Poor study management, misconduct, and data falsification threaten regulatory decisions on product safety and efficacy. This session will cover regulatory guidelines and case studies of clinical trial electronic systems, risk assessment strategies.
Learning Objectives
Describe regulatory expectations for electronic systems in clinical trials, including electronic health records (EHRs); Examine criteria for evaluating whether these systems are suitable for trials. Discuss methods for identifying and mitigating fraud and misconduct risks in these systems; Understand case studies of fraud and mismanagement to emphasize the need for thorough risk assessments.
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
