Good Clinical Practice

What Makes a Clinical Trial GCP Compliant?

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Kimberly Brunton, RN, MSN

Director of Operations

Clinical Research Office

University at Buffalo

Tuesday, February 11, 2020

4:00 – 6:00 PM

Room 2213A, Jacobs School of Medicine and Biomedical Sciences

Downtown Campus, University at Buffalo

We will review the basics of Good Clinical Practice (GCP) and the recent updates that impact practice in an increasingly electronic environment. We will highlight the responsibilities the Sponsor/Clinical Research Office (CRO), the Institutional Review Board (IRB), independent ethics committees and study staff have in conducting GCP compliant research, with a focus on investigator responsibilities. The session will include multiple case studies that every researcher has or will run into, and what to do to remain GCP compliant.

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.