By Olubukola Oseni, inSeption Group
Risk-based monitoring (RBM) commonly is conflated with remote monitoring or is assumed to eliminate on-site monitoring. In fact, all clinical trials require some on-site monitoring, and remote monitoring is just one element of RBM. Additional misconceptions surrounding RBM include diminished data quality, disruptive process changes, or inconsistency across operations. Also, RBM is sometimes believed to diminish trial oversight, when it actually increases overall trial oversight. It balances “must do” data collection and “nice-to-have” data against site and patient burden — and, more important, patient safety
However, all this flexibility introduces the challenge of change management when implementing RBM. Moving away from well-established monitoring parameters changes the mindset and processes for various stakeholders in the company. So, it involves overcoming resistance to change and managing the transition effectively through collaboration between the sponsor, each site, the CRO, and regulatory agencies.