Current and Emerging Topics in Clinical Research

3 units

This course will explore current and emerging advances in clinical research design and conduct review and discussion of recent guidance documents from the FDA in response to the 21st Century Cures Act and other sources. Students will gain familiarity with the Act and its implementation via exploration and critical review of recent FDA Guidance Documents and supplemental materials. Additional emerging topics may be identified and explored by the instructor and students. At the conclusion of this course students will be able to effectively communicate recent and emerging innovative and technological advances in clinical research design and conduct, and identify key implications and application. Prerequisite can be waived for students with established clinical research experience and instructor's approval.