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 EPI 150.03
 Schedule
 Syllabus
 Roster
 Protocol
 Objectives
 Prerequisites
 Faculty & Staff
 Format
 Textbook
 Grading
 Assignments
 Enrollment
 

Designing Clinical Research (One Month)
EPI 150.03 Summer 2016 (2 units)


Application Deadline: July 15, 2016

  • A two month version of this course (EPI 202) is also available for scholars whose schedules allow for the two month version. The curriculum is the same in the two courses, but the longer duration of EPI 202 allows for achievement of a more complete research proposal for scholars who intend to implement their projects in the coming year. All students in the ATCR Certificate and Master's Degree Programs are required to take the two month version.
  • An online version of this course will be available to a limited number of students on a first come, first served basis. Please note that the time of the online small group session will be announced presently. Priority will be given to learners outside of the San Francisco Bay Area.
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, 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.
PREREQUISITES
  • Possession of 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 you have 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 & STAFF

Course Director:

Peter Chin-Hong, MD
Professor, Department of Medicine
Phone: 415-502-9585
email: peter.chin-hong@ucsf.edu

Course
Co-director:

Miriam Kuppermann, PhD, MPH
Professor, Department of Obstetrics, Gynecology and Reproductive Sciences
email: kuppermannm@obgyn.ucsf.edu

Lecturers:

Doug Bauer, MD
Professor, Department of Medicine
email: dbauer@psg.ucsf.edu

 

Kirsten Bibbins-Domingo, MD, PhD, MAS
Director, Clinical and Translational Training and Professor, Department of Medicine
email: bibbinsk@medicine.ucsf.edu

 

 

Steve Cummings, MD
Professor Emeritus, Departments of Medicine and Epidemiology & Biostatistics
email: scummings@sfcc-cpmc.net
  Deborah Grady, MD
CTSI Co-Director and Associate Dean of Clinical and Translational Research
email: Deborah.Grady@ucsf.edu
 

Miriam Kuppermann, PhD, MPH
Professor, Department of Obstetrics, Gynecology and Reproductive Sciences
email: kuppermannm@obgyn.ucsf.edu

  Michael Kohn, MD, MPP
Associate Professor, Department of Epidemiology & Biostatistics
email:michael.kohn@ucsf.edu
  Tom Newman, MD, MPH
Professor, Departments of Epidemiology & Biostatistics and Pediatrics
email: newman@epi.ucsf.edu
Online Section Leader:

Jonathan Lee, MD
email: jonathan.lee2@ucsf.edu

Resident Section Leaders:

Beth Cohen, MD
email: beth.cohen@ucsf.edu

Raymond Hsu, MD, MAS
email: raymond.hsu@ucsf.edu

Betty Smoot, PT, DPTSc, MAS
email: betty.smoot@ucsf.edu

Daniel West, MD
email: daniel.west@ucsf.edu

Non-resident Section Leaders:

Lindsay Hampson, MD
email: lindsay.hampson@ucsf.edu

Vasantha Jotwani, MD
email: vasantha.jotwani@ucsf.edu

Cassie Kline, MD
email: cassie.kline@ucsf.edu

Mitchell Lunn, MD
email: mitchell.lunn@ucsf.edu

Kala Mehta, MD
email: kala.mehta@ucsf.edu


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: Mondays and Wednesdays: 9:00 to 10:15 AM
    Lecture recordings will be online later the same day. To determine if you have sufficient bandwidth to view online lectures, please visit our demonstration site.


  2. Small Group Sections:
    Content: Review of assigned protocol components and discussion of readings and exercises.
    A. In-person Small Group Sections: Mondays and Wednesdays: 10:30 AM to Noon.
    B. Online: Time to be announced presently.
    Note: A high-speed internet connection is required
    .

  3. Final Protocol Review: Protocols due (via e-mail) by Monday, August 22.
    Student pairs or trios meet with a different faculty member to evaluate their protocols.

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

TEXTBOOK

Required:
Designing Clinical Research
by Stephen B. Hulley, MD, MPH et al. Wolters Kluwer. 4th Edition. 2013. UCSF library call number: R853.C55 D47.

Recommended:
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., Amazon.com).

GRADING

Students are expected to attend all lectures/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

ASSIGNMENTS

Sessions 1-7

  • Read Designing Clinical Research (Fourth Edition).
  • Do the exercises
  • Compose parts of your protocol (specific assignments in the syllabus section)
  • Bring the first draft of your homework (on paper) to section. Then you can make revisions and e-mail it to your section leader by MIDNIGHT on that day.

Final Session

  • Finish your protocol and submit by email.
  • Critique one another's protocols in groups of 2 or 3 with a new faculty member.
ENROLLMENT

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 8, 2016.

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APPLICATION Information for how to pay;
please read before applying