| GovernedElement |
|
no |
| Governed |
A mixin that provides slots for audit trail and standards governance, including mandatory status, comments, and attribution |
no |
| MetaDataVersion |
A container element that represents a given version of a specification, linking to a particular usage context such as a study, dataset, or data collection instrument. |
no |
| Item |
A data element that represents a specific piece of information within a defined context, with data type, constraints, and derivation methods |
no |
| ItemGroup |
A collection element that groups related items or subgroups within a specific context, used for tables, FHIR resource profiles, biomedical concept specializations, or form sections |
no |
| CodeList |
A value set that defines a discrete collection of permissible values for an item, corresponding to the ODM CodeList construct |
no |
| Comment |
A descriptive element that contains explanatory text provided by a data or metadata handler |
no |
| ReifiedConcept |
A canonical information layer that makes abstract concepts explicit and referenceable, showing how different data implementations represent the same underlying meanings through a star schema structure with multiple properties |
no |
| ConceptProperty |
A reified property concept that exists within the context of its containing topic concept |
no |
| WhereClause |
A conditional element that describes the circumstances under which a containing context applies, linking conditions to structures where they are used |
no |
| Condition |
A reusable, composable, and nestable logical construct allowing for complex expressions. Conditions are most useful when given a meaningful name and linked to Study Definitions. |
no |
| Method |
A reusable computational procedure that describes how to derive values and can be referenced by Items.
Analysis and Derivation concepts can be implemented by a Method. Properties can be referenced by Parameters in its expressions. |
no |
| SiteOrSponsorComment |
A feedback element that contains comments from a site or sponsor, distinct from the general Comment class |
no |
| NominalOccurrence |
An event element that represents occurrences such as planned or unplanned encounters or adverse events |
no |
| DataStructureDefinition |
A structural element that defines the organization of a data cube for analysis, including dimensions, attributes, and measures |
no |
| Dataflow |
An abstract representation that defines data provision for different reference periods, where a Distribution and its Dataset are instances |
no |
| CubeComponent |
An abstract data field that represents a component in a data structure definition, referencing an Item for its definition |
no |
| Measure |
A data cube property that describes a measurable quantity or value |
no |
| Dimension |
A data cube property that describes a categorical or hierarchical dimension |
no |
| DataAttribute |
A data cube property that describes additional characteristics or metadata about observations |
no |
| DataProduct |
A governed collection that represents a purpose-driven assembly of datasets and services with an owning team and lifecycle. The DataProduct defines the boundary of accountability between data producers and consumers. |
no |
| ProvisionAgreement |
An agreement element that describes the contractual relationship between a Data Provider and a Data Consumer regarding data provision |
no |
| Analysis |
Analysis extends Method to capture analysis-specific metadata including the reason for analysis, its purpose, and data traceability for the results used.
Expressions and parameters from Method can be generic or implementation-specific. |
no |
| Display |
A rendered output of an analysis result. |
no |