Graduate Student at Large Certificate in Clinical Trials and Regulatory Management

We offer international students the opportunity to study abroad in Chicago through a 16-week program in clinical trials and regulatory management.

About

The 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.

Students will have full access to the University of Chicago library system, reference materials, athletic facilities and student health and well-being services. Accommodation is included.

Why Chicago?

The University of Chicago has been at the leading edge of discoveries in oncology and cancer biology, in genetics and microbiology. As one of the world’s premier medical research institutions, University of Chicago researchers conduct hundreds of clinical trials each year, finding treatments for a wide range of diseases. Twelve recipients of the Nobel Prize in Physiology or Medicine have been researchers at the University of Chicago.

Program Structure

Students will travel to Chicago before the academic quarter starts in order to take four weeks of intensive foundation courses and participate in an English language workshop for social scientists.  All will be held on the University of Chicago campus.  Students will then enjoy a week-long break before beginning the eleven-week long spring quarter.

Program Requirements

  • Two foundation courses
  • English language workshop
  • Five Clinical Trials courses
  • Hospital observation study
Course Descriptions

Foundation courses:

  • Good Clinical Practices
    This course provides an introduction to good clinical practice (GCP) in clinical research according to FDA regulations and International Conference on Harmonization (ICH) guidelines. Topics include conducting clinical trials in accordance with GCP; regulations established by state, federal, and international regulatory bodies; and the roles and responsibilities of investigators, sponsors, monitors, and auditors.
  • The Drug Development Process
    This course provides an overview of the drug development and clinical trials processes. Topics include the discovery of new molecules, how discoveries become drugs or devices, the purpose of clinical and pharmaceutical research and development, the economics of drug development, cost/benefit analyses in clinical development, Phase I-IV clinical trials, and an introduction to the special problems of each phase.

Clinical Trials Courses:

  • Statistical Concepts for Clinical Research
    This course introduces basic statistical concepts, such as hypothesis testing, the meaning of P value, and power determination. Other concepts with particular relevance to clinical research design and monitoring-such as the importance of randomization and randomization procedures, stratification, crossover designs, nonrandomized concurrent control studies, and the use of historical controls-will also be introduced.
  • Fundamentals of Site Management
    This course covers the process of coordinating and managing a clinical study from the perspective of the study site. Students will learn the essentials of coordinating and managing the day-to-day operations of a clinical research study, from planning site logistics and constructing timelines for the study-initiation visit to closing out a study. The course will focus on the operational, interpersonal, and data-management aspects of the process.
  • Fundamentals of Clinical Monitoring
    This course introduces students to the processes and procedures of monitoring a clinical trial from the perspective of the sponsor or contract research organization from the site-initiation visit to the closing out of a clinical study.
  • Fraud and Misconduct
    This course will provide an overview of clinical research-related fraud and scientific misconduct. Topics include the identification of suspected fraud and misconduct, significant cases that shaped the definition of clinical research-related fraud, recent regulatory changes, and your role in the identification and reporting of suspected fraud and misconduct. Students will gain an understanding of the various acts that define fraud and misconduct and the impact that they have on the clinical research process.
  • Elective course in the Biological Sciences

Application Requirements

  • Institutional nomination
  • TOEFL/IELTS scores
  • Statement of purpose
  • Official transcripts
  • Admissions interview

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