Definitions of Medical Device Product Complaints
https://w3id.org/m11-rdf/C217350.C218783
- Definition
- A concise explanation of the meaning of medical device product complaints within the context of the trial.
- Namespace
- ICH M11 Section 9 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.9+C218783(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218783 (EVS identifier)
NCIT_C218783 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217350.C218783 (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 |
|---|---|---|---|---|---|---|---|
| 413 | {<Definitions of Medical Device Product Complaints>} | 9.1.3.1 Definitions of Medical Device Product Complaints | Conditional: when there is Medical Device Product Complaints | One to one | Text (D) | No |
In the ICH M11 Template
The Template heading of 9.1.3.1 Definitions of Medical Device Product Complaints is this element.
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 9.1.3.1 Definitions of Medical Device Product Complaints 9.1.3.1 | <Enter Definitions of Medical Device Product Complaints> | conditional | p. 50 | 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.