U.S. Food and Drug Administration | Dataset-JSON Pilot Report and Next Steps @US_FDA | Uploaded 2 months ago | Updated 4 hours ago
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. This presentation will present the findings of the pilot and next steps as published in the PHUSE white paper.

Timestamps

00:42 – The Dataset JSON Pilot

06:45 – Technical Implementation

Speakers:

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

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

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