CRM Independent Study: Fundamentals I

1.5 units

This introductory course provides the basic foundation for clinical research. We examine the historical evolution of research, linking it to the current regulations and guidelines for good clinical practice. Course material includes research roles and responsibilities, institutional review boards, phases of drug development, the informed consent process, human subject protections, and an overview of study conduct. For students in the Master of Science in Clinical Research Management and by advisor permission, only. Students enrolled in CAPS-CRM 5175 and 5178 join the foundational courses CAPS-CRM 2000 and 2001 for 1.5 units each, in place of taking CAPS-CRM 5000 for 3 units.