Investigator Clinical Research Implementation Course

  • About the Program

    This hybrid Spring-quarter, 10-week, 100-hour, 3.0 credit, pass/fail course will be a step-by-step examination of the process of constructing and implementing a formal translational clinical research protocol at an academic medical center. It is in line with competency domains set forth in the Joint Task Force for Clinical Trial Competency Revisions Workgroup’s Harmonized Core Competency Framework for the Clinical Research Professional. Emphasis will be placed on evaluation of study feasibility, design of the formal clinical study protocol suitable for Institutional Review Board (IRB) review, and use of appropriate institutional resources to conduct human clinical trials. Applicants will be selected by the Clinical and Translational Science Center (CTSC) selection committee. This course can be taken for credit or not for credit.

    Download sample course syllabus (PDF)

  • Requirements

    • Resident physician, institutional/NIH scholar, or early career clinical faculty member who are developing their own clinical trial or beginning their own research project
    • Ability to dedicate about 100 hours over 10 weeks to complete the course
    • Preferred: Applicants to the UC Davis CTSC’s Mentored Clinical Research Training Program (MCRTP) or who are applying for graduate-level study in the UC Davis Clinical Research Graduate Group
    • Preferred: Completion of CLH 202: Clinical Epidemiology and Study Design and/or completion of CLH-215 Clinical Trials in Medicine course
    • Completed application
    • For questions, contact Olga Kishchenko at okishchenko@ucdavis.edu.

  • Learning Outcomes and Objectives

    • Introduce key aspects of implementation of a clinical research protocol
    • Describe investigator responsibilities
    • Explain clinical trial cost estimation and financial management
    • Introduce study data management tools and best practices
    • Review best practices for current and future use of data and biological materials
    • Describe a regulatory and ethical informed consent process and associated documentation
    • Discuss evaluation of recruitment feasibility and development of recruitment strategy
    • Describe the required essential documents for a clinical trial
    • Define and discuss protocol deviations and corrective and preventive actions (CAPAs)
    • Introduce clinical trial quality management
Frequently Asked Questions

The course is delivered over 10 weeks utilizing a hybrid model. The course contains asynchronous learning using materials posted in Canvas, discussion boards, and meetings with scientific advisors (can be held remotely). Each student will develop a final presentation describing implementation of their proposed protocol using the concepts learned from this course. This presentation will be held in person at the Clinical and Translational Science Center at the end of the course.

For students who choose to take this course for credit, this is a 3-unit course. Students can take this course for credit by taking it as part of the Clinical Research Certificate or through an Open Campus mechanism. To learn more about taking this course for credit, please contact Stacy Hayashi, Academic Program Management Supervisor, at sahayashi@ucdavis.edu.

For students who choose to audit this course, no credit will be given. These students will receive a certificate of completion upon completing and passing the course.

For students who choose to take this course for credit, the cost is $900 for the full course. This course is free of charge for students who choose to not obtain credit and/or audit this course.

For students who choose to audit this course and/or take the course for no credit, complete this online application.

To take this course for credit, please contact Stacy Hayashi at sahayashi@ucdavis.edu.

Contact the education program team at hs-ctoeducation@ucdavis.edu with any additional questions.