hl7.org/fhir" }, { "system" : "email", "value" : "fhir@lists.hl7.org" }] }], "description" : "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" : "http://unstats.un.org/unsd/methods/m49/m49.htm", "code" : "001", "display" : "World" }] }], "caseSensitive" : true, "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-phase", "content" : "complete", "concept" : [{ "code" : "n-a", "display" : "N/A", "definition" : "Trials without phases (for example, studies of devices or behavioral interventions)." }, { "code" : "early-phase-1", "display" : "Early Phase 1", "definition" : "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." }, { "code" : "phase-1", "display" : "Phase 1", "definition" : "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." }, { "code" : "phase-1-phase-2", "display" : "Phase 1/Phase 2", "definition" : "Trials that are a combination of phases 1 and 2." }, { "code" : "phase-2", "display" : "Phase 2", "definition" : "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." }, { "code" : "phase-2-phase-3", "display" : "Phase 2/Phase 3", "definition" : "Trials that are a combination of phases 2 and 3." }, { "code" : "phase-3", "display" : "Phase 3", "definition" : "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." }, { "code" : "phase-4", "display" : "Phase 4", "definition" : "Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use." }] }
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 Wed, Oct 2, 2024 17:55+0000.
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