Adoption of ICH E6(R2) Risk-Based Quality Management approaches has brought significant changes to the site monitoring processes. The processes have changed – how do you evaluate and manage these new monitoring approaches? Do metrics used to oversee “traditional” site monitoring processes still apply? The industry needs come together to develop a new set of standardized metrics that align with the new emerging approaches of risk-based site monitoring. MCC is launching a new work group to develop a comprehensive set of performance metrics in this important area. During the initial info gathering stage, we welcome participation of member and non-member stakeholders through an online survey. Specifically, the survey gather input on high level processes, current process issues, and current metrics utilized to oversee and manage the processes. We will provide those who complete the survey with an executive summary recap of the results.
CLICK HERE to complete the survey by 10-Oct-2019.
The MCC work group will convene for an online meeting on 17-Oct-2019 at 10 am EDT. During the meeting, we review survey results and discuss the following aspects related to the process of centralized, remote and site monitoring:
- What does the high-level process look like?
- What are the process issues organizations are encountering?
- What are the important questions that we want metrics to help us answer?
REGISTER NOW – Open to public
For additional information about this new work group, please visit the Centralized and Site Monitoring Metrics work group page.