CyntegrityEDU is a wide range of courses and seminars that Cyntegrity offers to everybody, who is interested to explore the exciting world of clinical risk management and RBM. (A.Andrianov)
Risk-based Monitoring Education
- Introduction into RBM
- Quality by Design Introduction
- Design Space
- The notion of Risk
- Properties of Risks
- Methods of Risk Management
- RBM Definition
- Regulatory requirements
- FDA vs. EMA: RBM duality
- RBM and Data Quality
- RBM Platform “EarlyBird”
- Design and UI
- Internal helping system
- Understanding of KRI
- Metrics
- Thresholds, types of thresholds
- Dealing with KRIs
- Ticketing and issue management
- Actions
- Root cause analysis
- Mitigation plans
- Chat
- Site’s Profile
- KPIs
- Reading the KRIs for each sites
- RBM Feedback System
- RBM Monitoring Plan
- Reduced monitoring strategies
- How to specify KRIs?
- Structure of RBM Team
- What is the basis for adaptive risk-based monitoring
- Trial design, operational and IMP-related risk areas
- Study and site level critical components your risk-based monitoring plan must reflect on
- Critical data that you should always monitor
- What risk-based monitoring tapering means
- How source data verification (SDV) adjustments and monitoring visit schedules must be planned
- RBM efficacy and efficiency assessment From pilot to full implementation
- Moving from on-site to centralized monitoring
- RBM metrics How to measure poor performance and non-compliance
- How to evaluate RBM effectiveness during trial conduct
- Identification of systemic issues and their root causes
What warning signals will inform you when and how to increase SDV at clinical sites
- RBM Process Integration
- Process integration
- Roles and responsibilities
- Dealing with resistance