FDA Study Data Technical Conformance Guide v4.4 - Nov 22, 2019

CDER’s Helena Sviglin, Heather Crandall, and Stephanie Leuenroth-Quinn provide an overview of recent updates made to FDA’s Study Data Technical Conformance Guide v4.4. This includes updates since March 2019 sdTCG, using the simplified TS.xpt, section 8.2.2 specifics, and detailed examples of the intricacies of using the simplified TS.xpt with nonclinical submissions.
The Study Data TGC provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog.
Learn more at www.fda.gov/dr...
_______________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Visit www.fda.gov/cd... and www.fda.gov/cd... for news and a repository of training activities.
Email: [e-mail]
Phone: [phone] I [phone]
LinkedIn: / cder-small-business-an...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...