ResearchStudy Phase Code System

{
  "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" : "2022-05-15T16:55:11.085+11:00",
  "meta" : {
    "lastUpdated" : "2023-03-26T15:21:02.749+11:00",
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  },
  "publisher" : "HL7 (FHIR Project)",
  "jurisdiction" : [ {
    "coding" : [ {
      "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
      "code" : "001",
      "display" : "World"
    } ]
  } ],
  "content" : "complete",
  "property" : null,
  "name" : "ResearchStudyPhase",
  "experimental" : false,
  "resourceType" : "CodeSystem",
  "title" : "ResearchStudy Phase Code System",
  "extension" : [ {
    "valueCode" : "brr",
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"
  }, {
    "valueCode" : "trial-use",
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    "valueInteger" : 0
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  "status" : "active",
  "id" : "d28547cf-d870-4fda-ac29-2ada78e4597b",
  "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-phase",
  "url" : "http://hl7.org/fhir/research-study-phase",
  "caseSensitive" : true,
  "version" : "5.0.0",
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      "value" : "http://hl7.org/fhir"
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      "value" : "fhir@lists.hl7.org"
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  } ],
  "text" : {
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n            <p>This code system \n              <code>http://hl7.org/fhir/research-study-phase</code> defines the following codes:\n            </p>\n            <table class=\"codes\">\n              <tr>\n                <td style=\"white-space:nowrap\">\n                  <b>Code</b>\n                </td>\n                <td>\n                  <b>Display</b>\n                </td>\n                <td>\n                  <b>Definition</b>\n                </td>\n              </tr>\n              <tr>\n                <td style=\"white-space:nowrap\">n-a\n                  <a name=\"research-study-phase-n-a\"> </a>\n                </td>\n                <td>N/A</td>\n                <td>Trials without phases (for example, studies of devices or behavioral interventions).</td>\n              </tr>\n              <tr>\n                <td style=\"white-space:nowrap\">early-phase-1\n                  <a name=\"research-study-phase-early-phase-1\"> </a>\n                </td>\n                <td>Early Phase 1</td>\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              </tr>\n              <tr>\n                <td style=\"white-space:nowrap\">phase-1\n                  <a name=\"research-study-phase-phase-1\"> </a>\n                </td>\n                <td>Phase 1</td>\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              </tr>\n              <tr>\n                <td style=\"white-space:nowrap\">phase-1-phase-2\n                  <a name=\"research-study-phase-phase-1-phase-2\"> </a>\n                </td>\n                <td>Phase 1/Phase 2</td>\n                <td>Trials that are a combination of phases 1 and 2.</td>\n              </tr>\n              <tr>\n                <td style=\"white-space:nowrap\">phase-2\n                  <a name=\"research-study-phase-phase-2\"> </a>\n                </td>\n                <td>Phase 2</td>\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              </tr>\n              <tr>\n                <td style=\"white-space:nowrap\">phase-2-phase-3\n                  <a name=\"research-study-phase-phase-2-phase-3\"> </a>\n                </td>\n                <td>Phase 2/Phase 3</td>\n                <td>Trials that are a combination of phases 2 and 3.</td>\n              </tr>\n              <tr>\n                <td style=\"white-space:nowrap\">phase-3\n                  <a name=\"research-study-phase-phase-3\"> </a>\n                </td>\n                <td>Phase 3</td>\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              </tr>\n              <tr>\n                <td style=\"white-space:nowrap\">phase-4\n                  <a name=\"research-study-phase-phase-4\"> </a>\n                </td>\n                <td>Phase 4</td>\n                <td>Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.</td>\n              </tr>\n            </table>\n          </div>",
    "status" : "generated"
  }
}