Recommendations on Decentralized Elements in Clinical Trials

Recommendation

9/10 May 2023

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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.

Data Collection / Management & Handling of Source Data

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:

• All parties involved in the DCT have an overview of the data flow (e.g. via a data flow diagram with additional explanations in the protocol).
• Data acquisition tools (DATs) are configured and validated (see also Notice to sponsors on validation and qualification of computerised systems used in clinical trials).
• Adequate data protection in compliance with the GDPR.
• When Source data captured by a DAT is transferred to another location and subsequently irreversibly deleted from the DAT, both the data and the metadata are transferred (Certified Copy).
• Measures such as encryption to minimize the risk of unauthorized access, when transferring data from a DAT to a server.
• Access to trial data is controlled by defined user rights and methods of access for all relevant parties involved. Unauthorized access should be prevented using appropriate security measurers (e.g. firewalls).
• Control of and continuous and complete access by the investigator to both source data generated either on-site or off-site as well as source data reported to the sponsor (e.g. central lab data).
• Measures to minimize the risk of erroneous data entry for data measured and entered directly by trial participants (especially on primary, key-secondary or safety endpoints).

Overview of the current National DCT Provisions  

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.