Overview of New Features 
ODM-5 Open
| 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. |
Note the block below is to be removed after the table is accepted
- Coding: 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
- Nested ItemGroupDef: 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
- StudyEventGroupDef: Groups of StudyEventGroups or StudyEvents, allowing nesting
- CDISC 360 Support: Allows representation of
- Study Design Model (SDM-XML) integration and enhancement: 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: Provides the metadata needed to retrieve data from a FHIR resource to populate a variable referenced by an ItemRef. Origin, Resource, Coding specifications.
- Trace-XML Features: Machine-readable end-to-end metadata traceability. Origin specification.
- Data Query Support: Explicit support for data queries and the data query lifecycle. Query specification.
- Enhanced MethodDef: 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
- Enhanced Data Capture: 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.
- Enhanced TranslatedText: TranslatedText supports alternative media-types so, for example, XHTML which can be used to enhance the display of the text. TranslatedText specification.
- Enhanced Multi-lingual Support: Expanded use of TranslatedText to provide broader multi-lingual support. TranslatedText specification.
- Updated AdminData: Elements improved based on input from usage experience and updated for compatability with CTR-XML and SDM-XML AdminData specification
- Operational Datasets: 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: ODM v2.0 can be serialized as XML or JSON. The odm-xml is now an IANA media-type and JSON will be added once complete.
- Dataset-JSON: ODM v2.0 includes an updated version of Dataset-XML and a serialization optimized for JSON called Dataset-JSON.
Deprecated Elements and Attributes
| Functionality | Element | Attribute | Notes | Replacement Functionality |
|---|---|---|---|---|
FormDef | Deprecated | |||
| Presentation | Deprecated | Presentation metadata can be added as an extension. | ||
| ItemData[Type]: | Deprecated | |||
| Certificate | Deprecated | |||
| BasicDefinitions | Deprecated | An alternative method of associating units with measurement variables that better aligns with CDASH and SDTM has been implemented. | ItemRef/@UnitsItemOID | |
| Annotations (Container) | Deprecated | The Annotations container was only allowed in conjunction with ItemData[Type]. | Annotation | |
| AuditRecords | Deprecated | The AuditRecords was only allowed in conjunction with ItemData[Type]. |
Note the block below is to be removed after the table is accepted
- FormDef: The FormDef element is deprecated and has been replaced by an ItemGroupDef with Type="Form".
- Presentation: The Presentation element has been deprecated for ODM v2.0.
- ItemData[Type]: The ItemData[Type] elements are deprecated for ODM v2.0 and the ItemData element has been updated.
- Certificate: The Certificate element has been deprecated for ODM v2.0.
- BasicDefinitions: The BasicDefinitions element has been deprecated for ODM v2.0 and an alternative method of associating units with measurement variables that better aligns with CDASH and SDTM has been implemented.
- Annotations: Annotations were used in conjunction with ItemData[Type] and have been deprecated for ODM v2.0.
- AuditRecords: AuditRecords were used in conjunction with ItemData[Type] and have been deprecated for ODM v2.0
Future specifications
As ODM v.2.0 has a representation in XML as well as in JSON, ODM-4 - Getting issue details... STATUS 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.
Similarly, a standardized REST-API specification, for the exchange of ODM v2.0 data and metadata, is currently under development.