High-level summary of changes in ICH-GCP E6(R3) versus E6(R2)
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About this course
ICH-GCP E6(R3) represents a significant evolution from E6(R2), moving away from a checklist-driven interpretation of Good Clinical Practice towards a more principles-based, risk-aware, and proportionate approach to clinical trials. Many professionals are familiar with E6(R2) but are unsure what has really changed in practice under E6(R3), what regulators now expect, and how this impacts day-to-day trial design, oversight, data governance, and roles and responsibilities. This course provides a clear, high-level comparison of ICH-GCP E6(R3) versus E6(R2), focusing on what is new, what has shifted in emphasis, and what this means in practical terms for sponsors, investigators, CROs, and trial teams.
ICH-GCP E6(R3) introduces important conceptual and structural changes compared to E6(R2), reflecting a shift towards a more principles-based, risk-aware, and proportionate approach to clinical trials. This 1.5-hour high-level session is designed to help clinical research professionals quickly understand what has changed between ICH-GCP E6(R3) and E6(R2), why these changes were introduced, and what they mean at a practical level. The focus is on orientation and clarity, not detailed implementation. Rather than reviewing the guideline in detail, the course highlights the most relevant differences, explains the new principles and structure of E6(R3), and clarifies how regulatory expectations are evolving for sponsors, investigators, and trial teams. It is ideal for professionals who already have a solid understanding of GCP and want a concise, structured overview of E6(R3). ***Note that this course is only an overview of ICH-GCP E6 (R3) and this course should not be a substitute for a formal GCP certification. ***
Programme highlight
- Purpose and scope of ICH-GCP E6(R3
- High-level comparison of E6(R3 versus E6(R2
- Key principles introduced or reinforced in E6(R3
- How the structure of the guideline has changed
- What remains unchanged from E6(R2
- Shifts in regulatory focus and expectations
- Early practical considerations for trial teams
Learning objectives
At the end of this course, participants will be able to:
- Understand the key structural and conceptual differences between ICH-GCP E6(R3) and E6(R2)
- Identify the new principles introduced in E6(R3) and how they change regulatory expectations
- Recognize shifts in responsibilities for sponsors, investigators, and other stakeholders
- Understand the increased focus on risk-based approaches, data governance, and trial design
- Translate high-level regulatory changes into practical implications for clinical trial conduct
Who should attend
This course is intended for clinical research professionals who already have a basic understanding of ICH-GCP, including but not limited to:
- Clinical Operations and Study Management
- CRAs and Monitoring staff
- Quality Assurance and Compliance
- Regulatory Affairs
- Data Management and Clinical Systems
- Investigators and site staff
- CRO and vendor oversight roles
Competencies
This course covers competencies that are part of the ECCRT Competency FrameworkComplete the number of competencies per domain listed
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Trainers
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