Designing Clinical Research (Two Month)

EPI 202 Summer 2019 (2 units)
Course Director: Mark J. Pletcher, MD, MPH
Professor
Department of Epidemiology & Biostatistics

OBJECTIVES

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 that is intended to address a relevant research question in their specific area of interest.

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.
PREREQUISITES
  • Possession of at least an undergraduate degree or enrollment in the UCSF Pre-Health Undergraduate Program (PUP).
  • 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 with Pubmed, and reference management software (Endnote, RefWorks or other software).
FACULTY
Course Director: Mark Pletcher, MD, MPH
Phone: 415-514-8008
Professor of Epidemiology & Biostatistics
email: mpletcher@epi.ucsf.edu
Course Co-Director: Joel Simon, MD, MPH
Professor Emeritus, Departments of Medicine and Epidemiology & Biostatistics
email: joel.simon@ucsf.edu
Lecturers: Warren Browner, MD, MPH
CEO, California Pacific Medical Center; Professor of Medicine and Epidemiology & Biostatistics
email: warren@cpmcri.org
  Steve Cummings, MD
Professor Emeritus, Departments of Medicine and Epidemiology & Biostatistics
email: scummings@sfcc-cpmc.net
  Deborah Grady, MD
Professor Emeritus, Department of Medicine
email: Deborah.Grady@ucsf.edu
  Michael Kohn, MD, MPP
Professor, Department of Epidemiology & Biostatistics
email: michael.kohn@ucsf.edu
  Thomas Newman, MD
Professor Emeritus, Departments of Epidemiology & Biostatistics and Pediatrics
email: newman@epi.ucsf.edu
Online Section Leader: TBA
In-Person Section Leaders: TBA
FORMAT

Both an in-person and online version of the course are offered. The online version will feature the exact materials as the in-person version, with content being delivered through online recordings of the weekly lectures as well as online web conferencing for small group discussion sections. The online version also features the same access to course faculty for discussion and questions as the in-person version.

  1. Lectures:
    Each week, a pre-recorded lecture provides an overview of the curriculum material for the week. The video is available on the course website and can be viewed at the student's convenience. To determine if you have sufficient bandwidth to view online lectures, please visit our demonstration site.
  2. Interactive Discussion: Tuesdays, 9:00 AM to 9:50 AM, July 30 through September 10.
    The Course Director and a weekly guest expert field questions about the week's curriculum and provide insights from the guest's research career.
  3. Small Group Sections:
    Content: Review of assigned protocol components and discussion of readings and exercises.
    A. In-person Small Group Sections: Tuesdays: 10:00 AM to 12:00 Noon. Begin July 30.
    B. Online: Please note that the time of the online small group session will be announced presently and will be chosen to accommodate the greatest number of interested students. Course fees will be refunded if the time chosen does not fit a student’s schedule. Note: a high-speed internet connection is required.

Weekly assignments will generally include:

  • Reading portions of Designing Clinical Research (DCR-4)
  • Doing DCR-4 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 (deadlines for the online section may be different).

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. 4th Edition. 2013. 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.

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

TO ENROLL

To apply for this course, please fill out and submit the application below. Please see our fee page for cost information. The deadline for application is July 15, 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