Risk Based Monitoring
Join the Program on Risk Based Monitoring (RBM)
Develop a deep understanding of the rationale and the methodology of RBM and the evolving regulations driving the same.
Program Highlights
Industry Relevant Curriculum
- Acquire deeper understanding of the philosophy of risk-based monitoring
- Live Online and Recorded Sessions
Program Curriculum
– Industry Overview and Existing Models of RBM
– Risk Identification and Evaluation
– Risk Control and Review
– Risk Reporting
– Role of Technology and Data Standards
– Vendor Selection in RBM
Methodology
– Live Online and Recorded Sessions via WebEx
– Hands-on Practical training on the RBM platform
Duration
25 hours of Live Online Sessions via WebEx.
20 hours of Hands-on training on the platform including an assessment
Key Takeaways
At the end of this Program you will be able to:
Understand how to perform study level risk assessment, define KRIs and thresholds and determine risk scores
- Understand concepts around Risk Management Plans and determine key performance metrics
- Recognize the RBM methodology and key implementation challenges key elements
- Understand the evolving roles of key stakeholders (onsite CRA, central monitor, investigator, data manager, clinical analyst) in RBM and the significance of change management
- Understand the site’s perspective on RBM
- Recognize the importance of technology in RBM
- Understand the complexities of vendor selection in RBM
Who should enroll?
– Sponsors/CROs Clinical Operations Staff
– Clinical Research Associates and Managers
– Clinical Data Management Staff
– Investigators and Staff
– Clinical Quality Compliance and Quality Assurance Professionals
For more information please contact 1-848-299-5900 or mail workshops@sollers.edu
