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 (HL7® FHIR® Standard) R4. The current version which supersedes this version is 7.0.1. For a full list of available versions, see the Directory of published versions
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{
"resourceType" : "CodeSystem",
"id" : "research-study-phase",
"meta" : {
"lastUpdated" : "2020-04-09T21:10:28.568+00:00"
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n \n <h2>ResearchStudyPhase</h2>\n \n <div>\n \n <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>\n\n \n </div>\n \n <p>This code system http://terminology.hl7.org/CodeSystem/research-study-phase defines the following codes:</p>\n \n <table class=\"codes\">\n \n <tr>\n \n <td style=\"white-space:nowrap\">\n \n <b>Code</b>\n \n </td>\n \n <td>\n \n <b>Display</b>\n \n </td>\n \n <td>\n \n <b>Definition</b>\n \n </td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">n-a\n \n <a name=\"research-study-phase-n-a\"> </a>\n \n </td>\n \n <td>N/A</td>\n \n <td>Trials without phases (for example, studies of devices or behavioral interventions).</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">early-phase-1\n \n <a name=\"research-study-phase-early-phase-1\"> </a>\n \n </td>\n \n <td>Early Phase 1</td>\n \n <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>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">phase-1\n \n <a name=\"research-study-phase-phase-1\"> </a>\n \n </td>\n \n <td>Phase 1</td>\n \n <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>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">phase-1-phase-2\n \n <a name=\"research-study-phase-phase-1-phase-2\"> </a>\n \n </td>\n \n <td>Phase 1/Phase 2</td>\n \n <td>Trials that are a combination of phases 1 and 2.</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">phase-2\n \n <a name=\"research-study-phase-phase-2\"> </a>\n \n </td>\n \n <td>Phase 2</td>\n \n <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>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">phase-2-phase-3\n \n <a name=\"research-study-phase-phase-2-phase-3\"> </a>\n \n </td>\n \n <td>Phase 2/Phase 3</td>\n \n <td>Trials that are a combination of phases 2 and 3.</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">phase-3\n \n <a name=\"research-study-phase-phase-3\"> </a>\n \n </td>\n \n <td>Phase 3</td>\n \n <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>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">phase-4\n \n <a name=\"research-study-phase-phase-4\"> </a>\n \n </td>\n \n <td>Phase 4</td>\n \n <td>Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.</td>\n \n </tr>\n \n </table>\n \n </div>"
},
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"valueCode" : "brr"
},
{
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"valueCode" : "draft"
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"valueInteger" : 1
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],
"url" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
"identifier" : [
{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.1.1247"
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],
"version" : "4.2.0",
"name" : "ResearchStudyPhase",
"title" : "ResearchStudyPhase",
"status" : "draft",
"experimental" : false,
"date" : "2020-04-09T21:10:28+00:00",
"publisher" : "HL7 (FHIR Project)",
"contact" : [
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"value" : "http://hl7.org/fhir"
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{
"system" : "email",
"value" : "fhir@lists.hl7.org"
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]
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],
"description" : "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"caseSensitive" : true,
"valueSet" : "http://terminology.hl7.org/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."
}
]
}
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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