University at Buffalo (UB) 
Clinical and Translational Science Institute
Clinical and Translational Science InstituteAdvancing research discoveries to improve health for all
Good Clinical Practice
Surviving a Research Audit
Richard Karalus, PhD
Director of Research Compliance
Office of Research Compliance
University at Buffalo
Tuesday, February 25, 2020
4:00 – 6:00 PM
Room 2213A, Jacobs School of Medicine and Biomedical Sciences
Downtown Campus, University at Buffalo
The Food and Drug Administration (FDA) conducts clinical investigator inspections in order to determine whether clinical studies are being conducted in compliance with applicable requirements. These investigations can be held with or without prior notice. Therefore, an investigator should always be prepared for an audit. This workshop will provide an overview of what the FDA is looking for during an investigator audit.
ACCREDITATION: The University at Buffalo Jacobs School of Medicine and Biomedical Sciences is accredited by the ACCME to provide continuing medical education for physicians.
CERTIFICATION: The University at Buffalo Jacobs School of Medicine and Biomedical Sciences designates this live activity for a maximum of 2.0 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CREDIT: This program is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number UL1TR001412.