Handling of Missing Data in Relation to Primary Estimand(s)

https://w3id.org/m11-rdf/C217351.C218804

Definition
A description of how missing data associated with the primary estimand will be handled, including the rationale for the approach.
Namespace
ICH M11 Section 10 Terminology
ICH pair
2.16.840.1.113883.3.989.2.3.3.10 + C218804 (stated in the Technical Specification)
NCIt concept
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218804 (EVS identifier)
NCIT_C218804 (OBO PURL)
EVS term
http://rdf.ich.org/ich-terminology#C217351.C218804 (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
473<Handling of Missing Data in Relation to Primary Estimand(s)>10.4 Analyses Associated with the Primary Objective(s)
10.4.X.3
RequiredOne to oneText (D)Yes, repeatable for each objective as a series of level 4 sections (10.4.X.1, 10.4.X.2, 10.4.X.3, 10.4.X.4, 10.4.X.5).

In the ICH M11 Template

The Template heading of 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s) is this element.

SectionFieldTemplatePageLinked by
10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s) 10.4.1.3<Enter Handling of Missing Data in Relation to Primary Estimand(s)>p. 56ts-term / verb-dropped / section

Mapping statements to USDM v4

One row per published mapping row that names this element (SSSOM record). The link to the USDM attribute is the mapping publisher's; how the row was tied to this element is in the third column. Paths as given.

SourceUSDM attribute (usdm-rdf)IdentifiedTarget pathCondition
HL7 CSP IG ballot
row 270
NarrativeContentItem-text
stated: NarrativeContentItem.text (attribute name)
by-unique-nameStudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@textStudy/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>
CDISC DDF-RA v4.0.0
row 270
NarrativeContentItem-text
stated: NarrativeContentItem.text (attribute name)
by-unique-nameStudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@textStudy/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>

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.