Purchase the recording of a web seminar you have attended in the past and SAVE 50%! Contact Barnett Customer Service for details: +1 781.972.5400 or toll-free in the U.S. at 800.856.2556.
Web Seminar Archives provided through Barnett’s Learning Management System (Single User access) or by electronic file transfer (Site License).
Site license archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.
Bulk Archive access is available via Barnett’s Training Subscription. Click here to learn more.
Archive: Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective
Course Description
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.
Video Preview
Learning Objectives
- 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
Who Should Attend
- Clinical Research Associates
- Clinical Research Associate Managers
- Project Managers
Instructor
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.
