Dataset-JSON Is Coming: What FDA Adoption Could Mean for Standards, Systems, and Submission Readiness

About this session

Part of Session 7, Track B: End-to-End Flow (Chair: Kent Letourneau, ICON).

With the FDA signaling potential adoption of CDISC Dataset-JSON v1.1, sponsors, standards leaders, and technology teams need to understand both the strategic importance and the implementation realities of this emerging submission format. Designed as a modern alternative to SAS XPT, Dataset-JSON enables more structured, machine readable data exchange, richer metadata representation, and improved compatibility with contemporary analytics and review workflows.
This presentation provides a practical overview of why Dataset-JSON matters, what capabilities it introduces, and what organizations should be doing now to prepare. Based on experience from the PHUSE and CDISC joint pilot and informed by William Qubeck's leadership of the original Define-XML initiative, the session explores implications for standards governance, metadata alignment, legacy process integration, automation, traceability, and GxP validation. Attendees will gain a pragmatic view of the road ahead and a framework they can use to support internal planning, cross functional alignment, and modernization of submission ecosystems.

Speaker

• BQ

  Bill Qubeck

  Sycamore Informatics

  Speaker