Conducting risk assessments is a key part of any clinical QMS and the first step into deciding the most efficient and effective monitoring strategies for your trial. The results of the risk assessment are used to decide on a risk-based monitoring strategy that suits the needs of the trial best. This TRIUM Session will ensure a proper understanding of the definitions of risks, risk management and risk-based monitoring strategies and plans and lists the different steps involved in conducting risk assessments to get you on the right track.
At the end, you will receive a certificate and handy hand-outs for later use.
By the end of this TRIUM Training you should be able to:
- Define risks, risk-based monitoring techniques and plans
- Describe the steps involved in conducting risk assessments
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.