ICH M11 Section 4 Terminology
https://w3id.org/m11-rdf/C217345
- Kind
- Namespace (section code list)
- ICH OID
2.16.840.1.113883.3.989.2.3.3.4(OID Listing, 2025-10-16)- Definition
- Terminology relevant to the data elements in section 4 of the ICH M11 protocol template.
- Section
- 4 TRIAL DESIGN
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C217345 (EVS identifier)
NCIT_C217345 (OBO PURL) - EVS code list
- http://rdf.ich.org/ich-terminology#C217345 (EVS term IRI; does not resolve)
Elements (18)
| Element | IRI |
|---|---|
| Trial Stopping Rules | C217345.C142698 |
| Overall Rationale for Trial Design | C217345.C142705 |
| Overall Description of Trial Design and Description of Intervention Model | C217345.C147139 |
| Rationale for Intervention Model | C217345.C215629 |
| Description of Trial Duration | C217345.C218726 |
| Description of Level and Method of Blinding | C217345.C218727 |
| Additional Description of Trial Design | C217345.C218728 |
| Stakeholder Input into Design | C217345.C218729 |
| Rationale for Estimand(s) | C217345.C218730 |
| Rationale for Control Type | C217345.C218731 |
| Rationale for Trial Duration | C217345.C218732 |
| Rationale for Adaptive or Novel Trial Design | C217345.C218733 |
| Rationale for Interim Analysis | C217345.C218734 |
| Rationale for Other Trial Design Aspects | C217345.C218735 |
| Start of Trial | C217345.C218736 |
| End of Trial | C217345.C218737 |
| Access to Trial Intervention After End of Trial | C217345.C218738 |
| Description of Method of Assignment to Trial Intervention | C217345.C219658 |
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.