Remote- and Risk-Based Monitoring Reduce the Need for CRAs in Clinical Trials 
​[Posted on: Thursday, 21 January, 2016] 

Clinical monitoring is the most expensive component of a clinical trial. More than half of the total budget of a given clinical trial is allocated for monitoring costs. Monitoring is essential for source data verification (SDV). Additionally, up to 80% of the time spent to manage a trial goes into the logistics and execution of monitoring. The CRAs (clinical research associates) tasked with monitoring account for more than 60% of a clinical trial team. This all may change in not so distant future. Two new regulatory processes – remote monitoring and risk-based monitoring are expected to contribute to the changing paradigm of clinical monitoring. In August 2013, FDA released its guidance on Risk-Based Monitoring, which emphasized the need to reduce on-site SDV. Through the guidance document, FDA emphasized use of electronic medical records to remotely verify source data. FDA recommended “Centralized Monitoring” whereby the monitors could remotely conduct SDV, provided the processes and expectations for site record-keeping, data entry, and reporting are compliant with 21 CFR Part 11. It was recommended to automate SDV where possible, and implement criteria for risk-based on-site monitoring. This was not a new concept; it had been published previously that remote access of electronic medical records could greatly reduce the resources needed for monitoring without compromising quality. In clinical studies, it was found that more than 99.5% of the source data could be monitored remotely. Only about 0.12% of the times study coordinators were needed to help the monitors, meaning that given access to all the source documents, the monitors could verify practically the entire source data on their own. Since, 2013, electronic data capture and electronic medical records have become almost universal. Even informed consent is increasingly being conducted electronically. The number of companies offering centralized remote monitoring has increased exponentially. So, this brings in a fair question; are the CRAs soon to be extinct? There is no simple answer. Even with remote monitoring, CRAs are needed for SDV, albeit fewer in number due to reduction of travel and logistics. Remote monitoring encourages international outsourcing further reducing the costs. Your remote monitors for a trial in the US could be located in India. Some estimates put CRA work-force reduction to a more modest 10-20% over the next 5 years, while others are more aggressive. No matter the days of CRAs visiting sites for SDV seems to getting over.