Articles by Sam Hume

1. No More XPT? Piloting New Dataset-JSON For FDA Submissions 7/12/2023

   CDISC has developed Dataset-JSON, a new dataset exchange format, to replace XPT. Working with the FDA and industry participants, CDISC and PHUSE are leading a new pilot project to test Dataset-JSON for use in regulatory submissions as well as other dataset exchange scenarios.

2. The CDISC Open Rules Engine (CORE): Open-Source Software For Clinical Trials 3/29/2023

   Open-source software development, widely used across most industries globally, has recently been gaining ground in clinical research. Discover how CDISC's Open Rule Engine (CORE) can make sharing standardized data sets easier and improve your workflow.