Clinical Trial Monitoring

With regulatory inspectors increasingly finding GCP issues with monitoring clinical trials, it is becoming even more important for the biopharmaceutical industry, study sites, and CROs to employ efficient and accurate strategies for monitoring clinical trials.

Also, the global COVID-19 pandemic has changed the ways clinical trials are monitored and resulted in remote and centralized monitoring techniques at the forefront of monitoring. This has created an environment that requires monitors to not only purely focus on-site visits. These alternative ways of monitoring trial data are promoted by regulatory authorities and the future is likely to include a more hybrid monitoring approach.

This course will assure monitors understand the importance of compliance with latest GCP standards, and how new monitoring approaches in clinical trials are being employed for the future.

Key Objectives:

Ensure GCP compliance for monitoring clinical trials including during Covid and monitoring approaches for the future
Evaluate the development of monitoring plans through protocol analysis for remote risk management
Discuss tools and risk evaluation approaches for remote monitoring
Ensure appropriate site selection, initiation, monitoring, and close out visits are carried out including during a pandemic.
Review sponsor and CRO oversight of monitors