Now that paper records are disappearing from the clinical trial landscape, functionalities of the clinical trial enterprise should be easily available at one website and with one login. While documents can sit in the trial master file (TMF), access to the EDC system should be seamless from the time that the patient electronically signs the informed consent form (eICF).
From CBI Conference, March 2015: Impact of Risk-Based Monitoring and eSource Methodologies on Clinical Sites, Patients, Regulators and Sponsors
Avoiding resistance and inefficiencies when there are new ideas and new opportunities, and experience from the real world.
Experience from Phase 3 Study Using Risk-Based Monitoring and eSource
Slides from Society for Clinical Trials, The goal of this CTTI-sponsored project was to describe current clinical monitoring methods for a range of clinical trial types, and to explore the rationale for the use of those methods.