http://hl7.org/fhir/research-study-phase|5.0.0

{
  "description" : "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
  "compose" : null,
  "package" : "hl7.fhir.r5.core@5.0.0",
  "date" : "2022-05-15T05:55:11Z",
  "meta" : {
    "profile" : [ "http://hl7.org/fhir/StructureDefinition/shareablecodesystem" ],
    "lastUpdated" : "2023-03-26T15:21:02.749+11:00"
  },
  "publisher" : "HL7 (FHIR Project)",
  "jurisdiction" : [ {
    "coding" : [ {
      "code" : "001",
      "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
      "display" : "World"
    } ]
  } ],
  "content" : "complete",
  "name" : "ResearchStudyPhase",
  "experimental" : false,
  "resourceType" : "CodeSystem",
  "title" : "ResearchStudy Phase Code System",
  "supliment" : null,
  "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
  } ],
  "status" : "active",
  "id" : "d6704375-60aa-5ffa-9f76-e9f32ed02ba5",
  "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-phase",
  "url" : "http://hl7.org/fhir/research-study-phase",
  "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."
  } ],
  "caseSensitive" : true,
  "version" : "5.0.0",
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      "value" : "fhir@lists.hl7.org",
      "system" : "email"
    } ]
  } ]
}