ABSTRACT
Retain the study records for a period of two years after the NDA is submitted to the FDA. In the event that you retire, relocate, or for any reason withdraw from the responsibility for maintaining records for the period of time required, custody of the records must be transferred to another person who will accept the responsibility for the records. Notice of such transfer should be given in writing to the sponsor and to this Board. Allow FDA, OHPR, and other regulatory authorities access to the study records.
