ICH M11 Section 5 Terminology

https://w3id.org/m11-rdf/C217346

Kind
Namespace (section code list)
ICH OID
2.16.840.1.113883.3.989.2.3.3.5 (OID Listing, 2025-10-16)
Definition
Terminology relevant to the data elements in section 5 of the ICH M11 protocol template.
Section
5 TRIAL POPULATION
NCIt concept
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C217346 (EVS identifier)
NCIT_C217346 (OBO PURL)
EVS code list
http://rdf.ich.org/ich-terminology#C217346 (EVS term IRI; does not resolve)

Elements (12)

ElementIRI
RescreeningC217346.C179373
Description of Trial Population and RationaleC217346.C218739
Definitions Related to Childbearing PotentialC217346.C218740
Contraception RequirementsC217346.C218741
Lifestyle RestrictionsC217346.C218742
Meals and Dietary RestrictionsC217346.C218743
Caffeine, Alcohol, Tobacco, and Other RestrictionsC217346.C218744
Physical Activity RestrictionsC217346.C218745
Other Activity RestrictionsC217346.C218746
Exclusion CriterionC217346.C25370
Inclusion CriterionC217346.C25532
Screen FailureC217346.C49628

Draft, not normative. A derived rendering of the ICH M11 Technical Specification, Template, code lists and OID Listing (© ICH, used under the ICH Legal Mentions) and of the ICH M11 Terminology published by NCI EVS (CC BY 4.0). Not an ICH, CDISC or HL7 artifact, and not endorsed or sponsored by ICH.