HL7 Terminology
2.0.0 - Publication

This page is part of the HL7 Terminology (v2.0.0: Release) based on FHIR R4. The current version which supercedes this version is 5.2.0. For a full list of available versions, see the Directory of published versions

: ResearchStudyPhase - JSON Representation

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{
  "resourceType" : "CodeSystem",
  "id" : "research-study-phase",
  "meta" : {
    "lastUpdated" : "2020-04-10T07:10:28.568+10:00"
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This code system http://terminology.hl7.org/CodeSystem/research-study-phase 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" : "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" : "0.1.0",
  "name" : "ResearchStudyPhase",
  "title" : "ResearchStudyPhase",
  "status" : "draft",
  "experimental" : false,
  "date" : "2020-04-09T21:10:28+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://terminology.hl7.org/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."
    }
  ]
}