Research Integrity & Compliance

Investigational New Drug or Investigational Device Exemption Assistance Program

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The mission of the ¹ú²ú¶ÌÊÓƵ IND/IDE Assistance Program is to provide education to Sponsor-Investigators who plan to file an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application for U.S. Food and Drug Administration (FDA) regulated clinical research. The ¹ú²ú¶ÌÊÓƵIND/IDE Assistance Program is available to ¹ú²ú¶ÌÊÓƵfaculty researchers.

The ¹ú²ú¶ÌÊÓƵIND/IDE Assistance Program is currently being re-developed to meet the needs of our research community. We can currently only offer an educational consultation via our Quality Assurance/Quality Improvement Program. For questions regarding our future plans or for an education consult, please contact us by email, QA-QI@usf.edu.

Education & Training

The ¹ú²ú¶ÌÊÓƵIND/IDE Assistance Program offers training on subjects such as those listed below:

  • Investigator responsibilities per FDA regulations
  • IND regulation (21 CFR Part 312) overview training
  • IDE regulation (21 CFR Part 812) overview training
  • Good Clinical Practice (GCP) training
  • IND and IDE application process overview
  • IND and IDE annual FDA reporting requirements training (e.g. annual reports, safety reports)

Investigational New Drug Applications

Investigational Device Exemption