The MCC Centralized and Site Monitoring Process Metrics Work Group – comprised of more than 300 individuals representing over 60 organizations – worked collaboratively from December 2019 to March 2021 to develop the assets contained in the Centralized and Site Monitoring Process Metrics Toolkit v1.0. Recent regulatory guidance (FDA, EMA, ICH E6 (R2)) has led to significant changes in the approach to monitoring clinical trials. Concepts such as risk-based monitoring, targeted site monitoring, and centralized monitoring have been implemented in various forms at organizations in the industry. The metrics used to manage and oversee the process should align with the process itself – and so, as the process has changed significantly, a Work Group was formed to define metrics to oversee, manage and assess the new approach. The Work Group aimed to develop standardized metrics for this new process in order to:
- Facilitate comparison / benchmarking across industry
- Monitor processes and identify process improvement opportunities
- Provide objective evidence of impact of process improvement efforts
- Ensure the use of a balanced set of metrics (i.e. measure more than just “time”)
Additional metrics will be added to the metric toolkit in early 2022 when the group completes its review of the monitoring process.
More about this group can be found by visiting the MCC Centralized & Site Monitoring Process Metrics page. MCC members can access the toolkit by logging in to the member portal.
Not a member? Contact Terry Holland, MCC Membership Director, to discuss membership options.