Dataset-XML supports exchanging tabular data in clinical research applications using ODM-based XML technologies, enabling the communication of study datasets for regulatory submissions.

Dataset-XML v1.0

Release Date: 22 Apr 2014

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

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

Package icon Dataset-XML v1.01.41 MB