Prior Protocol Amendment(s)
https://w3id.org/m11-rdf/C217353.C218835
- Definition
- An indication as to whether the protocol has not been amended, is the first protocol amendment, or a statement that the protocol has been amended previously.
- Namespace
- ICH M11 Section 12 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.12+C218835(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218835 (EVS identifier)
NCIT_C218835 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217353.C218835 (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 |
|---|---|---|---|---|---|---|---|
| 551 | Prior Protocol Amendment(s) | 12.3 Prior Protocol Amendment(s) | 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 12.3 Prior Protocol Amendment(s) is this element.
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.