Zdrowie i gospodarka · 13/12/2023

FDA Announces Support for CDISC Study Data Tabulation Model Updates

The FDA's CBER and CDER are launching support for CDISC Study Data Tabulation Model version 2.0, Study Data Tabulation Model Implementation Guide version 3.4, and Standard for Exchange of Nonclinical Data Implementation Guide-- Genetox version 1.0, while marking the end of support for version 3.2 of the Study Data Tabulation Model Implementation Guide, and will update the FDA Data Standards Catalog and publish technical specifications for implementation of new variables.