Clinical Trials Management and Regulatory Compliance
Curriculum Details for Clinical Trials Management and Regulatory Compliance Online or In-person Courses
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.
Click to View Core Courses
-
Students must take 5 or 6 core courses, depending on experience:
- CLIN10100: Introduction to Clinical Research: Conception to Protocol Development* (Available online or in-person at the Gleacher Center)
- CLIN11100: Good Clinical Practices (Available online or in-person at the Gleacher Center)
- CLIN11200: The Drug Development Process (Online)
- CLIN11300: Statistical Concepts for Clinical Research (Available online or in-person at the Gleacher Center)
- CLIN11400: Fundamentals of Site Management (Online)
- CLIN11500: Fundamentals of Clinical Monitoring (Available online or in-person at the Gleacher Center)
Click to View Elective Courses (One Required)
-
- CLIN10100: Introduction to Clinical Research: Conception to Protocol Development* (Available online or in-person at the Gleacher Center)
- CLIN21100: Fraud and Misconduct (Online)
- CLIN21200: Project Management and Leadership in the Healthcare Industry (In-person at the Gleacher Center)
*For students with fewer than one year of clinical trials experience.
Clinical Trials students effectively:
- 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
Program Structure and Class Formats
- 5 required courses and 1 elective
- Students can complete the certificate in as little as 3 quarters
- Class sizes are small, ranging from 10-20 students per course
- 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.
Online classes
- 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 classes
- Courses are offered in a convenient 3-day seminar format Wednesday-Friday from 8:30am-4:30pm at the University of Chicago Gleacher Center in downtown Chicago.