RISK-BASED MONITORING

Course Modules

Module 1: Introduction to Clinical Research and Monitoring (Weeks 1-2)

Overview of clinical research phases and drug development
Good Clinical Practice (GCP) principles and regulatory landscape (ICH-GCP E6 R2/R3)
Traditional monitoring vs. risk-based monitoring (RBM)
Roles and responsibilities in clinical monitoring

Module 2: Evolution of Risk-Based Monitoring Regulations (Weeks 3-4)

Historical context of monitoring practices
Key regulatory guidance documents (FDA, EMA, ICH)
Understanding the shift towards risk-based approaches
Impact of regulatory changes on clinical trial design and execution

Module 3: Risk-Based Quality Management (RBQM) Principles (Weeks 5-7)

Fundamentals of RBQM and its components
Risk assessment and identification methodologies
Developing risk mitigation strategies and action plans
Establishing Quality Tolerance Limits (QTLs) and Key Risk Indicators (KRIs)
Risk management planning and documentation

Module 4: TransCelerate BioPharma Initiatives (Weeks 8-9)

Introduction to TransCelerate and its mission
TransCelerate's RBM initiative and its impact on the industry
Key deliverables and resources from TransCelerate
Practical application of TransCelerate's tools and methodologies

Module 5: Centralized Monitoring Techniques (Weeks 10-12)

Overview of centralized monitoring strategies
Statistical data analysis and trend detection
Remote data review and analysis techniques
Data visualization tools and techniques for identifying anomalies
Case studies of successful centralized monitoring implementation

Module 6: Technology and Data Analytics in RBM (Weeks 13-15)

Electronic Data Capture (EDC) systems and data management
Clinical Trial Management Systems (CTMS) and their role in RBM
Data analytics platforms and tools for RBM
Introduction to AI and machine learning applications in clinical monitoring

Module 7: CRO Services in RBM (Weeks 16-19)

Overview of CRO service offerings in clinical monitoring
How CROs implement RBM strategies in their operations
Case studies of CRO-driven RBM initiatives
Technology and data analytics solutions provided by CROs
Vendor oversight and management

Module 8: Implementation of RBM Strategies and Quality Assurance (Weeks 20-23)

Developing a risk-based monitoring plan
Site selection and risk stratification
Designing targeted monitoring activities
Source Data Verification (SDV) and Source Data Review (SDR) in RBM
Audit and inspection preparedness
Documentation and record-keeping
Handling deviations and non-compliance

Module 9: Practical Applications and Case Studies (Week 24)

Real-world case studies of RBM implementation
Simulations and exercises on risk assessment and monitoring
Group projects on developing RBM plans
Review of course materials and final exam

Course Modules

Week 1: Foundations of Remote Site Monitoring

Defining remote site monitoring and its evolution
Regulatory landscape and guidance specific to remote monitoring
Benefits and challenges of remote site monitoring

Week 2: Technology for Remote Site Monitoring

Telehealth platforms and video conferencing tools
Remote data capture and transmission technologies
Electronic document sharing and management
Data security and privacy considerations

Week 3: Remote Source Document Review (SDR) and Verification (rSDV)

Techniques and best practices for SDR/rSDV
Risk-based approaches to SDR/rSDV in remote settings
Utilizing electronic health records (EHRs) for remote verification

Week 4: Remote Site Qualification and Initiation

Conducting remote site assessments and feasibility studies
Remote site training and initiation procedures
Establishing effective communication channels

Week 5: Remote Monitoring of Site Performance and Compliance

Monitoring site performance metrics remotely
Identifying and addressing potential compliance issues
Remote audit trails and documentation

Week 6: Patient-Centric Remote Monitoring

Ensuring patient safety and data privacy in remote settings
Utilizing ePROs and patient-reported outcomes (PROs) remotely
Patient engagement and support strategies

Week 7: Regulatory Compliance and Data Integrity in Remote Monitoring

Addressing regulatory requirements for remote monitoring activities
Ensuring data integrity and quality in remote data collection
Preparing for regulatory inspections of remote monitoring data

Week 8: Practical Application and Future Trends

Case studies and simulations of remote site monitoring scenarios
Developing a remote site monitoring plan
Emerging technologies and future directions in remote monitoring