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What does the site have to do if during IMP transport the Temperature logger is missing or malfunctions and ther is no data to transfer to bi@liberomanager.com.
Site has to complete the Product DeviceComplaints Form (PDCF). Site sends the Form to CTSU Complaint mailbox (manual PDCF). Site would quarantine the IMP, register IMP in IRT as quarantined, & wait for instructions on status of IMP by CTSU. They will send a copy of POD form to CTSU with PDCF