Product Accountability. In accordance with federal regulations (21CFR 312.62), all Investigators are required to keep accurate records showing final disposition of all investigational drugs. Investigational drugs are to be used only in accordance with this protocol and under supervision of the Principal Investigator. The Principal Investigator or his designee will maintain an accurate record of the receipt of the test drug as shipped by the Sponsor/Designee, including the date received. In addition, an accurate drug disposition record will be kept, specifying the amount dispensed to each patient and the date of dispensation. This inventory record must be available for inspection at any time. Copies of this record will be provided to the Sponsor by the Principal Investigator at the conclusion of the study. After the study is completed, the Principal Investigator must account for all drug used, unused and partially used. Unused study medication from the study site will be returned to the Sponsor/Designee as directed in writing by the Sponsor for gross reconciliation.
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