Introduction to Clinical and Translational Research

Educational Objectives

To learn and understand:

  • How to develop a research question
  • Types of studies
  • To develop a research design
  • The Institutional Review Board (IRB) applications process
  • The concept behind and usage of relational databases
  • Basics of research statistics

To demonstrate knowledge by:

  • Utilizing local resources available for research
  • Developing a mock project in the ‘Small Groups’ workshops

The research training program will be held in the second half of July each year. The first half of the day will be dedicated to basic science research training. hands-on practical training in the laboratory. This research experience will be supervised and monitored by Dr. Ruxana Sadikot.

The afternoons will be dedicated to the “Introduction to Clinical and Translational Research” course provided by the CTSI. A sample structure of these two is as below:

GMS 7093: Introduction to Clinical/Translational Research (sample structure)

Day 1: Ideas to Hypotheses: Examples of Clinical/Translational Research Moderator: Ronald Shorr, MD, MS

DAY 1LessonLecturer
2:00-2:30 PM Course overview Ron Shorr
2:30-3:00 PM How and why I do community based research Linda Cottler
3:00-3:30 PM How and why I do outcomes research Elizabeth Shenkman
3:30-4:00 PMHow and why I do qualitative research Debbie Treise
4:00-5:00 PM Small group intro and AssignmentsJon Shuster

Day 2: Developing the Research Question, Moderator: Jon Shuster, PhD

DAY 2 LessonLecturer
2:00-2:30 PM Course overview Jennifer Lyon
2:30-3:00 PM Are the Data Available? Secondary Data AnalysisRon Shorr
3:00-3:30 PM Is It Feasible?Jon Shuster
3:30-4:00 PMFraming AimsMark Segal
4:00-5:00 PM Small groups—————–

Day 3: Study Design, Moderator: Wayne McCormack, PhD

DAY 3LessonLecturer
2:00-3:00 PM Overview of observational and interventional studies J. Glenn Morris
3:00-4:00 PM Evaluation of clinical trials Mini Devidas
4:00-5:00 PM Small Groups

Day 4: Data Management Tools, Moderator: Douglas Theriaque

DAY 4LessonLecturer
2:00-2:40 PM Data Management Issues and Principles Douglas Theriaque
2:40-3:30 PM How to Make a Data Management Plan Christopher Barnes
3:30-4:00 PM Introduction to REDCap Douglas Theriaque
4:00-5:00 PMSmall Groups

Day 5: Statistical Considerations, Moderator: Ron Shorr

DAY 5LessonLecturer
2:00-2:15 PM Why learn statistics? Ron Shorr
2:15-3:15 PM Cyndi Garvan/Under the hood of research Ron Shorr
3:15-3:45 PM Cyndi Garvan/ Statistical software considerations Ron Shorr
3:45-4:00 PM How to learn statistics at UF Yueh-Yun Chi
4:00-5:00 PM Small Groups

Day 6: Local Resources: CTSI, Moderator: Jon Shuster

DAY 6LessonLecturer
2:00-2:20 PM Intro to the Clinical and Translational Science Institute Mike Conlon
2:20-4:00 PM Research Design and Analysis Program (RDAP) Jon Shuster
4:00-5:00 PMSmall Groups

Day 7: Local Resources Continued, Moderator: Eve Johnson, MA

DAY 7LessonLecturer
2:00-2:30 PM Library and Reference Resources Jennifer Lyon
2:30-3:00 PM UF Clinical Research Center (CRC) Teresa D’Angelo
3:00-4:00 PM Integrated Data Repository Felix Liu
4:00-5:00 PM Small Groups

Day 8: IRB and Regulatory Considerations Moderator: Wayne McCormack

DAY 8LessonLecturer
2:00-2:30 PM Overview of the IRB Tiffany Pineda
2:30-3:15 PM Ethical and Patient Considerations Ray Moseley
3:15-3:45 PM HIPAA Everall Peele
3:45-4:00 PM Research Billing Compliance Edythe Zettler
4:00- 5:00 PM

Day 9: Other Issues and Opportunities, Moderator: Eve Johnson

DAY 9LessonLecturer
2:00-2:30 PM Conflict of interest policy and procedures Gary Wimsett
2:30-3:15 PM Investigational New Drug (IND) applications Wajeeh Bajwa
3:15-4:00 PM Genetics and Pharmacogenetics resources Taimour Langaee
4:00-5:00 PMSmall Groups

Day 10: Career Development Awards: Next Steps Moderator: Ron Shorr

DAY 10LessonLecturer
2:00-2:30 PM NIH grants Susan Nayfield
2:30-3:00 PM VA grants Scott Berceli
3:00-3:30 PM Dehoff Success story: NIH K23 Rhonda Cooper
3:30-4:00 PM Mileposts and guidelines Mark Brantly
4:00-5:00 PMSmall Groups