Study Devices. Records of study device shipments and disposition shall be maintained. Records of shipments shall include the name and address of the consignee, type and quantity of devices shipped. Records of disposition shall describe the batch numbers of any devices returned to the Sponsor, repaired, or disposed of in other ways by the Investigator or another person, and the reasons for and method of disposal.
Appears in 2 contracts
Sources: Clinical Investigational Plan, Clinical Investigational Plan