Do you need regulatory assistance?
Research Project Navigators work with the CTSI’s Regulatory Knowledge and Support Program to help researchers understand and meet many regulatory and compliance requirements including Investigational New Drug (IND) and Investigational Device Exemption (IDE) submissions, UF Institutional Review Boards, ClinicalTrials.gov and the Office of Clinical Research. We also provide toolkits for facilitating FDA inspections and assisting clinical investigators with templates and sample forms for the development and conduct of high-quality clinical research studies.
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.
During this COVID-19 disruption of workflow processes, the FDA is mandating electronic submission of IND/IDE related applications and materials. Each division has their own process for electronic submission. Please contact Sheila Austin by email for assistance with submission.
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
Access application resources, templates and guidelines for Investigational New Drug submissions.
Contact Regulatory Specialist Sheila Austin (email below, or call 352.273.8702) for assistance with your IDE application.
Toolkit and resources for clinical research
This toolkit of materials contains templates, sample forms and information materials to assist clinical investigators in the development and conduct of high-quality clinical research studies.
Are you preparing for an FDA inspection? This document, “Facilitating FDA Inspections”, outlines the process for FDA sponsor or clinical investigator inspection, and describes activities that should be done to facilitate the inspection.
Sheila Austin, MS, CIP
Research Project Navigator