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. Regulatory authorities promote these alternative ways of monitoring trial data and the future is likely to include a more hybrid monitoring approach.
This highly interactive course, which includes group discussions, ensures that monitors not only understand the importance of compliance with the latest GCP standards but also gain insights into how new monitoring approaches are shaping the future of clinical trials.
Benefits of attending
- 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
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
Who Should Attend
- Monitors
- Clinical research associates (CRA)
- Clinical trial managers
- Study coordinators
- Project managers
- Research nurses
- Study site assistants
- Those responsible for oversight of monitoring
- Investigators seeking to move into clinical trial monitoring
This course will benefit those involved in the monitoring of clinical trials, including new and soon-to-be monitors. This will also be an ideal refresher including how monitoring has changed because of the pandemic and those responsible for oversight of monitors.
