Background: The COVID-19 pandemic has posed daunting challenges for the conduction of clinical research. Adopting new technologies such as remote electronic consent (e-Consent) can help overcome them. However, guidelines for e-Consent implementation in ongoing clinical trials are currently lacking. The NeuroSAFE PROOF trial is a randomised clinical trial evaluating the role of frozen section analysis during RARP for prostate cancer. In response to the COVID-19 crisis, recruitment was halted, and a remote e-Consent solution was designed. The aim of this paper is to describe the process of implementation, impact on recruitment rate and patients’ experience using e-Consent. Methods: : A substantial amendment of the protocol granted the creation of a remote e-Consent framework based on the REDCap environment, following the structure and content of the already approved paper consent form. A new pathway was developed which offered continuous support to patients through remote consultations. The whole process was judged to be compliant with regulatory requirements before implementation. Results: : Before the first recruitment suspension, NeuroSAFE PROOF was recruiting an average of 9 patients per month. After e-Consent implementation, 63 new patients (4/month) have been enrolled despite a second lockdown, none of whom would have been recruited using the old methods given restrictions on face-to-face consultations. Patients have given positive feedback on the use of the platform. Limited troubleshooting has been required after implementation. Conclusion: Remote e-Consent based recruitment was critical for the continuation of the NeuroSAFE PROOF trial during the COVID-19 pandemic. The described pathway complies with ethical and regulatory guidelines for informed consent, while minimizing face-to-face interactions that increase the risk of COVID-19 transmission. This guide will help researchers integrate e-Consent to ongoing or planned clinical trials while uncertainty about the course of the pandemic continues. Trial registration: The NeuroSAFE PROOF trial has the registration number NCT03317990 (23 October 2017). Regional Ethics Committee;reference 17/LO/1978
E-Consent - a guide to implement an innovative solution to maintain recruitment in clinical trials during the COVID-19 pandemic (preprint)/ en