Dataset-XML supports exchanging tabular data in clinical research applications using ODM-based XML technologies, enabling the communication of study datasets for regulatory submissions.
CDISC developed Dataset-XML v1.0 as a drop-in replacement for SAS V5 XPORT to enable testing using existing processes. Dataset-XML is a truly non-proprietary, global standard, removing many SAS V5 Transport file restrictions (the current file format required by the FDA and PMDA), such as 8-character variable names and 200-character text fields. Dataset-XML and Define-XML are complementary standards; Define-XML metadata describes the Dataset-XML dataset content.
Dataset-XML can represent any tabular dataset including SDTM, ADaM, SEND, or non-standard legacy datasets. It requires an accompanying Define-XML file to provide the machine-readable metadata that describes the contents of the datasets. Dataset-XML supports all language encodings supported by XML.
Now that Dataset-XML v1.0 has been shown to work as a SAS V5 XPORT replacement, the CDISC XML Technologies Team will add additional features in the next versions, including improved relationships and traceability.
For information on tool support, visit http://wiki.cdisc.org/display/PUB/CDISC+Dataset-XML+Resources
The FDA completed a "Transport Format for the Submission of Regulatory Study Data” Dataset-XML Pilot and has posted the resulting test report on their web site.