ShortName = Intervention Use Response Terminology LongName = Intervention Use Response Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.1.8 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.1.8.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217285
| 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" |
|---|---|---|---|
| C207614 | Additional Required Treatment | A medicinal product that must be administered along with the experimental treatment (e.g., drug studies wherein opioid blockers are administered to prevent overdose). | y |
| C165822 | Background Treatment | 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 |
| C158128 | Challenge Agent | A non-investigational medicinal product (NIMP) given to trial participants to produce a physiological response that is necessary before the pharmacological action of the investigational medicinal product can be assessed. (CDISC Glossary) | y |
| C18020 | Diagnostic | Any procedure or test to diagnose a disease or disorder. | y |
| C41161 | Experimental Intervention | The drug, device, therapy, procedure, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study (e.g., health-related quality of life, efficacy, safety, pharmacoeconomics). (CDISC Glossary) | y |
| C753 | Placebo | A pharmaceutical preparation that does not contain the investigational agent and is generally prepared to be physically indistinguishable from the preparation containing the investigational product. | y |
| C165835 | Rescue Medicine | Medicinal products identified in the protocol as those that may be administered to participants when the efficacy of the investigational medicinal product (IMP) is not satisfactory, the effect of the IMP is too great and is likely to cause a hazard to the patient, or to manage an emergency situation. (CDISC Glossary) | 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