Amendment Scope Enrollment Definition
https://w3id.org/m11-rdf/C217357.C218695
- Definition
- The enrollment description as to whether the amendment scope applies globally, locally, or per cohort across the trial.
- Namespace
- ICH M11 Section Amendment Details Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.15+C218695(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218695 (EVS identifier)
NCIT_C218695 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217357.C218695 (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 |
|---|---|---|---|---|---|---|---|
| 62 | <Amendment Scope Enrollment Definition> | Amendment Details | Conditional if Original Protocol =No | One to Amendment Number | Valid Value (V) | Amendment Scope Enrollment Description Response Terminology 2.16.840.1.113883.3.989.2.3.1.2 OID as stated in the TS: 2.16.840.1.113883.3.989.2.3.1.2 | Yes, reuse to section 12.3 |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| Amendment Details Amendment Details | <enter Amendment Scope Enrollment Definition> | optional | p. 13 | ts-term / verb-dropped / 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.