Overview of New Features 
ODM-5 Open
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| Functionality | Use case | Element | Attribute | Description of Functionality Change | Detailed Functionality |
|---|---|---|---|---|---|
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 | Coding specification | ||
| 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 | ItemGroupDef specification | ||
| StudyEventGroupDef | New | Groups of StudyEventGroups or StudyEvents, allowing nesting | StudyEventGroupDef specification. | ||
CDISC 360 Support | New | Allows representation of | ParameterValue, ItemGroupDef, ItemDef, CodeList, CodeListItem, EnumeratedItem, Annotation, Coding specifications. | ||
Study Design Model (SDM-XML) integration and enhancement | 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 specification. | ||
HL7 FHIR Interoperability | New | Provides the metadata needed to retrieve data from a FHIR resource to populate a variable referenced by an ItemRef. | Origin, Resource, Coding specifications. | ||
| Traceability (Trace-XML Features) Support | Enhanced | Machine-readable end-to-end metadata traceability. | Origin specification. | ||
Data Query Support | New | New | Explicit support for data queries and the data query lifecycle. | Query specification. | |
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 specification | ||
Data Capture | Enhanced | 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 specification. | ||
TranslatedText | Enhanced | TranslatedText supports alternative media-types so, for example, XHTML which can be used to enhance the display of the text. | TranslatedText specification. | ||
Multi-lingual Support | Enhanced | Expanded use of TranslatedText to provide broader multi-lingual support. | TranslatedText specification. | ||
AdminData | Enhanced | Elements improved based on input from usage experience and updated for compatability with CTR-XML and SDM-XML. | AdminData specification. | ||
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. | |||
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 specification. | ||
Origin | Enhanced | New | Removed | ODM v2.0 includes an Origin element that replaces and enhances the Origin attribute in ODM 1.3.2. The Origin information on an ItemDef has also been moved to an ItemRef, so that an Item can have a different Origin depending on where it is used. | Origin specification. |
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