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Over 400 pages answering 150+ questions sites have asked the FDA about using eRegulatory and eSource in clinical research.
Topics covered: Audits, Audit Trails, Case Report Forms, Certified Copies, Cloud-Based Software, Electronic Data Capture (EDC), Electronic Records, Electronic Services, IRB, Mobile Technology, Printed Copies, Scanning, Signatures, Source Files, Storage of Files, Trial Master Files (TMFs), Validation, and Other Topics
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.