Recommendation Paper on Decentralized Elements in Clinical Trials

13 December 2022 – the European Commission published the recommendation paper on decentralized elements in clinical trials, version 01.

The recommendation paper will address the roles and responsibilities of the sponsor and investigator, electronic informed consent, IMP delivery, trial related procedures at home, data management and monitoring in a decentralized clinical trial setting. The intention of this recommendation paper is to facilitate the use of decentralized elements in clinical trials in the EU/EEA.

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