Designing Clinical Research (EPI 150.03)

The objectives for this course are for participants to:

• Acquire introductory 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.

• 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 a research mentor.
• Proficiency with word processing software, biomedical literature searching, and reference management software (Endnote, RefWorks or other software).
• Exceptions to prerequisites may be made with Course Director Consent.

For each of 7 blocks, which are held over a 1-month period, curricular material is introduced with a lecture and accompanying reading. Each block will focus on a new component of a research protocol, which students will discuss with faculty at the twice-weekly (Monday and Wednesday) small group discussion section.

Lectures:For each block, a pre-recorded lecture provides an overview of the curricular material for the block. The video is available on the course website and can be viewed at the student's convenience.

Small Group Sections: Mondays and Wednesday, 10:30 AM to 12:00
Review of assigned protocol components and discussion of readings and exercises. Most small group sections will be held on Mondays and Wednesdays from 10:30 AM to 12:00 Noon. A smaller number will be available at 5:30 PM to 7:00 PM. Final Protocol Review: Student pairs or trios meet with a different faculty member to evaluate their protocols.

For each of the 7 blocks, students will:

• Watch the lecture
• Read portions of Designing Clinical Research (DCR-5)
• 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 to small group section. Revisions can subsequently be emailed to section leaders by MIDNIGHT

Two calendar tracks are offered:

Track 1: Begins July 27. Small Group Session held on July 27, August 1, 3, 8, 10, 15 and 17.
Track 2: Begins August 10. Small Group Session held on August 10, 15, 17, 22, 24, 29, 31.
Track 3: Begins September 7. Small Group Sessions held on September 7, 12, 14, 19, 21, 26,  28.

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

Required:
Designing Clinical Research by Warren Browner, MD, MPH, et al. Wolters Kluwer. 5th Edition. 2022. 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 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

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Apply by September 2, 2022 for Fall quarter

Only one application needs to be completed for all courses desired during the quarter.