Why EDC and RBQM Work Better Together in Clinical Trials
Electronic data capture (EDC) systems are essential for organizing and managing clinical trial data. However, when it comes to identifying and managing risks, they often fall short. As the ICH E6(R3) revision emphasizes a proactive approach to quality management, relying solely on EDC can result in gaps that affect trial performance and compliance.
This is where a risk-based quality management (RBQM) platform like the MyRBQM® Portal complements EDC systems, providing efficient oversight and reducing operational burdens.
EDC Systems and Their Limits
EDC systems are built to do what they do best—collect, store, and organize clinical trial data with precision. However, EDC typically captures only around 50-70% of clinical trial data, focusing mainly on CRF (Case Report Form) data. The remaining data resides outside the EDC, including information from systems like CTMS, ePRO, lab data management systems (LIMS), and imaging platforms. They ensure that data entries are accurate and consistent across the board, but this partial coverage limits comprehensive oversight. When it comes to spotting early warning signs, such as patterns that indicate a site might be struggling or trends that suggest potential risks, EDC systems fall silent.
To fill this gap, many clinical teams rely on creating hundreds of edit checks—rules designed to flag data inconsistencies. At first glance, this may seem like a wise safeguard. But as trials become more complex, these checks can become a double-edged sword. Each new rule adds layers of maintenance, slows down processes, and generates a flood of system queries—many of which highlight minor issues rather than meaningful risks. Instead of creating clarity, this approach can bog teams down, diverting valuable time and resources away from what matters most: ensuring trial quality and patient safety.
Why Relying on Edit Checks Alone is Inefficient
- More extended Study Setup: Creating and validating hundreds of edit checks during study design delays trial launch.
- Ongoing Maintenance: Edit checks require constant updates as protocols change, increasing the time and effort needed to manage the system.
- Increased Query Volume: Edit checks often lead to excessive queries, many of which flag minor inconsistencies instead of meaningful risks.
- Limited Focus: Static edit checks validate data points individually rather than monitoring broader patterns or site-specific trends.
How RBQM Platforms Enhance EDC Systems
RBQM platforms improve EDC systems by transforming stored data into actionable insights that support more insightful oversight and risk mitigation. Here’s how RBQM platforms address key challenges:
- Risk Identification: Tracks trends in EDC and other connected data to highlight areas that may require intervention.
- Targeted Protocol Monitoring: Provides reports that allow stakeholders to monitor compliance, subject data, and site performance without sifting through raw data.
- Regulatory Preparedness: Aligns processes with regulatory expectations, making it easier to meet ICH E6(R3) requirements.
MyRBQM Portal: The Preferred RBQM Platform
Unlike EDC systems, which primarily handle CRF data, the MyRBQM Portal connects to various data sources such as CTMS, ePRO, LIMS, and imaging data to provide a unified view of all critical trial information. While many RBQM platforms offer general solutions, the MyRBQM Portal stands out by providing features designed explicitly for GCP-compliant clinical trials:
| Feature | EDC Systems | Generic RBQM Platforms | AI-Augmented MyRBQM Portal |
|---|---|---|---|
| Data Collection | Accurate CRF data capture | Data imports only | Real-time integration with all clinical data sources |
| Risk Detection | None | Limited pattern tracking | Proactive detection, historical, and predictive data views |
| Protocol Monitoring | Manual checks | Basic tracking | Protocol complexity assessment and optimization |
| Audit Readiness | Raw data logs | Limited audit trails | Full traceability with multi-timestamp records |
| Collaboration | Static reports | Some real-time features | Multi-user collaboration for synchronized workflows |
| System Reliability | Stable data storage | Varies | Handles large datasets and complex queries efficiently |
Moving Beyond Edit Checks to Smarter Oversight
With the ICH E6(R3) revision reinforcing the need for proactive quality management, relying solely on EDC systems with hundreds of edit checks is no longer practical. The MyRBQM Portal bridges the gap by providing a streamlined, compliant solution that enhances trial oversight and reduces unnecessary complexity.
Why EDC Alone Falls Short of Meeting ICH E6(R3) Requirements
While EDC systems play a vital role in collecting and storing data, they are not equipped to provide the full spectrum of risk oversight required by ICH E6(R3), which emphasizes proactive risk management, transparency, and collaboration. Here’s how the MyRBQM Portal supports a complete risk management process and bridges the gaps left by EDC systems:
- Predictive Analytics for Smarter Decisions: The MyRBQM Portal uses machine learning-driven predictive analytics to forecast potential risks at every level of the study. This allows study teams to anticipate issues before they arise and take preventative measures, which static EDC data cannot provide.
- Risk Level Drill-Down Dashboards: The platform’s user-friendly dashboards offer drill-down views by risk, risk category, or across all categories. Teams can navigate from a high-level study overview down to individual patient-level data to understand how risks vary across locations and subjects. This enables precise identification, assessment, and mitigation of risks at every level.
- Transparency and Historical Data Views: The portal captures each data point with three timestamps, allowing users to review how data appeared at any point in time and see the progression of risks and mitigation efforts. This ensures teams can trace how decisions influenced study outcomes and refine future strategies accordingly.
- Data Verifiability: Meeting ICH E6(R3) expectations requires more than just accurate data—it demands that data be fully traceable. The MyRBQM Portal time-stamps each data point’s recording, import, and system entry, providing a verifiable history that supports thorough reviews and builds trust in data integrity.
- Audit-Friendly Design: Comprehensive audit trails are a must for regulatory inspections. The MyRBQM Portal documents every data transformation and decision, ensuring that the entire risk management process—from identification to mitigation—is fully auditable. This eliminates the guesswork often associated with reconstructing decision-making processes using raw EDC data.
- Protocol Complexity Assessment: The platform’s AI-enhanced assessment tools highlight areas of the protocol that could pose risks to patient safety, timelines, or budgets. By identifying these complexities early, teams can refine their protocols and avoid costly delays—an essential capability that standard EDC systems cannot offer.
- Real-Time Collaboration: The MyRBQM Portal enables cross-functional teams to collaborate in real time, ensuring that all stakeholders can review and act on updated data without delays. This is especially crucial for effective risk mitigation, as decisions often require input from multiple departments. EDC systems, by contrast, typically lack the collaborative features necessary for simultaneous, informed decision-making.
