Overview of New Features

#FunctionalityUse caseElementAttributeDescription of Functionality ChangeDetailed 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 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

EnhancedNewRemoved

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

NewNew

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

(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

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 the Appendices.

#FunctionalityElementAttributeNotesReplacement Functionality

1

FormDef

Deprecated



ItemGroupDef/@Type="Form"

2
Origin

Deprecated

Origin element

(ItemRef/Origin, ItemGroupDef/Origin)

3
SASFormatName
DeprecatedSAS 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
PresentationDeprecated
Presentation metadata can be added as an extension.
7
CertificateDeprecated


8
Annotations (Container)
Deprecated
The Annotations container was only allowed in conjunction with ItemData[Type].
Annotation
9
AuditRecordsDeprecated
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 functionalityCodeList

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.

Similarly, a standardized REST-API specification, for the exchange of ODM v2.0 data and metadata, is currently under development.

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