Dear colleagues,
Dear friends of Dr. Notghi CRO,
The new version of the ICH GCP E6 (R3) will come into effect on July 23, 2025, following a comprehensive restructuring and modernization. It introduces significant changes to the planning, conduct, and oversight of clinical trials.
As an experienced CRO, we would like to provide you with a concise overview of what’s changing and how you can benefit.
What’s new in ICH GCP E6 (R3)?
- More flexibility – a risk-based approach
The guideline emphasizes a risk-based approach to study design, conduct, and monitoring. Trials should be designed proportionally to the risks posed to participants – this reduces workload and focuses resources on critical elements. - Focus on quality by design
Quality aspects should be considered from the earliest stages of trial design – keyword: Quality by Design (QbD). The aim is to identify and minimize potential sources of error early on. - Modernized documentation and technology
E6 (R3) acknowledges the increasing role of digital tools – such as eConsent, remote monitoring, or decentralized clinical trials (DCTs). The guideline calls for validated systems – but no return to paper. - Clearer roles and responsibilities
The responsibilities of sponsors, CROs, and investigators are more precisely and practically defined – improving collaboration, especially in outsourced or hybrid trial models.
Why is this important?
Implementation of E6 (R3) will be mandatory from July 23, 2025. Those who adapt their processes and documentation early will be well-prepared – including for inspections and audits.
We are happy to support you in integrating the new requirements into your trial operations.
Courses at the Dr. Notghi Academy
Our upcoming ICH GCP E6(R3) course offers a practical introduction to the key changes and their application. Learn how to pragmatically integrate risk-based approaches – without compromising data quality.
🎓 Web Seminar – Save the Date!
GCP Refresher/Update Course (online)
🕙 4 teaching units (3 hours)
🌐 Register at: academy@notghi.com
