Polaris

CompanyIRB Study Termination AcknowledgementProposal No. _________Protocol No. _________Dear Dr. On , the received notification of the termination of the protocol entitled. No additional subjects may beenrolled in this study.To be in compliance with the requirements of this Board and FDA regulations, you must:• Retain the study records for a period of two years after the NDA is submitted to the FDA. Inthe event that you retire, relocate, or for any reason withdraw from the responsibility formaintaining records for the period of time required, custody of the records must betransferred to another person who will accept the responsibility for the records. Notice ofsuch 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.Sincerely,ChairmanSt Term Ack.doc© 2004 by CRC Press LLC