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FDA Requests Public Comment on CDISC Dataset-JSON Standard

FDA Requests Public Comment on CDISC Dataset-JSON Standard

Owned by Nicola Newton
Last updated: Apr 11, 2025

Project Scope 

The U.S. Food and Drug Administration (FDA) has recently published a Federal Register Notice exploring the potential adoption of CDISC Dataset-JSON v1.1 as a new exchange standard for electronic study data submissions potentially replace the SAS v5 XPORT Transport Format (XPT) in the long term.
The FDA is seeking comments on whether to accept Dataset-JSON for regulatory applications in the future, specifically regarding:
  • The risks and benefits of industry adoption of Dataset-JSON as a new exchange standard.
  • Any integration challenges with existing tools and systems.
PHUSE, given its expertise and commitment to advancing the implementation of data standards within the pharmaceutical industry, and its recent PHUSE/CDISC pilot, is launching a short-term project to collect and synthesize comments from its members on this Federal Register Notice.
Building on the PHUSE/CDISC pilot this is an opportunity to:
  • Influence the future of regulatory data submissions.
  • Share your expertise and perspectives on data standards.
  • Collaborate with fellow PHUSE members on a timely and impactful initiative.
  • Contribute to PHUSE's position on this important topic.
Project LeadsEmail

Chris Price, Roche

chris.price@phuse.global

Nicola Newton, PHUSE Project Coordinator 

nicky@phuse.global

CURRENT STATUS Q1 2025

  • Project Approved ​​​
Objectives & DeliverablesTimelines
TBCQ2 2025

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