Challenges to the Implementation of Risk-Based Monitoring

Abstract

Regulatory agencies, multinational companies, and contract research organizations across the globe advocate implementation of risk-based monitoring (RBM) due to its perceived benefits, yet the pharmaceutical industry has yet to employ it on a full scale. Implementing the RBM strategy confidently and consistently among all stakeholders requires a shift in mindset from conducting 100% source data verification to a risk-based approach, cognizance of evolving roles, consistent understanding of RBM’s underlying principles and methodology, objective decision-making, and more regulatory guidance.