ShortName = ICH M11 Section 1 Terminology LongName = ICH M11 Section 1 Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.3.1 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.3.1.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217342
| 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" |
|---|---|---|---|
| C218706 | Adaptive Trial Design Indicator | An indication as to whether the clinical trial uses an adaptive trial design. | y |
| C218838 | Additional Description of Duration | A narrative providing additional details about the duration of a participant's use of a trial intervention or their planned participation time in the trial. | y |
| C218714 | Alternate Description of Planned Duration of Trial Intervention | An alternative textual narrative for the planned duration of trial intervention. | y |
| C218717 | Alternate Description of Planned Duration of Trial Participation | An alternative narrative for the planned duration of trial participation. | y |
| C218709 | Blinded Roles | An identifying designation assigned to a blinded individual within a clinical trial that corresponds with their function. | y |
| C49647 | Control Type | A characterisation or classification of the comparator against which the study intervention is evaluated. | y |
| C218708 | Drug/Device Combination Product Indicator | An indication as to whether the clinical trial is testing a drug-device combination product. | y |
| C218718 | Independent Committees | An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities. | y |
| C142585 | INN | A unique name that is globally recognised and public property, which identifies pharmaceutical substances or active pharmaceutical ingredients. | y |
| C218475 | Intervention Assignment Method | The technique used to assign trial participants to a trial intervention or trial arm. | y |
| C98746 | Intervention Model | The overall design configuration for assigning intervention to participants. | y |
| C218707 | Master Protocol Indicator | An indication as to whether the protocol is a master protocol. | y |
| C49694 | Maximum Age | The anticipated maximum age of the participants to be entered in a clinical trial. | y |
| C49693 | Minimum Age | The anticipated minimum age of the participants to be entered in a clinical trial. | y |
| C97054 | Nonproprietary Name(s) | Drug name that is not protected by a trademark, usually descriptive of its chemical structure, and sometimes a public name. | y |
| C98771 | Number of Arms | The planned number of intervention groups. | y |
| C49692 | Number of Participants | The planned number of participants to be entered in a clinical trial. | y |
| C218719 | Other Committees | A committee that is different than the one(s) previously specified or mentioned. | y |
| C223138 | Other Intervention Assignment Method | Description of any intervention assignment method that is different than the one(s) previously specified or mentioned. | y |
| C112038 | Population Diagnosis or Condition | A description of the condition, disease or disorder that the clinical trial is intended to investigate or address. | y |
| C218703 | Population Type | A characterisation or classification of the trial population. | y |
| C218839 | Primary and Secondary Objectives and Estimands | A descriptive summary of the primary and secondary objectives and their associated estimands related to the trial. | y |
| C223137 | Randomisation Type | A characterisation or classification of the randomisation used to assign trial participants to treatment or control groups. | y |
| C218711 | Randomly Assigned to Trial Intervention/Enrolled | The target or maximum number of participants who have been randomly assigned to the trial intervention or enrolled in the trial. | y |
| C132349 | Schedule of Activities | A standardised representation of planned clinical trial activities including interventions (e.g., administering drug, surgery) and study administrative activities (e.g., obtaining informed consent, distributing clinical trial material and diaries, randomisation) as well as assessments. | y |
| C218720 | Schema Notes | A brief written record describing the trial schematic. | y |
| C218704 | Site Distribution | An indication as to whether the occurrence applies to a single or multiple trial sites. | y |
| C218705 | Site Geographic Scope | An indication as to whether the trial is taking place in one or more countries. | y |
| C223137 | Stratification Indicator | A characterisation or classification of the randomisation used to assign trial participants to treatment or control groups. | y |
| C218710 | Target/Maximum | A characterisation or classification of the trial participant numbers as to whether the numbers reflect a target or maximum. | y |
| C218713 | Total Planned Duration of Trial Intervention Unit of Time | The unit of time associated with the numeric value for the planned duration of trial intervention. | y |
| C218712 | Total Planned Duration of Trial Intervention | The numeric value for the planned duration of trial intervention. | y |
| C218716 | Total Planned Duration of Trial Participation Unit of Time | The unit of time associated with the numeric value for the planned duration of trial participation. | y |
| C218715 | Total Planned Duration of Trial Participation | The numeric value for the planned duration of trial participation. | y |
| C49658 | Trial Blind Schema | The type of experimental design used to describe the level of awareness of the trial participants and/ or personnel as it relates to the respective intervention(s) or assessments being observed, received or administered. | y |
| C93682 | Trial Schema | A diagram that outlines the decision points (e.g. randomisation, response evaluation) that define the different paths a participant could take through the trial. | y |
| C50400 | Units of Age | Those units of time that are routinely used to express the age of a person. | 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