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ABOUT THIS EVENT (Hosted by CDER SBIA)

The FDA collaborated with PHUSE/CDISC to execute a pilot from September 2023 thru April 2024 to test the feasibility of using CDSIC Dataset-JSON as a transport format for study data submitted with regulatory applications. The pilot aimed to demonstrate that CDISC Dataset-JSON can serve as a transport file for study data without loss of data and no significant impact to business operations. The presentation will present the findings of the pilot and next steps as published in the PHUSE white paper available here.

Attendees will learn more about the FDA Dataset-JSON pilot results, CDISC’s plans for upcoming technical implementation changes to Dataset-JSON, and the planned next steps.

INTENDED AUDIENCE

  • Regulatory science and regulatory affairs professionals who submit IND/NDA/BLAs to the agency for regulatory decision making
  • Consultants focused on data standards and regulatory submissions
  • Foreign regulators

TOPICS

  • Dataset-JSON as an Alternative Transport Format
  • Business Case for Dataset-JSON
  • Known Technical Implementation Challenges and Proposed Solutions
  • Future Strategy Plans

SPEAKERS

The Dataset-JSON Pilot
Jesse Anderson, M.P.H.
Data Standards Lead
Office of Computational Science(OCS)
Office of Translational Sciences (OTS) | CDER | FDA

Technical Implementation
Sam Hume, D.Sc.
Vice President, Data Science
CDISC

FDA RESOURCES