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