Clinical Trials Office
Investigator Clinical Research Implementation Course
Applications for the Spring 2024 Clinical Research Implementation Course are no longer being accepted.
About the Program
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Overview
Download sample course syllabus (PDF)The Clinical Research Implementation program is a synchronous online, Spring-quarter, 10-week, 80-hour, 3.0 credit, pass/fail course. Students will learn how to construct and implement a formal translational clinical research protocol at an academic medical center. Topics covered include evaluation of study feasibility, budget, recruitment, and regulatory specifics, utilization of EMR to derive study cohorts, and design and management of study data collection tools.
Emphasis will be placed on evaluation of study feasibility, design of a 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.
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Requirements
- Resident physician, institutional/NIH scholar, or early career clinical faculty member who is developing their own clinical trial or beginning their own research project
- Ability to dedicate about 80 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: 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
- Completed application
- For questions, contact Olga Kishchenko at okishchenko@ucdavis.edu.
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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
- Discuss evaluation of recruitment feasibility and recruitment strategy development
- Introduce study data management tools and best practices
- Review advanced EMR functionalities, including the Slicer Dicer Tool
- Describe Internal Review Board (IRB) reporting requirements
- Explain the informed consent process and associated documentation
- Identify clinical trial essential documents
Frequently Asked Questions
The course is delivered over 10 weeks. The course includes a virtual 1.5-hour lecture and discussion on Tuesdays and a virtual 1.5-hour small group session/lab on Thursdays. Students are also assigned reading and protocol-related project assignments. 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 an 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.