The Food and Drug Administration (FDA) is considering using the Clinical Data Interchange Standards Consortium (CDISC) Dataset—JavaScript Object Notation (Dataset-JSON) version 1.1 as a new format to submit electronic study data, which may replace the current SAS version 5 XPORT Transport Format. They are asking for comments from the industry about this potential change, specifically about the advantages and disadvantages and any difficulties that might emerge when integrating it with current systems. The FDA conducted a pilot study and is open to more tests to ensure a smooth transition. Public comments on this matter are due by June 9, 2025.
Simple Explanation
The FDA is thinking about using a new way to send and receive study data using a special kind of computer language called JSON. They want to know what people think about this idea, especially if it will make things easier or harder for them.