This Suite of 3 courses covers how the US FDA Bioresearch Monitoring Program (BIMO) is organized and focuses specifically on the responsibilities of the sponsor and investigational site/primary investigator of a clinical study with an investigational medical device in the US.
This suite offers you a comprehensive illustration of the areas in which the US FDA BIMO will inspect during a bioresearch inspection at the sponsor’s location and at the clinical study site
Upon completion of this course, trainees will be able to correctly and successfully:
identify the types of audit outcomes that can occur, as well as the current issues and program enhancements that are affecting the BIMO program today
• Distinguish the particular areas of which the FDA will review during a bioresearch monitoring visit to the specific sponsor’s location, clinical study site and primary clinical investigator at the clinical site.
• Recognize and define the regulatory pathways in which human clinical research involving an investigational medical device is obtained.
• Demonstrate how the harmonized European Standard ISO 14155 relates to the US FDA BIMO program and why clinical sites located outside of the United States must comply with these US FDA regulations.