Briefly Explain Substantial Impact On Safety
https://w3id.org/m11-rdf/C217357.C218699
- Definition
- A short descriptive account of any substantial impacts on the safety or rights of the participants due to the protocol amendment.
- Namespace
- ICH M11 Section Amendment Details Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.15+C218699(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218699 (EVS identifier)
NCIT_C218699 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217357.C218699 (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 |
|---|---|---|---|---|---|---|---|
| 76 | {<If yes, briefly explain>} | Amendment Details | Conditional: if there is an amendment and if "Is this amendment likely to have a substantial impact on the safety or rights of the participants? " is Yes | One to one Amendment Identifier, Is this amendment likely to have a substantial impact on the safety or rights of the participants? Response when Yes | Text (D) | No |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| Amendment Details Amendment Details | <If yes, briefly explain> | conditional | p. 14 | ts-heading-context / exact / 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.