Background Trial Intervention
https://w3id.org/m11-rdf/C217347.C222329
- Definition
- Description of medicinal products that are administered to each clinical trial participant, regardless of randomisation group, a) to treat the indication which is the object of the study, or b) required in the protocol as part of standard care for a condition that is not the indication under investigation, and is relevant for the clinical trial design. (CDISC Glossary)
- Namespace
- ICH M11 Section 6 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.6+C222329(derived from the ToC section)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C222329 (EVS identifier)
NCIT_C222329 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217347.C222329 (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 |
|---|---|---|---|---|---|---|---|
| 346 | {<Background Trial Intervention>} | 6.9.1 Background Trial Intervention | Conditional: when any background interventions are defined | One to one | Text (D) | No |
In the ICH M11 Template
The Template heading of 6.9.1 Background Trial Intervention is this element.
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 6.9.1 Background Trial Intervention 6.9.1 | <Enter Background Trial Intervention> | conditional | p. 41 | 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.