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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.

• Possession of at least 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 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).

Course Director:	Peter Chin-Hong, MD Professor, Department of Medicine Phone: 415-502-9585 email: peter.chin-hong@ucsf.edu
Course Co-Director:	Alison Huang, MD, MAS, MPhil Associate Professor, Department of Medicine and of Epidemiology & Biostatistics Phone: 415-502-9585 email: alison.huang@ucsf.edu
Lecturers:	Kirsten Bibbins-Domingo, MD, PhD, MAS Chair, Department of Epidemiology and Biostatistics email: bibbinsk@medicine.ucsf.edu
	Michael A. Kohn, MD, MPP Professor, Department of Epidemiology & Biostatistics email: michael.kohn@ucsf.edu
	Beth Cohen, MD, MAS Associate Professor, Departments of Medicine email: beth.cohen@ucsf.edu
	Deborah Grady, MD Professor Emeritus, Department of Medicine email: deborah.grady@ucsf.edu
	Charles McCulloch, PhD Professor, Departments of Medicine and Epidemiology & Biostatistics email: charles.mcculloch@ucsf.edu
Online Section Leader:	Chi Chu, MD chi.chu@ucsf.edu
Resident In-Person Section Leaders:	Beth Cohen, MD, MAS email: beth.cohen@ucsf.edu
	Samuel Goldman, MD, MPH email: Samuel.Goldman@ucsf.edu
	Tiffany Kim, MD email: tiffany.kim@ucsf.edu
	Amy Beck, MD, MPH email: Amy.Beck@ucsf.edu
Non-Resident In-Person Section Leaders:	Kala Mehta, DSc, MPH email: Kala.Mehta@ucsf.edu
	Dan Kelly, MD email: dan.kelly@ucsf.edu
	Diana Kwong, MD email: diana.kwong@ucsf.edu
	Paige Bracci, PhD, MPH, MS email: Paige.Bracci@ucsf.edu

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, August 5 through August 26. 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. Begin August 5.
   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.
   
3. Final Protocol Review: Protocols are due (via e-mail) by Wednesday, August 28. 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.

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).

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

UCSF Graduate Division Policy on Disabilities

Sessions 1-7

• Read Designing Clinical Research
• Complete the exercises
• Compose parts of your protocol (specific assignments in the syllabus section). Students are asked to bring the first draft of their homework (on paper) to small group section. Revisions can subsequently be emailed to section leaders by MIDNIGHT on that day (deadlines for online sections may be different).

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.

To apply for this course, please fill out and submit the application below. Please see our fees 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