Clinical trials are not nice neat compartmentalized studies that occur in one lab. They tend to be massive projects that cover as many as 500 different sites – that means 500 locations producing data for collation and analysis. Instead of looking for a needle in a haystack, monitors have to tear apart 500 different haystacks looking for the one errant needle.
Historically, monitors went from site to site to investigate potential problems and make sure everything was running as planned. Electronic data capture and risk-based monitoring have changed the way monitors function to improve processing, reduce backlogs and enhance clinical studies.
The Stages of Risk-Based Monitoring
Risk-based monitoring isn’t a new concept, but in the last few years, it’s been better defined and formalized. RBM serves two purposes:
- Control the data quality
- Ensure patient safety
The risk isn’t about something bad happening, it is about determining potential. Risk-based monitoring implementation starts with an evaluation of the study. As part of the risk assessment, specific sources of risk are identified and the effect they have may have on the study investigated.
Sponsors and monitors assign a measurement method and target the monitoring activities like Source Document Verification (SDV). The monitor also evaluates each site to decide where monitoring will best serve the study.
Through the use of electronic data capture, monitoring is no longer 100 percent SDV. With dynamic monitoring options, sponsors can selectively mark different forms of SDV to identify critical data and processes.
The second stage involves developing a monitoring plan. The most recent Food and Drug Administration guidance defines the monitoring plan as:
- Monitoring methods
- Monitor responsibilities
- Requirements of the trial
In 2013, the FDA stated in their final guidance for risk-based monitoring that a focused approach to managing risks is necessary to achieve a study’s objectives. The plan communicates the potential risks and defines the monitoring procedures to manage them. With effective EDC, monitors spend less time on sites and on SDV. Data management allows them to use monitoring time more efficiently by providing:
- A central source review – Improves the sponsor’s ability to ensure the quality of the data and detect anomalies.
- Centralized monitoring – Provides reports highlighting questionable data and high-risk sites
EDC System Enablement
Thanks to robust EDC systems built to manage RBM efficiently, monitors avoid days of sorting through piles of data pinpointing entry error and creating queries, as well. That time is spent managing high-risk scenarios. OmniComm leads the industry in providing advanced risk-based monitoring solutions.
The three core components of our RBM solution work together to provide study teams with the technology and support they need to best utilize risk-based monitoring.
1. TrialMaster EDC – Customers utilize advanced RBM capabilities provided through TrialMaster to:
- Configure and actively manage diverse, targeted SDV/SDR plans
- Centrally monitor key risk indicators (KRIs) and identify emerging risks across sites and subjects
- Remotely monitor selected source documents
- Integrate seamlessly with best-in-class 3rd-party RBM and centralized reporting tools
2. RBM Enablement Services Consulting - Guided by extensive clinical research and development and RBM expertise, OmniComm will enable your organization with a simple, smart methodology to ensure RBM success on an accelerated timeline.
3. Key Risk Indicators Report (KRI) Delivery Services – We understand the key role that centralized analytics and KRIs play in an effective RBM implementation. Ensuring that KRI’s are selected and configured to ensure both optimal reliability and early issue detection is critical to success. Based on your team’s needs, we will develop and deploy highly effective KRI reports accessible directly within TrialMaster.
The decision to use risk-based monitoring was a drastic one for the industry, but essential to managing the need for 100 percent source data verification while still reducing monitoring costs. EDC solution providers were challenged to meet the industry’s growing and changing requests for systems to match their needs.
Leveraging EDC technology allows studies to meet both the letter of the new FDA regulations regarding risk-based monitoring and save time on monitoring costs like travel, accommodations and direct payments.