The US Food and Drug Administration (FDA) has a comprehensive program of on-site inspections and data audits to monitor the conduct of reporting of FDA-regulated research. The aims of these programs are to provide uniform guidance and specific instructions for conducting clinical investigator inspections and to gather evidence to support the regulatory decision-making process. This course is designed to help clinical investigators understand the goals of the inspections, prepare for them, and how to conduct any post-inspection follow-up.
- Understand the history and importance of the Bioresearch Monitoring Program
- Understand the difference between routine and for cause inspections
- Discover best practices for preparing for an inspection, participating in an inspection, and following up after the inspection.
By completing/passing this course, you will attain the certificate Advarra Completion Certificate
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