University at Buffalo (UB) 
Clinical and Translational Science Institute
Clinical and Translational Science InstituteAdvancing research discoveries to improve health for all
Clinical and Translational Science InstituteThe Good Clinical Practice Workshop Series explains the fundamental principles of the protection of human subjects, 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 attendees 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: |
| 2/6/2024 | Surviving Research Audit | Richard J. Karalus, PhD Director of Research Compliance Office of Research Compliance |
| 2/13/2024 | What Makes a Clinical Trial GCP Compliant? | Kimberly Brunton, RN, MSN Director of Operations Clinical Research Office |
| 2/20/2024 | ICH, GCP, CFR, ISO: Making Sense of this Soup of Acronyms | Sanjay Sethi, MD Professor and Chief, Pulmonary, Critical Care and Sleep Medicine Assistant Vice President for Health Sciences Department of Medicine Jacobs School of Medicine and Biomedical Sciences |
| 2/27/2024 | When is an Informed Consent Truly Informed? | Christian Marks, PHD Director Social and Behavioral Research Program |
| 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? | CHRISTIAN MARKS, PHD Director Social and Behavioral Research Program University at Buffalo |
Date: | Title: | Presenter: |
4/17/18 | ICH, GCP, CFR, ISO: Making Sense of This Soup of Acronyms | Sanjay Sethi, MD Professor and Chief, Pulmonary, Critical Care and Sleep Medicine Assistant Vice President for Health Sciences |
4/24/18 | When is an Informed Consent Truly Informed? | Christian Marks, PhD Director, Social and Behavioral Research Support Program |
5/01/18 | What Makes a Clinical Trial GCP Compliant? | Kimberly Brunton, RN, MSN Associate Director of Operations, Clinical Research Office |
5/08/18 | Surviving a Research Audit | Jennifer Smith, JD Quality Assurance/Quality Improvement Administrator, Office of Research Compliance |