FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ELECTRONIC STUDY DATA SUBMISSION; DATA STANDARDS; CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM DATASET-JAVASCRIPT OBJECT NOTATION; REQUEST FOR COMMENTS

WASHINGTON, April 9 -- Food and Drug Administration has issued a notice called: Electronic Study Data Submission; Data Standards; Clinical Data Interchange Standards Consortium Dataset-JavaScript Object Notation; Request for Comments.

The notice was published in the Federal Register on April 9 by P. Ritu Nalubola, Associate Commissioner for Policy.

Summary: The Food and Drug Administration (FDA or Agency) is exploring Clinical Data Interchange Standards Consortium (CDISC) Dataset-JavaScript Object Notation (Dataset-JSON) version 1.1 as a new exchange standard, with the long-term potential to replace Statistical Analysis System (SAS) version 5 XPORT Transport Format (XPT), for submission of electronic study data to the Center for Biologics...