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Designing Clinical Research for Residents and Students
EPI 150.03 Winter 2008 (2 units)
Course Director: Douglas Bauer, MD
Professor, General Internal Medicine and
Epidemiology and Biostatistics
Co-Director: Thomas Novotny, MD MPH
Professor, Epidemiology and Biostatistics
| OVERVIEW |
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This course guides research scholars through the essential
components for writing a clinical research protocol, developed around
their own clinical research question. The students will attend twice-weekly
lectures and small seminar groups for four weeks as well as a peer review
session in the last week of the course. The course will cover generation
of research questions, hypotheses, specific aims, study design, sample
size estimation, and data analysis.
| OBJECTIVES |
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1. Understand study design, data analysis and management,
and sample size calculations.
2. Understand the inferences that may be drawn from findings of clinical
research studies.
3. Draft a five-page clinical research protocol.
4. Provide peer review and be able to helpfully critique co-learners'
protocols.
| PREREQUISITES |
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Must be a dental, medical, nursing, or pharmacy student, or be serving
as a postgraduate clinical trainee (e.g., Resident).
Must have consent of training program supervisor.
Must provide a Research Question they will work on and the name
of a mentor with whom they will work.
| FACULTY & STAFF |
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FORMAT
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Lectures: 9-10:15 AM on Friday, Feb. 1 and every Monday and Wednesday
in Feb. except Feb. 18th.
Small Groups: 10:30-Noon, following the lectures each day.
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TEXTBOOK
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Designing Clinical Research
by S. Hulley et al. Lippincott Williams & Wilkins. 3rd Edition. 2006.
Take NIH Certification on-line for Human Subject Protections:
Basic Course https://www.researchonline.ucsf.edu/
| GRADING |
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Students are expected to attend all classes and small groups
with only ONE excused absence permitted. Participation in small groups,
completion of reading assignments and problems on a daily basis, and final
submission of completed protocol are minimum requirements for a passing
grade.
| ASSIGNMENTS |
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See syllabus for reading assignments.
| ENROLLMENT/PAYMENT |
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PLEASE APPLY EARLY AS SPACE IS LIMITED. APPLICATIONS FOR
WINTER 2008 ARE DUE BY JANUARY 4, 2008.
Application
(Word doc, 20KB)
Payment for this course for UCSF Residents is provided
by the Clinical and Translational Science Training (CTST) Resident Research
Program. Payment for School of Medicine Medical Students is provided by
the Department of Epidemiology and Biostatistics. Course fees apply for
all other students.
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