Definition for Code SystemResearchStudyPhase

{
  "resourceType" : "CodeSystem",
  "id" : "research-study-phase",
  "meta" : {
    "lastUpdated" : "2023-12-18T15:12:07.602+11:00",
    "profile" : ["http://hl7.org/fhir/StructureDefinition/shareablecodesystem"]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><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-ballot1",
  "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."
  }]
}