Population-level Summary
https://w3id.org/m11-rdf/C217344.C188853
- Definition
- Population level summary for the clinical endpoint of interest, which provides a basis for comparison between treatment conditions.
- Namespace
- ICH M11 Section 3 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.3+C188853(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C188853 (EVS identifier)
NCIT_C188853 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217344.C188853 (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 |
|---|---|---|---|---|---|---|---|
| 186 | {<Population-level Summary>} | 3.1 Primary Objective(s) and Associated Estimand(s) 3.1.X where X is a unique number for each Primary Objective | Conditional: If there is a population-level summary as estimand | One to Row Heading; One to Primary Objective Table; Project Identifier | Text (D) | Yes, repeatable for each numbered Primary Objective | |
| 204 | {<Population-level Summary>} | 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 population for Secondary | One to Row Heading; One to Secondary Objective Table; Project Identifier | Text (D) | Yes, repeatable for each numbered Secondary Objective. | |
| 222 | {<Population-level Summary>} | 3.3 Exploratory Objective(s) 3.3.X where X is a unique number for each Exploratory Objective | Conditional: If there is a population-level summary | 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 Population-level Summary> | conditional | 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 136 | Estimand-populationSummary stated: Estimand.populationSummary (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@populationSummary | StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" |
| HL7 CSP IG ballot row 138 | Estimand-populationSummary stated: Estimand.populationSummary (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@populationSummary | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" |
| HL7 CSP IG ballot row 140 | Estimand-populationSummary stated: Estimand.populationSummary (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@populationSummary | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" |
| CDISC DDF-RA v4.0.0 row 140 | Estimand-populationSummary stated: Estimand.populationSummary (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@populationSummary | StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" |
| CDISC DDF-RA v4.0.0 row 142 | Estimand-populationSummary stated: Estimand.populationSummary (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@populationSummary | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" |
| CDISC DDF-RA v4.0.0 row 144 | Estimand-populationSummary stated: Estimand.populationSummary (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@populationSummary | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | 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.