The revised ICH Good Clinical Practice guideline emphasises proportionality, quality by design and fit-for-purpose data. Here is what it means at site level.
The third revision of the ICH Good Clinical Practice guideline, E6(R3), was adopted by ICH in January 2025. It modernises GCP to reflect today's wider range of trial designs and data sources while keeping participant protection and reliable results at its core.
1. Quality by design
Sites are encouraged to understand which processes and data are critical to quality for each study, and to focus effort on them.
2. Proportionate, risk-based approaches
Oversight, monitoring and documentation should be proportionate to the risks to participants and to the reliability of results.
3. Stronger focus on data governance
The guideline gives greater attention to data integrity across the full data lifecycle, including computerised systems used at sites.
4. Flexibility for modern trial designs
E6(R3) is designed to accommodate decentralised elements, pragmatic designs and the use of digital health technologies.
5. Clearer investigator responsibilities
Investigators remain responsible for trial conduct at the site, including appropriate oversight of delegated activities and service providers.
Ethica Research builds its SOPs and training around E6(R3) and can help partner sites put these principles into practice.