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| # | Functionality | Use case | Element | Attribute | Description of Functionality Change | Detailed Functionality (Specification) |
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1
| Coding
|
| New |
| The Coding element references a symbol from a defined code system. It uses a code defined in a terminology system to associate semantics with a given term, codelist, variable, or group of variables. The presence of a Coding element associates a meaning to its parent element. | Coding
| 2
| Nested ItemGroupDef |
| Enhanced |
| Groups of ItemGroups or ItemsDefs, allowing nested structures that can represent a more diverse range of data structures. The revised ItemGroupDef element facilitates a number of new capabilities based on a more flexible re-use of groups of items; for instance, defining enhanced semantics when items share a common relationship or grouping common behaviors such as skip logic or pre-population. | ItemGroupDef | 3
| StudyEventGroupDef |
| New |
| Groups of StudyEventGroups or StudyEvents, allowing nesting of StudyEventGroups. StudyEventGroups are also used to define "study cells", i.e. crossings of epochs and arms. | StudyEventGroupDef
| 4
| Origin | Enhanced | New | Removed | ODM v2.0 includes an Origin element that replaces and enhances the functionality offered by the @Origin attribute in ODM 1.3.2. The Origin information on the ItemDef element has also been moved to the ItemRef element, so that an Item can have a different Origin depending on where it is used. | Origin | 5
| MethodDef
|
| Enhanced
|
| Improved traceability and checking added with a method signature that defines zero or more input parameters and a return datatype(s). Support for external FormalExpression references that can point to a code library. | MethodDef FormalExpression
| 6
| TranslatedText |
| Enhanced
|
| TranslatedText supports alternative media-types so, for example, XHTML which can be used to enhance the display of the text. | TranslatedText
| 7
| Multi-lingual Support
| Enhanced
| Enhanced
|
| Expanded use of TranslatedText to provide broader multi-lingual support. | TranslatedText
| 8
| Data Query Support
| New
| New
|
| Explicit support for data queries and the data query lifecycle. | Query
| 9
| AdminData |
| Enhanced
|
| Elements improved based on input from usage experience and updated for compatability with CTR-XML and SDM-XML. | AdminData
| 10
| Traceability (Trace-XML Features) Support
| Enhanced
| New |
| Machine-readable end-to-end metadata traceability. | Origin
MethodSignature | 11
| HL7 FHIR Interoperability
| New
| New |
| Provides the metadata needed to retrieve data from a FHIR resource to populate a variable referenced by an ItemRef. | Origin, Resource, Coding
| 12
| Study Design Model (SDM-XML) integration and enhancement | New | New |
| The many new study design model elements provide rigorous, machine-readable, interchangeable descriptions of study designs, including treatment plans, study design parameters, eligibility, and times and events. The new and updated study design elements permit various levels of detail in any representation of a clinical study’s design. | Protocol
| 13
| CDISC 360 Support | New |
|
| Allows representation of biomedical concepts using new ODM v2.0 features such as nested ItemGroupDefs. | ParameterValue ItemGroupDef ItemDef CodeList CodeListItem EnumeratedItem Annotation Coding
| 14
| Data Capture | Enhanced
| Enhanced
| New
| ODM Repeating ItemGroup based on a code list so that each term in the code list represents one or more questions on a CRF. Support for matrix style forms. | ItemGroupDef (@RepeatingRepeating, @RepeatingLimitRepeatingLimit) | 15
| Define-XML extension
part of ODM core |
| New
| New
| Most elements and attributes in the Define-XML v2.1 extension have been incorporated in the ODM v2.0 core set. Only the list of new MetadataVersion child elements referenced. | Standards ValueListRef ValueListDef WhereClauseDef AnnotatedCRF SupplementalDoc DocumentRef | 16
| Operational Datasets
| New
|
|
| Reference implementation that uses ODM v2.0 to represent datasets for the exchange of tabular raw data, such as an EDC vendor, CRO or service provider sending data to a sponsor as a tabular dataset. |
| 17
| JSON Serialization | New
|
|
| ODM v2.0 includes an updated version of Dataset-XML and a serialization optimized for JSON called Dataset-JSON | JSON representation for ODM |
|
Overview of a Few Deprecated Elements and Attributes
A complete list of deprecated components can be fount in Appendix -- Deprecated Componentsthe Appendices.
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| # | Functionality | Element | Attribute | Notes | Replacement Functionality |
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1
| FormDef | Deprecated |
|
| ItemGroupDef/@Type="Form"
| 2
| Origin
|
| Deprecated
|
| Origin element (ItemRef/Origin, ItemGroupDef/Origin) | 3
| SASFormatName |
| Deprecated | SAS related metadata definitions can be provided using a child Alias element.
| CodeList element (CodeList/Alias) | 4
| ItemData[Type] | Deprecated |
|
|
| 5
| BasicDefinitions (MeasurementUnit)
| Deprecated |
| An alternative method of associating units with measurement variables that better aligns with CDASH and SDTM has been implemented. | ItemRef/@UnitsItemOID
| 6
| Presentation | Deprecated |
| Presentation metadata can be added as an extension. |
| 7
| Certificate | Deprecated |
|
|
| 8
| Annotations (Container)
| Deprecated |
| The Annotations container was only allowed in conjunction with ItemData[Type].
| Annotation | 9
| AuditRecords | Deprecated |
| The AuditRecords was only allowed in conjunction with ItemData[Type].
|
| 10
| EnumeratedItem
| Deprecated |
| Enhanced CodeListItem covers the EnumeratedItem functionality
| CodeListItem | 11
| ExternalCodeList
| Deprecated |
| Enhanced CodeList, with the Coding element, covers the ExternalCodeList functionality | CodeList |
|
Future Specifications
As ODM v.2.0 has a representation in XML as well as in JSON, a "format-neutral" path- and navigation language "ODMPath" (based on FHIRPath) is currently in development. This is "work in progress" and the current status (non-normative) can be found here. As such, ODMPath is not part of the current specification.
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