The International Council for Harmonisation (ICH) adopts the ICH E6(R3) Guideline

On January 6, 2025, the International Council for Harmonisation (ICH) adopted the ICH E6(R3) Guideline, introducing significant advancements in Good Clinical Practice (GCP). This updated guideline emphasizes a modernized, risk-based approach tailored to critical-to-quality factors, ensuring enhanced participant safety and data reliability. It recognizes the growing role of digital technologies, such as wearables and remote monitoring, to improve trial capabilities and supports digital tools for informed consent and engagement. The guideline also offers greater flexibility, accommodating diverse trial designs and emerging methodologies, while embedding quality by design (QbD) principles to simplify operations and focus on success-critical elements. Reinforcing ethics and participant safety, the updates expand informed consent processes to ensure clarity and inclusivity, particularly for vulnerable populations. Additionally, new provisions for data governance strengthen the integrity, traceability, and security of data throughout the trial lifecycle. At Clinica Group, we remain dedicated to aligning with these updates to deliver ethically conducted, high-quality clinical trials that prioritize participant well-being and generate reliable outcomes.

You can find the guideline here : https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf