Courses in the Clinical Trials Management and Regulatory Compliance certificate use real-world clinical trials case studies to reinforce the foundational clinical trials knowledge that will accelerate your career in clinical research.
Students must take 5 or 6 core courses, depending on experience:
This course introduces students to the processes and procedures of monitoring a clinical trial from the perspective of the sponsor or contract research organization from the site-initiation visit to the closing out of a clinical study.
This course focuses on advanced strategic, operational, and project management topics in clinical research with an emphasis on increasing efficiency and quality at all levels of the process.
This course is designed for those interested in starting a career in clinical research. It provides an overview of clinical research from concept to close-out and covers the foundation of how to develop a sound and effective protocol with participant’s safety and regulatory compliance in-mind. Students will have an opportunity to discuss the v
This course covers the process of coordinating and managing a clinical study from the perspective of the study site.
This course provides an introduction to good clinical practice (GCP) in clinical research according to FDA regulations and International Conference on Harmonization (ICH) guidelines.
This course introduces basic statistical concepts, such as hypothesis testing, the meaning of P value, and power determination.
“I learned a lot about the clinical research field: how drug research is conducted, different job positions involved in running a clinical trial, regulations. The Clinical Trials Management and Regulatory Compliance certificate helped me expand on my current job knowledge and gave me a bigger picture of research.”
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