Sample Size Determination
https://w3id.org/m11-rdf/C217351.C115467
- Definition
- A statistical calculation to determine the number of participants required for the primary analysis, which should be large enough to provide a reliable answer to the questions addressed and should be determined by the primary objective of the trial. If the sample size is determined on some other basis, then this should be made clear and justified.
- Namespace
- ICH M11 Section 10 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.10+C115467(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C115467 (EVS identifier)
NCIT_C115467 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217351.C115467 (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 |
|---|---|---|---|---|---|---|---|
| 501 | <Sample Size Determination> | 10.11 Sample Size Determination | Required | One to one | Text (D) | No 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS |
In the ICH M11 Template
The Template heading of 10.11 Sample Size Determination is this element.
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 10.11 Sample Size Determination 10.11 | <Enter Sample Size Determination> | p. 59 | 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 283 | NarrativeContentItem-text stated: NarrativeContentItem.text (attribute name) | by-code | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text | Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section> |
| CDISC DDF-RA v4.0.0 row 283 | NarrativeContentItem-text stated: NarrativeContentItem.text (attribute name) | by-code | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text | Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section> |
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.