Good Clinical Practice

ICH, GCP, CFR, ISO: Making Sense of This Soup of Acronyms


Sanjay Sethi, MD

Professor and Chief, Pulmonary, Critical Care and Sleep Medicine

Jacobs School of Medicine and Biomedical Sciences

Assistant Vice President for Health Sciences

University at Buffalo

Tuesday, April 17, 2018

5:00 – 7:00 p.m.

Clinical and Translational Research Center

875 Ellicott Street, Buffalo, NY 14203

Rm. 6003 A + B

We will discuss the meaning of good clinical practice (GCP) and where it is applicable and how it differs from other regulations governing clinical research. The focus will be on aspects of GCP relevant to the investigator.  Scenarios to determine whether research conduct was compliant with GCP or not will provide an opportunity to understand the practical application of GCP. There has been increasing recognition of the limitations of the GCP guidelines, and the context of these potential limitations and potential remedies will be explored.

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.