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. Two quality experts will share what critical questions to pose to cover the highest risks through an example risk assessment log, aligned with the TransCelerate structure, that can be used as a template or starting point. This log is included in the price and will be shared during the training with each attendee.
In this repeat session emphasis will be laid on up to date regulatory body expectations and the expected status of the risk assessment after weeks of COVID-19 measures. We also ensure plenty of opportunity for questions and discussions through open mics. Attendees say this was ‘Timely, to the point and very helpful’!
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.