Regulatory Assistance

Do you need regulatory assistance? Contact a Research Project Navigator.

Research Project Navigators work with the CTSI’s Regulatory Knowledge and Support Program to help researchers understand and meet many regulatory and compliance requirements of Investigational New Drug (IND) and Investigational Device Exemption (IDE) submissions, as well as submissions for UF Institutional Review Boards (IRB)  and the Office of Clinical Research (including submissions formerly handled by the Research Administration and Compliance (RAC) office). The program can also advise you on compliance with ClinicalTrials.gov requirements.

IND and IDE Applicability and Submissions

Navigators can assist with:

  • Determination of product classification (i.e., drug, device, combination product, biologic)
  • Applicability of an IND or IDE
  • Assistance with submission of an IND or IDE application
  • Preparation, coordination, facilitation, and attendance at FDA meetings
  • Preparation for regulatory support during FDA inspections of investigator sponsored clinical trials
  • Provide information about new guidance documents, inspection trends, inspection actions and new regulatory actions taken by FDA relating to clinical trials

Research Project Navigators identify projects that may need IND or IDE assistance, clarify and provide support for the FDA-mandated obligations of sponsor/investigators.

We also work with with sponsor/investigators to facilitate pre-IND, IND or IDE meetings with the FDA, provide guidance during the preparation process (slides and document preparation, proper inquiry format and process, subject matter preparation and communication), and will attend FDA meetings as a facilitator, when requested.

IRB, RAC and ClinicalTrials.gov Services

Tiered support services help investigators navigate the complexities of preparing submissions for UF Institutional Review Boards (IRB)  and the Office of Clinical Research (including submissions formerly handled by the 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 any of the specialists listed below with questions about IRB, RAC, or ClinicalTrials.gov submission preparation.

Billing Compliance Review Assistance

In the coming months, the new Office of Clinical Research will streamline processes and workflows for clinical research. Until new workflows are announced, researchers should continue to submit to RAC. CTSI Research Project Navigators can assist with these submissions. 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. Learn more about RAC requirements.

When it is time to prepare a RAC Billing Compliance Review submission, this presents an ideal opportunity to schedule — at no charge — an hour with a Research Project Navigator to discuss RAC documents. Specialist navigators have been trained by RAC staff and regularly attend 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 Research Project Navigator 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 Research Project Navigator review the study to provide a quote for the preparation of a complete package that is ready for submission to RAC

No preparation is required for your consultation. The Research Project Navigator will show you how to move forward in preparing for the RAC Billing Compliance Review at any point in the process, even if you only have a proposal.

Contacts

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

Tiffany Pineda
Research Project Navigator
tiffany.danielle@ufl.edu 352-273-5132