ICH M11 Section 11 Terminology

https://w3id.org/m11-rdf/C217352

Kind
Namespace (section code list)
ICH OID
2.16.840.1.113883.3.989.2.3.3.11 (OID Listing, 2025-10-16)
Definition
Terminology relevant to the data elements in section 11 of the ICH M11 protocol template.
Section
11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
NCIt concept
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C217352 (EVS identifier)
NCIT_C217352 (OBO PURL)
EVS code list
http://rdf.ich.org/ich-terminology#C217352 (EVS term IRI; does not resolve)

Elements (23)

ElementIRI
Description of Informed Consent ProcessC217352.C184390
Regulatory and Ethical ConsiderationsC217352.C218811
Trial OversightC217352.C218812
Investigator ResponsibilitiesC217352.C218813
Sponsor ResponsibilitiesC217352.C218814
Description of Assent ProcessC217352.C218815
Description of Emergency Consent ProcessC217352.C218816
Informed Consent for RescreeningC217352.C218817
Informed Consent for Use of Remaining Samples in Exploratory ResearchC217352.C218818
CommitteesC217352.C218819
Insurance and IndemnityC217352.C218820
Risk-Based Quality ManagementC217352.C218821
Data GovernanceC217352.C218822
Data ProtectionC217352.C218823
Source Records IntroductionC217352.C218824
Investigator Expectations for Source RecordsC217352.C218825
Trial Monitor Expectations for Source RecordsC217352.C218826
Protocol DeviationsC217352.C218827
Decision Rights for Site ClosureC217352.C218828
Criteria for Early ClosureC217352.C218829
Responsibilities Following Early Site ClosureC217352.C218830
Data DisseminationC217352.C218831
Identification of Source RecordsC217352.C222675

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.