Extensions for Using Data Elements from FHIR R4B in FHIR STU3
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Extensions for Using Data Elements from FHIR R4B in FHIR STU3 - Downloaded Version null See the Directory of published versions

: R4BResearchStudyPhaseForR3 - JSON Representation

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{
  "resourceType" : "ValueSet",
  "id" : "R4B-research-study-phase-for-R3",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet R4B-research-study-phase-for-R3</b></p><a name=\"R4B-research-study-phase-for-R3\"> </a><a name=\"hcR4B-research-study-phase-for-R3\"> </a><p>This value set expansion contains 8 concepts.</p><table class=\"codes\"><tr><td><b>System</b></td><td><b>Version</b></td><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td><a name=\"R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-early-phase-1\"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style=\"white-space:nowrap\">\u00a0\u00a0<a href=\"CodeSystem-research-study-phase.html#research-study-phase-early-phase-1\">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><a name=\"R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-n-a\"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style=\"white-space:nowrap\">\u00a0\u00a0<a href=\"CodeSystem-research-study-phase.html#research-study-phase-n-a\">n-a</a></td><td>N/A</td><td>Trials without phases (for example, studies of devices or behavioral interventions).</td></tr><tr><td><a name=\"R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-phase-1\"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style=\"white-space:nowrap\">\u00a0\u00a0<a href=\"CodeSystem-research-study-phase.html#research-study-phase-phase-1\">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><a name=\"R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-phase-1-phase-2\"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style=\"white-space:nowrap\">\u00a0\u00a0<a href=\"CodeSystem-research-study-phase.html#research-study-phase-phase-1-phase-2\">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><a name=\"R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-phase-2\"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style=\"white-space:nowrap\">\u00a0\u00a0<a href=\"CodeSystem-research-study-phase.html#research-study-phase-phase-2\">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><a name=\"R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-phase-2-phase-3\"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style=\"white-space:nowrap\">\u00a0\u00a0<a href=\"CodeSystem-research-study-phase.html#research-study-phase-phase-2-phase-3\">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><a name=\"R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-phase-3\"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style=\"white-space:nowrap\">\u00a0\u00a0<a href=\"CodeSystem-research-study-phase.html#research-study-phase-phase-3\">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><a name=\"R4B-research-study-phase-for-R3-http://terminology.hl7.org/CodeSystem/research-study-phase-phase-4\"> </a><code>http://terminology.hl7.org/CodeSystem/research-study-phase</code></td><td>4.3.0</td><td style=\"white-space:nowrap\">\u00a0\u00a0<a href=\"CodeSystem-research-study-phase.html#research-study-phase-phase-4\">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-fmm",
      "valueInteger" : 1
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode" : "brr"
    },
    {
      "extension" : [
        {
          "url" : "packageId",
          "valueId" : "hl7.fhir.uv.xver-r4b.r3"
        },
        {
          "url" : "version",
          "valueString" : "0.1.0"
        },
        {
          "url" : "uri",
          "valueUri" : "http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r4b.r3"
        }
      ],
      "url" : "http://hl7.org/fhir/StructureDefinition/package-source"
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode" : "trial-use",
      "_valueCode" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueUri" : "http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r4b.r3"
          }
        ]
      }
    }
  ],
  "url" : "http://hl7.org/fhir/uv/xver/ValueSet/R4B-research-study-phase-for-R3",
  "version" : "0.1.0",
  "name" : "R4BResearchStudyPhaseForR3",
  "title" : "Cross-version ValueSet R4B.ResearchStudyPhase for use in FHIR STU3",
  "status" : "active",
  "experimental" : false,
  "date" : "2026-03-17T21:02:03.8104715+00:00",
  "publisher" : "Biomedical Research and Regulation",
  "contact" : [
    {
      "name" : "Biomedical Research and Regulation",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://www.hl7.org/Special/committees/rcrim"
        }
      ]
    }
  ],
  "description" : "This cross-version ValueSet represents content from `http://hl7.org/fhir/ValueSet/research-study-phase|4.3.0` for use in FHIR STU3.",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code" : "001",
          "display" : "World"
        }
      ]
    }
  ],
  "purpose" : "This value set is part of the cross-version definitions generated to enable use of the\r\nvalue set `http://hl7.org/fhir/ValueSet/research-study-phase|4.3.0` as defined in FHIR R4B\r\nin FHIR STU3.\r\n\r\nThe source value set is bound to the following FHIR R4B elements:\r\n* `ResearchStudy.phase` as Example\r\n\r\nAcross FHIR versions, the value set has been mapped as:\r\n* `http://hl7.org/fhir/ValueSet/research-study-phase|4.3.0`\n* `http://hl7.org/fhir/ValueSet/research-study-phase|4.0.1`\r\n\r\nNote that all concepts are included in this cross-version definition because no concepts have compatible representations\r\n\r\nFollowing are the generation technical comments:\r\nAll concepts in the comparison are listed as identical.\nThe source and target value sets have the same number of active concepts (8).\nFHIR ValueSet `http://hl7.org/fhir/ValueSet/research-study-phase|4.3.0`, defined in FHIR R4B does not have any mapping to FHIR STU3",
  "compose" : {
    "include" : [
      {
        "system" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
        "version" : "4.3.0",
        "concept" : [
          {
            "code" : "early-phase-1",
            "display" : "Early Phase 1"
          },
          {
            "code" : "n-a",
            "display" : "N/A"
          },
          {
            "code" : "phase-1",
            "display" : "Phase 1"
          },
          {
            "code" : "phase-1-phase-2",
            "display" : "Phase 1/Phase 2"
          },
          {
            "code" : "phase-2",
            "display" : "Phase 2"
          },
          {
            "code" : "phase-2-phase-3",
            "display" : "Phase 2/Phase 3"
          },
          {
            "code" : "phase-3",
            "display" : "Phase 3"
          },
          {
            "code" : "phase-4",
            "display" : "Phase 4"
          }
        ]
      }
    ]
  },
  "expansion" : {
    "timestamp" : "2026-03-17T21:02:03.8104715+00:00",
    "contains" : [
      {
        "system" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
        "version" : "4.3.0",
        "code" : "early-phase-1",
        "display" : "Early Phase 1"
      },
      {
        "system" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
        "version" : "4.3.0",
        "code" : "n-a",
        "display" : "N/A"
      },
      {
        "system" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
        "version" : "4.3.0",
        "code" : "phase-1",
        "display" : "Phase 1"
      },
      {
        "system" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
        "version" : "4.3.0",
        "code" : "phase-1-phase-2",
        "display" : "Phase 1/Phase 2"
      },
      {
        "system" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
        "version" : "4.3.0",
        "code" : "phase-2",
        "display" : "Phase 2"
      },
      {
        "system" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
        "version" : "4.3.0",
        "code" : "phase-2-phase-3",
        "display" : "Phase 2/Phase 3"
      },
      {
        "system" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
        "version" : "4.3.0",
        "code" : "phase-3",
        "display" : "Phase 3"
      },
      {
        "system" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
        "version" : "4.3.0",
        "code" : "phase-4",
        "display" : "Phase 4"
      }
    ]
  }
}