ICH M11 Section 1 Terminology

https://w3id.org/m11-rdf/C217342

Kind: Namespace (section code list)
ICH OID: 2.16.840.1.113883.3.989.2.3.3.1 (OID Listing, 2025-10-16)
Definition: Terminology relevant to the data elements in section 1 of the ICH M11 protocol template.
Section: 1 PROTOCOL SUMMARY
NCIt concept: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C217342 (EVS identifier)
NCIT_C217342 (OBO PURL)
EVS code list: http://rdf.ich.org/ich-terminology#C217342 (EVS term IRI; does not resolve)

Elements (38)

Element	IRI
Population Diagnosis or Condition	`C217342.C112038`
Schedule of Activities	`C217342.C132349`
INN	`C217342.C142585`
Intervention Assignment Method	`C217342.C218475`
Sponsor’s Investigational Product Code(s)	`C217342.C218675`
Population Type	`C217342.C218703`
Site Distribution	`C217342.C218704`
Site Geographic Scope	`C217342.C218705`
Adaptive Trial Design Indicator	`C217342.C218706`
Master Protocol Indicator	`C217342.C218707`
Drug/Device Combination Product Indicator	`C217342.C218708`
Blinded Roles	`C217342.C218709`
Target/Maximum	`C217342.C218710`
randomly assigned to trial intervention/enrolled	`C217342.C218711`
total planned duration of trial intervention	`C217342.C218712`
total planned duration of trial intervention unit of time	`C217342.C218713`
Alternate Description of Planned Duration of Trial Intervention	`C217342.C218714`
total planned duration of trial participation	`C217342.C218715`
total planned duration of trial participation unit of time	`C217342.C218716`
Alternate Description of Planned Duration of Trial Participation	`C217342.C218717`
Independent Committees	`C217342.C218718`
Other Committees	`C217342.C218719`
Schema Notes	`C217342.C218720`
Additional Description of Duration	`C217342.C218838`
Primary and Secondary Objectives and Estimands	`C217342.C218839`
Stratification Indicator	`C217342.C223136`
Randomisation Type	`C217342.C223137`
Other Intervention Assignment Method	`C217342.C223138`
Control Type	`C217342.C49647`
Trial Blind Schema	`C217342.C49658`
Number of Participants	`C217342.C49692`
Minimum Age	`C217342.C49693`
Maximum Age	`C217342.C49694`
Units of Age	`C217342.C50400`
Trial Schema	`C217342.C93682`
Nonproprietary Name(s)	`C217342.C97054`
Intervention Model	`C217342.C98746`
Number of Arms	`C217342.C98771`

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.