You can expect that FDA will review all records that are associated with how the clinical trial was conducted. Always remember that, “if it isn’t documented, it didn’t happen” in the eyes of FDA. FDA will review the protocol, Informed consent forms, written procedures, IRB correspondence, Investigational medical product (IMP) dispensing and accountability, documentation that the IMP was shipped under labeled storage conditions, case report forms, training & qualification of personnel and raw data to verify adverse reactions, deaths, protocol deviations. This is by no means an all-inclusive listing. FDA’s authority does not extend to personal, sales and financial data.
