Audits

Routinely FDA audits clinical trials.  These audits may be “for cause”; routine; because they were in the area; or this was a high recruiting site.  When FDA notifies you that your study will be audited, contact the IRB and OIC immediately.  They will counsel you as to when to contact the sponsor and our contractual obligations.  Investigators and research team members who have experienced FDA audits can be found through Clinical and Translational Sciences Institute: PCIR core, http://louisville.edu/ctsi or hscro@louisville.edu