Other Regulatory or Clinical Trial Identifier
https://w3id.org/m11-rdf/C217356.C218690
- Definition
- A sequence of characters assigned by a regulatory agency or other health authority that is used to identify a clinical trial, and that is different than the one(s) previously specified or mentioned.
- Namespace
- ICH M11 Section Title Page Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.16+C218690(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218690 (EVS identifier)
NCIT_C218690 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217356.C218690 (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 |
|---|---|---|---|---|---|---|---|
| 49 | <Other Regulatory or Clinical Trial Identifier> | Title Page | Optional | One to one; One to Sponsor Protocol Identifier | Text (D) | Yes, repeatable for each regulatory agency identifier |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| Title Page Title Page | <Other Regulatory or Clinical Trial Identifier> | optional | p. 12 | 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 42 | Identifier-text stated: StudyIdentifier.text (attribute name, inherited) | by-code | StudyVersion/@studyIdentifiers/StudyIdentifier/@text | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code IN ("C93453","C188863") |
| CDISC DDF-RA v4.0.0 row 42 | Identifier-text stated: StudyIdentifier.text (attribute name, inherited) | by-unique-name | StudyVersion/@studyIdentifiers/StudyIdentifier/@text | StudyVersion/@studyIdentifiers/StudyIdentifier/@scope/Organization/@type/Code/@code IN ("C93453","C188863") |
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.