Risk Based Monitoring (RBM) is a clinical trial-monitoring method that was developed to fulfil regulatory requirements but moves away from 100% source data verification (SDV) of patient data. RBM, in theory, allows the Sponsor or CRO team to focus resources on specific trial-related matters that deal with potential issues with trial conduct, safety, data integrity, compliance and enrolment. RBM can have a centralized component.
Guidance for RBM was issued in August 2013 and the FDA is currently working on a Questions and Answers document for release this summer.
Now that Risk Based Monitoring has been utilized for several years, let us look at thoughts and concerns from the investigators and coordinators.
Thoughts on Risk Based Monitoring
The monitor plan is shared with most investigators during the Site Initiation Visit. However, the details on what the critical data and processes that, if not performed or done so incorrectly, would threaten patient safety or integrity of the data, are not clearly identified. Clear Identification of this critical data and of critical processes would provide more insight to the research team and help facilitate the development of site processes that meet the needs of both the sponsor and patient.
From the site perspective, centralized monitoring seems to be more labor intensive than on site visits. The requests for items to be copied and scanned has become overwhelming along with the deadlines for when the information is due. Although the centralized monitoring calls are scheduled at convenient times for both the monitor and the site staff, day-to-day activities at the site can change instantly.
One coordinator expressed that “experienced coordinators are being penalized by having the majority of monitoring visits be conducted centrally and therefore taking up valuable coordinator time.” Although experienced sites are not as likely to make errors that will compromise patient safety or data integrity, it feels as though the site is not valued by the sponsor.
One investigator stated that “I used to think of the monitors for the study as a safety net, looking out to ensure our site was audit ready. Now it seems that the monitors are only concerned about the data and do not identify issues outside of the critical data and processes.” GCP violations can occur without identification due to the RBM plan.
Although Risk Based Monitoring may be an efficient way to monitor a study from the sponsor’s perspective, the investigators and coordinators are left feeling undervalued and overworked.