Op 14 december 2022 is door het Directoraat-generaal Gezondheid en Voedselveiligheid de ‘Recommendation paper on decentralised elements in clinical trials‘ gepubliceerd.
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 (GCP-IWG). It includes broad perspectives from the European medicines regulatory network (EMRN) as well as perspectives by patient and health care professional representatives.
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.