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Codesystem-research-study-phase.json

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: Informative

Raw JSON (canonical form + also see JSON Format Specification)

Definition for Code System ResearchStudyPhase

{
  "resourceType" : "CodeSystem",
  "id" : "research-study-phase",
  "meta" : {
    "lastUpdated" : "2019-09-18T23:14:37.696+00:00"
  },
  "text" : {
    "status" : "generated",
    "div" : "<div>!-- Snipped for Brevity --></div>"
  },
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode" : "brr"
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
    "valueCode" : "draft"
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger" : 1
  }],
  "url" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
  "identifier" : [{
    "system" : "urn:ietf:rfc:3986",
    "value" : "urn:oid:2.16.840.1.113883.4.642.1.1247"
  }],
  "version" : "4.1.0",
  "name" : "ResearchStudyPhase",
  "title" : "ResearchStudyPhase",
  "status" : "draft",
  "experimental" : false,
  "date" : "2019-09-18T23:14:37+00:00",
  "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.",
  "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."
  }]
}

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.