Back-up Method for Reporting
https://w3id.org/m11-rdf/C217350.C218790
- Definition
- A description of alternative techniques by which trial related events, such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events, are reported to the sponsor and/or regulatory authority.
- Namespace
- ICH M11 Section 9 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.9+C218790(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218790 (EVS identifier)
NCIT_C218790 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217350.C218790 (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 |
|---|---|---|---|---|---|---|---|
| 430 | <Back-up Method for Reporting> | 9.2 Timing and Procedures for Collection and Reporting | Optional if table is used | One to one | Text (D) | Yes, repeatable for each Event Type, Situational Scope, and Reportable Period Start. |
In the ICH M11 Template
No Template heading or field is linked to 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.