Trial Blind Schema

https://w3id.org/m11-rdf/C217342.C49658

Definition
The type of experimental design used to describe the level of awareness of the trial participants and/ or personnel as it relates to the respective intervention(s) or assessments being observed, received or administered.
Namespace
ICH M11 Section 1 Terminology
ICH pair
2.16.840.1.113883.3.989.2.3.3.1 + C49658 (stated in the Technical Specification)
NCIt concept
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C49658 (EVS identifier)
NCIT_C49658 (OBO PURL)
EVS term
http://rdf.ich.org/ich-terminology#C217342.C49658 (EVS term IRI; does not resolve)
Label from
ICH M11 Terminology, NCI EVS, release 2025-12-19

Specifications in the Technical Specification

One row per component block of Appendix 1 that names this element. Text as printed.

BlockTermSectionConformanceCardinalityData typeValue code listRepeating / reuse
136[Trial Blind Schema]1.1.2 Overall DesignRequiredOne to oneValid Value (V)Trial Blinding Schema Response Terminology 2.16.840.1.113883.3.989.2.3.1.17
OID as stated in the TS: 2.16.840.1.113883.3.989.2.3.1.17
No

In the ICH M11 Template

SectionFieldTemplatePageLinked by
1.1.2 Overall Design 1.1.2[Trial Blind Schema]p. 24ts-term / exact / section

Mapping statements to USDM v4

None: no row of the two pinned mappings is identified with this element and resolves in USDM v4.0.0.

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.