Designing Clinical Research (EPI 150.03)

Summer/Fall 2025 (2 units)

This online course guides residents and students through the essential components for writing a clinical research protocol, developed around their own clinical research question. Students attend lectures and small group seminars as well as being given the opportunity for an optional peer review session in the last week of the course. The course will cover research questions, hypotheses, specific aims, study types, sample size estimation, power calculations, and data analysis.

Tracks 1 & 3 Syllabus

Track 2 Syllabus

Objectives

The objectives for this course are for participants to:

  • Acquire introductory skills for designing and interpreting clinical research.
  • Produce a complete clinical research protocol, including background, sampling, measurements, and data analysis.
  • Help others in the class to develop these skills and protocols.

 

Prerequisites

  • Possession of at least an undergraduate degree or enrollment in the UCSF Pre-Health Undergraduate Program (PUP) or SF-BUILD program.
  • An idea for a research question in clinical research that has been discussed with a research mentor.
  • Proficiency with word processing software, biomedical literature searching, and reference management software (Endnote, RefWorks or other software).
  • Exceptions to prerequisites may be made with Course Director Consent.

Faculty

Course Director: Megie Okumura, MD, MAS

Professor of Pediatrics
email: [email protected]

Format

For each of 7 blocks, which are held over a 1-month period, curricular material is introduced with a lecture and accompanying reading. Each block will focus on a new component of a research protocol, which students will discuss with faculty at the twice-weekly (Monday and Wednesday) small group discussion section.

Lectures:For each block, a pre-recorded lecture provides an overview of the curricular material for the block. The video is available on the course website and can be viewed at the student's convenience.

Small Group Sections: Mondays and Wednesday, 10:30 AM to 12:00
Review of assigned protocol components and discussion of readings and exercises. Most small group sections will be held on Mondays and Wednesdays from 10:30 AM to 12:00 Noon. A smaller number will be available at 5:30 PM to 7:00 PM. Final Protocol Review: Student pairs or trios meet with a different faculty member to evaluate their protocols.

For each of the 7 blocks, students will:

  • Watch the lecture
  • Read portions of Designing Clinical Research (DCR-5)
  • Complete the exercises
  • Compose parts of your protocol (specific assignments in the syllabus section). Students are asked to bring the first draft of their homework to small group section. Revisions can subsequently be emailed to section leaders by MIDNIGHT

Two calendar tracks are offered:

Track 1: Begins July 30. Small Group Session held on July 30, August 4, 6, 11, 13, 18, 20 and 25.
Track 2: Begins August 13. Small Group Session held on August 13, 18, 20, 25, 27, September 3, and 8 (7 Sessions)
Track 3: Begins September 10. Small Group Sessions held on September 10, 15, 17, 22, 24, 29, October 1 and 6

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

Track 1: Syllabus

Tracks 2 & 3: Syllabus

Materials

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).

Grading

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.

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.

UCSF Graduate Division Policy on Disabilities

To Enroll

ATCR and MAS students use the Student Portal

Students taking individual courses:



Apply:  Application will be available by May 23, 2025

Only one application needs to be completed for all courses desired during the quarter.