FDA/Clinical Trial Federal Requirements (1572)
If you are seeking an IND/NDA please contact the Human Subjects Protection Program Office (http://louisville.edu/research/humansubjects/HSPPO-Staff) for guidance along with FDA (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm )
or Device (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm ).
If you develop the drug/device for the IND/NDA contact the Office of Technology Transfer (OTT, http://louisville.edu/thinker, 852-2965) before proceeding to release any information about your development. A non-disclosure agreement may be needed.
Please study your obligations for conducting a clinical trial from an FDA Q&A on form 1572: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf . The form can be found at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf .
After your clinical trial has been reviewed by the HSPP (IRB), you will be required to list the study at: http://www.clinicaltrials.gov/
Routinely FDA audits clinical trials. These audits may be “for cause”, routine, because they were in the area, or you were a high recruiting site. When FDA notifies you that they will be auditing you, contact the IRB and OIC immediately. They will counsel you as to when to contact the sponsor.