Course Description

With the need to “shelter in place” and reduced social interactions due to the COVID-19 pandemic, it is more important than ever to look at ways to manage the conduct of clinical trials remotely, in real-time. Sites have had to modify strategies to manage patients in clinical trials and sponsors/CROs need to adapt quickly to meet obligations to the FDA and the general public to ensure trials are conducted under GCP. With sponsors/CROs focusing on expanding approaches to monitoring remotely, this web seminar will evaluate process and documentation, explore techniques for identifying issues at sites remotely, and examine the regulatory expectations for managing compliance. Better utilization of remote monitoring is critical to ensure sites are compliant and the data is accurate and consistent. Strategies for remote monitoring will be addressed, including the review of data trends, remote study management and communication, and “red flags” that may indicate issues on site.

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Learning Objectives

• Evaluate development of monitoring plans through protocol analysis for remote risk management
• Discuss tools and risk evaluation approaches for remote monitoring
• Explain techniques for practical corrective and preventive actions to ensure clear communication and resolution and documentation of issues

Who Should Attend

• Clinical Research Associate Managers
• Clinical Research Associates
• Project Managers
• Clinical Trial Managers
• Study Coordinators

Instructor

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.