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Narrative

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Source1

{
  "resourceType": "CodeSystem",
  "id": "research-study-phase",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "trial-use"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 0
    },
    {
      "extension": [
        {
          "url": "packageId",
          "valueId": "hl7.fhir.uv.xver-r5.r4b"
        },
        {
          "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://hl7.org/fhir/research-study-phase",
  "version": "5.0.0",
  "name": "ResearchStudyPhase",
  "title": "ResearchStudy Phase Code System",
  "status": "active",
  "experimental": false,
  "date": "2022-05-15T15:55:11.085+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|4.3.0",
  "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."
    }
  ]
}