Research Integrity & Compliance
Investigational New Drug or Investigational Device Exemption Assistance Program
The mission of the 91社区 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 USF IND/IDE Assistance Program is available to USF faculty researchers.
The USF IND/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 USF IND/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)