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Graduate Course Proposal Form Submission Detail - GMS6182

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Current Status: Approved, Permanent Archive - 2008-06-09
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  1. Department and Contact Information

    Tracking Number Date & Time Submitted
    1604 2008-01-25
     
    Department College Budget Account Number
    Internal Medicine MD unknown
     
    Contact Person Phone Email
    Shyam Mohapatra (813)9748568 Smohapat@health.usf.edu

  2. Course Information

    Prefix Number Full Title
    GMS 6182 Clinical Research Methods

    Is the course title variable? N
    Is a permit required for registration? N
    Are the credit hours variable? N
    Is this course repeatable?
    If repeatable, how many times? 0

    Credit Hours Section Type Grading Option
    3 C - Class Lecture (Primarily) R - Regular
     
    Abbreviated Title (30 characters maximum)
    Clinical Research Methods
     
    Course Online? Percentage Online
    -

    Prerequisites

    General Biology (1 year), General Chemistry (1 year),

    Corequisites

    Course Description

    The course will provide a foundation for healthcare providers to pursue investigator-initiated clinical research. It is not restricted to majors or nonmajors and cannot be repeated for credit.


  3. Justification

    A. Please briefly explain why it is necessary and/or desirable to add this course.

    The course will provide healthcare professionals with a solid foundation in the essential aspects of clinical research methods. To meet its growing research interests, USF Health must create an infrastructure to train medical residents, fellows, and facul

    B. What is the need or demand for this course? (Indicate if this course is part of a required sequence in the major.) What other programs would this course service?

    This course will be a required component of the Graduate Certificate in Clinical Research Methods, which is currently under review by the Committee. We anticipate that a total of 30 students will enroll each semester in which the course is offered. This course is also being offered in part to address the needs of students who will be trained as part of the Fogarty International Center-sponsored Program in Adolescent HIV/AIDS Research Training grant (PI Patricia Emmanuel). Students from the grant program will be required to take this course during their second semester (fall semester) of their training program. We also expect that this course would be useful to programs such as the K30 Scholars (SPOR) and other research training programs offered at USF.

    C. Has this course been offered as Selected Topics/Experimental Topics course? If yes, how many times?

    No

    D. What qualifications for training and/or experience are necessary to teach this course? (List minimum qualifications for the instructor.)

    At a minimum, the course instructor must have a terminal graduate or professional degree (PhD or MD or equivalent) and relevant experience in the area of clinical research.


  4. Other Course Information

    A. Objectives

    1. Understand the scope of clinical research and clinical trials.

    2. Identify clinical research questions and appropriate methodology.

    3. Understand the most important ethical issues in clinical research.

    4. Understand the Institutional Review Board process.

    5. Identify methods for seeking funding sources.

    6. Improve grant writing skills.

    7. Understand the special considerations involved in conducting international research.

    8. Understand how to manage research projects and grants.

    9. Interpret research data appropriately.

    10. Develop skills in manuscript preparation and publication.

    11. Develop presentation and communication skills for disseminating findings.

    B. Learning Outcomes

    1. Understand the scope of clinical research and clinical trials.

    2. Identify clinical research questions and appropriate methodology.

    3. Understand the most important ethical issues in clinical research.

    4. Understand the Institutional Review Board process.

    5. Identify methods for seeking funding sources.

    6. Improve grant writing skills.

    7. Understand the special considerations involved in conducting international research.

    8. Understand how to manage research projects and grants.

    9. Interpret research data appropriately.

    10. Develop skills in manuscript preparation and publication.

    11. Develop presentation and communication skills for disseminating findings.

    C. Major Topics

    Major course topics will include the following: clinical research; clinical trials, evidence based medicine; literature searching; critical review of literature; selecting a research question; clinical research methodology; ethical considerations; protection of human subjects; informed consent; HIPAA compliance; institutional review boards; funding sources; preparation of concept papers and grant proposals; leadership and management; interpretation of study findings; dissemination and publication of findings.

    D. Textbooks

    Although no textbooks are required, the following are highly recommended:

    1. Fundamentals of Clinical Trials. 3rd ed. Lawrence M. Friedman, David L. DeMets, Curt D. Furberg, Springer-Verlag New York, LLC. May 2006.

    2. Designing Clinical Research: An Epidemiologic Approach. 2nd ed. SB Hulley, SR Cummings, WS Browner, D Grady, N Hearst and TB Newman. 2001.

    E. Course Readings, Online Resources, and Other Purchases

    F. Student Expectations/Requirements and Grading Policy

    G. Assignments, Exams and Tests

    H. Attendance Policy

    I. Policy on Make-up Work

    J. Program This Course Supports


  5. Course Concurrence Information



- if you have questions about any of these fields, please contact chinescobb@grad.usf.edu or joe@grad.usf.edu.