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 decentralised clinical trial setting. An overview of the current national provisions applicable in each Member State (MS)in relation to these topics is outlined in the appendix. It should be noted that the national provision appendix is for guidance purposes only as it is not feasible to give a complete overview of all scenarios for implementing decentralised elements in a clinical trial. It is at the discretion of the MS involved in the assessment of a clinical trial whether the use of certain decentralised elements is acceptable in a specific clinical trial.

Sponsors are encouraged to seek scientific advice via the European Medicine Agency [EMA, scientific advice working party (SAWP)], or via national competent authorities [national or simultaneous national scientific advice (SNSA)] regarding the use of specific decentralised elements, especially on decentralised elements where experience and the evidence of their impact may be limited. Sponsors may also request a consolidated opinion via the Clinical Trial Coordination Group (CTCG) for regulatory issues of general impact not related to a specific trial.

This recommendation paper was created as part of the priority action 8 ‘Methodology guidances’ of the ACT EU initiative of the European Commission (EC), the Heads of Medicines Agencies (HMA) and the EMA. It was drafted in a collaboration between the HMA Clinical Trial Coordination Group (CTCG), EC Clinical Trial Expert Group (CTEG) and the EMA GCP Inspectors Working Group (GCPIWG). It includes broad perspectives from the European medicines regulatory network (EMRN) as
well as perspectives by patient and health care professional representatives. Given the rapid advances in the field of decentralised clinical trials, the paper is expected to evolve when new insights and experiences are gained.