This page is part of the Pharmaceutical Clinical Trial Protocols (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions
Page standards status: Trial-use | Maturity Level: 2 |
{
"resourceType" : "ValueSet",
"id" : "m11-phase-vs",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet m11-phase-vs</b></p><a name=\"m11-phase-vs\"> </a><a name=\"hcm11-phase-vs\"> </a><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/6.5.0/CodeSystem-v3-nciThesaurus.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C54721</td><td>Early Phase 1</td></tr><tr><td>C15600</td><td>Phase 1</td></tr><tr><td>C15693</td><td>Phase 1/Phase 2</td></tr><tr><td>C198366</td><td>Phase 1/Phase 2/Phase 3</td></tr><tr><td>C198367</td><td>Phase 1/Phase 3</td></tr><tr><td>C217024</td><td>Phase 2/Phase 3/Phase 4</td></tr><tr><td>C15601</td><td>Phase 2</td></tr><tr><td>C15694</td><td>Phase 2/Phase 3</td></tr><tr><td>C217025</td><td>Phase 3/Phase 4</td></tr><tr><td>C15602</td><td>Phase 3</td></tr><tr><td>C15603</td><td>Phase 4</td></tr></table></li></ul></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 2
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "trial-use",
"_valueCode" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical" : "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol"
}
]
}
}
],
"url" : "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-phase-vs",
"version" : "1.0.0-ballot",
"name" : "M11PhaseVS",
"title" : "M11 Phase Value Set",
"status" : "draft",
"experimental" : false,
"date" : "2025-08-01T12:18:30+00:00",
"publisher" : "HL7 International / Biomedical Research and Regulation",
"contact" : [
{
"name" : "HL7 International / Biomedical Research and Regulation",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim"
},
{
"system" : "email",
"value" : "UDP@HL7Vulcan.org"
}
]
}
],
"description" : "Codes drawn from NCI Thesaurus value set $NCIT#C217045 ICH M11 Trial Phase Value Set Terminology\nThese codes represent phases of a study as defined by ICH.",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
]
}
],
"compose" : {
"include" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"concept" : [
{
"code" : "C54721",
"display" : "Early Phase 1"
},
{
"code" : "C15600",
"display" : "Phase 1"
},
{
"code" : "C15693",
"display" : "Phase 1/Phase 2"
},
{
"code" : "C198366",
"display" : "Phase 1/Phase 2/Phase 3"
},
{
"code" : "C198367",
"display" : "Phase 1/Phase 3"
},
{
"code" : "C217024",
"display" : "Phase 2/Phase 3/Phase 4"
},
{
"code" : "C15601",
"display" : "Phase 2"
},
{
"code" : "C15694",
"display" : "Phase 2/Phase 3"
},
{
"code" : "C217025",
"display" : "Phase 3/Phase 4"
},
{
"code" : "C15602",
"display" : "Phase 3"
},
{
"code" : "C15603",
"display" : "Phase 4"
}
]
}
]
}
}