Clinical Trials Management and Regulatory Compliance

This comprehensive certificate program provides rigorous clinical research training across the entire clinical trials process, from the perspective of the clinical study site as well as that of the sponsor or monitor. The broad curriculum covers ICH good clinical practice guidelines, regulatory requirements, and compliance, detecting fraud and misconduct, and statistics for clinical research. Students will build the skills and knowledge to initiate clinical research studies, apply monitoring methods, and write documents and reports, while understanding and abiding by FDA regulations and International Conference on Harmonization (ICH) guidelines.