Designing Clinical Research (One Month) for Clinical Residents

Fall 2019 (2 Units)
Course Director: Alison Huang, MD, MAS
Associate Professor
Department of Epidemiology & Biostatistics


This course is an introduction to the process of clinical research, defined broadly as patient-oriented, translational, epidemiologic, comparative effectiveness, behavioral, outcomes, or health services research (i.e., any 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. This is primarily accomplished by instructing students in the creation of a research protocol, which is intended to address a relevant research question in their specific discipline.

The objectives for this course are for participants to:

  • acquire skills for designing and interpreting clinical research;
  • produce a complete clinical research protocol, including background, sampling, measurements, and data analysis; and
  • help others in the class to develop these skills and protocols.
  • Currently working as a clinical resident at UCSF.
  • An idea for a research question in clinical research that you have discussed with an experienced investigator who is willing to serve as a project mentor.
  • Proficiency with word processing software, biomedical literature searching with Pubmed, and reference management software (Endnote, RefWorks or other software).
Course Director:

Alison Huang, MD, MAS
Phone: 415-514-8697

Section Leaders:

Jeff Kohwles, MD, MPH


Amy Padula, PhD, MSc

  Nynikka Palmer, DrPH, MPH
  Priya Prasad, PhD, MPH

Content is delivered via textbook readings, lectures, which students view on their own online, in-person small group discussion sections, and a final protocol review.

  1. Small Group Sections:
    Content: Review of assigned protocol components and discussion of readings and exercises. Small groups are offered at the below times and campuses.
    Mondays and Wednesdays, 10:30 AM to 12:00 PM at Parnassus
    Mondays and Wednesdays, 5:00 PM to 6:30 PM at Parnassus
  2. Final Protocol Review: Protocols to be posted on the course website by Monday, Sept. 23, and protocol review sessions will take place on Wednesday, September 25 or at a time mutually convenient for the student and reviewer.


All course materials and handouts will be posted on the course's online syllabus.

Consult the CLE course website for instructions and deadlines for submitting course assignments. Students will receive an e-mail during the week of August 19-23 with instructions for preparing the first course assignment, which is due at the start of the first small group section on Wednesday, Sept. 4.


Designing Clinical Research
by Stephen B. Hulley, MD, MPH et al. Lippincott Williams & Wilkins. 4th Edition. 2013. UCSF library call number: R853.C55 D47.

Evidence-Based Diagnosis by Thomas B. Newman and Michael A. Kohn. Cambridge University Press. 1st Edition. 2009. UCSF library call number: RC71.3.N49 2009.

Books may be purchased either through the publisher or a variety of commercial venues (e.g.,


Students are expected to attend all small groups 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.

Students not in full-year TICR Programs who satisfactorily pass all course requirements will, upon request, receive a Certificate of Course Completion.

UCSF Graduate Division Policy on Disabilities


This course is limited to clinical residents at UCSF. To appy for this course, please fill out and submit the application below. Cost information is in the application. The deadline for application is August 16, 2019. Only one application needs to be completed for all courses desired during the quarter.

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APPLICATION Information for how to pay;
please read before applying