Changes to ICH-GCP requirements— in the form of ICH-E6(R2) — and adoption by regulatory agencies are expected to impact processes and operations in the clinical research industry. A new survey from eClinical Forum, in partnership with OmniComm Systems Inc., highlights the current state of implementation of ICH-E6(R2) and RBM in various segments of the clinical research industry. The survey results pointed to a sharp divergence in implementing ICH-E6(R2) and adopting risk-based approaches to monitoring between large sized and non-large organizations.
I strongly believe that simplicity is key to successful implementation of Risk-Based Monitoring for any organization. I have unfortunately seen too many organizations unintentionally over-engineer processes at their first attempts, particularly in areas such as the pre-study risk assessment and risk identification. The start-up period of a study is a very busy time for cross-functional study teams, so organizations implementing Risk-Based Monitoring need to make sure they don’t create a resource- and time-heavy process which will increase burden and may actually contribute to increased risk.