Connecting while Complying: The Regulatory Trend Towards Clear Communication in Clinical Trials

Connecting while Complying: The Regulatory Trend Towards Clear Communication in Clinical Trials

SOCRA's 2020 Virtual Annual Conference

Christopher Trudeau, JD, Associate Professor, University of Arkansas at Little Rock, Bowen School of Law SOCRA 

This session will explore the global regulatory trend towards improving participant understanding in clinical trials. It will focus on aspects of the Revised Common Rule, GDPR, EMA Policy 0070, and the EU/US Privacy Shield that mandate clear communication with trial participants. Mr. Trudeau will discuss best practices for better connecting with participants while still also better complying with the new regulatory requirements.