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Archive: The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring
Course Description
Strategies for saving time and money, without compromising oversight and quality, are an ongoing challenge within the industry. In an age where technology is ever present from ordering medications online, consulting with a physician, and having “live” conversations in chat rooms about medical issues, the clinical research industry has been slow to maximize the use of technology. With sponsors/CROs implementing the FDA’s final guidance on a risk-based approach to monitoring, time on site is being reduced to one day visits and/or on-site visits are scheduled few and far between per monitoring plans. Better utilization of remote monitoring is critical to ensure sites are compliant and the data is accurate and consistent. During this web seminar, strategies for remote monitoring will be discussed, including the review of data for trends, how to make the most of writing queries, and what “red flags” to look for that may indicate issues on site.
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Learning Objectives
- Describe approaches and techniques for remote data review
- Explain techniques for query writing to ensure clear communication of issues
- Implement strategies to identify problem areas and how to maximize time on site following remote monitoring
Who Should Attend
- Study Coordinators
- Clinical Research Associate Managers
- Clinical Research Associates
- Project Managers
Instructor
Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.
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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.