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Graduate Course Proposal Form Submission Detail - GMS6844

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Current Status: Approved, Permanent Archive - 2007-03-14
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  1. Department and Contact Information

    Tracking Number Date & Time Submitted
    1736 2006-10-18
     
    Department College Budget Account Number
    USF Health Office of Research MD 600105
     
    Contact Person Phone Email
    Sandra Anderson 45566 sanders2@hsc.usf.edu

  2. Course Information

    Prefix Number Full Title
    GMS 6844 Principles of Patient-Oriented Research

    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
    1 C - Class Lecture (Primarily) R - Regular
     
    Abbreviated Title (30 characters maximum)
    Patient-Oriented Research
     
    Course Online? Percentage Online
    -

    Prerequisites

    Postdoctoral Status

    Corequisites

    Permission of Instructor

    Course Description

    Introduction to the Scholars in Patient-Oriented Research (SPOR) Program. Assists in identifying important clinical and translational research questions, approaches, sources of support and regulatory issues. Instructor permission. Not repeatable.


  3. Justification

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

    This course has been developed to meet the requirements of a National Institutes of Health-sponsored program for training health professionals with the knowledge and skills necessary to conduct academic patient-oriented research. The course is required t

    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?

    No course currently exists that provides the basic information on patient-oriented research necessary to prepare students for success in the more specific in-depth courses in clinical research methods. This course is part of the required sequence that also includes the more in-depth methodology courses that are part of the concentration in Clinical and Translational Research in the Master of Science in Medical Sciences degree program in the College of Medicine. The course would only be available to other programs after consultation with the course director.

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

    Yes. One time.

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

    Minimum qualifications include a PhD and/or MD and experience in patient-oriented research.


  4. Other Course Information

    A. Objectives

    1. Discuss how to obtain the maximum benefit from the SPOR program. 2. Emphasize the importance of attention to detail in conducting patient-oriented research. 3. Provide an overview of different types of clinical research. 4. Discuss how therapeutic targets are identified and pharmacologic agents against those targets are identified, screened for efficacy and safety in preclinical studies and moved into clinical studies. 5. Describe the progression of pharmacological studies from Phase I to Phase IV. 6. Discuss how to integrate testing of both clinical and translational hypotheses in the same study. 7. Discuss how individual investigators and institutions can perform health outcomes and population studies. 8. Discuss the role of meta-analysis in the spectrum of patient-oriented research. 9. Discuss how to design a clinical and translational research plan that is appropriate for a career development grant application. 10. Discuss how to structure a clinical and translational research career development grant application.

    B. Learning Outcomes

    Students will be able to delineate the most important aspects of undertaking the design and implementation of a patient-oriented study. They will be able to list the study phases necessary to reach the level of a clinical research study and identify details that require monitoring during the conduct of the study. They will design a research plan in an area of patient-oriented research relevant to their area of expertise and outline a structure for preparing a career development grant application in patient-oriented research.

    C. Major Topics

    Orientation to the Scholars in Patient-Oriented Research (SPOR) program and an introduction to ways to maximize the opportunities provided by the didactic and mentored research training afforded by the program. How to design a therapeutic clinical trial. Interacting with pharmaceutical and biotechnology companies to carry-out investigator-initiated research. Incorporation of translational research into clinical studies. Drug discovery-from the research lab to the clinic. Clinical and translational research career development grants. The anatomy of clinical research studies. Evidence-based medicine-population studies. Meta-analysis. Preparation of clinical/translational research protocols and letters of intent.

    D. Textbooks

    Materials to be distributed in class.

    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.