Designing Clinical Research (EPI 202)

Summer 2022 (2 units)

This course is an introduction to the methods of designing clincial 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

Prerequisites

  • Possession of a graduate or professional doctoral degree (MD, PhD, DDS, PharmD, or international equivalent), currently enrolled in an undergraduate, graduate, of projessional 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.

Faculty

Course Director: Mark Pletcher, MD, MPH

Professor of Epidemiology & Biostatistics
email: [email protected]

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 19 through August 30, 2022.
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 19 through August 30, 2022
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: Fridays, 10:10 AM to 11:00 AM
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 Stephen B. Hulley, 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).

To Enroll

ATCR and MAS students use the Student Portal

Students taking individual courses:

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

Apply by July 11, 2022 for summer quarter
Fall quarter application available August 1, 2022
Only one application needs to be completed for all courses desired during the quarter.