Annual Conference 2020

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

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.  

From Data to Discoveries: Creating a Research Program for All of Us

Rachele Peterson, MS, CCRP, CRA, Director of Healthcare Provider Organization Engagement, All of Us Research Program / Vibrent Health

The National Institutes of Health (NIH) All of Us Research Program is among the most ambitious research efforts that our nation has ever undertaken. It is an historic effort to gather data from one million or more people living in the United States to accelerate research and improve health. By taking into account individual differences in lifestyle, environment, and biology, researchers will uncover paths toward delivering precision medicine. Unlike research studies that focus on one disease or group of people, All of Us is building a diverse database that can inform thousands of studies on a variety of health conditions as part of a new era in which researchers, health care providers, technology experts, community partners, and the public work together to develop individualized health care.