ICH M11 Section 8 Terminology

https://w3id.org/m11-rdf/C217349

Kind
Namespace (section code list)
ICH OID
2.16.840.1.113883.3.989.2.3.3.8 (OID Listing, 2025-10-16)
Definition
Terminology relevant to the data elements in section 8 of the ICH M11 protocol template.
Section
8 TRIAL ASSESSMENTS AND PROCEDURES
NCIt concept
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C217349 (EVS identifier)
NCIT_C217349 (OBO PURL)
EVS code list
http://rdf.ich.org/ich-terminology#C217349 (EVS term IRI; does not resolve)

Elements (17)

ElementIRI
Vital SignsC217349.C154628
ElectrocardiogramsC217349.C168186
Medical Resource Utilisation and Health EconomicsC217349.C176849
Physical ExaminationC217349.C20989
Trial Assessments and Procedures ConsiderationsC217349.C218769
Screening Assessments and ProceduresC217349.C218770
Baseline Assessments and ProceduresC217349.C218771
Efficacy Assessments and ProceduresC217349.C218772
Safety Assessments and ProceduresC217349.C218773
Clinical Laboratory AssessmentsC217349.C218774
Suicidal Ideation and Behaviour Risk MonitoringC217349.C218775
PharmacokineticsC217349.C218776
Genetics, Genomics, Pharmacogenetics and PharmacogenomicsC217349.C218777
Pharmacodynamic BiomarkersC217349.C218778
Other BiomarkersC217349.C218779
Immunogenicity AssessmentsC217349.C218780
Pregnancy TestingC217349.C92949

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.