Focus on the things that matter … a risk proportionate approach to clinical trial management

A recording of the webinar held on Thursday March 21, 2024.

Both the finalised E8(R1) and the forthcoming E6(R3) emphasise the importance of using a risk proportionate approach to managing clinical trials.

Indeed, this was encouraged by the FDA, Health Canada and MHRA in their recent joint symposium.

This 2-hour webinar will cover:

• Prevention rather than cure, the new thinking … incorporating quality by design and critical thinking.
• Using risk assessment to manage issues occurring during trials.
• Identifying critical to quality factors and using these to focus on things that matter.
• Risk proportionate approach to data governance and using computerised systems.
• Sponsor oversight.
• Risk-based monitoring and the impact on data integrity.
• The importance of monitoring plans and SOP content.
• ‘Patients’ role in the development of clinical trials.