Storage and Dispensing of Study Drug. All clinical drug supplies are to be stored in a secure, monitored, limited-access area in accordance with labeled storage conditions. The Investigator will maintain accurate records of the disposition of all clinical drug supplies received during the study. These records shall include the amounts of drug supplies and the dates on which drug supplies were received from the Sponsor (or an authorized representative), dispensed to the subject, returned by the subject and returned to the Sponsor (or an authorized representative). If errors or damages in the clinical drug supply shipments occur, the Investigator must contact the Sponsor (or an authorized representative) immediately.
