Source Records Introduction
https://w3id.org/m11-rdf/C217352.C218824
- Definition
- A description of trial-related source records including the importance of source record maintenance and expectations for data traceability.
- Namespace
- ICH M11 Section 11 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.11+C218824(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218824 (EVS identifier)
NCIT_C218824 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217352.C218824 (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 |
|---|---|---|---|---|---|---|---|
| 530 | <Source Records Introduction> | 11.9 Source Records | Required | One to one | Text (D) | No |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 11.9 Source Records 11.9 | <Enter Source Records Introduction> | p. 62 | 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.