By YourEncore Webinars
Developed and led by Liz Wool, Managing Expert with YourEncore’s Quality Center of Excellence, our team discusses the regulatory insights and practical guidance needed to modify and execute monitoring plans for remote monitoring in the COVID-19 era.
With the COVID-19 pandemic, sponsors and their CRO partners are rapidly determining the needs for their current and upcoming trials using a robust risk assessment, directing the Monitoring Plan modifications for site monitoring. International regulatory authorities guidances and local laws (e.g., privacy laws) impact the remote monitoring approach the sponsor or CRO is able to execute in specific regions and countries.
This webinar will address the similarities and differences between the FDA, EMA and MHRA COVID-19 guidances for remote monitoring and review what a monitor or CRA needs to do to prepare, conduct, and follow-up aspects of the monitoring activity, as well as the documentation.
1. Explain two similarities and two differences between FDA, EMA, and MHRA for site monitoring-related activities.
2. Describe what the monitor needs to be provided with regarding the monitoring plan modifications for COVID-19.
3. Identify what the monitor needs to assess before contacting a site for a remote monitoring visit.
4. Evaluate what the monitor will need to do for remote monitoring activities that includes planning, conduct, and follow-up.