Good Clinical Practice

Surviving a Research Audit

Richard Karalus.

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.

REGISTER FOR THIS WORKSHOP BY feb 24

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.