In September 2021, the US Food and Drug Administration (FDA) published the first update to its Bioresearch Monitoring (BIMO) Compliance Program Manual for Sponsors and Contract Research Organizations since 2017. This document, which serves as FDA’s standard operating procedure for conducting a GCP inspection, is a critical resource for sponsors and CROs preparing for inspections.
Other than a change in fonts, what’s new? The manual has been restructured to be more intuitive. For example, Outsourced Services is its own section; Data Collection and Handling now directly proceeds Electronic Records and Electronic Signatures; the section formerly known as “Test Article” has been renamed “Investigational Product.” The manual also adds a significant amount of detail to the sections on safety reporting and data handling. Sponsors typically prepare to discuss these newly-enumerated issues during an inspection, but there are a few surprises. Overall, the impression is that FDA inspectors are putting the spotlight on process, more in line with their EMA counterparts.
Here are some highlights:
We’ll be looking at these new and expanded sections in detail in future blog posts. Meanwhile, download the updated manual here.