Clinical Trials Management and Regulatory Compliance

The clinical trials management and regulatory compliance certificate 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.

Courses and Order of Completion: Six online courses to be completed sequentially.

• CLIN11100 - Good Clinical Practices
• CLIN11200 - The Drug Development Process
• CLIN11300 - Statistical Concepts for Clinical Research
• CLIN11400 - Fundamentals of Site Management
• CLIN11500 - Fundamentals of Clinical Monitoring
• CLIN21200 - Project Management and Leadership in the Healthcare Industry

Learn more about the Clinical Trials Management and Regulatory Compliance certificate.