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.

Office of Clinical Research, IRB 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 office). The program can also advise investigators on compliance with ClinicalTrials.gov requirements. The new Office of Clinical Research is streamlining processes and workflows for clinical research.

Support is available to anyone, from the novice researcher to the experienced investigator, for any step of the process. Initial consultations are always free, and hands-on support for any component of the IRB process is available on a fee-for-service basis. Contact any of the specialists listed below with questions about IRB or ClinicalTrials.gov submission preparation.

 

Contacts

Sheila Austin, MS, CIP
Regulatory Specialist
sheila.austin@ufl.edu 352-273-8702

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