Primary Objective

https://w3id.org/m11-rdf/C217344.C85826

Definition
The principle reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study.
Namespace
ICH M11 Section 3 Terminology
ICH pair
2.16.840.1.113883.3.989.2.3.3.3 + C85826 (stated in the Technical Specification)
NCIt concept
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C85826 (EVS identifier)
NCIT_C85826 (OBO PURL)
EVS term
http://rdf.ich.org/ich-terminology#C217344.C85826 (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
176<Primary Objective>3.1 Primary Objective(s) and Associated Estimand(s)
3.1.X where X is a unique number for each Primary Objective
RequiredOne to one; One to Table of Contents Number 3.1.X; One to Estimand Characteristics Table, Primary Objective <#>, Protocol IdentifierText (D)Yes, repeatable for each numbered Primary Objective. Yes, reuse to the table in Section 1.1.1.for each Primary Objective

In the ICH M11 Template

SectionFieldTemplatePageLinked by
3.1.1 Primary Objective 3.1.1<Enter Primary Objective>p. 28ts-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 114
SyntaxTemplate-label
stated: Objective.label (attribute name, inherited)
by-codeStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@labelStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826"
HL7 CSP IG ballot
row 115
SyntaxTemplate-text
stated: Objective.text (attribute name, inherited)
by-codeStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@textStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826"
HL7 CSP IG ballot
row 147
SyntaxTemplate-label
stated: Objective.label (attribute name, inherited)
by-codeStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@labelStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827"
HL7 CSP IG ballot
row 149
SyntaxTemplate-label
stated: Objective.label (attribute name, inherited)
by-codeStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@labelStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559"
CDISC DDF-RA v4.0.0
row 118
SyntaxTemplate-label
stated: Objective.label (attribute name, inherited)
by-codeStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@labelStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826"
CDISC DDF-RA v4.0.0
row 119
SyntaxTemplate-text
stated: Objective.text (attribute name, inherited)
by-codeStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@textStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826"
CDISC DDF-RA v4.0.0
row 151
SyntaxTemplate-label
stated: Objective.label (attribute name, inherited)
by-codeStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@labelStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827"
CDISC DDF-RA v4.0.0
row 153
SyntaxTemplate-label
stated: Objective.label (attribute name, inherited)
by-codeStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@labelStudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559"

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.