Safety Analyses
https://w3id.org/m11-rdf/C217351.C218808
- Definition
- A description of the analyses of relevant safety variables, including adverse events of special interest.
- Namespace
- ICH M11 Section 10 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.10+C218808(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218808 (EVS identifier)
NCIT_C218808 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217351.C218808 (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 |
|---|---|---|---|---|---|---|---|
| 493 | <Safety Analyses> | 10.7 Safety Analyses | Required | One to one | Text (D) | No |
In the ICH M11 Template
The Template heading of 10.7 Safety Analyses is this element.
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 10.7 Safety Analyses 10.7 | <Enter Safety Analyses> | p. 57 | 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 279 | NarrativeContentItem-text stated: NarrativeContentItem.text (attribute name) | by-unique-name | 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 279 | NarrativeContentItem-text stated: NarrativeContentItem.text (attribute name) | by-unique-name | 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.