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Master of Science in Biomedical Regulatory Affairs

Certificate in Clinical Trials

On This Page: Format | Courses | Cost | Credit/Noncredit Options | Admissions

Gain expertise in running and managing clinical trials and make a substantial contribution to our evolving medical system.  

In this three-course certificate program, you’ll learn about the principles, regulations and proper design of clinical trials. Delve into the business dimensions of clinical trials, including project management, planning, analysis, contingency and follow-up. Along the way, you’ll get hands-on experience in the various aspects of clinical trials, including ethical issues.


This eight-month certificate program is offered in person on the UW campus in Seattle. Classes are held on weekdays in the evening.


You’ll take nine credits over three quarters.

Autumn Quarter

Introduction to Clinical Trials

Instructors: David Hammond and Mary Lessig
Credits: 3
This course introduces the major concepts underlying how clinical trials are designed and run. It focuses on the phases of clinical trials, the role of the U.S. Food and Drug Administration, institutional review boards, the Code of Federal Regulations and ethical principles. Clinical study design and statistical concepts are also addressed. 

Credit course number: PHRMRA 524
Noncredit course number: CLINIC 110

Winter Quarter

Implementation & Conduct of Clinical Trials

Instructors: David Hammond and Mary Lessig
Credits: 3
This course outlines how to carry out a clinical trial. It covers the complex work of study initiation, issues of site and data management, preparation of the final report and study close-out as well as the myriad regulations that control how the study is conducted. 

Credit course number: PHRMRA 525
Noncredit course number: CLINIC 120

Spring Quarter

Project Management & the Business of Clinical Trials

Instructors: David Hammond and Mary Lessig
Credits: 3
This course addresses the business dimension of clinical trials. It covers the principles of project management, planning, analysis, contingency and follow-up within the context of clinical trials that involve a large number of tasks and people responsible for parts of the overall study. 

Credit course number: PHRMRA 526
Noncredit course number: CLINIC 130


The Certificate in Clinical Trials costs $4,212 for the noncredit option and $8,595 for the credit option (2024–25). Each quarter, students also pay registration ($55) and technology fees ($4–$22). Costs for textbooks and other course materials are extra.

Choose From Credit and Noncredit Options

By completing this certificate program, you can earn up to nine credits toward degree requirements should you later be accepted into the Master of Science in Biomedical Regulatory Affairs. To use these credits, you must enroll in the credit version of the certificate program and obtain graduate nonmatriculated status before you register for the first course. The certificate also has a noncredit option if you don’t plan to pursue a graduate degree. For instructions on how to apply for GNM status, see the GNM section on the Admissions page. 


Application Deadline

This program begins on September 25, 2024. We're accepting applications until 5 p.m. (Pacific Time) on September 11, 2024. We’ll consider applications received after that date if space is available.  

Admission Requirements 

  • Bachelor's or equivalent degree or experience in clinical trials or a closely related field of health and medicine 
  • Demonstrated English language proficiency if English isn’t your native language

Also Recommended:

Application Steps 

Step 1: Gather the following materials 

  • A brief letter (250-word maximum) that describes your relevant experience, transferable skills, knowledge of the field and commitment to professional growth 
  • A resume that highlights how your education and any applicable experience fulfill the program's admission requirements 

Step 2: Apply 

Complete your application and submit the materials listed in step 1.

Next, pay the $50 nonrefundable application fee. In one to two business days after you submit your application, you’ll receive an email with a link to pay your fee.

Apply – Noncredit

After Applying

We’ll contact you within two weeks of receiving your application materials to let you know if you’ve been accepted to the program.

If you’re accepted, we’ll send you details about your first-term course, including information on how to register and pay your course fees. To ensure your spot in class, we recommend that you register by the priority registration deadline, which is four weeks before class begins. After that time, we may release your seat to another student. The final registration deadline is two days before the first class meeting.