Applied Clinical Statistics in Risk-Based Monitoring

With the release of FDA’s guidance on risk-based monitoring (RBM), the FDA is requiring centralized monitors to have adequate training to perform centralized monitoring activities. Moreover, with the increase in the availability of clinical operational data, and with more biopharmaceutical and medical device enterprises outsourcing, clinical operations teams need to have the necessary skills to centrally and efficiently monitor and manage their clinical trials. This web seminar will provide a brief background as to how the industry is changing, address why centralized and RBM is gaining importance, and offer applied clinical statistical training and tools that can be utilized towards centralized clinical trial monitoring applications and identifying site underperformance. These tools are also flexible towards clinical business operations. Attendees will learn to interpret and graph histograms, quantify risk in histograms and datasets, identify clinical trial underperformance, and utilize minimum random sampling for RBM in histograms and datasets.

• Describe the role of centralized monitoring
• Interpret P-values, histograms, and confidence intervals and distribution
• Identify risk and clinical trial underperformance

• Clinical Operations Personnel
• Clinical Affairs Professionals
• Clinical Research Associates
• Principal Investigators
• Clinical Research Coordinators
• Subject Enrollment Managers
• Research Nurses and Scientists
• Clinical Project Managers

Moe Alsumidaie, M.B.A., M.S.F.

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$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-15-084-L01-P. Released: 9/15. 

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