Page History

Overview of New Features

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Data Query Support MethodDef Multi-lingual Support # Functionality Use case Element Attribute Description of Functionality Change Detailed Functionality (Specification) 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 Image RemovedODM-6 Done element 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 Image RemovedODM-2 Under Team Review grouping common behaviors such as skip logic or pre-population. ItemGroupDef 3 StudyEventGroupDef New Groups of StudyEventGroups or StudyEvents, allowing nesting Image RemovedODM-3 Under Team Review of nesting of StudyEventGroups. StudyEventGroups are also used to define "study cells", i.e. crossings of epochs and arms. StudyEventGroupDef CDISC 360 Support New Allows representation of Image RemovedODM-7 Under Team Review biomedical concepts using new ODM v2.0 features such as nested ItemGroupDefs. 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 ParameterValue ItemGroupDef ItemDef CodeList CodeListItem EnumeratedItem Annotation Coding12 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 HL7 FHIR Interoperability 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 New Provides the metadata needed to retrieve data from a FHIR resource to populate a variable referenced by an ItemRef. Origin, Resource, Coding Traceability (Trace-XML Features) Support Enhanced Machine-readable end-to-end metadata traceability. Origin New New Explicit support for data queries and the data query lifecycle. Query 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 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 TranslatedText Enhanced TranslatedText supports alternative media-types so, for example, XHTML which can be used to enhance the display of the text. TranslatedText Enhanced Expanded use of TranslatedText to provide broader multi-lingual support. TranslatedText AdminData Enhanced Elements improved based on input from usage experience and updated for compatability with CTR-XML and SDM-XML. (Repeating, RepeatingLimit) 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 AdminData 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 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

Overview of a Few Deprecated Elements and Attributes

A complete list of deprecated components can be fount in the Appendices.