With regulators supporting the concept of risk based monitoring on the basis that it enhances data quality, Sponsors are giving more attention to RBM, particularly for larger studies. At the risk planning stage, CROS NT can provide statistical support in determining the critical data and the establishment of thresholds.
As data comes in our statisticians can analyze the metadata, outliers and intra-site information to determine areas in most need of monitoring. The feedback we can provide enables the monitors to work more efficiently, deploying their effort where it is most needed. We can also provide valuable oversight for Sponsors.
CROS NT SOLUTIONS
CROS NT can provide Risk-Based Metrics during a study that give CRAs the necessary information on which sites need attention most and which areas. This approach relies on close collaboration between the Data Manager and CRA. It results in more targeted monitoring, quicker resolution of problem areas, and identification of the least well performing sites.
CROS NT’s Risk-Based Metrics solution includes a set of 28 standard reports built into an EDC platform to bring Sponsors quality metrics that improve site performance.
The Risk-Based Metrics approach includes:
- Risk-Based Metric Plan Document
- Risk-Based Metric Report Document
- Metrics development including metrics programming and validation in the EDC system
- Data Management activities: definition of Sponsor requirements, development and maintenance of RBM report, ongoing review of metrics