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

  1. 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
  2. RBM and Data Quality
  1. 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
  1. 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
  1. RBM Process Integration
    • Process integration
    • Roles and responsibilities
    • Dealing with resistance

Interested in CyntegrityEDU courses and seminars? Drop us a line.