The COVID-19 pandemic obliges sponsors and clinical researchers in general to conduct an impact risk assessment for their trials. If you are not sure where to start, or want confirmation of the accuracy and completeness of what you did thus far, then join this TRIUM live online workshop. We will share what questions to pose to cover the highest risks and will show an example risk assessment log, aligned with the TransCelerate structure, that can be used as a template or starting point.
By the end of this TRIUM Training you should be able to:
- List the official recommendation documents shared by the regulatory bodies
- Describe the key considerations and take-aways to ensure patient safety, data quality and overall compliance
- Start or continue your trial related risk assessment and management
- Prioritize actions taken per the highest risks identified
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.