CDISC Announces Study Data Set – XML Draft Standard Available for Public Review

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FDA Posts Notice of Pilot Project to Evaluate CDISC SDS-XML

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SDS-XML was designed to support the standards as they exist today, but also to enable innovative enhancements to the standards going forward.

The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce that the StudyDataSet–XML Specification Version 1 (SDS-XML) has been released for Public Comment. To view the draft standard and provide comments, please visit the CDISC website. Comments on SDS-XML are due by 3 January 2014.

SDS-XML is a CDISC Extensible Markup Language (XML) format for CDISC SDTM, SEND, ADaM or legacy data sets. It has been developed to provide an alternative to SAS Version 5 Transport (XPT) for data set transmission and is designed to work with Define-XML. Sam Hume, XML Technologies Team co-lead, noted: “SDS-XML is a relatively simple, ODM-based transport standard that complements Define-XML v2.0 nicely. It is really the first step in eliminating restrictions in the CDISC standards that carry over from the transport format. SDS-XML was designed to support the standards as they exist today, but also to enable innovative enhancements to the standards going forward.”

In response to the development of SDS-XML, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) released a notice on 27 November 2013 of their intent to begin a pilot project to evaluate SDS-XML. In the notice, it was highlighted that “although [SAS Transport] has been a reliable exchange format for many years, it is not an extensible modern technology,” and that “FDA is announcing an invitation to sponsors to participate in this pilot project to evaluate the SDS-XML transport format.” For more information on this FDA pilot project, please visit the Federal Register website.

Thanks to the CDISC XML Technologies Team that worked to develop this draft standard. CDISC would also like to express its gratitude to Dr. Jozef Aerts of the University of Applied Sciences FH Joanneum and XML4Pharma, who has set up a public site for the Smart SDS-XML Viewer software, including the latest version of the tutorial. To access the Smart Viewer for the CDISC SDS-XML Standard, please click here. “The Smart SDS-XML Viewer is simple to use and allows reviewers to create their own views of the data, including those that show the relationships in the data,” stated Dr. Aerts. “SDS-XML eliminates many of the limitations of SAS V5 Transport files, and the Smart SDS-XML Viewer enables reviewers to take advantage of these enhancements.”

CDISC is a 501(c)(3) global non-profit charitable organization, with over 300 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can significantly decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

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Andrea Vadakin
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