Dataset-XML: an Expanding Toolbox

Despite just being released in Q2 of 2014, a number of freely available tools are already available to work with Dataset-XML files. The recently-introduced CDISC Dataset-XML standard enables the interchange of tabular datasets, like SDTM or ADaM, using ODM-based XML, and provides a convenient alternative to SAS V5 XPORT files. Tools supporting Dataset-XML are listed on the publicly accessible CDISC Dataset-XML Resources page on the CDISC Wiki. Early versions of many of these tools were available before Dataset-XML was released as a final standard. The speedy availability of these tools highlights the CDISC community’s culture of innovation as inspired by the availability of machine-readable standards.

The availability of software tools with the release of Dataset-XML enabled the FDA to begin planning the "Transport Format for the Submission of Regulatory Study Data” pilot prior to the standard’s final release. In order to test Dataset-XML’s suitability as a replacement for SAS V5 XPORT for submission datasets, tools were needed to create Dataset-XML files from existing SAS V5 XPORT files, to validate the Dataset-XML files, to view the content of the Dataset-XML files, and to convert the Dataset-XML files into SAS datasets.  The availability of Dataset-XML tools made it easy for sponsors to participate in the pilot, and the availability of a robust set of software tools is essential to the adoption of data standards.

Tools available that support Dataset-XML include:  
  • XPT2DatasetXML by XML4Pharma to convert SAS V5 XPORT files to Dataset-XML
  • Smart Dataset-XML Viewer by the University of Applied Sciences FH Joanneum Graz – eHealth to enable Dataset-XML viewing, filtering and other basic visual review capabilities
  • EZ Convert by Sally Cassells to convert Dataset-XML to SAS datasets
  • SAS Clinical Standards Toolkit by SAS provides Dataset-XML support as a pre-release package, and the final version will be part of the next Clinical Standards Toolkit release
  • OpenCDISC v1.5 by OpenCDISC to validate Dataset-XML files
  • R4CDISC by Ippei Akiya to read Dataset-XML datasets and return an R dataframe

More details are available on the Dataset-XML Resources CDISC Wiki page. If your Dataset-XML tool is not listed on the please let us know about it by adding a comment to the wiki page.  Happy tooling with Dataset-XML!

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