ICH M11 Section 10 Terminology

https://w3id.org/m11-rdf/C217351

Kind
Namespace (section code list)
ICH OID
2.16.840.1.113883.3.989.2.3.3.10 (OID Listing, 2025-10-16)
Definition
Terminology relevant to the data elements in section 10 of the ICH M11 protocol template.
Section
10 STATISTICAL CONSIDERATIONS
NCIt concept
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C217351 (EVS identifier)
NCIT_C217351 (OBO PURL)
EVS code list
http://rdf.ich.org/ich-terminology#C217351 (EVS term IRI; does not resolve)

Elements (16)

ElementIRI
Sample Size DeterminationC217351.C115467
Interim AnalysesC217351.C142582
General ConsiderationsC217351.C164387
Sensitivity AnalysisC217351.C218480
Supplementary AnalysisC217351.C218481
Statistical Analysis MethodC217351.C218482
Analysis SetsC217351.C218801
Analyses of Demographics and Other Baseline VariablesC217351.C218802
Handling of Data in Relation to Primary Estimand(s)C217351.C218803
Handling of Missing Data in Relation to Primary Estimand(s)C217351.C218804
Handling of Data in Relation to Secondary Estimand(s)C217351.C218805
Handling of Missing Data in Relation to Secondary Estimand(s)C217351.C218806
Analyses Associated with the Exploratory Objective(s)C217351.C218807
Safety AnalysesC217351.C218808
Other AnalysesC217351.C218809
Multiplicity AdjustmentsC217351.C218810

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.