Course Description

In an environment where remote monitoring and management techniques are becoming the daily practice, preventive measures need to be implemented to identify risks. You need to be able to identify protocol data thresholds and parameters for risks to establish management and escalation triggers. As data becomes available in real time, you should not be waiting to intervene until deviations become a “trend” before intervention is implemented; you need to know how to look for outliers and “red flags” on a daily basis. With the increasing use of CROs and vendors, it is essential that best practices are established for identifying risk signals in management and monitoring practices. In this web seminar, we will discuss how to detect risk signals in protocols, data, and monitoring based on risk-based quality management, industry guidances, and practical application.

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Learning Objectives

• Describe quality risk management and regulatory expectations based on industry and international guidance
• Apply proactive quality management techniques through signal detection and training for operational and scientific management of clinical trials
• Identify key risk factors, thresholds, and issues in protocols, reports, and data listings
• Apply signal detection techniques and preventive measures through hands-on application

Who Should Attend

• Clinical Research Associates
• Project Managers

Instructor

The course will be led by one of the following instructors:

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

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