ShortName = ICH M11 Section 5 Terminology LongName = ICH M11 Section 5 Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.3.5 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.3.5.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217346
| 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" |
|---|---|---|---|
| C218744 | Caffeine, Alcohol, Tobacco, and Other Restrictions | A description of the restrictions related to participant intake of caffeine, alcohol, tobacco, and other habit-forming substances during the trial. | y |
| C218741 | Contraception Requirements | A description of the requirements for the prevention of conception or impregnation by the use of devices or drugs or surgery within a context of a trial, or state not applicable. | y |
| C218740 | Definitions Related to Childbearing Potential | A concise explanation of the meaning of participants of childbearing potential and nonchildbearing potential within the context of a trial, or state not applicable. | y |
| C218739 | Description of Trial Population and Rationale | A description of the rationale for selection of trial population describing how the selected population can meet the trial objectives and how the enrollment criteria reflect the targeted populations. | y |
| C25370 | Exclusion Criterion | List of characteristics in a protocol, any one of which excludes a potential participant from participation in a study. (CDISC glossary) | y |
| C25532 | Inclusion Criterion | The criteria in a protocol that prospective participants must meet to be eligible for participation in a study. (CDISC glossary) | y |
| C218742 | Lifestyle Restrictions | A description of the restrictions related to trial participant lifestyle such as diet, substance intake, and physical or other daily activities. | y |
| C218743 | Meals and Dietary Restrictions | A description of the restrictions related to participant diet during the trial. | y |
| C218746 | Other Activity Restrictions | An activity restriction that is different than the one(s) previously specified or mentioned. | y |
| C218745 | Physical Activity Restrictions | A description of the restrictions related to participant physical activity during the trial. | y |
| C179373 | Rescreening | The process of active consideration of participants for enrollment in a trial, for those potential participants who have failed a prior screening attempt. | y |
| C49628 | Screen Failure | The potential participant who does not meet eligibility (inclusion/exclusion) criteria during the screening period. | 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