ShortName = Trial Phase Response Terminology LongName = Trial Phase Response Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.1.19 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.1.19.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217045
| code Id="code" (required) Type="string" |
english-label Id="en" (optional) Type="string" Lang="en" |
M11 Definition Id="en_def" (optional) Type="string" Lang="en" |
current flag Id="cf" (optional) Type="string" Lang="en" |
|---|---|---|---|
| C54721 | Early Phase 1 | 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. | y |
| C15600 | Phase 1 | 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. | y |
| C15693 | Phase 1/Phase 2 | 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. | y |
| C198366 | Phase 1/Phase 2/Phase 3 | A single clinical trial that combines elements of Phase 1, Phase 2, and Phase 3 trials, which may begin as a Phase 1 trial and transitions through Phase 2 and Phase 3 based upon predetermined criteria. | y |
| C198367 | Phase 1/Phase 3 | A single clinical trial that combines elements of Phase 1 and Phase 3 trials, which may begin as a Phase 1 trial and transition into Phase 3 based upon predetermined criteria. | y |
| C15601 | Phase 2 | 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. | y |
| C15694 | Phase 2/Phase 3 | A single clinical trial that combines elements of Phase 2 and Phase 3 trials, which may begin as a Phase 2 trial and transition into Phase 3 based upon predetermined criteria. | y |
| C217024 | Phase 2/Phase 3/Phase 4 | A single clinical trial that combines elements of Phase 2, Phase 3, and Phase 4 trials, which may begin as a Phase 2 trial and transitions through Phase 3 and Phase 4 based upon predetermined criteria. | y |
| C15602 | Phase 3 | 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. | y |
| C217025 | Phase 3/Phase 4 | A single clinical trial that combines elements of Phase 3 and Phase 4 trials, which may begin as a Phase 3 trial and transition into Phase 4 based upon predetermined criteria. | y |
| C15603 | Phase 4 | 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. | y |
This file contains a code list co-maintained by ICH M2 ESTRI and CDISC in collaboration with the NCI Enterprise Vocabulary Services (EVS). It is encoded using OASIS genericode. More information on ICH technical standards is available via the M2 ESTRI webpages at www.ich.org.
Change History: v1.0 (November 11 2025)
Report created by ICH_M2_CDISC_Codelist.xsl : [Revision: 1.1 ] : ICH : Harmonisation for Better Health