Clinical trials with decentralised elements

Clinical trials for medicines are increasingly using procedures outside the traditional research site or using digital tools. We call these decentralised elements. A 'recommendation paper on decentralised elements in clinical trials' was published on 13 December 2022.

This paper highlights the roles and responsibilities of the sponsor and investigator, the electronic consent form, delivery of the Investigational Medicinal Product, procedures at the participant's home, data processing and monitoring in a decentralised clinical trial.

More information can be found on the EMA website.

Last updated on 13/02/2023