Clinical Trials Management & Regulatory Compliance

This Certificate program provides comprehensive training across the entire clinical trials process from the perspective of the clinical study site as well as that of the sponsor or monitor.

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About the Program

The program's curriculum covers good clinical practices, regulatory requirements and compliance, detecting fraud and misconduct, and statistics for clinical research.  Certificate recipients will have the skills and knowledge to initiate clinical research studies, apply monitoring methods, and write documents and reports, while understanding and abiding by regulations.

Program Structure

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

Face-to-face courses are offered in a convenient three-day format at the University of Chicago Gleacher Center in downtown Chicago.

Online courses are three to five weeks long, with live classroom sessions once a week. Between the weekly synchronous sessions, participants complete required readings, assignments, and self-study activities. All participants' equipment and software must meet minimal technical standards for online learning

Program Requirements/Curriculum

Participants must complete five required courses and one elective to earn the Certificate:

  • 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, offers a brief, supervised opportunity to observe and to learn from a clinical trial in progress. The Observation Study is required for students in the certificate program who do not have at least six months of work experience in the field of clinical research. It is offered any quarter at the discretion of the student, faculty, and program manager. Each Observation Study must be individually arranged with the program director.

Credit and Grades

Participants do not earn credit toward an undergraduate or graduate degree in this special career program. When you complete the entire six-course program (seven if you need to participate in the Observation Study) successfully, you will be awarded a Certificate in Clinical Trials Management from the University of Chicago Graham School. The certificate signifies your achievement in a high-quality, career-related continuing education program.

Technical Requirements

Adobe Connect Practice Sessions for Online Courses (optional)

A virtual classroom will be available on Tuesdays, from 8:00-9:00pm Central Time and Thursdays, from 11:00-11:30am Central Time, if you'd like to test your computer and audio equipment or try to solve a technical issue. An Online Course Monitor will be logged on as well during these times to provide any technical assistance you may need. To enter the space, go to the virtual classroom, and log in as a guest, using your full name. You do not need a password.

Access the virtual classroom here.

See our FAQ page for more information.

Application/Registration Requirements

Students should hold a bachelor's degree and have prior work experience and/or interest in the field of clinical research. 

To apply, please submit:

  • Completed application form
  • $40 application fee
  • Statement of purpose (250 words)
  • Current resume

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View previously offered Clinical Trials Management courses.