Extensions for Using Data Elements from FHIR R4B in FHIR STU3 - Downloaded Version null See the Directory of published versions
| Page standards status: Trial-use | Maturity Level: 1 |
{
"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"
}
]
}
}