rt_gcp_irbm

Basics of Good Clinical Practices for Institutional Review Board Members

Objective: To introduce, apply, and analyze internationally accepted guidelines for clinical research on humans, including those of the International Conference on Harmonization (ICH) and the Food and Drug Administration (FDA).
Selected Topics: Focus on Primary IRB Responsibilities, Ethics, and GCP Overview
Exercise in Informed Consent
Exercise in Trial Designs
Panel Discussion
Guidelines for FDA/ICH/GCP Acceptance Standard
Audience: Institutional review board members