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.
Learners can earn a certificate of completion upon attending all workshops. The first workshop must be attended live. A maximum of two workshops can be completed via recorded video before the next live workshop.
Workshops:
February 1
Surviving Research Audit
Richard J. Karalus, PhD
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February 8
ICH, GCP, CFR, ISO: Making Sense of this Soup of Acronyms
Sanjay Sethi, MD
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February 15
What Makes a Clinical Trial GCP Compliant?
Kimberly Brunton, RN, MSN
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February 22
When is an Informed Consent Truly Informed?
Christian Marks, PhD, CIP
Dr. Hannah Norris
Email: hlnorris@buffalo.edu
Phone: (716) 829-6268