In 2016, MCC conducted an industry survey that examined organizational approaches and e-data sources driving centralized monitoring programs. With the adoption of ICH E6 (R2), MCC is conducting a new survey in order to assess how Centralized Monitoring is being implemented across organizations. MCC is soliciting your feedback about how responsibilities are distributed, the impact on study plans, approaches to KRIs and other methods of assessing data, and whether organizations have experience with regulatory inspections of studies using Centralized Monitoring. Specifically, the survey questions explore the following areas:
- Project/protocol-level risk assessment practices
- Definition and purpose of centralized monitoring
- Centralized monitoring adoption
- Centralized monitoring sourcing strategies
- Centralized monitoring roles and responsibilities
- Documents prepared for each study using centralized monitoring
- Data sources used in centralized monitoring
- Data analytic approaches
- Key risk indicator utilization (number and types)
- How key risk indicator action levels are established
- Utilization of quality tolerance limits
- Experience of regulatory inspections on studies with CM
The survey should take approximately 10 minutes to complete and all survey responses will be kept confidential. A summary of the results will be available to those who complete the survey and provide their contact details.
Please forward this survey to any colleagues who are responsible for the areas covered in the survey.