Secondary Reason for Amendment
https://w3id.org/m11-rdf/C217357.C218697
- Definition
- Additional rationale for the protocol amendment that is not considered the primary rationale.
- Namespace
- ICH M11 Section Amendment Details Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.15+C218697(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218697 (EVS identifier)
NCIT_C218697 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217357.C218697 (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 |
|---|---|---|---|---|---|---|---|
| 69 | {[Secondary Reason for Amendment]} | Amendment Details | Conditional If Protocol Original = No | One to one; One to Protocol Identifier; One to Amendment Identifier | Valid Value (V) | Reason for Amendment Response Terminology 2.16.840.1.113883.3.989.2.3.1.14 OID as stated in the TS: 2.16.840.1.113883.3.989.2.3.1.14 | Yes, Multiple accepted except for the Original |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| Amendment Details Amendment Details | [Secondary Reason for Amendment] | conditional | p. 13 | ts-term / exact / 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 53 | StudyAmendmentReason-code stated: StudyAmendmentReason.code (attribute name) | by-code | StudyVersion/@amendments/StudyAmendment/@secondaryReasons/StudyAmendmentReason/@code/Code/@decode | |
| CDISC DDF-RA v4.0.0 row 54 | StudyAmendmentReason-code stated: StudyAmendmentReason.code (attribute name) | by-unique-name | StudyVersion/@amendments/StudyAmendment/@secondaryReasons/StudyAmendmentReason/@code/Code/@decode |
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.