The Florence Guide to FDA eSource and eRegulatory Compliance compiles 11 real questions sites, sponsors, and CROs have asked the FDA about electronic signatures, source data, monitoring, and recordkeeping — each paired with the FDA’s actual answer and a plain-language “Note from Flo” on what’s changed, including under ICH GCP E6(R3).

As it is our mission at Florence to simplify clinical trial document and project management, we also aim to provide sites and sponsors with a more natural way to access, understand, and apply the FDA’s guidance on eSource and eRegulatory. Currently, the FDA’s new published material is challenging to navigate and access.

To save you time and headache, we have created a library of those GCP inquiries regarding electronic processes in clinical investigations. Inside this library live the original questions, the FDA’s responses, and our summary of those exchanges.