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.
What do Clinical Trials Students Learn?
- Understand the entire clinical trials process, from the perspective of the clinical study site and the sponsor or monitor
- Consider and maintain regulatory compliance practices and the ethical considerations of conducting clinical research
- Initiate clinical research studies, apply monitoring methods, and write documents and reports
Clinical Trials Program Structure
- 5 required courses and 1 elective
- Students can complete the certificate in as little as 3 quarters
- Class sizes range from 10-20 students per course
- Classes are offered online or in-person.
View Core Courses
Students must take 5 or 6 core courses, depending on experience:
- CLIN10100: Introduction to Clinical Research: Conception to Protocol Development (Online) Only required for Core if student has less than 6 months professional experience. Course can then count as the elective requirement.
- CLIN11100: Good Clinical Practices (Online)
- CLIN11200: The Drug Development Process (Online)
- CLIN11300: Statistical Concepts for Clinical Research (Online or in-person)
- CLIN11400: Fundamentals of Site Management (Online)
- CLIN11500: Fundamentals of Clinical Monitoring (Online)
View Elective Courses (One Required)
- CLIN10100: Introduction to Clinical Research: Conception to Protocol Development (Online) If student has less than 6 months professional experience this course must be taken as the elective requirement.
- CLIN21100: Fraud and Misconduct (Online)
- CLIN21200: Project Management and Leadership in the Healthcare Industry (In-person)
Online and In-person Class Formats
- 3 to 5 weeks course length
- All online courses start 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
- Synchronous sessions are conducted through Zoom
- Attendance to synchronous sessions is mandatory
- Learn more about taking online courses
- Courses are offered in a convenient 3-day seminar format Wednesday–Friday from 8:30 a.m.–4:30 p.m. in downtown Chicago.
- In-person courses are limited. Check the upcoming schedule for current offerings.