ICH M11 Section 12 Terminology

https://w3id.org/m11-rdf/C217353

Kind: Namespace (section code list)
ICH OID: 2.16.840.1.113883.3.989.2.3.3.12 (OID Listing, 2025-10-16)
Definition: Terminology relevant to the data elements in section 12 of the ICH M11 protocol template.
Section: 12 APPENDIX: SUPPORTING DETAILS
NCIt concept: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C217353 (EVS identifier)
NCIT_C217353 (OBO PURL)
EVS code list: http://rdf.ich.org/ich-terminology#C217353 (EVS term IRI; does not resolve)

Elements (14)

Element	IRI
Sponsor Approval Date	`C217353.C132352`
Brief Rationale for Change	`C217353.C181233`
Amendment Identifier	`C217353.C218477`
Approximately <#/%> enrolled	`C217353.C218478`
Section # and Name	`C217353.C218479`
Description of Change	`C217353.C218483`
Amendment Scope Enrollment Description	`C217353.C218695`
Country/Region Identifier	`C217353.C218832`
Country/Region-Specific Requirements	`C217353.C218833`
Country/Region Specific Protocol Clarifications	`C217353.C218834`
Prior Protocol Amendment(s)	`C217353.C218835`
specify alternative location	`C217353.C218836`
Additional Appendices	`C217353.C220640`
Clinical Laboratory Tests	`C217353.C25294`

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.