Navigating the Future of Informed Consent: Implementing eConsent in Clinical Trials

Session chaired by Joby John

Description:

In the digital age, the transition from traditional paper-based informed consent to electronic informed consent (eConsent) represents a pivotal shift in how participants are engaged and informed in clinical trials. This session aims to explore the multifaceted landscape of eConsent, focusing on its potential to enhance participant understanding, streamline the consent process, and improve compliance and auditability.

We will begin by introducing the concept of eConsent, highlighting its advantages over traditional methods, including increased accessibility, real-time updates, and better monitoring of the consent process. The session will delve into the regulatory framework governing eConsent, offering insights into how different jurisdictions are navigating the legalities and ethical considerations of implementing eConsent in clinical trials.

Key challenges in the adoption of eConsent will be examined, including technological barriers, participant and investigator acceptance, and integration with existing clinical trial management systems. Practical strategies for overcoming these hurdles will be discussed, drawing on case studies and real-world examples of successful eConsent implementation.

Furthermore, the session will address the critical role of data managers in driving the adoption of eConsent, from selecting appropriate platforms to ensuring compliance with regulatory standards and facilitating smooth integration into the data management workflow.

Attendees will leave with a comprehensive understanding of eConsent, equipped with the knowledge and tools necessary to navigate its implementation in their clinical trials. This session is designed for clinical data managers, trial coordinators, regulatory affairs professionals, and anyone interested in the evolving landscape of clinical trial participant engagement and data management.