Certificate in Clinical Trials Management and Regulatory Compliance
Use real-world case studies to reinforce the foundational knowledge that will accelerate your career in clinical research.
During this comprehensive certificate program, you will develop procedural and administrative understanding of the clinical trials process and the skills needed to lead clinical research studies. The broad curriculum covers International Conference on Harmonization (ICH) clinical practice guidelines, regulatory requirements and compliance, detecting fraud and misconduct, and statistics for clinical research. You will build the skills and knowledge to initiate studies, apply monitoring methods, and write documents and reports, while abiding by FDA regulations and ICH guidelines.
Designed for early or mid-career professionals with an interest in clinical research. Students go on to work in regulatory compliance, medical writing, site management, and data analysis, across the pharmaceutical industry, clinical research organizations, and academic institutions.
Offered by the University of Chicago and conferred by (opens in new tab) Graham School of Continuing Liberal and Professional Studies.