Electronic Study Data Submission; Data Standards; Clinical Data Interchange Standards Consortium Dataset-JavaScript Object Notation; Request for Comments
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or Agency) is exploring Clinical Data Interchange Standards Consortium (CDISC) Dataset- JavaScript Object Notation (Dataset-JSON) version 1.1 as a new exchange standard, with the long-term potential to replace Statistical Analysis System (SAS) version 5 XPORT Transport Format (XPT), for submission of electronic study data to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). FDA is requesting comments on whether to accept Dataset-JSON to exchange electronic study data as part of regulatory applications in the future. In particular, FDA is requesting feedback on the risks and benefits of industry adopting Dataset-JSON as a new exchange standard for submitting electronic study data to FDA and any integration challenges with existing tools and systems.
Abstract as published in the Federal Register.
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