Clinical Trials Risk Management

1. Clinical Investigators
2. CRAs/Monitors
3. Clinical Trial Managers
   
4. Sponsors
5. Compliance specialists
6. Regulatory Affairs professionals
7. Students and academic staff
8. Risk Management Staff

1. What is risk management and is it worth the effort?
2. Regulatory background to risk management – ICH Q9
3. Basic principles of risk management
4. Utilising risk management methodology in a clinical trial including usual risk triggers
5. How to get started
6. Documenting risks
7. Identifying mitigating actions and managing them
8. Risk management when CROs and/or other contractors are involved
9. What next?

This training is also available as a corporate solution, which allows professionals with administrative functions, such as R&D, Training, QA, Clinical Operation, HR Managers, to manage and monitor the whole learning process/curve:

1. licences and access management
2. performance statistics and outcomes
3. certificate management
4. reports