Traditional monitoring requires 100% SDV where data quality is checked at the site according to a monitoring plan. With the implementation of the ICH GCP E6(R2) addendum (the biggest change in the ICH guidelines in 20 years), Sponsors are looking to adopt a more risk-based approach to monitoring which means data quality, integrity and patient safety should be achieved by combining several approaches:
1. Supervised Analysis: based on risk indicators and a definition of thresholds
2. Remote manual data review based on pre-decided KRI/KPI
3. Adaptive SDV: setting up different SDV according to data quality
Risk Management Metrics changes the way we look at data. The fundamental idea is to monitor data taking into account risk factors and categories to track study progression and solve critical situations.
How can companies align themselves with the new guidelines?
- Quality by Design thinking
- Risk Assessment, Measurement, Action
- More focus on quality management, data analytics and centralized statistical monitoring
What is involved in Risk Planning?
- Understanding the elements related to the protocol which are of significant importance such as study design, regulatory submission, subject safety and subsequent analysis for future trials
- Thresholds and mitigation plans