Definition

FDA's program for inspecting clinical trials, including sponsor oversight of safety reporting, investigator compliance, and IRB operations.

Example

BIMO inspection of the sponsor examines: SAE reporting procedures, safety monitoring, protocol compliance, and oversight of clinical sites for a Phase III trial.

Regulatory source

FDA BIMO Program

Common mistakes

Not maintaining adequate documentation of sponsor oversight activities at clinical sites.

Inspector question

Describe your sponsor oversight program. How do you monitor site compliance with safety reporting?

Related terms