Many trial sites think Risk-Based Monitoring (RBM) is only intended to reduce costs via fewer onsite monitoring visits, but in reality it often results in an increase in site workload. While RBM methods are still relatively new and there are several different approaches to implementation, adopting Risk-Based Monitoring does not have to mean an increased burden for a clinical trial site.
In traditional monitoring, sites typically enter data into the CRF just before the next on-site monitoring visit. Often, this may mean entering large volumes of data at one time, potentially resulting in a need for more resources to cope with that volume which diverts resources from other key activities. Additionally, due to the interval between on-site monitoring visits, these data will often be several weeks old.
In more modern Risk-Based Monitoring studies, sites are encouraged to enter their data into the CRF within a few days of the patient visit – regardless of when the next on-site monitoring visit is scheduled – reducing the volume to be entered at one time and, thus, resources required to complete the data entry. By making the data available to medical reviewers earlier, this transparency allows emerging risks to be identified earlier and improves both data quality and patient safety.
Of course, sites are under pressure to do more with less. Study coordinators must enter complex data as they navigate a dynamic range of online forms and automatic validations with limited assistance by a CRA on site. In a RBM study, sites that achieve high quality performance may receive less on-site support as risk-based tactics stretch time between on-site visits.
A site-centric approach
Although there will be a maximum interval between two on-site monitoring visits, our monitors help sites in getting timely answers as questions arise, rather than wait until the next on-site visit. It is our goal for the relationship between PAREXEL monitors and study coordinators to be open, supportive, and channelled through one point-of-contact handling all site concerns quickly and proficiently.
These relationships have evolved into positive interactions that build connections with PAREXEL staff and provide a better site experience. The PAREXEL monitors have all data available through integrated eClinical technology and are ready to help with issues as they arise, supporting the site in near real-time and preventing queries and issues building up with a corresponding increase in site workload. Close interactions promote data quality and patient safety, ensuring that queries and site contacts are conducted focusing on areas aligned with site priorities. This eliminates challenges associated with past approaches, which may have resulted in large numbers of queries on non-critical data that were time-consuming for sites.
By its nature, Risk-Based Monitoring should promote a closer relationship with the site as the focus shifts from traditional, after-the-fact correction, non-compliance monitoring, to a preventative, focused-on-quality approach. The intent is to identify risk, trends and outliers in the data early to prevent long-term issues that may affect data quality, patient safety, or the site’s reputation.