- Sponsors adopt a risk-based approach in design and executive of clinical trials
- Increased safety for patients, increased vigilance of potential misconduct, better data quality and more efficient monitoring
- Sponsors do not totally outsource responsibility for the quality of and integrity of the data collected from sites
The ICH E6(R2) addendum states “evolutions in technology and risk management processes offer new opportunities to increase efficiency…(guideline) amended to encourage implementation of improved and more efficient approaches…”.
How can companies enable ICH E6(R2) compliance?
It works like a cycle.
Risk Identification and Evaluation (5.0.2, 5.0.3, 5.0.4, 5.0.5)
- Cross-functional IQRMP
- Prioritization of risks
- Creating indicators and critical data points
Risk Control and Review (5.0.4, 5.0.6)
- Data Visualizations
- Thresholds and email alerts
- Simple statistical methods
Data Driven Monitoring
Nature of Monitoring (5.18.3)
- Centralized Monitoring
- Site monitoring recommendations
Risk Communication and Reporting (5.0.5, 5.0.7)
- Recording issues and communicating actions
A specialized RBM solution enables a standardized approach, through a validated platform, so Sponsors can demonstrate good practice in place. The efficient combination of different data types then drives secondary value of data previously held in silos.
CROScheckTM combines leading statistical methodology with an easy-to-follow E6(R2) compliant workflow. It leverages information from Statisticians and Data Managers for the benefit of the CRAs by identifying the key risk indicators, pinpointing where to focus monitoring effort, and providing a mechanism to track corrective actions. It offers Sponsors of clinical trials an independent oversight of data coming from sites. Its key components are:
- Centralized Statistical Intelligence which gives Sponsors oversight of the quality of data coming from sites using Principal Component Analysis and assigning a risk score per site to highlight erroneous data and potential misconduct
- Risk Management Metrics which is a series of threshold reports in conjunction with EDC technology platforms to produce real-time reports on potentially problematical data
- Data Visualization and Analytics to have immediate visibility and comprehensive profiles of both sites and subjects