Good Clinical Practice Workshop Series, Spring 2022

The Good Clinical Practice Workshop Series explains the fundamental principles of the protection of human subject, the main authoritative bodies, key codes and scope of enforcement. This series investigates the preparation of an application for IRB approval and the essential elements of voluntary informed consent. Workshop goers will critique proposals for risks to human subjects and protections of vulnerable populations. Finally, this series investigates the principles of research documentation, validation and audit.

Date:   Title: Presenter:
2/1/2022 Surviving Research Audit Richard J. Karalus, PhD
Director of Research Compliance
Office of Research Compliance
University at Buffalo
2/8/2022 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
2/15/2022 What Makes a Clinical Trial GCP Compliant? KIMBERLY BRUNTON, RN, MSN
Director of Operations
Clinical Research Office
University at Buffalo
2/22/2022 When is an Informed Consent Truly Informed?
Social and Behavioral Research Program
University at Buffalo

Past Series