Vocabulary
| Term | Name | Type |
|---|---|---|
| Basis | m11:Basis | Class |
| Code list | m11:CodeList | Class |
| Conditional | m11:Conditional | ConformanceCategory |
| Conformance category | m11:ConformanceCategory | Class |
| controlled terminology | m11:ControlledTerminology | TemplateFieldKind |
| derived from the ToC section | m11:DerivedFromSection | Basis |
| ICH M11 Terminology, NCI EVS, release 2025-12-19 | m11:EVSTerminology | Basis |
| Element | m11:Element | Class |
| Namespace | m11:Namespace | Class |
| Optional | m11:Optional | ConformanceCategory |
| Required | m11:Required | ConformanceCategory |
| Section | m11:Section | Class |
| Specification | m11:Specification | Class |
| stated in the Technical Specification | m11:StatedInTS | Basis |
| ICH M11 Technical Specification, Step 4, 2025-11-19 | m11:TechnicalSpecification | Basis |
| Template field | m11:TemplateField | Class |
| Template field kind | m11:TemplateFieldKind | Class |
| text insertion point | m11:TextInsertion | TemplateFieldKind |
| Value code list | m11:ValueCodeList | Class |
| cardinality | m11:cardinality | DatatypeProperty |
| concept | m11:concept | ObjectProperty |
| condition path | m11:conditionPath | AnnotationProperty |
| conformance | m11:conformance | DatatypeProperty |
| data type | m11:dataType | DatatypeProperty |
| data, value or heading | m11:dvh | DatatypeProperty |
| field kind | m11:fieldKind | ObjectProperty |
| field label | m11:fieldLabel | DatatypeProperty |
| for section | m11:forSection | ObjectProperty |
| has conformance category | m11:hasConformanceCategory | ObjectProperty |
| has specification | m11:hasSpecification | ObjectProperty |
| has Template field | m11:hasTemplateField | ObjectProperty |
| has value code list | m11:hasValueCodeList | ObjectProperty |
| heading element | m11:headingElement | ObjectProperty |
| ICH concept code | m11:ichConceptCode | DatatypeProperty |
| ICH namespace OID | m11:ichNamespaceOid | DatatypeProperty |
| ICH OID | m11:ichOid | Datatype |
| in section | m11:inSection | ObjectProperty |
| label source | m11:labelSource | ObjectProperty |
| mapped to | m11:mappedTo | AnnotationProperty |
| name match | m11:nameMatch | DatatypeProperty |
| name source | m11:nameSource | DatatypeProperty |
| object resolution | m11:objectResolution | AnnotationProperty |
| pair basis | m11:pairBasis | ObjectProperty |
| place scope | m11:placeScope | DatatypeProperty |
| realises | m11:realises | ObjectProperty |
| repeat pattern | m11:repeatPattern | DatatypeProperty |
| repeating and reuse rules | m11:repeatReuse | DatatypeProperty |
| section number | m11:sectionNumber | DatatypeProperty |
| source row | m11:sourceRow | AnnotationProperty |
| source section | m11:sourceSection | AnnotationProperty |
| stated attribute | m11:statedAttribute | AnnotationProperty |
| stated class | m11:statedClass | AnnotationProperty |
| code list OID as stated | m11:statedCodeListOid | DatatypeProperty |
| subject identification | m11:subjectIdentification | AnnotationProperty |
| target path | m11:targetPath | AnnotationProperty |
| Template conditional | m11:templateConditional | DatatypeProperty |
| Template heading | m11:templateHeading | DatatypeProperty |
| Template optional | m11:templateOptional | DatatypeProperty |
| Template order | m11:templateOrder | DatatypeProperty |
| Template page | m11:templatePage | DatatypeProperty |
| Template section number | m11:templateSectionNumber | DatatypeProperty |
| ToC reference | m11:tocReference | DatatypeProperty |
| TS block | m11:tsBlock | DatatypeProperty |
| TS term | m11:tsTerm | DatatypeProperty |
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.