[INFOGRAPHIC] ICH GCP E6 (R2) Addendum: Risk-Based Approach and What to Know

The new ICH GCP E6 guidelines with the R2 addendum are set to come into effect on 14th June 2017, and it is the biggest revision of clinical research guidelines in over 20 years. The guidelines encourage Sponsors to employ a risk-based approach to clinical trial monitoring, data management and preparing Clinical Study Reports.

ICH GCP E6 R2 Guidelines

As CROS NT specializes in the collection, analysis and reporting of data we can support companies in being compliant with these guidelines in the following areas:

  • Risk Management Plans
  • Regulatory Development Plans
  • A range of risk-based data collection tools (EDC) including partial SDV and Risk-Based Metrics which is a set of 28 reports built into an EDC platform to bring Sponsors quality metrics for more targeted monitoring, quicker resolution of problem areas and identification of poor performing sites.
  • Targeted Monitoring
  • Centralized Statistical Intelligence, a comprehensive data visualization tool that enables sponsors to see a risk score for each site, identify issues and track corrective action. It also allows full drill down of data including patient profiles. This technology identifies issues such as lack of variability or implausible values that go undetected using other approaches. It uses Principal Component Analysis (PCA) to convert p-values observations using statistical analysis to identify problematic sites rather than subjective thresholds.