PREV 633 APPLICATION OFLEGAL AND REGULATORY ISSUES IN CLINICAL RESEARCH

This is a multidisciplinary course covering application of legal and regulatory topics critical to performing clinical research including the informed consent process, privacy and confidentiality issues; investigational new drug (IND) applications; financial disclosure and conflict of interest; the institutional review board (IRB) process; recruitment and retention strategies; data safety monitoring plans; and quality management and clinical research conduct issues.