Proprietary Name(s)

https://w3id.org/m11-rdf/C217356.C71898

Definition
A commercial name granted by an authority for use in marketing/registering a product.
Namespace
ICH M11 Section Title Page Terminology
ICH pair
2.16.840.1.113883.3.989.2.3.3.16 + C71898 (stated in the Technical Specification)
NCIt concept
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C71898 (EVS identifier)
NCIT_C71898 (OBO PURL)
EVS term
http://rdf.ich.org/ich-terminology#C217356.C71898 (EVS term IRI; does not resolve)
Label from
ICH M11 Terminology, NCI EVS, release 2025-12-19

Specifications in the Technical Specification

One row per component block of Appendix 1 that names this element. Text as printed.

BlockTermSectionConformanceCardinalityData typeValue code listRepeating / reuse
24<Proprietary Name(s)>Title PageOptional; BlankOne to many; Many to Sponsor Investigational Product Code(s); Many to Sponsor Protocol IdentifierText (D)Yes, repeatable for each proprietary name

In the ICH M11 Template

SectionFieldTemplatePageLinked by
Title Page Title Page<Enter Proprietary Name(s)>optionalp. 10ts-term / verb-dropped / section

Mapping statements to USDM v4

One row per published mapping row that names this element (SSSOM record). The link to the USDM attribute is the mapping publisher's; how the row was tied to this element is in the third column. Paths as given.

SourceUSDM attribute (usdm-rdf)IdentifiedTarget pathCondition
HL7 CSP IG ballot
row 18
AdministrableProduct-label
stated: AdministrableProduct.label (attribute name)
by-codeStudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@labelStudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@productDesignation/Code/@code="C202579"
CDISC DDF-RA v4.0.0
row 18
AdministrableProduct-label
stated: AdministrableProduct.label (attribute name)
by-codeStudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@labelStudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@productDesignation/Code/@code="C202579"

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.