Risk-based approaches to monitoring (RBM) in clinical research1, 2, characterized by more cerebral operations with focus on critical processes and data components, are growing in popularity.
The FDA has cleared for marketing a medical cooling device from Lund, Swedenbased Dignitana. Digitana engaged Target Health as its CRO, using its web-based eSource-enable EDC system to collect direct data entry from patients. According to Target Health, this is the first product to be approved using in its pivotal trial, direct data entry of patient data at the time of the clinic visit into an EDC system, with no need for paper records.
Dr. Jules Mitchel, President of Target Health, speaks at DIA 2015 in Washington DC.
This article proposes a practical risk-based monitoring approach based on published statistical evidence addressing the impact of database changes subsequent to Source Document Verification (SDV).
The benefits of eSource data: collecting data digitally without having to record the data on a piece of paper first.
From CBI Conference, March 2015: Impact of Risk-Based Monitoring and eSource Methodologies on Clinical Sites, Patients, Regulators and Sponsors
When original data are captured through validated electronic systems, there is no need to perform source document verification (SDV)> The key to regulatory compliance becomes the availability of validated, independent, contemporaneous copies of source records.
Experience from Phase 3 Study Using Risk-Based Monitoring and eSource