This course provides a comprehensive understanding of the ICH E6(R3) guideline, which updates Good Clinical Practice (GCP) standards to modernise clinical trial conduct. The curriculum is structured into modules based on key presentations from the ICH E6(R3) sessions, covering principles, regulatory roles, risk-based approaches, and practical applications. Participants will gain insights into the evolution of GCP, the shift toward participant-centric and flexible trial designs, and the integration of innovative methodologies like digital health technologies (DHTs) and real-world data (RWD).
Course Modules
- Introduction to ICH and Clinical Trial Harmonization
- Overview of the International Council for Harmonisation (ICH), its mission, and its impact on global regulatory standards.
- Key ICH guidelines (Quality, Safety, Efficacy, Multidisciplinary) and their role in clinical research.
- ICH E6(R3) Guideline Development and Structure
- Evolution from E6(R2) to E6(R3), including the rationale for updates.
- Core principles: Ethical conduct, participant safety, scientific validity, and data integrity.
- Emphasis on Quality by Design (QbD) and risk-proportionate approaches.
- Designing and Analyzing Clinical Trials
- Application of the Design, Analyze, Communicate (DAC) framework.
- Tools like the DAC Assessment Tool (DAT) and NAFDAC’s e-CTAP platform for trial informativeness.
- Roles and Responsibilities in Clinical Trials
- Sponsor responsibilities: Trial design, oversight, and risk-based monitoring.
- Investigator duties: Participant safety, protocol compliance, and data integrity.
- Ethics Committees (ECs): Ethical review, informed consent oversight, and participant protection.
- Essential Records and Data Governance
- Dynamic documentation practices under E6(R3).
- Data governance frameworks: Ensuring availability, usability, integrity, and security of trial data.
- Regulatory and Ethical Oversight
- Role of National Regulatory Authorities (e.g., NAFDAC): Protocol review, GCP compliance, and inspections.
- Ethical challenges in low-resource settings and strategies for equitable research participation.
- Key Updates in E6(R3) vs. E6(R2)
- Streamlined GCP principles (13 to 11).
- Modernized informed consent (remote/multimedia tools).
- Enhanced flexibility for decentralized trials and innovative designs.
- Case Studies and Practical Applications
- Analysis of real-world GCP violations (e.g., expired comparators, protocol deviations).
- Lessons on risk management, corrective actions (CAPA), and regulatory consequences.
- Serious Non-Compliance and Issue Management
- Identifying and addressing deviations impacting participant safety or data reliability.
- TransCelerate’s framework for classifying and escalating critical issues.
- Annex 2: Innovative Trial Designs and Data Sources
- Guidance on trials using DHTs, RWD, and decentralized models.
- Proportional oversight strategies for hybrid or remote trials.
Learning Outcomes
By the end of the course, participants will:
- Understand the principles and structure of ICH E6(R3) and its differences from E6(R2).
- Apply risk-based approaches to trial design, monitoring, and documentation.
- Recognize the roles of sponsors, investigators, and regulators in ensuring GCP compliance.
- Navigate ethical and regulatory challenges in diverse clinical trial settings.
- Leverage modern technologies and flexible designs to enhance trial efficiency without compromising quality.
Target Audience
- Clinical researchers, sponsors, and investigators.
- Regulatory affairs professionals and ethics committee members.
- Data managers, monitors, and quality assurance personnel.
- Professionals involved in global clinical trial operations.
