This practical course defines the role of the clinical research monitor and explains the interaction with others in key roles as part of the clinical trial process as well as exploring the more complex aspects of clinical trial monitoring. Guidance will be given on best practices for selecting investigators, conducting monitoring visits and safety reporting. Delegates will explore strategies for dealing with common clinical trial management issues and how to adopt a preventative approach to handling monitoring issues. The course uses a blend of trainer input, exercises and delegate interaction.
• Define the roles and responsibilities of Monitors, Sponsors, Investigators and Ethics Committees
• Describe the key criteria for selecting investigators
• Summarise the preparation, conduct and follow-up of the major types of monitoring visit
• Define the requirements for safety reporting
• Prioritise tasks
• Apply risk based techniques to monitoring
• Refresher on the purpose of GCP
• Roles and responsibilities of monitors, investigators, & sponsors
• Investigator selection
• Preparing & conducting pre- study visits
• Preparing and conducting initiation visits
• Conducting monitoring visits
• SDV
• IMP
• Safety reporting
• Informed consent
• Monitoring visit reports
• Prioritising activities
• Preparing & planning close out visits
• Essential Documents