ShortName = ICH M11 Section 4 Terminology LongName = ICH M11 Section 4 Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.3.4 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.3.4.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217345
| 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" |
|---|---|---|---|
| C218738 | Access to Trial Intervention After End of Trial | A narrative description containing information about whether and how trial participants have access to the trial interventions after the trial ends. | y |
| C218728 | Additional Description of Trial Design | An extra or further textual description of the trial design. | y |
| C218727 | Description of Level and Method of Blinding | A description of the level of awareness of the study participants and/or personnel to the respective intervention(s) or assessments being observed, received or administered, and the methodology by which study participants or personnel are blinded. | y |
| C219658 | Description of Method of Assignment to Trial Intervention | A description of the methodology used to assign trial participants to a trial intervention or trial arm. | y |
| C218726 | Description of Trial Duration | A description of the trial duration. | y |
| C218737 | End of Trial | A description containing a concise explanation, any local regulatory requirements and considerations, extensions, follow-up, and analysis for the trial end. | y |
| C147139 | Overall Description of Trial Design and Description of Intervention Model | A description summarizing the overall trial design and intervention model. | y |
| C142705 | Overall Rationale for Trial Design | An explanation as to the scientific reasons for the choice of the trial design. | y |
| C218733 | Rationale for Adaptive or Novel Trial Design | An explanation as to the scientific reasons for why an adaptive or novel trial design was chosen for the trial. | y |
| C218731 | Rationale for Control Type | An explanation as to the scientific reasons for the choice of the control types used in the trial. | y |
| C218730 | Rationale for Estimand(s) | An explanation as to the scientific reasons for the choice of the trial estimand(s). | y |
| C218734 | Rationale for Interim Analysis | An explanation for the analysis comparing intervention groups at any time before the formal completion of the trial, usually before recruitment is complete. | y |
| C215629 | Rationale for Intervention Model | An explanation as to the scientific reasons for why the intervention model was chosen for the trial. | y |
| C218735 | Rationale for Other Trial Design Aspects | An explanation as to the scientific reasons for additional trial design considerations that are different than the one(s) previously specified or mentioned. | y |
| C218732 | Rationale for Trial Duration | An explanation as to the scientific reasons for the trial duration. | y |
| C218729 | Stakeholder Input into Design | A description of the way in which trial stakeholders were consulted when determining the trial design and how that input was applied. | y |
| C218736 | Start of Trial | A description containing a concise explanation, any local regulatory requirements and considerations, extensions, follow-up, and analysis for the trial start. | y |
| C142698 | Trial Stopping Rules | A criterion that, when met by the accumulating data, indicates that the trial can or should be stopped early to avoid putting participants at risk unnecessarily or because the intervention effect is so great that further data collection is unnecessary. | 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