Product Accountability Clause Samples
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.
Product Accountability. Cysteamine Bitartrate Delayed-release Capsules (RP103) will be supplied by the Sponsor or its representative. The Investigational Pharmacy will record the lot numbers. Accountability will be performed on the clinical trial supply. The Investigator or a designee will verify and acknowledge receipt of the RP103 by signing and returning all required forms. All medication must be stored in a secured area under the proper storage requirements with access restricted to the Investigator or designees. Medication designated for this clinical Study must not be administered to any subjects other than those enrolled in this specific investigation and may not be used for any laboratory or animal research. All medication dispensed to subjects must be properly labeled and accurately recorded on the drug accountability records maintained at the pharmacy. A copy of this record must be returned to the Sponsor or its designee on completion of the Study for accountability purposes. A clinical research associate will periodically review the drug accountability during the Study. At the end of the Study, all unused and expired medication will be retained until disposition of study medication has been made by the Sponsor or its designee.