A Case Example of the Review of Audit Trails in GCP Inspections (11of11) GCP Data Integrity Workshop

Phillip D. Kronstein from CDER’s Good Clinical Practice Assessment Branch provides a case study when a sponsor submitted an NDA for a new molecular entity. The drug was the first targeted treatment for a serious disorder and the OND review division requested data audit inspections of the sponsor, CRO, and several clinical investigators. For more data integrity case studies, visit https://www.fda.gov/drugs/cder-small-... _______________________________ FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming training and free continuing education credits: https://www.fda.gov/cdersbia CDER SBIA 2018 Playlist:    • 2018 CDER Small Business and Industry Assi...   LinkedIn:   / cder-small-business-and-industry-assistance   Training resources: https://www.fda.gov/cderbsbialearn Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... Email: CDERSBIA@fda.hhs.gov Phone: (301) 796-6707 I (866) 405-5367