ResearchStudyPhase

{
  "description" : "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
  "date" : "2020-04-09T21:10:28+00:00",
  "meta" : {
    "lastUpdated" : "2020-04-09T21:10:28.568+00:00"
  },
  "publisher" : "Health Level Seven International",
  "content" : "complete",
  "property" : null,
  "name" : "ResearchStudyPhase",
  "copyright" : "This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html",
  "experimental" : false,
  "resourceType" : "CodeSystem",
  "title" : "ResearchStudyPhase",
  "extension" : [ {
    "valueCode" : "brr",
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"
  }, {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger" : 1
  }, {
    "extension" : [ {
      "valueString" : "concept",
      "url" : "path"
    }, {
      "url" : "count",
      "valueInteger" : 8
    } ],
    "url" : "http://health-samurai.io/extensions/excised-data"
  }, {
    "url" : "http://health-samurai.io/extensions/source",
    "valueCode" : "db"
  } ],
  "status" : "draft",
  "id" : "760d0cd5-8b4a-406d-9404-4da6fcf0981f",
  "valueSet" : "http://terminology.hl7.org/ValueSet/research-study-phase",
  "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"
  } ],
  "caseSensitive" : true,
  "version" : "1.0.0",
  "contact" : [ {
    "telecom" : [ {
      "system" : "url",
      "value" : "http://hl7.org"
    }, {
      "system" : "email",
      "value" : "hq@HL7.org"
    } ]
  } ],
  "text" : {
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem research-study-phase</b></p><a name=\"research-study-phase\"> </a><a name=\"hcresearch-study-phase\"> </a><a name=\"research-study-phase-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Last updated: 2020-04-09 21:10:28+0000</p></div><p>This case-sensitive code system <code>http://terminology.hl7.org/CodeSystem/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>",
    "status" : "generated"
  }
}