In this highly practical course we look at the root cause of typical inspection findings and work with delegates to develop personal corrective and preventative action plans. Through case studies, we will address challenging monitoring situations and develop strategies for investigator selection, fraud detection, improving patient recruitment and for motivating investigator sites. Delegates will explore how both technology and legislation will impact the role of the monitor.
We also discuss key principles in project planning and execution to allow experienced CRAs to begin to develop the skills required for a Lead CRA or Clinical Trial Manager role. Delegates will learn how to apply project planning principles to monitoring to improve efficiency.
It is recommended that delegates have a minimum of two years of monitoring experience.
• Describe the most frequent inspection findings
• Complete a root cause analysis and develop a corrective and preventative action plan
• Understand how key project management principles and tools apply to monitoring
• Participate more effectively in mentoring and co-monitoring assessments
• Develop strategies to address complex monitoring situations
• Develop a monitoring plan
• Identify key components of a typical clinical trial budget
• Current trends in clinical research
• GCP Inspection Findings - root causes and CAPAs
• Optimising Site Selection & Patient recruitment
• Fraud prevention and detection
• Maximising efficiency - yours and the sites
• Monitoring Challenges in Global Studies
• Preparing a site for Audit/Inspection
• Co-monitoring, Accompanied and Oversight Visits
• Developing and adapting monitoring plans
• Introduction to project planning and management
• Project definition, planning & tracking
• Managing stakeholders
• Budget management