{
  "resourceType" : "CodeSystem",
  "id" : "research-study-phase",
  "text" : {
    "status" : "generated",
    "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>"
  },
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
    "valueCode" : "draft"
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger" : 1
  },
  {
    "extension" : [{
      "url" : "packageId",
      "valueId" : "hl7.fhir.uv.xver-r4b.r4"
    },
    {
      "url" : "version",
      "valueString" : "0.0.1-snapshot-2"
    }],
    "url" : "http://hl7.org/fhir/StructureDefinition/package-source"
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode" : "brr"
  }],
  "url" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
  "version" : "4.3.0",
  "name" : "ResearchStudyPhase",
  "title" : "ResearchStudyPhase",
  "status" : "draft",
  "experimental" : false,
  "date" : "2021-01-17T06:06:13+10:00",
  "publisher" : "Biomedical Research and Regulation",
  "contact" : [{
    "name" : "Biomedical Research and Regulation",
    "telecom" : [{
      "system" : "url",
      "value" : "http://www.hl7.org/Special/committees/rcrim"
    }]
  }],
  "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|4.0.1",
  "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."
  }]
}