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Application Deadline: June 28, 2013

• A one month version of this course (EPI 150.03) is also available for scholars whose schedules do not 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 day/time for the online small group session is to be determined. Priority will be given to learners outside of San Francisco.
  
  

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;
• help others in the class to develop these skills and protocols; and
• have, over the years, a multiplier effect by teaching these skills to others.

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. 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

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: Tuesdays: 9:00 to 9:50 AM.
   Lecture recordings will be available online later in the 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: Tuesdays: 10:00 AM to 11:50 AM
   B. Online: Time to be determined
   Note: a high-speed internet connection is required.
   
   
3. Final Protocol Review: Protocols due (via e-mail) by 5:00 PM: Sept. 17
   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.

TEXTBOOKS

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 WEDNESDAY

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 (if you are NOT in the ATCR or Master's program). Students in the ATCR and Master's programs review their protocols during Fall Work-In-Progress seminars.

ENROLLMENT

APPLICATION

For scholars taking the online version: Partial 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 textbook, any software, or any local costs associated with accessing a high-speed internet connection.