Risk-Based Site Monitoring

Course Description

In the current GCP regulatory climate, risk-based decision-making should be supported within the clinical Quality System. A management approach used in many industries where performance is critical under tight timelines for regulated activities, risk-based decision-making makes sense for such activities as sponsor monitoring in clinical research. Applying a risk-based approach to the monitoring and site management should be based on a given project’s risk profile. A risk-based approach can address current monitoring practices that are costly and ineffective, and help projects meet financial and compliance goals. This web seminar will present the concepts and case scenarios of risk-based monitoring (RBM).

Learning Objectives

• Recognize where risk-based decision-making fits into the clinical quality system
• Identify risks for a project related to monitoring
• Identify components to include in building the project profile risk score
• Apply risk factors to various study decisions, i.e., monitoring plan, site assignments, and frequency

Who Should Attend

• Site Research Managers
• Clinical Research Associates/Monitors
• Study/Clinical Research Associate Managers
• Sponsors/CROs

Instructors

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20participants 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.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

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#: 0778-0000-20-050-L01-P.Released: 3/20. 

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