10/11 April 2024
The EU Commission has supplemented the area of clinical trials (see also corresponding guidelines for complex clinical trials) with "Recommendations on decentralized elements in clinical trials". The paper deals with procedures that, due to new approaches and advanced technical possibilities, can now take place outside study centers. The document also addresses sponsor and investigator roles and responsibilities, electronic informed consent, Investigational Medicinal Product (IMP) delivery, study-related home procedures, data management, and monitoring in a decentralized clinical trial (DCT) setting.
DCTs are characterized by an extensive shift of data collection from the investigator/investigator site to the trial participants and/or their caregiver and/or home nurses. Direct data capture by electronic systems (e.g., eCRFs, ePROs, wearables etc.) may occur, for example, at the clinical trial site or off-site locations.
Utilising multiple systems and parties requires an adequate sponsor oversight and implementation of adequate measures. The sponsor should therefore ensure the following:
An overview of national provisions is provided in the appendix of the document. The answers to the questions stated in the national provision overview are given by the individual Member States (MS) and related to the context and general recommendation as provided in the recommendation paper. In addition, footnotes (providing legislation reference, background etc.) from each MS are given in the tables following the national provision overview. The appendix will be updated as new data emerge.
For further information please see the Recommendation paper on decentralised elements in clinical trials published in EudraLex Volume 10.