Generated Narrative: ValueSet m11-phase-vs Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version ?1.0.0-ballot2 Code Display Definition C54721 Early Phase 1 Trial 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. C15600 Phase I Trial 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. C15693 Phase I/II Trial 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. C198366 Phase I/II/III Trial A study that begins as a Phase I study and transitions into Phases II and III based upon successful completion of each previous portion. C198367 Phase I/III Trial A study that begins as a Phase I study and transitions into a Phase III study upon successful completion of the Phase I portion. C15601 Phase II Trial 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. C15694 Phase II/III Trial A type of clinical study that combines elements characteristic of traditional Phase II and Phase III trials. C217024 Phase II/III/IV Trial A study that begins as a Phase II study and transitions into Phases III and IV based upon successful completion of each previous portion. C15602 Phase III Trial 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. C217025 Phase III/IV Trial A type of clinical study that combines elements characteristic of traditional Phase III and Phase IV trials. C15603 Phase IV Trial 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.
ICH M11 Trial Phase Value Set Terminology
HL7 International / Biomedical Research and Regulation
Terminology associated with the trial phase value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217045 drawn from the NCI Thesaurus and represented here in FHIR format.
Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license For more licensing information and links see: [licenses.html](licenses.html)