Zdrowie i gospodarka · 12.01.2015
Study Data Technical Conformance Guide and Data Standards Catalog; Availability
The Food and Drug Administration (FDA) is announcing the availability of a Study Data Technical Conformance Guide, Version 2.0 (Guide), and an update to the Data Standards Catalog (Catalog). The Guide supplements the final guidance for industry entitled "Providing Regulatory Submissions in Electronic Format--Standardized Study Data" (eStudy Data guidance) and provides specifications and recommendations for, as well as general considerations on, submitting standardized study data using FDA-supported data standards specified in the Catalog. The Guide is intended to complement and promote interactions between sponsors and FDA review divisions.