Is this amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial?
https://w3id.org/m11-rdf/C217357.C218700
- Definition
- An indication as to whether the amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial.
- Namespace
- ICH M11 Section Amendment Details Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.15+C218700(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218700 (EVS identifier)
NCIT_C218700 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217357.C218700 (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 |
|---|---|---|---|---|---|---|---|
| 78 | {[Yes/No]} | Amendment Details | Conditional: if there is an amendment | One to one; One to Amendment Identifier; One to Sponsor Protocol Identifier | Valid Value (V) | No Yes Response Terminology 2.16.840.1.113883.3.989.2.3.1.11 OID as stated in the TS: 2.16.840.1.113883.3.989.2.3.1.11 | No |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| Amendment Details Amendment Details | [Yes/No] | 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.