Nonproprietary Name(s)
https://w3id.org/m11-rdf/C217356.C97054
- Definition
- Drug name that is not protected by a trademark, usually descriptive of its chemical structure, and sometimes a public name.
- Namespace
- ICH M11 Section Title Page Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.16+C97054(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C97054 (EVS identifier)
NCIT_C97054 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217356.C97054 (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.
| Block | Term | Section | Conformance | Cardinality | Data type | Value code list | Repeating / reuse |
|---|---|---|---|---|---|---|---|
| 23 | <Nonproprietary Name(s)> | Title Page | Optional | One to many; Many to Sponsor Investigational Product Code(s); Many to Sponsor Protocol Identifier | Text (D) | Yes, repeatable for each nonproprietary name Yes, repeatable in 1.1.2 under intervention |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| Title Page Title Page | <Enter Nonproprietary Name(s)> | optional | p. 10 | ts-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.
| Source | USDM attribute (usdm-rdf) | Identified | Target path | Condition |
|---|---|---|---|---|
| HL7 CSP IG ballot row 17 | Substance-label stated: Substance.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredients/Ingredient/@substance/Substance/@label | StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@productDesignation/Code/@code="C202579" | StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredient/Ingredient/@role/Code/@code="100000072072" |
| CDISC DDF-RA v4.0.0 row 17 | Substance-label stated: Substance.label (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@studyInterventions/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredients/Ingredient/@substance/Substance/@label | StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@productDesignation/Code/@code="C202579" | StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredient/Ingredient/@role/Code/@code="100000072072" |
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.