Research 1B – Electronic Systems in Clinical Research: How to Remain Compliant in the New Virtual World””
Knowledge Level: Intermediate
Candida Barlow, Clinical Research Informatics Specialist, Bio-Optronics, Inc.
Christine Nelson, Director, Office of Clinical Trials, University of North Carolina at Chapel Hill
Laura Fluharty, Director, Clinical Research Operations, University of Pennsylvania
· Educate compliance professionals on FDA guidance for electronic systems
· Explain FDA guidance as it relates to electronic systems used to collect data in clinical research
· Describe steps an organization can take to remain compliant when leveraging technology