Primary Reason for Amendment
https://w3id.org/m11-rdf/C217357.C218696
- Definition
- The rationale of greatest importance for the protocol amendment.
- Namespace
- ICH M11 Section Amendment Details Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.15+C218696(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218696 (EVS identifier)
NCIT_C218696 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217357.C218696 (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 |
|---|---|---|---|---|---|---|---|
| 65 | [Primary Reason for Amendment]} | Amendment Details | Conditional: if the protocol is = No | One to Amendment Details | 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 values can be selected except when it is Original Protocol |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| Amendment Details Amendment Details | [Primary 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 51 | StudyAmendmentReason-code stated: StudyAmendmentReason.code (attribute name) | by-code | StudyVersion/@amendments/StudyAmendment/@primaryReason/StudyAmendmentReason/@code/Code/@decode | |
| CDISC DDF-RA v4.0.0 row 53 | StudyAmendmentReason-code stated: StudyAmendmentReason.code (attribute name) | by-unique-name | StudyVersion/@amendments/StudyAmendment/@primaryReason/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.