{
  "resourceType": "CodeSystem",
  "id": "research-study-phase",
  "meta": {
    "lastUpdated": "2023-03-26T15:21:02.749+11:00",
    "profile": [
      "http://hl7.org/fhir/StructureDefinition/shareablecodesystem"
    ]
  },
  "text": {
    "status": "generated",
    "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This code system <code>http://hl7.org/fhir/research-study-phase</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style=\"white-space:nowrap\">n-a<a name=\"research-study-phase-n-a\"> </a></td><td>N/A</td><td>Trials without phases (for example, studies of devices or behavioral interventions).</td></tr><tr><td style=\"white-space:nowrap\">early-phase-1<a name=\"research-study-phase-early-phase-1\"> </a></td><td>Early Phase 1</td><td>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.</td></tr><tr><td style=\"white-space:nowrap\">phase-1<a name=\"research-study-phase-phase-1\"> </a></td><td>Phase 1</td><td>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.</td></tr><tr><td style=\"white-space:nowrap\">phase-1-phase-2<a name=\"research-study-phase-phase-1-phase-2\"> </a></td><td>Phase 1/Phase 2</td><td>Trials that are a combination of phases 1 and 2.</td></tr><tr><td style=\"white-space:nowrap\">phase-2<a name=\"research-study-phase-phase-2\"> </a></td><td>Phase 2</td><td>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.</td></tr><tr><td style=\"white-space:nowrap\">phase-2-phase-3<a name=\"research-study-phase-phase-2-phase-3\"> </a></td><td>Phase 2/Phase 3</td><td>Trials that are a combination of phases 2 and 3.</td></tr><tr><td style=\"white-space:nowrap\">phase-3<a name=\"research-study-phase-phase-3\"> </a></td><td>Phase 3</td><td>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.</td></tr><tr><td style=\"white-space:nowrap\">phase-4<a name=\"research-study-phase-phase-4\"> </a></td><td>Phase 4</td><td>Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.</td></tr></table></div>"
  },
  "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
    }
  ],
  "url": "http://hl7.org/fhir/research-study-phase",
  "version": "5.0.0",
  "name": "ResearchStudyPhase",
  "title": "ResearchStudy Phase Code System",
  "status": "active",
  "experimental": false,
  "date": "2022-05-15T16:55:11.085+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.",
  "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",
  "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."
    }
  ]
}