The regulations require that sponsors ensure the selection of qualified monitors and the proper monitoring of clinical investigations. However, sponsors are frequently cited by the FDA for failure to meet those requirements. These regulatory communications note that although monitors might have identified issues, they did not appreciate the significance of those findings. As a result, opportunities to promptly secure compliance might be missed.
Clinical research is structured to incorporate monitoring processes more frequently than auditing. Yet as monitoring integrates a risk-based approach, monitors can utilize many auditing techniques to assist them in more effectively performing their tasks and meeting their obligations. This web seminar will explore the processes for critically reviewing findings to discern the implications and impact on subject safety and data integrity.
- Utilize auditing techniques when performing monitoring tasks
- Define “proper monitoring” and who is responsible for its conduct
- Discuss monitoring findings within the context of regulatory risk
- Review standard monitoring report templates and discuss ways to adapt them to develop a compliance assessment
- Describe processes for discerning patterns in information reviewed
- Explore methods for developing monitoring tools that facilitate a systems review and communication
- Clinical Research Associates
- Clinical Research Associate Managers
- Project Managers
Elizabeth Ronk Nelson, M.P.H.
Click here for complete trainer biographies
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.