Country/Region-Specific Requirements
https://w3id.org/m11-rdf/C217353.C218833
- Definition
- A description of any country or region-specific requirements related to the trial but not related to individual items in the protocol.
- Namespace
- ICH M11 Section 12 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.12+C218833(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218833 (EVS identifier)
NCIT_C218833 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217353.C218833 (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 |
|---|---|---|---|---|---|---|---|
| 548 | <Country/Region-Specific Requirements> | 12.2 Country/Region-Specific Differences | Optional if there is Country/Region-Specific Differences | One to many | Text (D) | Yes, repeatable for each Country/Region |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 12.2 Country/Region-Specific Differences 12.2 | <Enter Country/Region-Specific Requirements> | optional | p. 64 | 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 311 | NarrativeContentItem-text stated: NarrativeContentItem.text (attribute name) | by-unique-name | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text | Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section> |
| CDISC DDF-RA v4.0.0 row 309 | NarrativeContentItem-text stated: NarrativeContentItem.text (attribute name) | by-unique-name | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text | Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section> |
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.