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Do you have primary sites that transport materials to other locations? If yes, please answer the questions below.
o What do you call the primary and alternate sites (e.g. Primary Site, Satellite Sites, Alternate sites, etc.)?
o How are the products transported between sites (e.g., Hand delivered by Primary Investigator, hand delivered by staff, shipped in mail/FedEx)?
o How do you maintain appropriate storage conditions during transport?
o What is documented for the transporting process?
o What type of qualification/audit/oversight of the Primary Site is conducted before allowing the transportation of product to additional sites?
o Is the patient data reported to your company under one location or under multiple locations?