Clinical research is evolving, and so are its regulations. The ICH GCP E6 (R3) update brings fresh changes to improve flexibility, risk management, and tech integration in trials. But what does this mean for you? Let’s break it down.
What’s new in ICH GCP E6 (R3)?
1. Risk-based quality management
- Focus on identifying and mitigating key trial risks
- Encourages a smarter, risk-proportionate approach
2. Embracing technology
- Supports eConsent, remote monitoring and real-world data
- Recognises the role of digital tools in modern trials
3. Flexible, scalable guidelines
- Designed to fit both traditional and decentralised trials
- Adapts to evolving research methods and data sources
4. Clearer oversight and responsibilities
- Defines roles for sponsors and investigators
- Encourages accountability and collaboration
5. Stronger data integrity standards
- Reinforces ALCOA+ principles for reliable data
- Highlights security and transparency in digital records
Published on Apr 01, 2025 by Ella Thomas