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Designing Clinical Research for Residents


OVERVIEW

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 bi-weekly group 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 study questions, hypotheses, specific aims, study types, sample size estimation, power calculations, and data analysis. Please follow instructions for enrollment below.

OBJECTIVES

1. Understand study design, data analysis and management, sample size calculations, and power calculations.
2. Understand the inferences that may be drawn from findings of clinical research studies.
3. Draft a five-page clinical research protocol for use in their proposed research projects.
4. Provide peer review and be able to helpfully critique their co-learners' protocols.

PREREQUISITES
  • Must be a clinical resident.

  • Must have consent of instructor and residency program director.

  • Must provide a research question they will work on and the name of a mentor with whom they will work.

  • FACULTY & STAFF

    Course Director:

    Jeff Kohlwes, MD
    email: jeffk@medicine.ucsf.edu

    Co-Director:

    Douglas Bauer, MD
    email: dbauer@psg.ucsf.edu

    Section Leaders:

    Jeff Kohlwes, MD
    email: jeffk@medicine.ucsf.edu

     

    Emily von Scheven, MD, MAS
    email: evonsche@peds.ucsf.edu


    FORMAT

    Lectures: 9-10:15 AM on October 3, 5, 10, 12, 17, 19, and 24
    Small Groups: 10:30-Noon, following the lectures each day
    Final Peer Review Session: October 26

    TEXTBOOK

    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

    Students are expected to attend all lectures 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.

    ASSIGNMENTS

    See syllabus for reading assignments.

    ENROLLMENT

    PLEASE APPLY EARLY AS SPACE IS LIMITED. APPLICATIONS WILL BE SELECTED ON A FIRST COME, FIRST SERVED BASIS. APPLICATIONS ARE DUE BY SEPTEMBER 23, 2011.

    Application (Word doc, 20KB)

    Please fax your application form to Olivia DeLeon at 415-514-8150.

    COST: The course fee is waived for UCSF Residents. Residents from other institutions are required to pay the $2770 course fee.