Overview of New Features
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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  Image RemovedODM-6 Done element Coding element associates a meaning to its parent element. | Coding specification
| 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 specification | 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 specification.
| 4
| Origin | EnhancedCDISC 360 Support | New | Allows representation of Image RemovedODM-7 Under Team Review biomedical concepts using new ODM v2.0 features such as nested ItemGroupDefs. | 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. | 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
| 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. |
| 6
| TranslatedText |
| Enhanced
|
| TranslatedText supports alternative media-types so, for example, XHTML which can be used to enhance the display of the text. | TranslatedText specification.
| 7
| Multi-lingual Support
| Enhanced
| Enhanced
|
| Expanded use of TranslatedText to provide broader multi-lingual support. | TranslatedText specification.
| 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 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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Coding
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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 associates a meaning to its parent element.
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Coding specification
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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.
...
Groups of StudyEventGroups or StudyEvents, allowing nesting Image RemovedODM-3 Under Team Review of StudyEventGroups. StudyEventGroups are also used to define "study cells", i.e. crossings of epochs and arms.
...
CDISC 360 Support
...
Allows representation of Image RemovedODM-7 Under Team Review biomedical concepts using new ODM v2.0 features such as nested ItemGroupDefs.
...
ParameterValue,
ItemGroupDef,
ItemDef, CodeList,
CodeListItem,
EnumeratedItem,
Annotation,
Coding specifications.
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 |
|
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HL7 FHIR Interoperability
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Provides the metadata needed to retrieve data from a FHIR resource to populate a variable referenced by an ItemRef.
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Machine-readable end-to-end metadata traceability.
...
Data Query Support
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Explicit support for data queries and the data query lifecycle.
...
MethodDef
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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,
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AdminData
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Elements improved based on input from usage experience and updated for compatability with CTR-XML and SDM-XML.
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| 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 |
|
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TranslatedText
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TranslatedText supports alternative media-types so, for example, XHTML which can be used to enhance the display of the text.
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Multi-lingual Support
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Expanded use of TranslatedText to provide broader multi-lingual support.
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| 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 |
|
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Origin
...
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.
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Overview of a Few Deprecated Elements and Attributes
A complete list of deprecated components can be fount in the Appendices.
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 Image RemovedODM-6 Done element associates a meaning to its parent element. Coding specification.
- 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 Image RemovedODM-2 Under Team Review grouping common behaviors such as skip logic or pre-population. ItemGroupDef specification.
- StudyEventGroupDef: Groups of StudyEventGroups or StudyEvents, allowing nesting Image RemovedODM-3 Under Team Review of StudyEventGroups. StudyEventGroups are also used to define "study cells", i.e. crossings of epochs and arms. StudyEventGroupDef specification.
- CDISC 360 Support: Allows representation of Image RemovedODM-7 Under Team Review biomedical concepts using new ODM v2.0 features such as nested ItemGroupDefs. ParameterValue, ItemGroupDef, ItemDef, CodeList, CodeListItem, EnumeratedItem, Annotation, Coding specifications.
- 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
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| Functionality | Element | Attribute | Notes | Replacement Functionality |
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1
| FormDef | Deprecated |
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| ItemGroupDef/@Type="Form"
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| SAS related metadata definitions can be |
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provided using a child Alias element.
| CodeList element (CodeList/Alias) | 4
| ItemData[Type] |
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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].
|
|
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
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| 10
| EnumeratedItem
| Deprecated |
| Enhanced CodeListItem covers the EnumeratedItem functionality
| CodeListItem | 11
| ExternalCodeList
| Deprecated |
| Enhanced CodeList, with the Coding element, covers the ExternalCodeList functionality | CodeList |
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Future Specifications
As ODM v.2.0 has a representation in XML as well as in JSON,
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a 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.children