This document was created by experts from the HMA Clinical Trial Coordination Group(CTCG), EC Clinical Trial Expert Group (CTEG), and the EMA GCP Inspectors Working Group (GCPIWG). It aims to inform a harmonised perspective on the use of decentralised elements in clinical trials across the European Union and European Economic Area.
Clinical trials are increasingly taking place outside of the traditional clinical trial site, a concept that is often referred to as 'decentralisation'. This transition has highlighted the growing importance and utility of digital tools in clinical trials and overall healthcare settings. This document aims to offer a harmonised perspective on the introduction and usage of decentralised elements in clinical trials, regardless of health crises such as COVID-19, while advocating for iterative improvements with growing experience and evolving technologies.
The recommendation paper addresses several factors, including the roles and responsibilities of the sponsor and investigator, electronic methods to obtain informed consent, the delivery of Investigational Medicinal Products (IMP), the execution of trial-related procedures at home, and aspects of data management and trial monitoring.
1. Introduction, Scope and General Considerations
2. Clinical Trial Oversight - Roles and Responsibilities
3. Informed Consent Processes
4. Delivery of Investigational Medicinal Products and Administration at Home
5. Trial Related Procedures at Home
6.Data Collection and Management Incl. Defining and Handling Source Data
APPENDIX: National Provisions Overview
Important notice: The views expressed in this recommendation paper on decentralised elements in clinical trials in the European Union/European Economic Area are not legally binding. Ultimately, only the European Court of Justice can give an authoritative interpretation of Community law.