ICH M11 Section 2 Terminology

https://w3id.org/m11-rdf/C217343

Kind
Namespace (section code list)
ICH OID
2.16.840.1.113883.3.989.2.3.3.2 (OID Listing, 2025-10-16)
Definition
Terminology relevant to the data elements in section 2 of the ICH M11 protocol template.
Section
2 INTRODUCTION
NCIt concept
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C217343 (EVS identifier)
NCIT_C217343 (OBO PURL)
EVS code list
http://rdf.ich.org/ich-terminology#C217343 (EVS term IRI; does not resolve)

Elements (6)

ElementIRI
Purpose of TrialC217343.C146997
Trial-specific Intervention Risks and MitigationsC217343.C218721
Trial-specific Procedure Risks and MitigationsC217343.C218722
Trial-specific Other Risks and MitigationsC217343.C218723
Benefit SummaryC217343.C218724
Overall Risk-Benefit AssessmentC217343.C218725

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.