It has been more than five years by now that the risk-based approaches were introduced and recommended to be used, and even became mandatory for the conduct of clinical trials. However, in real life still a lot of sponsors and sites struggle with its implementation. This mostly due to lack of understanding of its strategies and implementation, making people think it is too complicated and expensive.
This TRIUM training provides insights into the strategies and steps to follow for setting up a company-wide risk management plan that can be used for all trials, including tips on ensuring a successful change management process and stakeholders’buy-in. Next the outcome of the risk assessments done as per the risk management plan will be translated into a lean, feasible and affordable risk-based monitoring plan. The trainer, who is a strategic risk-management consultant in real life, will share real case studies and examples to ensure proper practical understanding. Risk-based approaches can be simple and affordable, whiles ensuring a healthy ROI after the initial investments of time and resources. Risk management does not have to be costly and daunting, in other words, it is not a risk but an opportunity to ensure efficiencies. You should be equally convinced of this after this training as the trainer.
By the end of this TRIUM Training you should be able to:
- Define risk management and risk-based monitoring
- Describe the strategies and steps for creating a risk management plan
- Write a risk-based monitoring plan based on the risk assessments following the company wide plan
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.