Endpoint
https://w3id.org/m11-rdf/C217344.C25212
- Definition
- The variable to be obtained for each patient that is required to address the clinical question. The specification of the variable might include whether the patient experiences an intercurrent event.
- Namespace
- ICH M11 Section 3 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.3+C25212(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25212 (EVS identifier)
NCIT_C25212 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217344.C25212 (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.
| Block | Term | Section | Conformance | Cardinality | Data type | Value code list | Repeating / reuse |
|---|---|---|---|---|---|---|---|
| 184 | {< Endpoint >} | 3.1 Primary Objective(s) and Associated Estimand(s) 3.1.X where X is a unique number for each Primary Objective | Required | One to Row Heading; One to Primary Objective Table; Project Identifier | Text (D) | Yes, repeatable for each numbered Primary Objective | |
| 202 | {< Endpoint >} | 3.2 Secondary Objective(s) and Associated Estimand(s) 3.2.X where X is a unique number for each Secondary Objective | Conditional: if there is a Secondary Objective | One to Row Heading, One to Secondary Objective Table, Project Identifier | Text (D) | Yes, repeatable for each numbered Secondary Objective. | |
| 220 | {<Endpoint>} | 3.3 Exploratory Objective(s) 3.3.X where X is a unique number for each Exploratory Objective | Conditional: if there is exploratory endpoint(s). | One to Row Heading; One to Exploratory Objective Table, Project Identifier | Text (D) | Yes, repeatable for each numbered Exploratory Objective. |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 3.1.1 Primary Objective 3.1.1 | <Enter Endpoint> | p. 28 | ts-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.
| Source | USDM attribute (usdm-rdf) | Identified | Target path | Condition |
|---|---|---|---|---|
| HL7 CSP IG ballot row 135 | SyntaxTemplate-text stated: Endpoint.text (attribute name, inherited) | by-code | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@text | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" |
| HL7 CSP IG ballot row 137 | SyntaxTemplate-text stated: Endpoint.text (attribute name, inherited) | by-code | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@text | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" |
| HL7 CSP IG ballot row 139 | SyntaxTemplate-text stated: Endpoint.text (attribute name, inherited) | by-code | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@text | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" |
| CDISC DDF-RA v4.0.0 row 139 | SyntaxTemplate-text stated: Endpoint.text (attribute name, inherited) | by-code | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@text | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" |
| CDISC DDF-RA v4.0.0 row 141 | SyntaxTemplate-text stated: Endpoint.text (attribute name, inherited) | by-code | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@text | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" |
| CDISC DDF-RA v4.0.0 row 143 | SyntaxTemplate-text stated: Endpoint.text (attribute name, inherited) | by-code | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@text | StudyVersion/@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.