Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## ValueSet: ICH M11 Trial Phase Value Set Terminology

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-phase-vs | Version: 1.0.0-ballot2 | Highlight text changes?
Standards status: Trial-use Active as of 2026-04-09 | Maturity Level: 0 | Computable Name: M11PhaseVS
Copyright/Legal: 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

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.

References

- M11 Research Study Profile

### Logical Definition (CLD)

- 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.

### Expansion

Expansion performed internally based on codesystem Fragment of NCIT Code System v1.0.0-ballot2 (CodeSystem)

This value set contains 11 concepts

System | Code | Display (en) | Definition | JSON | XML
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | 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. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | 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. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | 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. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | 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. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | 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. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | 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. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C15694 | Phase II/III Trial | A type of clinical study that combines elements characteristic of traditional Phase II and Phase III trials. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | 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. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | 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. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C217025 | Phase III/IV Trial | A type of clinical study that combines elements characteristic of traditional Phase III and Phase IV trials. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | 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. |  |

Description of the above table(s).