ICH M11 Section 6 Terminology

https://w3id.org/m11-rdf/C217347

Kind: Namespace (section code list)
ICH OID: 2.16.840.1.113883.3.989.2.3.3.6 (OID Listing, 2025-10-16)
Definition: Terminology relevant to the data elements in section 6 of the ICH M11 protocol template.
Section: 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY
NCIt concept: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C217347 (EVS identifier)
NCIT_C217347 (OBO PURL)
EVS code list: http://rdf.ich.org/ich-terminology#C217347 (EVS term IRI; does not resolve)

Elements (33)

Element	IRI
Storage and Handling of Investigational Trial Intervention	`C217347.C115525`
Dosage Strength(s)	`C217347.C142517`
Regimen/Treatment Period/Vaccination Regimen	`C217347.C15697`
Arm Type	`C217347.C172457`
Accountability of Investigational Trial Intervention	`C217347.C176267`
Preparation of Investigational Trial Intervention	`C217347.C176274`
Intervention Name	`C217347.C177930`
Measures to Maintain Blinding	`C217347.C189349`
description of the overview of trial interventions or a heading for the optional table	`C217347.C218747`
Use	`C217347.C218748`
IMP or NIMP	`C217347.C218749`
Sourcing	`C217347.C218750`
Description of Investigational Trial Intervention	`C217347.C218751`
Rationale for Investigational Trial Intervention Dose and Regimen	`C217347.C218752`
Investigational Trial Intervention Administration	`C217347.C218753`
Investigational Trial Intervention Dose Modification	`C217347.C218754`
Management of Investigational Trial Intervention Overdose	`C217347.C218755`
Participant Assignment to Investigational Trial Intervention	`C217347.C218756`
Emergency Unblinding at the Site	`C217347.C218757`
Investigational Trial Intervention Adherence	`C217347.C218758`
Description of Noninvestigational Trial Intervention	`C217347.C218759`
Other Noninvestigational Trial Intervention	`C217347.C218761`
Prohibited Concomitant Therapy	`C217347.C218762`
Permitted Concomitant Therapy	`C217347.C218763`
Background Trial Intervention	`C217347.C222329`
Rescue Therapy	`C217347.C222330`
Randomisation	`C217347.C25196`
Route of Administration	`C217347.C38114`
Pharmaceutical Dose Form	`C217347.C42636`
Concomitant Therapy	`C217347.C53630`
Arm Name	`C217347.C93729`
Dosage Level(s)	`C217347.C94394`
Intervention Type	`C217347.C98747`

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.