{

"resourceType": "CodeSystem",
"id": "research-study-phase",
"meta": {
  "lastUpdated": "2019-11-01T09:29:23.356+11:00"
},
"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:2.16.840.1.113883.4.642.4.1247"
  }
],
"version": "4.0.1",
"name": "ResearchStudyPhase",
"title": "ResearchStudyPhase",
"status": "draft",
"experimental": false,
"date": "2019-11-01T09:29:23+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.",
"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."
  }
]

}