Clinical Trial Risk Management - ICH E6(R3) and FDA Expectations

Risk-based quality management (RBQM) is a fundamental component of modern clinical trial oversight, emphasized in ICH E6(R3) and FDA expectations. Traditional trial monitoring approaches often relied on extensive source data verification (SDV), but regulators now advocate for a proactive, risk-based approach that prioritizes critical-to-quality (CtQ) factors. This shift allows sponsors and investigators to focus resources on areas of greatest risk to patient safety, data reliability, and protocol compliance. Effective risk management begins with early risk identification and assessment, utilizing methodologies such as Failure Modes and Effects Analysis (FMEA) and Root Cause Analysis (RCA). Centralized and technology-driven monitoring further supports real-time risk mitigation, reducing inefficiencies while maintaining regulatory compliance. By adopting these strategies, clinical trial stakeholders can enhance trial quality, improve decision-making, and align with evolving global expectations.

This 60-minute webinar on Clinical Trial Risk Management will provide a comprehensive overview of the evolving regulatory landscape under ICH E6(R3) and FDA expectations for risk-based quality management (RBQM). Participants will explore the key updates from ICH E6(R2) to ICH E6(R3), focusing on enhanced risk assessment, data integrity, and patient safety measures. The session will cover practical strategies for risk identification, evaluation, and mitigation, incorporating advanced digital tools and centralized monitoring approaches. Real-world case studies will illustrate the implementation of risk-based clinical trial management, highlighting challenges, solutions, and best practices. By the end of this webinar, attendees will have a clearer understanding of how to align with global regulatory expectations while ensuring compliance, efficiency, and trial success.

WHY YOU SHOULD ATTEND

This training is essential for clinical research professionals seeking to stay ahead in the evolving regulatory landscape of ICH E6(R3) and FDA expectations for risk-based quality management (RBQM). Participants will gain practical insights into proactive risk identification, assessment, and mitigation strategies to enhance trial efficiency and compliance. With the increasing emphasis on patient safety, data integrity, and technology-driven monitoring, understanding the latest regulatory requirements is crucial for sponsors, CROs, and investigators. Through real-world case studies and expert guidance, attendees will be equipped with the knowledge and tools to implement risk-based approaches effectively, ensuring regulatory alignment and trial success.

AREAS COVERED

Introduction to Clinical Trial Risk Management 

• What is Risk Management in Clinical Trials?
  • Definition and importance
  • Traditional vs. risk-based approaches
• Overview of Regulatory Frameworks
  • ICH E6(R2) evolution to ICH E6(R3)
  • FDA’s perspective on risk-based trial management

Key Changes in ICH E6(R3) 

• Major Updates from ICH E6(R2) to ICH E6(R3)
  • Greater emphasis on patient safety and data reliability
  • Integration of risk-based quality management (RBQM)
  • Expanded role of technology and decentralized trials
• FDA’s Alignment with ICH E6(R3)
  • Key expectations from sponsors and investigators
  • Relationship to FDA’s Risk-Based Monitoring (RBM) guidance

Implementing Risk-Based Quality Management (RBQM) in Clinical Trials

• Risk Planning & Identification
  • Critical to quality factors (CtQ)
  • Risk assessment methodologies
  • Tools for proactive risk identification (e.g., FMEA, root cause analysis)
• Risk Evaluation and Mitigation Strategies
  • Defining acceptable risk levels
  • Data monitoring and centralized risk management
  • Implementing risk controls and corrective actions
• Technology and Digital Tools in Risk-Based Approaches
  • AI and automation for risk detection
  • Digital monitoring and real-time risk tracking

Case Study & Practical Applications 

• Real-World Example of Risk-Based Clinical Trial Management
  • Implementation challenges and solutions
  • Lessons learned and best practices

WHO SHOULD ATTEND

• Clinical Trial Managers
• Clinical Research Associates (CRAs)
• Clinical Project Managers
• Quality Assurance (QA) Professionals
• Regulatory Affairs Specialists
• Principal Investigators (PIs)
• Study Coordinators
• Medical Monitors
• Data Managers
• Risk Management Professionals
• Compliance Officers
• Sponsors and CRO Representatives
• Clinical Operations Professionals
• Pharmacovigilance Specialists
• GCP Auditors

Course Director: Charles H. Paul

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm.  Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject.  The firm works with both domestic and international clients designing solutions for complex training and documentation issues.