ICH M11 Section 9 Terminology

https://w3id.org/m11-rdf/C217350

Kind
Namespace (section code list)
ICH OID
2.16.840.1.113883.3.989.2.3.3.9 (OID Listing, 2025-10-16)
Definition
Terminology relevant to the data elements in section 9 of the ICH M11 protocol template.
Section
9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS
NCIt concept
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C217350 (EVS identifier)
NCIT_C217350 (OBO PURL)
EVS code list
http://rdf.ich.org/ich-terminology#C217350 (EVS term IRI; does not resolve)

Elements (25)

ElementIRI
Adverse Events of Special InterestC217350.C217358
Definitions of Adverse EventsC217350.C218476
Definitions of Serious Adverse EventsC217350.C218781
Definitions of Product ComplaintsC217350.C218782
Definitions of Medical Device Product ComplaintsC217350.C218783
Event TypeC217350.C218784
Situational ScopeC217350.C218785
Reportable Period StartC217350.C218786
Reportable Period EndC217350.C218787
Timing for Reporting to Sponsor or DesigneeC217350.C218788
Method for ReportingC217350.C218789
Back-up Method for ReportingC217350.C218790
Event Collection and Reporting TimingC217350.C218791
IdentificationC217350.C218792
RecordingC217350.C218793
Follow-upC217350.C218794
ReportingC217350.C218795
Regulatory Reporting RequirementsC217350.C218796
Disease-related Events or Outcomes Not Qualifying as AEs or SAEsC217350.C218797
Participants Who Become Pregnant During the TrialC217350.C218798
Participants Whose Partners Become Pregnant During the TrialC217350.C218799
Special Safety SituationsC217350.C218800
Other Event TypeC217350.C222263
SeverityC217350.C25676
CausalityC217350.C82552

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.