Statistical Analysis Method
https://w3id.org/m11-rdf/C217351.C218482
- Definition
- A description of the statistical model, hypothesis, and methods of analyses for each objective within the trial.
- Namespace
- ICH M11 Section 10 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.10+C218482(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218482 (EVS identifier)
NCIT_C218482 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217351.C218482 (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 |
|---|---|---|---|---|---|---|---|
| 469 | <Statistical Analysis Method > | 10.4 Analyses Associated with the Primary Objective(s) 10.4.X.1 | Required | One to one | Text (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). | |
| 481 | {<Statistical Analysis Method>} | 10.5 Analyses Associated with the Secondary Objective(s) 10.5.X.1 | Conditional: when there is Secondary Objective | One to one | Text (D) | Yes, repeatable for each objective as a series of level 4 sections (10.5.X.1, 10.5.X.2, 10.5.X.3, 10.5.X.4, 10.5.X.5). |
In the ICH M11 Template
The Template heading of 10.4.1.1 Statistical Analysis Method, 10.5.1.1 Statistical Analysis Method is this element.
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 10.4.1.1 Statistical Analysis Method 10.4.1.1 | <Enter Statistical Analysis Method> | p. 56 | ts-term / verb-dropped / section | |
| 10.5.1.1 Statistical Analysis Method 10.5.1.1 | <Enter Statistical Analysis Method> | conditional | p. 57 | ts-term / verb-dropped / section |
Mapping statements to USDM v4
None: no row of the two pinned mappings is identified with this element and resolves in USDM v4.0.0.
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.