Research sites are likely most familiar with traditional on-site monitoring, which requires monitors to conduct visits to check a high percentage of data, and ensure that everything is reported correctly. As clinical trials increase in complexity, on-site monitoring can become an inefficient and expensive process. In order to minimize cost and increase efficiency, Sponsors and CROs are considering several alternative solutions to complement monitoring strategies.

In 2011, the FDA released a guidance titled, “A Risk-Based Approach to Monitoring.” In these guidelines, the FDA acknowledged a growing consensus that risk-based approaches to monitoring are more likely than routine visits to all clinical sites to ensure subject protection and overall study quality. Since the FDA released these guidelines, sites have begun adapting to the changes in monitoring strategy.

As Sponsors and CROs explore different approaches to monitoring plans, it is important to remain aware of the variances and the impact each method will have on sites. Remote monitoring and risk-based monitoring are terms that are often used interchangeably; however, they are not synonymous. Remote monitoring does not indicate a risk-based approach and a risk-based approach does not always mean a study will include remote monitoring.

Remote monitoring refers to an approach where a clinical research associate (CRA) reviews data without physically being present at a site. In these studies, research sites must send all documents to the CRA to view, including source documents, labs or informed consent forms. The CRA will cross-check the information uploaded from the site with the information entered in the electronic case report form (eCRF).

When a remote monitoring plan is in place, any concerns regarding an increased workload should be addressed during the feasibility phase and there are important elements to consider during plan creation. How are documents intended to be shared with the monitor—will someone need to scan and send every document or upload them to a secure workstation? Will training be required to use a new technology platform?

Risk-based monitoring (RBM) is a strategy that includes performing a detailed risk assessment prior to study start-up, and tailoring a monitoring plan that mitigates the study-specific risks. A risk-based monitoring plan can include a combination of on-site as well as remote monitoring. A risk-based strategy recognizes a site’s ability to collect reliable data and ensure that internal quality processes are met. A RBM approach focuses on risks to crucial data elements that are necessary to achieve the study objective.

Targeted RBM focuses on specific data points that are typically defined before the trial begins. Data points, sites and events that may have the most risk are the focus for validation, rather than 100% source data verification. Triggered RBM can occur when certain events trigger comprehensive monitoring of particular endpoints or research sites. See Figure 1 for common triggers.

Risk-based monitoring plans rely on the ability of sites to enter data in a timely manner. These additional timelines can pose additional concerns and the benefits of adhering to them can far outweigh any downsides. When data is entered into an electronic data capture (EDC) system in a timely manner, Sponsors and CROs can provide feedback to sites in real-time, which allows for concerns to be addressed quickly.

Whether a study follows a traditional monitoring plan or will include a risk-based strategy, sites should be informed as early as possible. Once a site is aware of the strategy, resource needs and workflows can be considered. The time needed to perform certain tasks in order to adhere to the plan also need to be taken into account. Any impact this may have on a site budget should be identified early, and included in contract negotiations. Sites should be encouraged to evaluate new methodologies and be prepared to have documentation outlining what will be required for each study.

It is likely that sites will continue to notice a shift in the monitoring strategies implemented in each study. Fortunately, technology is making it possible for sites to adapt to these new approaches, and Sponsors and CROs are recognizing the importance of ensuring that sites are prepared to handle any changes in monitoring plans. The end goal is to produce more accurate and reliable data, increase patient safety and make the clinical trials process more efficient for all involved.

Dr. Christophe Berthoux has been the chief executive officer at Synexus since September 2010. Synexus is the world’s leading site management organization (SMO), dedicated to the recruitment and management of clinical trials across the globe for over 24 years. Synexus is proud to be the patient’s choice for clinical research. Email comments and questions to sarah@vanepercy.com.

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