Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2
Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2
Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions
| Page standards status: Trial-use | Maturity Level: 0 |
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"status" : "extensions",
"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=\"CodeSystem-ncit-cs.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><span title=\"Version is not explicitly stated, which means it is fixed to the version provided in this specification\"> version 📦1.0.0-ballot2</span><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C54721\">C54721</a></td><td>Early Phase 1 Trial</td><td>Exploratory clinical trials, in a small number of participants, that are conducted early in Phase 1. The investigational trial intervention is administered at a low dose for a limited time. Early Phase 1 trials provide insights into a variety of parameters such as pharmacokinetic, pharmacodynamic, and other biomarkers. They involve limited human exposure, have no therapeutic or diagnostic intent, and are not intended to assess clinical tolerability.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C15600\">C15600</a></td><td>Phase I Trial</td><td>Exploratory clinical trials that may be first-in-human, conducted in a small number of patients or healthy volunteers to evaluate clinical safety, tolerability, or therapeutic intent (pharmacokinetics and pharmacodynamics) of an investigational trial intervention.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C15693\">C15693</a></td><td>Phase I/II Trial</td><td>A single clinical trial that combines elements of Phase 1 and Phase 2 trials, which may begin as a Phase 1 trial and transition into Phase 2 based upon predetermined criteria.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C198366\">C198366</a></td><td>Phase I/II/III Trial</td><td>A study that begins as a Phase I study and transitions into Phases II and III based upon successful completion of each previous portion.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C198367\">C198367</a></td><td>Phase I/III Trial</td><td>A study that begins as a Phase I study and transitions into a Phase III study upon successful completion of the Phase I portion.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C15601\">C15601</a></td><td>Phase II Trial</td><td>Exploratory trials conducted to evaluate the safety and efficacy of the investigational trial intervention in patients with the disease or condition. Objectives may include, but are not limited to, clinical pharmacology, dose-ranging (dose-response, frequency of dosing), type of patients, or other characteristics of safety and efficacy.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C15694\">C15694</a></td><td>Phase II/III Trial</td><td>A type of clinical study that combines elements characteristic of traditional Phase II and Phase III trials.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C217024\">C217024</a></td><td>Phase II/III/IV Trial</td><td>A study that begins as a Phase II study and transitions into Phases III and IV based upon successful completion of each previous portion.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C15602\">C15602</a></td><td>Phase III Trial</td><td>Confirmatory trials conducted to demonstrate safety, efficacy and tolerability of the investigational trial intervention in patients with the disease or condition. Their objectives are to evaluate the overall benefit-risk relationship and may provide substantial evidence for regulatory approval and product information.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C217025\">C217025</a></td><td>Phase III/IV Trial</td><td>A type of clinical study that combines elements characteristic of traditional Phase III and Phase IV trials.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C15603\">C15603</a></td><td>Phase IV Trial</td><td>Post-approval (or post-marketing) trials conducted to further evaluate the safety and efficacy of an investigational trial intervention in its approved indication and may be conducted to address a regulatory requirement. These studies may explore use of the investigational trial intervention in the real-world setting of clinical practice and may also inform health economics and health technology assessments.</td></tr></table></li></ul></div>"
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"valueCode" : "trial-use",
"_valueCode" : {
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"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical" : "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"
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],
"url" : "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-phase-vs",
"version" : "1.0.0-ballot2",
"name" : "M11PhaseVS",
"title" : "ICH M11 Trial Phase Value Set Terminology",
"status" : "active",
"experimental" : false,
"date" : "2026-04-02T08:57:07+00:00",
"publisher" : "HL7 International / Biomedical Research and Regulation",
"contact" : [
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"description" : "Terminology associated with the trial phase value set codelist of the ICH M11 protocol template.\nThis is ICH M11 Value Set C217045 drawn from the NCI Thesaurus and represented here in FHIR format.",
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"code" : "C54721",
"display" : "Early Phase 1 Trial"
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{
"code" : "C15600",
"display" : "Phase I Trial"
},
{
"code" : "C15693",
"display" : "Phase I/II Trial"
},
{
"code" : "C198366",
"display" : "Phase I/II/III Trial"
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{
"code" : "C198367",
"display" : "Phase I/III Trial"
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{
"code" : "C15601",
"display" : "Phase II Trial"
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{
"code" : "C15694",
"display" : "Phase II/III Trial"
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{
"code" : "C217024",
"display" : "Phase II/III/IV Trial"
},
{
"code" : "C15602",
"display" : "Phase III Trial"
},
{
"code" : "C217025",
"display" : "Phase III/IV Trial"
},
{
"code" : "C15603",
"display" : "Phase IV Trial"
}
]
}
]
}
}
IG © 2026+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.clinical-study-protocol#1.0.0-ballot2 based on FHIR 6.0.0-ballot3.
Generated
2026-04-02
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