Amendment Details
https://w3id.org/m11-rdf/C217357.C218694
- Definition
- A written message within the study protocol that describes the amendment details, especially as to whether the protocol has been amended previously.
- Namespace
- ICH M11 Section Amendment Details Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.15+C218694(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218694 (EVS identifier)
NCIT_C218694 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217357.C218694 (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 |
|---|---|---|---|---|---|---|---|
| 57 | Amendment Details | Amendment Details | Required | One to one | Valid Value (V) | Amendment Details Statement Response Terminology 2.16.840.1.113883.3.989.2.3.1.1 OID as stated in the TS: 2.16.840.1.113883.3.989.2.3.1.1 | No |
In the ICH M11 Template
The Template heading of Amendment Details is this element.
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 |
|---|---|---|---|---|
| CDISC DDF-RA v4.0.0 row 61 | StudyVersion-amendments stated: StudyVersion.amendments (attribute name) | by-unique-name | StudyVersion/@amendments | StudyVersion/@amendments = null |
| CDISC DDF-RA v4.0.0 row 62 | StudyAmendment-previousId stated: StudyAmendment.previous (model name) | by-unique-name | StudyVersion/@amendments/StudyAmendment/@previous | StudyVersion/@amendments/StudyAmendment/@previous = null |
| CDISC DDF-RA v4.0.0 row 63 | StudyAmendment-previousId stated: StudyAmendment.previous (model name) | by-unique-name | StudyVersion/@amendments/StudyAmendment/@previous | StudyVersion/@amendments/StudyAmendment/@previous is not null |
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.