IRB, RAC and ClinicalTrials.gov Support Services

The UF Clinical and Translational Science Institute’s Regulatory Knowledge and Research Support (RKRS) Program offers tiered support services to help investigators navigate the complexities of preparing submissions for UF Institutional Review Boards and the College of Medicine’s Research Administration and Compliance (RAC) office. The program can also advise investigators on compliance with ClinicalTrials.gov requirements.

Support is available to anyone, from the novice researcher to the experienced investigator, for any step of the process—whether writing an informed consent or preparing the RAC billing grid. Initial consultations are always free, and hands-on support for any component of the IRB or RAC submission processes is available on a fee-for-service basis. Contact Wajeeh Bajwa, Ph.D., at bajwa@ufl.edu or (352) 273-8702 or any of the specialists listed below with questions about IRB, RAC, or ClinicalTrials.gov submission preparation.

Contacts

Wajeeh Bajwa, Ph.D. (352-273-8702, bajwa@ufl.edu)
Director, CTSI Regulatory Knowledge and Research Support Program
Office 3218, 3rd floor, North Wing
Clinical and Translational Research Building
2004 Mowry Road
Gainesville, FL 32610

Rebecca Wichman, M.S.
Research Program Coordinator
rwichman@ufl.edu, (352) 273-5132

H. Robert Kolb, RN, BS, CCRC
Research Project Navigator
kolbhr@ufl.edu, 352-273-8882

RAC Billing Compliance Review Assistance

How can CTSI RKRS help me with my RAC submission?

When it is time for an investigator to prepare a RAC Billing Compliance Review submission, it is an ideal opportunity to schedule a free hour of time to discuss RAC documents with a CTSI RAC submission specialist. This specialist has been trained by RAC staff and regularly attends RAC meetings in order to stay up-to-date on all RAC Billing Compliance Review requirements. This free hour can be used as:

  •   A consultation where the RAC specialist will show the investigator what is missing or needs revision from the study’s RAC documentation and how to complete it.
  •  An opportunity for the investigator to have the RAC specialist review the study to provide a quote for the preparation of a complete RAC Package that is ready for submission to RAC.

For more information or to schedule your free consultation, please contact Rebecca Wichman for details at rwichman@ufl.edu or (352) 273-5132.

How should I prepare for my consultation with the CTSI RAC specialist?

No preparation is required for investigators to consult with the CTSI RAC specialist. Our RAC specialist will show investigators how they should move forward in preparing for the RAC Billing Compliance Review at any point in the process, even if the investigator only has a proposal.

What is the RAC Research Billing Compliance Review?

Before submitting to an IRB, a study must undergo a RAC Research Billing Compliance Review. Just as the IRB considers the ethics of proposed studies, the RAC ensures that all billing related aspects of studies are planned correctly. To learn more about RAC requirements and the submission process to the RAC Office, please visit: http://rac.med.ufl.edu/preparation/rac_dsr_irb/rac/