Clinical Trials Management & Regulatory Compliance Certificate

This comprehensive certificate program provides rigorous 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 good clinical practices, 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 regulations.

Learn From Experts in Clinical Research

Instructors are experts in clinical trials and clinical research. Program instructors average over 10 years experience in the field and have expertise in all areas of clinical trials. Professional affiliations include managers of clinical trials programs, business executives in related medical companies, and certified American Society for Quality (ASQ) members.

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Program Structure

Students must complete 5 required courses and 1 elective to earn the certificate. The program can be completed in as little as three quarters (9 months).

Classes are offered in two formats, online or in-person. Students may take all courses online or enroll in a combination of online and in-person courses.


  • 3 to 5 weeks course length
  • Weekly live class sessions, offered weekday evenings and Saturday mornings
  • Between the weekly synchronous sessions, participants complete required readings, assignments and self-study activities

Learn more about taking online courses

In person

  • Courses are offered in a convenient 3-day seminar format at the University of Chicago Gleacher Center in downtown Chicago.
  • Seminar schedule is Wednesday-Friday from 8:30am-4:30pm.


Required Courses

  • Good Clinical Practices
  • The Drug Development Process
  • Statistical Concepts for Clinical Research
  • Fundamentals of Site Management
  • Fundamentals of Clinical Monitoring


  • Fraud and Misconduct
  • Project Management and Leadership in the Healthcare Industry

Observation Study

The Observation Study provides a unique opportunity to observe and learn from a clinical trial in progress. This interactive, supervised training is required for students who have less than six months of prior work experience in the field of clinical research. It is offered any quarter at the discretion of the student and program coordinator.

Application Requirements

Applications are accepted on a rolling basis throughout the year. A bachelor’s degree is a pre-requisite for the program.

Applicants must submit:

  • Completed online application
  • $40 application fee (non-refundable)
  • Personal statement
  • Current resume or CV

Students may take one course without applying to the program.

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