ShortName = ICH M11 Section 6 Terminology LongName = ICH M11 Section 6 Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.3.6 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.3.6.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217347
| 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" |
|---|---|---|---|
| C176267 | Accountability of Investigational Trial Intervention | The act or process for documenting the storage, inventory tracking, and disposition of the investigational trial intervention. | y |
| C93729 | Arm Name | The literal identifier (i.e. distinctive designation) for the arm. | y |
| C172457 | Arm Type | A characterisation or classification of the study arm. | y |
| C222329 | Background Trial Intervention | Description of medicinal products that are administered to each clinical trial participant, regardless of randomisation group, a) to treat the indication which is the object of the study, or b) required in the protocol as part of standard care for a condition that is not the indication under investigation, and is relevant for the clinical trial design. (CDISC Glossary) | y |
| C53630 | Concomitant Therapy | Description of any pharmaceutical agent, other than the trial interventions, that is administered to or used by the participant prior to or during a specified time period. | y |
| C218751 | Description of Investigational Trial Intervention | A description of the investigational trial intervention. | y |
| C218759 | Description of Noninvestigational Trial Intervention | A description of the noninvestigational trial intervention. | y |
| C218747 | Description of the Overview of Trial intervention or a Heading for the Optional Table | A free text description of the trial intervention; alternatively can be used as a heading for a table containing information about the trial intervention. | y |
| C94394 | Dosage Level(s) | Specified quantity of a medicine, to be taken at one time or at stated intervals. | y |
| C142517 | Dosage Strength(s) | The strength of a drug product, which indicates the amount of each active ingredient in a given dosage form, measured in units of volume or concentration. | y |
| C218757 | Emergency Unblinding at the Site | A description of the methodology used for unblinding of the trial treatment in the case of a sudden unforeseen crisis that requires immediate medical care of the participant. | y |
| C218749 | IMP or NIMP | An indication as to whether the investigational intervention is an investigational medicinal product or an auxiliary medicinal product. | y |
| C177930 | Intervention Name | The literal identifier (i.e. distinctive designation) for the study intervention. | y |
| C98747 | Intervention Type | The kind of product or procedure studied in a trial. | y |
| C218758 | Investigational Trial Intervention Adherence | A description of the measures taken to ensure trial intervention adherence, including mandatory documentation to be filled out and the source data that will be used to document investigational trial intervention compliance. | y |
| C218753 | Investigational Trial Intervention Administration | The way in which the investigational trial intervention is dispensed, applied, or tendered to the trial participant. | y |
| C218754 | Investigational Trial Intervention Dose Modification | A change, alteration, or adjustment to the dose of an investigational trial intervention. | y |
| C218755 | Management of Investigational Trial Intervention Overdose | A description of how a potential investigational trial intervention overdose will be handled. | y |
| C189349 | Measures to Maintain Blinding | A description of the measures taken to ensure the blinding is maintained. | y |
| C218761 | Other Noninvestigational Trial Intervention | Description of any noninvestigational intervention that is different than the one(s) previously specified or mentioned. | y |
| C218756 | Participant Assignment to Investigational Trial Intervention | The technique used to assign trial participants to a trial arm. | y |
| C218763 | Permitted Concomitant Therapy | Concomitant therapy that is approved for use in the trial. | y |
| C42636 | Pharmaceutical Dose Form | Physical characteristics of a drug product, (e.g., tablet, capsule, or solution) that contains a drug substance, generally-but not necessarily-in association with one or more other ingredients. (CDISC Glossary) | y |
| C176274 | Preparation of Investigational Trial Intervention | The way in which the investigational trial intervention is prepared for use or administration to the trial participant. | y |
| C218762 | Prohibited Concomitant Therapy | Concomitant therapy that is banned from use in the trial. | y |
| C25196 | Randomisation | The process of assigning trial participants to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. (CDISC Glossary) | y |
| C218752 | Rationale for Investigational Trial Intervention Dose and Regimen | An explanation as to the scientific reasons for the choice of the trial intervention dose and dose regimen. | y |
| C15697 | Regimen/Treatment Period/Vaccination Regimen | A description of the schedule and periodicity of a treatment or vaccination regimen. | y |
| C222330 | Rescue Therapy | Description of any rescue medications, treatments, and/or procedures identified in the protocol as those that may be administered to participants when the efficacy of the investigational intervention is not satisfactory, its effect is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. | y |
| C38114 | Route of Administration | Path by which the pharmaceutical product is taken into or makes contact with the body. | y |
| C218750 | Sourcing | An indication as to whether the investigational intervention is centrally or locally sourced. | y |
| C115525 | Storage and Handling of Investigational Trial Intervention | A narrative description containing information about the handling, storage, and distribution of investigational trial intervention. | y |
| C218748 | Use | The reason or intention for the use of the trial intervention within the trial arm. | 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