By Steven Begley and Jamie Schimmel
What You Should Know About Risk-Based Evaluation Before Designing The Eclinical System For Your Clinical Program.
“Risk” is the watchword for sponsors working to comply with ICH E6 (R2), the 2016 revisions to the International Council on Harmonisation’s guideline on good clinical practices. At the heart of these changes is the imperative to manage the risks--to patient safety and data integrity--that are posed by eClinical tools and electronic data processes. While the revisions to the guideline mainly impact sponsors, technology providers and contract research organizations need to be aware of the changes and make adjustments to operational procedures, documentation practices, quality approaches and computerized system functionality.