The session will be divided into a part about eISF and a part about eConsent.
eISF: the session aims to provide insights and practical guidance for clinical research professionals who are considering or currently implementing electronic Investigator Site Files in their organizations. The adoption of eISF systems offers numerous benefits over its paper counterpart, including increased efficiency, improved data management, enhanced regulatory compliance, and cost savings. It can revolutionize the way clinical trials are conducted by streamlining processes and improving collaboration among stakeholders.
Participants are called to share experiences in the adoption of eISF systems. Currently, lots of sites still use physical binders. Many of the larger research centers have attempted to streamline their ISF by using generic document collaboration and extranet tools such as Microsoft SharePoint, Box…. However, these solutions are not built to support the highly regulated clinical trials market and do not provide proven compliance with regulatory records retention. Thus, let us see what an eISF solution can bring on as additional value to regulatory compliance. Freeing up precious resources at research sites and returning a site’s focus to what is most important: the thoughtful care of patients and the production of knowledge that heals. Additionally, the session may explore emerging technologies and innovations in the eISF space, such as artificial intelligence and machine learning applications for document processing and review.
eConsent breakout session: in the age of decentralized clinical trials (DCTs), an all-or-nothing approach is not usually practical. Some research participants prefer to speak to study staff in person, and may find that remote technology doesn’t establish the trust they need to enroll. Accommodating patient preference requires a hybrid eConsent model which allows for remote and on-site enrollment.
In this presentation we will discuss opportunities that will help researchers develop a more successful overall strategy for their patient enrollment. From eRecruitment, pre-screening and consent, we’ll discuss how anticipating and accommodating patient preferences streamlines enrollment and increases retention.
