On 23 July 2025, the updated version of the ICH E6 (R3) Good Clinical Practice guideline came into force in the European Union, replacing the previous ICH E6 (R2) version approved in 2016. The new guideline represents a real shift in the approach to GCP, emphasizing clearly defined principles and their practical application. It strongly highlights the importance of quality management and proportionate risk-based approaches, as well as the growing role of modern technologies in clinical research.

Key changes introduced with ICH E6 (R3)

Updated guideline structure

The core guideline has been reduced to 11 fundamental principles.
Annex 1 covers guidance for interventional clinical trials.
Annex 2 provides guidance for non-traditional trials, including decentralized, hybrid and real-world data-based studies.

Quality by Design

A proactive approach to quality in clinical trials, embedding quality considerations already at the design stage.

Proportionate risk management

Trial oversight activities should focus on factors critical to participant safety and data reliability while minimizing unnecessary burden.

Data governance

A new section emphasizes mechanisms ensuring data integrity, reliability and security throughout the trial lifecycle.

Patient engagement

Encouragement to involve patients already during trial planning to better reflect participant needs.

Roles and responsibilities

Clear definition of responsibilities across all parties to avoid accountability gaps and ensure data integrity oversight.

Use of modern technologies

Acceptance of electronic informed consent (e-consent) and emphasis on electronic systems for data collection and monitoring.

Practical impact for sites and CROs

Implementation of ICH GCP (R3) requires:

  • earlier quality planning at protocol design stage;

  • flexible, risk-based combination of on-site, remote and centralized monitoring;

  • dynamic adjustment of monitoring strategies;

  • appropriate validation and oversight of electronic systems;

  • clear contractual definition of roles, including vendor oversight.

The updated guideline strengthens quality- and risk-based thinking across the entire clinical trial lifecycle.

The Medical Research Agency offers a free, certified online ICH E6 (R3) course.
https://abm.gov.pl/pl/aktualnosci/3421,Certyfikowany-kurs-ICH-E6-R3-Good-Clinical-Practice.html