Good Clinical Practice Workshop Series
The 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 participants 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.
Participants can earn a certificate of completion and 6 CME credits (if applicable) upon attending all workshops.
Participants can also earn a micro-credential/digital badge upon completion of all workshops and weekly assignments. Digital badges allow learners to showcase their enhanced knowledge of good clinical practice on their digital resumes, e-Portfolios, or LinkedIn accounts. If you are interested in receiving the Good Clinical Practice digital badge, contact Catherine Sedota at cmp9@buffalo.edu.
2025 SCHEDULE
September 23, 2025 Richard J. Karalus, PhD |
September 30, 2025 ICH, GCP, CFR, ISO: Making Sense of This Soup of Acronyms Sanjay Sethi, MD |
October 7, 2025 What Makes a Clinical Trial GCP Compliant? Kimberly Brunton, RN, MSN |
October 21, 2025 When Is an Informed Consent Truly Informed? Sevie Kandefer, MS |
TIME: 4:00 p.m. – 5:30 p.m.
LOCATION: Zoom
PRESENTERS:
Richard J. Karalus, PhD
Director of Research Compliance
Office of Research Compliance
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
Kimberly A. Brunton, RN, MSN
Director of Operations
Clinical Research Office
Sevie Kandefer, MS
Clinical Research Associate
Clinical Research Office
For more information, contact cmp9@buffalo.edu or 716-844-9282.
Past Series
| 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: |
3/3/20 | 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 |
2/4/20 | When is an Informed Consent Truly Informed? | Christian Marks, PhD Director, Social and Behavioral Research Support Program |
2/11/20 | What Makes a Clinical Trial GCP Compliant? | Kimberly Brunton, RN, MSN Associate Director of Operations, Clinical Research Office |
2/25/20 | Surviving a Research Audit | Jennifer Smith, JD Quality Assurance/Quality Improvement Administrator, Office of Research Compliance |
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 |