ICH M11 Section Title Page Terminology

https://w3id.org/m11-rdf/C217356

Kind
Namespace (section code list)
ICH OID
2.16.840.1.113883.3.989.2.3.3.16 (OID Listing, 2025-10-16)
Definition
Terminology relevant to the data elements in the title page of the ICH M11 protocol template.
Section
Title Page
NCIt concept
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C217356 (EVS identifier)
NCIT_C217356 (OBO PURL)
EVS code list
http://rdf.ich.org/ich-terminology#C217356 (EVS term IRI; does not resolve)

Elements (38)

ElementIRI
Full TitleC217356.C132346
Sponsor Protocol IdentifierC217356.C132351
Approval DateC217356.C132352
NCT NumberC217356.C172240
Version NumberC217356.C181232
Sponsor Confidentiality StatementC217356.C181236
Country IdentifierC217356.C20108
Amendment IdentifierC217356.C218477
State location where sponsor approval information can be foundC217356.C218484
Original Protocol IndicatorC217356.C218672
Amendment ScopeC217356.C218673
Region IdentifierC217356.C218674
Sponsor's Investigational Product Code(s)C217356.C218675
Co-Sponsor NameC217356.C218678
Co-Sponsor Legal AddressC217356.C218679
Local Sponsor NameC217356.C218680
Local Sponsor Legal AddressC217356.C218681
Device Manufacturer NameC217356.C218682
Device Manufacturer Legal AddressC217356.C218683
EU CT NumberC217356.C218684
FDA IND NumberC217356.C218685
IDE NumberC217356.C218686
jRCT NumberC217356.C218687
NMPA IND NumberC217356.C218688
WHO/UTN NumberC217356.C218689
Other Regulatory or Clinical Trial IdentifierC217356.C218690
Medical Expert contact information (as designated by sponsor)C217356.C218693
sponsor signatory (e.g., name, title, signature and date)C217356.C222014
state location where Medical Expert contact information can be foundC217356.C222063
state location where sponsor signatory information can be found (e.g., electronic signature)C217356.C222064
Sponsor NameC217356.C222495
Trial PhaseC217356.C48281
Proprietary Name(s)C217356.C71898
Site IdentifierC217356.C83081
Version DateC217356.C93813
Trial Short TitleC217356.C94105
Trial AcronymC217356.C94108
Nonproprietary Name(s)C217356.C97054

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.