Trial Stopping Rules
https://w3id.org/m11-rdf/C217345.C142698
- Definition
- A criterion that, when met by the accumulating data, indicates that the trial can or should be stopped early to avoid putting participants at risk unnecessarily or because the intervention effect is so great that further data collection is unnecessary.
- Namespace
- ICH M11 Section 4 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.4+C142698(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C142698 (EVS identifier)
NCIT_C142698 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217345.C142698 (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 |
|---|---|---|---|---|---|---|---|
| 253 | <Trial Stopping Rules> | 4.3 Trial Stopping Rules | Required | One to one | Text (D) | No |
In the ICH M11 Template
The Template heading of 4.3 Trial Stopping Rules is this element.
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 4.3 Trial Stopping Rules 4.3 | <Enter Trial Stopping Rules> | p. 32 | 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 164 | 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 168 | 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.