12.2 Country/Region-Specific Differences
https://w3id.org/m11-rdf/C217272.C218668
- Definition
- Section 12.2 of the ICH M11 Protocol standard, Country/Region-Specific Differences.
- Section number
- 12.2
- Broader
- 12 APPENDIX: SUPPORTING DETAILS
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218668 (EVS identifier)
NCIT_C218668 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218668 (EVS term IRI; does not resolve)
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Country/Region Identifier | C217353.C218832 | Optional: if there is Country/Region-Specific Differences | 547 |
| Country/Region-Specific Requirements | C217353.C218833 | Optional if there is Country/Region-Specific Differences | 548 |
| Country/Region Specific Protocol Clarifications | C217353.C218834 | Optional if there is Country/Region-Specific Differences | 549 |
In the ICH M11 Template
- Heading
- Country/Region-Specific Differences
- Page
- p. 64
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Not applicable> | optional | p. 64 | none | |
[Country/Region Identifier] | optional | p. 64 | Country/Region Identifier | ts-term / exact / section |
<Enter Country/Region-Specific Requirements> | optional | p. 64 | Country/Region-Specific Requirements | ts-term / verb-dropped / section |
<Enter Country/Region-Specific Protocol Clarifications> | optional | p. 64 | Country/Region Specific Protocol Clarifications | ts-term / verb-dropped / 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.