Population
https://w3id.org/m11-rdf/C217344.C70833
- Definition
- The population of patients targeted by the clinical question. This will be represented by the entire trial population, a subgroup defined by a particular characteristic measured at baseline, or a principal stratum defined by the occurrence (or non-occurrence, depending on context) of a specific intercurrent event.
- Namespace
- ICH M11 Section 3 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.3+C70833(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C70833 (EVS identifier)
NCIT_C70833 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217344.C70833 (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 |
|---|---|---|---|---|---|---|---|
| 180 | {<Population>} | 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 as estimand characteristic | One to Row Heading; One to Primary Objective Table; Primary Objective <#>; Protocol Identifier | Text (D) | Yes, repeatable for each numbered Primary Objective | |
| 198 | {<Population>} | 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; Secondary Objective <#>; Protocol Identifier | Text (D) | Yes, repeatable for each numbered Secondary Objective. | |
| 216 | {<Population>} | 3.3 Exploratory Objective(s) 3.3.X where X is a unique number for each Exploratory Objective | Conditional: If there is a population as estimand characteristic | One to Row Heading; One to Exploratory Objective Table, Exploratory Objective <#>, Protocol 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> | 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 117 | AnalysisPopulation-text stated: AnalysisPopulation.text (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@analysisPopulation/AnalysisPopulation/@text | StudyVersion/@studyDesigns/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 118 | AnalysisPopulation-text stated: AnalysisPopulation.text (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@analysisPopulation/AnalysisPopulation/@text | 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 119 | AnalysisPopulation-text stated: AnalysisPopulation.text (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@analysisPopulation/AnalysisPopulation/@text | 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 121 | AnalysisPopulation-text stated: AnalysisPopulation.text (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@analysisPopulation/AnalysisPopulation/@text | StudyVersion/@studyDesigns/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 122 | AnalysisPopulation-text stated: AnalysisPopulation.text (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@analysisPopulation/AnalysisPopulation/@text | 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 123 | AnalysisPopulation-text stated: AnalysisPopulation.text (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@analysisPopulation/AnalysisPopulation/@text | 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.