| Dimension |
A data cube property that describes a categorical or hierarchical dimension |
no |
| IdentifiableElement |
|
no |
| Resource |
An external reference that serves as the source for a Dataset, ItemGroup, or Item |
no |
| Dataset |
A collection element that groups observations sharing the same dimensionality, expressed as a set of unique dimensions within a Data Product context |
no |
| DocumentReference |
A comprehensive reference element that points to an external document, combining elements from ODM and FHIR |
no |
| Method |
A reusable computational procedure that describes how to derive values and can be referenced by Items |
no |
| ComponentList |
An abstract definition that specifies a list of components within a data structure definition, including various descriptor types |
no |
| CodeList |
A value set that defines a discrete collection of permissible values for an item, corresponding to the ODM CodeList construct |
no |
| ProvisionAgreement |
An agreement element that describes the contractual relationship between a Data Provider and a Data Consumer regarding data provision |
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 |
| 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 |
| DataProvider |
An organization element that provides data to a Data Consumer, which can be a sponsor, site, or any other entity that supplies data |
no |
| FormalExpression |
A computational element that defines the execution of a data derivation within a specific context |
no |
| Timing |
A temporal element that describes the timing of an event or occurrence, which can be absolute, relative, or nominal |
no |
| Standard |
A collection element that groups related standards within a specific context, used for defining CDISC implementation guides and controlled terminologies |
no |
| GovernedElement |
|
no |
| Item |
A data element that represents a specific piece of information within a defined context, with data type, constraints, and derivation methods |
no |
| Parameter |
A variable element that describes an input used in a formal expression |
no |
| NominalOccurrence |
An event element that represents occurrences such as planned or unplanned encounters or adverse events |
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 |
| Measure |
A data cube property that describes a measurable quantity or value |
no |
| Relationship |
A semantic link that defines connections between elements such as Items or ItemGroups, capturing relationships like "is the unit for" or "assesses seriousness of" |
no |
| ReturnValue |
An output specification that defines the details of what a formal expression returns |
no |
| Dictionary |
A dictionary that defines a set of codes and their meanings |
no |
| SiteOrSponsorComment |
A feedback element that contains comments from a site or sponsor, distinct from the general Comment class |
no |
| DataStructureDefinition |
A structural element that defines the organization of a data cube for analysis, including dimensions, attributes, and measures |
no |
| CubeComponent |
An abstract data field that represents a component in a data structure definition, referencing an Item for its definition |
no |
| DataAttribute |
A data cube property that describes additional characteristics or metadata about observations |
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 |
| Comment |
A descriptive element that contains explanatory text provided by a data or metadata handler |
no |
| DataProduct |
A governed collection that represents a purpose-driven assembly of datasets and services with an owning team and lifecycle |
no |
| Organization |
An entity that represents organizational information, such as a site or sponsor |
no |
| Labelled |
A mixin that provides slots for detailing meanings and multilingual descriptions |
no |
| CodeListItem |
A structured member of a CodeList that extends the Coding class with additional context-specific properties |
no |
| User |
An entity that represents information about a specific user of a clinical data collection or data management system |
no |
| Dataflow |
An abstract representation that defines data provision for different reference periods, where a Distribution and its Dataset are instances |
no |
| DataService |
A service element that provides an API or endpoint for serving or receiving data |
no |
| ConceptProperty |
A reified property concept that exists within the context of its containing topic concept |
no |