Designing Clinical Research (EPI 202)

Summer 2023 (2 units)

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.

Online Syllabus

Objectives

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.

Prerequisites

  • 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.

Format

Each week, for seven weeks, material is introduced with a lecture and accompanying reading. Each week will focus on a new component of a research protocol, which students will discuss with faculty at the weekly small group discussion section.

Lectures: Tuesdays, 9:10 AM to 10:00 AM, July 18 through August 29, 2023.
Each week, a live lecture at 9 AM 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: Tuesdays, 10:10 AM to 12:00 Noon (see exceptions below), July 18 through August 29, 2023
Small groups will review concepts from lecture and readings, discuss student projects, and critique each other’s weekly written assignments. Most small group sections will be held in-person on Tuesdays from 10:10 AM to 12:00 Noon, beginning on July 19. 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: TBD
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)
  • Composing parts of your protocol (specific assignments in the syllabus section). Students are asked to bring the first draft of their homework (on paper) to section on TUESDAY. Revisions can subsequently be emailed to small group section leaders by MIDNIGHT WEDNESDAY.

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

UCSF Graduate Division Policy on Disabilities

To Enroll

ATCR and MAS students use the Student Portal

Students taking individual courses:

Summer 2023 Course Fees
How to pay (please read before applying)
Summer 2023 Course Schedule

Apply by July 17, 2023 for summer quarter. 
Only one application needs to be completed for all courses desired during the quarter.