Codesystem-research-study-phase.json

Definition for Code System ResearchStudyPhase

{
  "resourceType": "CodeSystem",
  "id": "research-study-phase",
  "meta": {
    "lastUpdated": "2018-04-03T12:05:46.262+10:00"
  },
  "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-ballot-status",
      "valueString": "Draft"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 1
    }
  ],
  "url": "http://hl7.org/fhir/research-study-phase",
  "identifier": {
    "system": "urn:ietf:rfc:3986",
    "value": "urn:oid:2.16.840.1.113883.4.642.1.822"
  },
  "version": "3.3.0",
  "name": "ResearchStudyPhase",
  "status": "draft",
  "experimental": false,
  "date": "2018-04-03T12:05:46+10:00",
  "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."
    }
  ]
}