Receipt and Storage. 6.1 The Company will:
Receipt and Storage. MVA-NP+M1 will be shipped to a distribution centre in the study region. It will then be shipped to the study sites at 2oC to 8oC with a continuous temperature-monitoring device. Upon receipt, the pharmacist or study vaccine manager must immediately inspect all vials for damage. Any damage or discrepancies from the packing list must be documented and promptly discussed with the Sponsor and the Study Monitor to determine the appropriate action. The temperature monitors should be downloaded according to the accompanying instructions in the shipment. Temperature records must be sent to the Local Sponsor and the site will receive written confirmation that the vials are clinically released before they are used. If the temperature monitor has been out of range then the shipment should be placed into quarantine and the Sponsor and Study Monitor contacted immediately to determine whether the study vaccine may be used. Vials of MVA-NP+M1 in the outer carton (to protect from light) must be stored between 2 and 8oC in a continuously monitored refrigerator. The vials of saline placebo will be stored at room temperature. All study treatments must be kept in a secured location with no access for unauthorised personnel. At the start of the study, a sufficient number of MVA-NP+M1 and placebo vials will be shipped to each study site to vaccinate approximately 20% of the planned participants based on recruitment projections. Further study vaccine supplies may be requested following the re- supply process in the Vaccine Management Manual.
Receipt and Storage. Upon receipt of Samples and payment, Saguaro Testing will process Samples and upload Sample information into our laboratory software testing database. Analytical Samples are stored room temperature upon receipt, unless specifically requested otherwise by Client and approved by Saguaro Testing. Storage conditions are based on the nature of the Sample. Samples will be discarded in accordance with Saguaro Testing’s standard operating procedures. Saguaro Testing will retain un-tested Samples in storage for no more than fourteen (14) days, unless longer storage is approved by Saguaro Testing, and Client submits payment of a storage fee, to be determined by Saguaro Testing at the time of approval of such storage request. Client may request that un-tested Samples be re-tested or transferred to another laboratory, provided Saguaro Testing will not be responsible for cost of delivery or transfer of such un-tested Samples. However, Client may request that Saguaro Testing transfer such un-tested Samples to another laboratory for a fee to be determined by Saguaro Testing at the time of Client’s request, which fee must be remitted to Saguaro Testing prior to any such transfer occurring.
Receipt and Storage
