IND/IDE

Education

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)