rt_gcp_pi

Basics of Good Clinical Practices for Principal Investigators

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 PI Responsibilities, Ethics, and Study Design
Exercise in Informed Consent
Exercise in Trial Designs
Analysis of Scientific Publications
Guidelines for Trial Document Completion and Acceptance
Audience: Principal investigators