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Overview
This course is an introduction to the methods of designing clinical research studies. We broadly define clinical research as patient-oriented, translational, epidemiologic, comparative effectiveness, behavioral, outcomes, or health services research, or any other health-realated research that has individual human beings or groups of human beings as its unit of observation). Students are exposed to overarching concepts and essential vocabulary for designing and interpreting clinical research, and apply these concepts by creating a research protocol that is intended to address a relevant research question in their specific area of interest.
Course Details
The objectives for this course are for participants to:
- Describe research study design, data analysis and management, sample size calculations, and power calculations.
- Describe inferences that may be drawn from findings of clinical research studies.
- Create a 5-page clinical research protocol for their proposed research projects.
- Provide peer review and be able to helpfully critique their co-learners' protocols.
- Possession of a graduate or professional doctoral degree (MD, PhD, DDS, PharmD, or international equivalent), currently enrolled in an undergraduate, graduate, of professional school, or relevant work experience.
- An idea for a research question in clinical research that has been discussed with an experienced investigator.
- Proficiency with word processing software, biomedical literature searching, and reference management software.
- Exceptions to prerequisites may be made with Course Director consent.
Each week, for seven weeks, material is introduced with a lecture and accompanying reading, and assignments will focus on a new component of a research protocol, which students will discuss with faculty at the weekly small group discussion section.
Lectures: Each week, a live lecture by the Course Director and guest experts provide an overview of the curriculum material for the week. This material is supplemental by pre-recorded lectures available on the course website that can be viewed at the student's convenience. Live lectures are recorded and made available on the course website shortly after the lecture.
Small Group Sections: Small groups will review concepts from lecture and readings, discuss student projects, and critique each other’s weekly written assignments. In-person attendance is required for all MAS and ATCR students. A small number of Zoom small groups will be supported for other students not able to attend in-person on a space available basis.
Drop In Office Hours: Course faculty are available to address questions on course content and student protocols.
Weekly assignments will generally include:
- Reading portions of Designing Clinical Research (DCR-5)
- Watching pre-recorded lectures
- Doing DCR-5 exercises (optional)
- Writing parts of your protocol and other short written assignments
All course materials and handouts will be posted on the course's online syllabus.
Required: Designing Clinical Research by Warren Browner, MD, MPH et al. Wolters Kluwer. 5th Edition. 2022. UCSF library call number: R853.C55 D47.
Books may be purchased either through the publisher or a variety of commercial venues (e.g., Amazon.com).
Students are expected to attend all small group sections with only ONE excused absence permitted, and students are expected to inform their small group section leaders beforehand about any absence. Participation in small groups, timely completion of reading assignments and problems sets, and final submission of a completed protocol are minimum requirements for a passing grade.
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 $2,300
For Non-UC-Affiliated learners, the course fee is $3,300
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.
The objectives for this course are for participants to:
- Describe research study design, data analysis and management, sample size calculations, and power calculations.
- Describe inferences that may be drawn from findings of clinical research studies.
- Create a 5-page clinical research protocol for their proposed research projects.
- Provide peer review and be able to helpfully critique their co-learners' protocols.
- Possession of a graduate or professional doctoral degree (MD, PhD, DDS, PharmD, or international equivalent), currently enrolled in an undergraduate, graduate, of professional school, or relevant work experience.
- An idea for a research question in clinical research that has been discussed with an experienced investigator.
- Proficiency with word processing software, biomedical literature searching, and reference management software.
- Exceptions to prerequisites may be made with Course Director consent.
Each week, for seven weeks, material is introduced with a lecture and accompanying reading, and assignments will focus on a new component of a research protocol, which students will discuss with faculty at the weekly small group discussion section.
Lectures: Each week, a live lecture by the Course Director and guest experts provide an overview of the curriculum material for the week. This material is supplemental by pre-recorded lectures available on the course website that can be viewed at the student's convenience. Live lectures are recorded and made available on the course website shortly after the lecture.
Small Group Sections: Small groups will review concepts from lecture and readings, discuss student projects, and critique each other’s weekly written assignments. In-person attendance is required for all MAS and ATCR students. A small number of Zoom small groups will be supported for other students not able to attend in-person on a space available basis.
Drop In Office Hours: Course faculty are available to address questions on course content and student protocols.
Weekly assignments will generally include:
- Reading portions of Designing Clinical Research (DCR-5)
- Watching pre-recorded lectures
- Doing DCR-5 exercises (optional)
- Writing parts of your protocol and other short written assignments
All course materials and handouts will be posted on the course's online syllabus.
Required: Designing Clinical Research by Warren Browner, MD, MPH et al. Wolters Kluwer. 5th Edition. 2022. UCSF library call number: R853.C55 D47.
Books may be purchased either through the publisher or a variety of commercial venues (e.g., Amazon.com).
Students are expected to attend all small group sections with only ONE excused absence permitted, and students are expected to inform their small group section leaders beforehand about any absence. Participation in small groups, timely completion of reading assignments and problems sets, and final submission of a completed protocol are minimum requirements for a passing grade.
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 $2,300
For Non-UC-Affiliated learners, the course fee is $3,300
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.