May 2023 brought two documents that clinical teams had been waiting for. ICH published the draft of E6(R3), the rewrite of Good Clinical Practice, for public consultation, and FDA released draft guidance on decentralised clinical trials (DCTs).
E6(R3) draft
The draft restructures GCP into principles and annexes, embeds quality by design and risk proportionality from E8(R1), and modernises expectations for computerised systems, data governance and the use of service providers. The consultation ran through the autumn of 2023.
FDA DCT draft guidance
The guidance covers trials where some or all activities occur away from traditional sites: remote visits, local healthcare providers, direct-to-participant shipping of investigational product, and digital health technologies. It stresses investigator oversight and the need for a clear data flow.
What to do with them now
Neither is final, but both signal where inspectors' expectations are heading. Sponsors updating SOPs in 2023 should write them to the direction of travel: risk-based monitoring plans, documented oversight of vendors and remote activities, and data integrity across the full data flow. Our trial monitoring team has been helping sponsors pilot centralised monitoring on active studies.