References

https://w3id.org/m11-rdf/C217355.C184397

Definition
The curated list of sources that are cited within the reference section of the document.
Namespace
ICH M11 Section 14 Terminology
ICH pair
2.16.840.1.113883.3.989.2.3.3.14 + C184397 (stated in the Technical Specification)
NCIt concept
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C184397 (EVS identifier)
NCIT_C184397 (OBO PURL)
EVS term
http://rdf.ich.org/ich-terminology#C217355.C184397 (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.

BlockTermSectionConformanceCardinalityData typeValue code listRepeating / reuse
575<References>14 APPENDIX: REFERENCESRequiredOne to oneText (D)No

In the ICH M11 Template

SectionFieldTemplatePageLinked by
14 APPENDIX: REFERENCES 14<Enter References>p. 67ts-term / verb-dropped / section

Mapping statements to USDM v4

One row per published mapping row that names this element (SSSOM record). The link to the USDM attribute is the mapping publisher's; how the row was tied to this element is in the third column. Paths as given.

SourceUSDM attribute (usdm-rdf)IdentifiedTarget pathCondition
HL7 CSP IG ballot
row 327
NarrativeContentItem-text
stated: NarrativeContentItem.text (attribute name)
by-codeStudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@textStudy/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>
CDISC DDF-RA v4.0.0
row 325
NarrativeContentItem-text
stated: NarrativeContentItem.text (attribute name)
by-codeStudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@textStudy/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section>

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.