On 6 January 2025, the updated Good Clinical Practice guideline, ICH E6(R3), was officially adopted, marking a major shift in clinical research.
The guideline came into effect in Europe on 23 July 2025, and the FDA adopted it in September 2025, with Annex 2 to follow.
Three key updates stand out. Risk based monitoring: focusing monitoring on the highest risk elements of the trial, for smarter resource allocation and better outcomes. Technology integration: embracing decentralized trials (DCT) and electronic data capture (EDC) to modernize trial management and protect data integrity. Stronger oversight: clearer requirements for accountability and regulatory compliance from every party, including vendors and CROs.
And what matters most for the companies developing the drug or device: under E6(R3), overseeing the CRO and vendors is not a recommendation, it is a regulatory requirement. The ultimate accountability for the trial always stays with the developing company, even when execution is outsourced. Structured, documented oversight is now part of regulatory compliance, not an optional extra.