Course Information

This focused training provides a concise but comprehensive review of the major changes introduced in ICH E6(R3). It is designed to help professionals understand how the revised guideline modernises Good Clinical Practice, particularly in light of technological innovation, proportional risk management, and the growing use of decentralised trial methods. The course is timed to coincide with the global adoption of the new standard and aims to ensure learners are prepared for implementation and inspection under E6(R3).

3rd July 2025 11am-2pm BST
9th July 2025 2pm-5pm BST

Learning Outcomes:

• Describe the rationale, development process, and structural changes in ICH E6(R3), including its alignment with ICH E8(R1) and the use of annexes
• Differentiate key updates between ICH E6(R2) and R3, particularly in areas such as risk proportionality, roles and responsibilities, and data governance
• Assess their organisation’s current practices against the expectations of ICH E6(R3) using a high-level gap analysis approach
• Identify required updates to SOPs, training, and documentation systems based on the revised principles and practical guidance in ICH E6(R3)
• Apply new GCP expectations in real-world scenarios, considering how changes affect site management, sponsor oversight, monitoring, and regulatory inspections
• Participate in informed discussions on best practices and implementation strategies, drawing on examples shared during the course and peer experiences.

By the end of the course, you will be able to:

• Summarise the development, structure, and guiding principles of ICH E6(R3), including its foundation in ICH E8(R1) and modular annex-based format
• Identify at least three key differences between ICH E6(R2) and E6(R3), including updated principles around risk, quality, and responsibilities
• Evaluate what ICH E6(R3) means for your organisation’s current practices by conducting a high-level gap analysis and identifying change priorities
• Apply role-specific expectations under E6(R3) through worked examples involving sponsors, investigators, and QA
• Recognise inspection-relevant documentation and oversight expectations under ICH E6(R3) to support regulatory compliance.

Intended participants:

Clinical research professionals across roles impacted by GCP compliance, including:

• Quality Assurance personnel
• Clinical Project Managers
• Clinical Research Associates/Monitors
• Investigators and Study Coordinators
• Regulatory Affairs professionals
• Trial sponsors and CRO representatives
• Clinical data managers and IT support teams

PLEASE NOTE: this course will be recorded to create an eLearning course, participant interaction will not be used for this.