Nonproprietary Name(s)
https://w3id.org/m11-rdf/C217342.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 1 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.1+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#C217342.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 |
|---|---|---|---|---|---|---|---|
| 97 | [NonProprietary Name(s)] | 1.1.2 Overall Design | Required Either Sponsor Investigational Product Code or Nonproprietary Name | One to one; One to Heading; One to Protocol Identifier | Text (D) | Yes, repeatable from Title Page Nonproprietary Name(s) Yes, reuse for each Investigational Product | |
| 108 | [Nonproprietary Name] | 1.1.2 Overall Design | Conditional: if there is a Nonproprietary Name | One to many | Valid Value (V) | Yes, repeatable for each Nonproprietary Name used as control |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 1.1.2 Overall Design 1.1.2 | <Enter Nonproprietary Name(s)> | conditional | p. 22 | ts-term / verb-dropped / section |
| 1.1.2 Overall Design 1.1.2 | [Nonproprietary Name] | conditional | p. 23 | ts-term / exact / 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 77 | Substance-label stated: Substance.label (attribute name) | by-unique-name | 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="C156473" | StudyVersion/@studyDesigns/StudyDesign/@studyIntervention/StudyIntervention/@administrations/Administration/@administrableProduct/AdministrableProduct/@ingredient/Ingredient/@role/Code/@code="100000072072" |
| CDISC DDF-RA v4.0.0 row 82 | Substance-label stated: Substance.label (attribute name) | by-unique-name | 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="C156473" | 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.