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Only one application needs to be completed for all courses desired during the quarter.
Deadline:
07/17/2026
Format:
In-person
Term Offered:
Summer
Overview
This course is designed to introduce students to the fundamentals of clinical trial design and methods, including strategies for selecting trial participants and allocating them to interventions; designing and administering both experimental and comparator interventions; implementing and maintaining blinding to intervention assignment; defining primary and secondary trial outcomes; measuring outcomes and adverse events; addressing ethical issues that arise in trials; monitoring trial participants and managing post-randomization problems; and performing interim data and safety monitoring in trials.
Course Details
By the end of this course, students should be able to:
- Describe the value of randomization and blinding in clinical trials
- Consider the strengths and shortcomings of different intervention comparators or controls
- Outline appropriate plans for measuring outcomes and adverse effects in trials
- Describe strategies for monitoring participants after initiation of interventions
- Rrecognize common trial compliance and post-randomization problems
- Describe common statistical issues in clinical trials
- Navigate important ethical issues and interim monitoring strategies in trials
There are two prerequisites for this course:
- Designing Clinical Research: Successful completion of the UCSF Designing Clinical Research course (EPI 202 or EPI 150.03) or equivalent past training.
- The ability to set aside 6 hours per week for course activities.
Exceptions to these prerequisites may be granted with the consent of the Course Director, subject to space availability.
Course content will be delivered through a combination of video lectures, large group workshops, and small group discussions:
- Video Lectures: Pre-recorded video lectures will be uploaded to the CLE website every week, usually by Monday before 12:00 pm (noon); if the Monday falls on a holiday, the lecture will be uploaded by noon on Tuesday. Students should plan on watching each week’s lecture by the Thursday of the same week.
- Workshops: Each week, an instructor will lead an interactive workshop designed to deepen students’ understanding of course concepts and provide an opportunity for students to ask questions. Workshops will be held in person in Mission Hall. Although slides from workshops will be posted online, participation is in-person only.
- Small Groups: Small group discussion sections will focus on discussion of and feedback on students’ draft clinical trial protocols. Sections will be held primarily in person at Mission Hall.
All course materials and handouts will be posted on the course's online syllabus.
Designing Clinical Research by Warren Browner, MD, MPH, et al. Wolters Kluwer. 5th Edition. 2022. UCSF library call number: R853.C55 D47.
Optional:
Fundamentals of Clinical Trials by Lawrence M. Friedman et al. Springer. 5th Edition. 2015. Available for downloading from UCSF library.
Books may be purchased either through the publisher or a variety of commercial venues (e.g., Amazon.com).
Grades will be based on total points achieved on homework (~25%), protocol development and critiquing (~50%), and the final exam (~25%). Late assignments are not accepted.
Lecture-related homework assignments are due by 12:00 noon on the Monday following the lecture in which they are assigned. If Monday is a holiday (such as MLK Day or Presidents Day), homework will be due by 12:00 noon on Tuesday of the same week.
Protocol Assignment: Email a copy of your cumulative protocol to your section leader by noon on the Monday before each Small Group Section. If Monday is a holiday, protocol assignments are due on Tuesday of the same week.
Students not in full-year DEB Education Programs who satisfactorily pass all course requirements will, upon request, receive a Certificate of Course Completion.
Only UCSF students (defined as individuals enrolled in UCSF degree or certificate programs) will receive academic credit for courses. Official transcripts are available to UCSF students only. A Certificate of Course Completion will be available upon request to individuals who are not UCSF students and satisfactorily pass all course requirements.
For UC-Affiliated learners, the course fee is $2,100
For Non-UC-Affiliated learners, the course fee is $2,500
UC-Affiliation: Concurrent enrollment in a University of California-sponsored residency or post-doctoral fellowship program that is recognized by the Office of Graduate Medical Education; or a registered student in one of the professional schools or graduate programs at the University of California (in a program other than the TICR program); or individuals who hold full-time salaried University of California faculty, academic or staff positions. Please note: Individuals will be asked to provide proof of UC status.
By the end of this course, students should be able to:
- Describe the value of randomization and blinding in clinical trials
- Consider the strengths and shortcomings of different intervention comparators or controls
- Outline appropriate plans for measuring outcomes and adverse effects in trials
- Describe strategies for monitoring participants after initiation of interventions
- Rrecognize common trial compliance and post-randomization problems
- Describe common statistical issues in clinical trials
- Navigate important ethical issues and interim monitoring strategies in trials
There are two prerequisites for this course:
- Designing Clinical Research: Successful completion of the UCSF Designing Clinical Research course (EPI 202 or EPI 150.03) or equivalent past training.
- The ability to set aside 6 hours per week for course activities.
Exceptions to these prerequisites may be granted with the consent of the Course Director, subject to space availability.
Course content will be delivered through a combination of video lectures, large group workshops, and small group discussions:
- Video Lectures: Pre-recorded video lectures will be uploaded to the CLE website every week, usually by Monday before 12:00 pm (noon); if the Monday falls on a holiday, the lecture will be uploaded by noon on Tuesday. Students should plan on watching each week’s lecture by the Thursday of the same week.
- Workshops: Each week, an instructor will lead an interactive workshop designed to deepen students’ understanding of course concepts and provide an opportunity for students to ask questions. Workshops will be held in person in Mission Hall. Although slides from workshops will be posted online, participation is in-person only.
- Small Groups: Small group discussion sections will focus on discussion of and feedback on students’ draft clinical trial protocols. Sections will be held primarily in person at Mission Hall.
All course materials and handouts will be posted on the course's online syllabus.
Designing Clinical Research by Warren Browner, MD, MPH, et al. Wolters Kluwer. 5th Edition. 2022. UCSF library call number: R853.C55 D47.
Optional:
Fundamentals of Clinical Trials by Lawrence M. Friedman et al. Springer. 5th Edition. 2015. Available for downloading from UCSF library.
Books may be purchased either through the publisher or a variety of commercial venues (e.g., Amazon.com).
Grades will be based on total points achieved on homework (~25%), protocol development and critiquing (~50%), and the final exam (~25%). Late assignments are not accepted.
Lecture-related homework assignments are due by 12:00 noon on the Monday following the lecture in which they are assigned. If Monday is a holiday (such as MLK Day or Presidents Day), homework will be due by 12:00 noon on Tuesday of the same week.
Protocol Assignment: Email a copy of your cumulative protocol to your section leader by noon on the Monday before each Small Group Section. If Monday is a holiday, protocol assignments are due on Tuesday of the same week.
Students not in full-year DEB Education Programs who satisfactorily pass all course requirements will, upon request, receive a Certificate of Course Completion.
Only UCSF students (defined as individuals enrolled in UCSF degree or certificate programs) will receive academic credit for courses. Official transcripts are available to UCSF students only. A Certificate of Course Completion will be available upon request to individuals who are not UCSF students and satisfactorily pass all course requirements.
For UC-Affiliated learners, the course fee is $2,100
For Non-UC-Affiliated learners, the course fee is $2,500
UC-Affiliation: Concurrent enrollment in a University of California-sponsored residency or post-doctoral fellowship program that is recognized by the Office of Graduate Medical Education; or a registered student in one of the professional schools or graduate programs at the University of California (in a program other than the TICR program); or individuals who hold full-time salaried University of California faculty, academic or staff positions. Please note: Individuals will be asked to provide proof of UC status.
Meet the Faculty
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How to Enroll
Whether you're exploring the field, enhancing your skills, or working toward a larger academic goal, most individual courses are open to everyone. Current learners enrolled in DEB Education programs have priority in enrollment for this course. Any extra spaces are available to non-DEB Education learners (i.e., those from the Institute for Global Health Sciences, School of Nursing, external groups, etc).
You’ll find details on course fees, how to apply and pay, and the full course schedule on the Course Enrollment & Payment page. Be sure you understand the enrollment policies and payment process before completing the enrollment form.
And remember: you only need to submit one form for all the new courses you want to take.