A deep dive into essential documents and the regulations that govern them.  This session will follow the life cycle of key documents from start-up through maintenance and close-out for a Site, Sponsor and CRO, exploring ICH and GCP guidelines as well as the FDA CFR to understand their importance in filling voids in the Investigator Site File.  This session will also include suggestions and tools to help sites set-up and maintain their site file to be audit and inspection ready at all times.