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 Epi 150.03
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Designing Clinical Research (One Month)
EPI 150.03 Summer 2014 (2 units)


Application Deadline: July 14, 2014

Note to Residents: Designing Clinical Reseach (One Month) is full. We will not be accepting further applications from Residents for that course, but we are still accepting applications from persons who are not Residents. There will be an online version of Designing Clinical Research for Residents in October 2014.

  • 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 the online small group session will be held on Mondays and Wednesdays from 7:00 to 8:30 PM (Pacific Time in the U.S.). Priority will be given to learners outside of 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 a graduate or professional doctoral degree (MD, PhD, DDS, PharmD or international equivalent) or currently enrolled in an undergraduate, graduate, or professional school, or residency program. Exceptions to these prerequisites may be made with the consent of the Course Director, space permitting.
  • 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

 

 

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

Margaret Handley, PhD, MPH
Associate Professor, Dept. of Epidemiology & Biostatistics and Center for Vulnerable Populations
email: handleym@medsfgh.ucsf.edu

 

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

 

Charles McCulloch, PhD
Professor, Deparment of Epidemiology & Biostats
email: chuck@biostat.ucsf.edu

  Tom Newman, MD, MPH
Professor, Departments of Epidemiology & Biostatistics and Pediatrics
email: newman@epi.ucsf.edu
Resident Section Leaders:

Andrew Avins, MD, MPH
email: andy.l.avins@kp.org

  Dejana Braithwaite, PhD
email: dbraithwaite@epi.ucsf.edu
  Diana Naranjo, PhD
email:naranjod@peds.ucsf.edu
  Helen Kim, PhD
email:kimhel@anesthesia.ucsf.edu
  Kala Mehta, DSc, MPH
email: Kala.Mehta@ucsf.edu
Online Section Leader: Eleni Linos, MD, MPH, DrPH
email: LinosE@derm.ucsf.edu
Student Section Leaders: Arpi Bekmezian, MD
email: BekmezianA@peds.ucsf.edu
  Valerie Flaherman, MD
email: flahermanv@peds.ucsf.edu
 

Amy Hsu, MD
email: amy.hsu@ucsf.edu

 

Nicole Ling, MD
email: nicole.ling@ucsf.edu

 

Jonathan Singer, MD
email: jon.singer@ucsf.edu

  Betty Smoot, PT, DPTSc
email: betty.smoot@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: 10:30 AM to Noon, following the lectures each day
    B. Online: Mondays and Wednesdays from 7:00 to 8:30 PM (Pacific Time in the U.S.)
    Note: A high-speed internet connection is required
    .

  3. Final Protocol Review: Protocols due (via e-mail) by Monday, August 25.
    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. Lippincott Williams & Wilkins. 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 who satisfactorily pass all course requirements may obtain a Certificate of Course Completion, upon request.

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 some revisions and e-mail it to your section leader by MIDNIGHT on the days the assignments are discussed in section.

Final Session

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

APPLICATION

For scholars taking the online version: Scholarships may be available, upon justification, to scholars residing in countries with low income or lower middle income economies as defined by the World Bank. If you believe you are eligible for a scholarship, please send a justification of less than one page to Olivia DeLeon at olivia@epi.ucsf.edu. In the justification, include the country in which you reside, your current income, and your access, if any, to educational funds from local institutions. Please also send your curriculum vitae (CV). Note that the scholarship does not include cost of textbooks, any software, or any local costs associated with accessing a high-speed internet connection.