ResearchStudyPhase
draftContentcompleteURL
http://terminology.hl7.org/CodeSystem/research-study-phaseCopied!
Version4.3.0Copied!
Date2021-01-17T07:06:13+11:00PublisherHL7 (FHIR Project)DescriptionCodes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
Concepts
Select a concept to view details
ResearchStudyPhase
Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
This code system http://terminology.hl7.org/CodeSystem/research-study-phase defines the following codes:
{
"description" : "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"date" : "2021-01-17T07:06:13+11:00",
"meta" : {
"lastUpdated" : "2022-05-28T13:47:40.239+11:00",
"profile" : [ "http://hl7.org/fhir/StructureDefinition/shareablecodesystem" ]
},
"publisher" : "HL7 (FHIR Project)",
"content" : "complete",
"property" : null,
"name" : "ResearchStudyPhase",
"experimental" : false,
"resourceType" : "CodeSystem",
"title" : "ResearchStudyPhase",
"extension" : [ {
"valueCode" : "brr",
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"
}, {
"valueCode" : "draft",
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"
}, {
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 1
}, {
"extension" : [ {
"valueString" : "concept",
"url" : "path"
}, {
"url" : "count",
"valueInteger" : 8
} ],
"url" : "http://health-samurai.io/extensions/excised-data"
}, {
"url" : "http://health-samurai.io/extensions/source",
"valueCode" : "db"
} ],
"status" : "draft",
"id" : "bd0c443d-7e28-491c-a46a-1c49f6bcc1f6",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-phase",
"url" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
"identifier" : [ {
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.4.1247"
} ],
"caseSensitive" : true,
"version" : "4.3.0",
"contact" : [ {
"telecom" : [ {
"system" : "url",
"value" : "http://hl7.org/fhir"
}, {
"system" : "email",
"value" : "fhir@lists.hl7.org"
} ]
} ],
"text" : {
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n \n \n <h2>ResearchStudyPhase</h2>\n \n \n <div>\n \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 \n </div>\n \n \n <p>This code system http://terminology.hl7.org/CodeSystem/research-study-phase defines the following codes:</p>\n \n \n <table class=\"codes\">\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">\n \n \n <b>Code</b>\n \n \n </td>\n \n \n <td>\n \n \n <b>Display</b>\n \n \n </td>\n \n \n <td>\n \n \n <b>Definition</b>\n \n \n </td>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">n-a\n \n \n <a name=\"research-study-phase-n-a\"> </a>\n \n \n </td>\n \n \n <td>N/A</td>\n \n \n <td>Trials without phases (for example, studies of devices or behavioral interventions).</td>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">early-phase-1\n \n \n <a name=\"research-study-phase-early-phase-1\"> </a>\n \n \n </td>\n \n \n <td>Early Phase 1</td>\n \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 \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">phase-1\n \n \n <a name=\"research-study-phase-phase-1\"> </a>\n \n \n </td>\n \n \n <td>Phase 1</td>\n \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 \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">phase-1-phase-2\n \n \n <a name=\"research-study-phase-phase-1-phase-2\"> </a>\n \n \n </td>\n \n \n <td>Phase 1/Phase 2</td>\n \n \n <td>Trials that are a combination of phases 1 and 2.</td>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">phase-2\n \n \n <a name=\"research-study-phase-phase-2\"> </a>\n \n \n </td>\n \n \n <td>Phase 2</td>\n \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 \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">phase-2-phase-3\n \n \n <a name=\"research-study-phase-phase-2-phase-3\"> </a>\n \n \n </td>\n \n \n <td>Phase 2/Phase 3</td>\n \n \n <td>Trials that are a combination of phases 2 and 3.</td>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">phase-3\n \n \n <a name=\"research-study-phase-phase-3\"> </a>\n \n \n </td>\n \n \n <td>Phase 3</td>\n \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 \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">phase-4\n \n \n <a name=\"research-study-phase-phase-4\"> </a>\n \n \n </td>\n \n \n <td>Phase 4</td>\n \n \n <td>Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.</td>\n \n \n </tr>\n \n \n </table>\n \n \n </div>",
"status" : "generated"
}
}