Education & Training

The educational foundation of the CTS Education & Training Program is a Core Curriculum that will be required of all trainees enrolled in the CTS Certificate program, MS, PhD and dual training programs such as the MD/PhD program. Select courses and experiences from the Core Curriculum will also be required for the Clinical Research Coordinator Certificate Program. The Core Curriculum is designed to instill fundamental understanding of the elements necessary to conduct multidisciplinary research in CTS. Because all trainees will be participating in the same experiences, they will interact as members of multi- and interdisciplinary research teams in the classroom setting and in the introductory Multidisciplinary Practicum. The major goal of the three core segments is to develop the skills needed to participate in collaborative teams conducting CTS. The Core Curriculum will begin in the summer semester with the Introduction to CTS. The practicum experience will begin after the Intro to CTS and the Ethics course will be completed in the Spring semester. The small number of required elements of the Curriculum is purposely designed to maximize interaction among trainees while enabling additional, program-focused content within the specific CTSI training tracks. For KL2 scholars, MS candidates and CTS Certificate participants, the Core Curriculum will be taken in the first year of graduate coursework. For TL1, PhD and combined MS degree trainees, the Curriculum will be taken in the summer following year 1 and in the spring of year 2 of graduate school.

1) Introduction to Clinical & Translational Research (GMS 7093) is adapted from the popular "Science of Clinical Research" course developed over the last 15 years by UF General Clinical Research Center (GCRC) for multidisciplinary trainees in patient-oriented research. The course includes lectures, panel discussions and small group activities that introduce students to major CTS concepts and prepares them for other advanced required and elective courses. Session topics include: Study Design; Choosing an Analysis To Maximize Study Impact & Efficiency; Practical Issues in Study Design & Management; Translating Basic Science to Clinical Research; Resources at UF; Developing Your Protocol; Regulatory Issues; and Going Full Circle - Bench to Bedside to Community and Back. The class is divided into small groups that are balanced across educational background and level of training of the participants to ensure multidisciplinary representation. Each group applies the lecture content in developing a mock research proposal that is presented to the entire class on the final day. Student participation is facilitated by one of the course faculty with expertise in study design and provides practical experience in a developmental setting for multidisciplinary research. This course will be taught in Summer B in 2009, beginning on July 15th.

2) Ethical, Regulatory, and Practical Conduct of Clinical Research (GMS 6931) is offered in the spring semester and provides an in-depth analysis of topics focusing on human subjects research. This course will be required for combined professional/CTS graduate degree students; for clinical postdoctoral trainees, including KL2 CR Scholars; and for PhD students with the CTS major or minor. The course is available as an elective to all other students. PhD students in the CTSI Interdisciplinary Program will also take "Responsible Conduct of Biomedical Research" (GMS 7003), as it completes the ethics training module, focusing on laboratory research.

3) CTS Multidisciplinary Practicum - under development. This course will involve a mentored research experience in a multidisciplinary research team.

CTS Advanced Curriculum

The CTS Advanced Curriculum includes student participation in data and literature discussions and presentations; a weekly CTS Journal Club involving both trainees and mentors; a CTS seminar series; and a series of program-specific advanced courses. Students will give one CTS seminar each year to present their hypotheses and research results as appropriate for their stage of training. In addition, all students will be expected to present their completed work at the CTSI Annual Research Symposium.

Each of the partner PhD discipline-based programs (e.g., Chemistry) has agreed that by the end of the second year of graduate study each doctoral student's customized advanced program will be comprised of a blend of discipline-based and CTS-specific courses. This strategy allows coursework to be drawn from all participating programs. UF Graduate School requires that a major consists of at least 12 CTS credits while a minor requires 9 credits from within the CTS curriculum.

We are aware that participation in the CTS program could extend the overall degree time-line due to the increased course load. However, our experience with other interdisciplinary concentrations is that most students adapt well to the added load without a significant increase in time to completed degree. All milestones for graduate study, such as the qualifying exam and dissertation defense, will be tracked using the established deadlines of both the partner programs and the UF Graduate School. We expect the CTS students to reach the same milestones as other PhD students.

An extensive set of existing and new CTS elective courses will be available to CTS trainees, including: Research Design and Analysis I and II, Manuscript and Abstract Writing for the Clinical Scientist, Grant Writing, Essentials of Graduate Research and Professional Development, Fundamentals of Epidemiology, Intermediate Epidemiology, Clinical Trials I and II, Measurement in Clinical Research I and II, Advanced Cohort and Longitudinal Research Designs, Experimental and Quasi-Experimental Designs in Community Settings, Meta-Analysis, Advanced Case Control Study Design Issues, Methods in Translational Research, Applied Biostatistics for Clinical Scientists I and II, Data Management, Leading Multidisciplinary Teams, and Presentation and Communication of Research Findings to the Community and Lay Public.

A rich assortment of graduate-level elective courses is also available to trainees who wish to focus more deeply in specific CTS areas. For example, the CTSI Clinical and Research Ethics Program and UF Center of Excellence for Regenerative Health Biotechnology (CERHB) offer courses on federal regulations governing ethical treatment of animal and human research subjects and in current Good Laboratory/Manufacturing/Clinical Practices for those interested in the preclinical processes of FDA-compliant drug, biologic and device development. The College of Pharmacy has integrated into the CTS Education & Training Program its curriculum that leads to an MS in Clinical Investigation with a Major in Clinical Research Regulation and Ethics. Trainees who desire didactic and hands-on experience in state-of-the-art technological tools for research may engage the various cores of the Translational Technologies and Resources Program. The Participant and Clinical Interactions Program offers practical experience in developing and conducting FDA-compliant early phase clinical trials through its Clinical Research Units, particularly the Center for Clinical Trials Research that is recognized nationally as a unique academic site for conducting phase 1 and 2 clinical trials. The Community Engagement and Research Program has several graduate level courses relevant to the design and conduct of participatory community research, including subject recruitment and retention strategies. Training in effective media and community presentations will be available through the Program for Facilitating the CTSI - Community Interchange (FCCI). Indeed, virtually every Program and Core affiliated with the CTSI offers didactic and practicum courses available to CTS trainees to craft highly specialized educational experiences in pursuit of their CTS certificate or degree.