Non-Credit Certificates | Online

Clinical Trials Management and Regulatory Compliance

Curriculum

A Competitive Advantage You Can Take to Work

Courses in the Clinical Trials Management and Regulatory Compliance certificate use real-world clinical trials to reinforce your foundational knowledge and accelerate your career in clinical research with hands-on training.

Learning objectives:

  • Understand the entire clinical trials process from the perspective of both the clinical study site and the sponsor or monitor
  • Consider and maintain regulatory compliance practices and the ethical standards of clinical research
  • Initiate clinical research studies, apply monitoring methods, and write documents and reports

Clinical Trials Management Program Structure

  • The program consists of six core requirements with a flexible sequential course progression
  • Students can complete the certificate in as little as nine months to three years
  • Class sizes range from ten to twenty students per course
  • Classes are offered remotely with live, interactive, synchronous sessions

Online course format

  • Each course is five weeks in length
  • All online courses begin on a Monday with a full week of self-study activities in Canvas, our learning management system
  • Weekly, self-paced learning and materials are time-sensitive and must be completed within required timeframes
  • Weekly, self-paced learning in Canvas leads to one synchronous session per week
  • When registering for a course, "Online self-paced" refers to the course's beginning and end dates, "Online fixed dates" refer to synchronous sessions.
  • Synchronous sessions are conducted through Zoom
  • Attendance to synchronous sessions is mandatory

Core Courses

Core courses allow students to 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. Each of the six core courses is required to complete the certificate program.

Image
Scientist looks through documents at a lab.

Ready to Accelerate Your Career in the Clinical Trials Industry?

Enroll in the Clinical Trials Management and Regulatory Compliance certificate program at UChicago.

Enroll Today