Reply To: Satellite Site Benchmark
June 30, 2020 at 4:32 pmAt a high level this is very site dependent but to date I only have experience with this in the US. See my responses below.
o What do you call the primary and alternate sites (e.g. Primary Site, Satellite Sites, Alternate sites, etc.)?
Primary site is called a ‘site’ and alternate sites are called ‘satellite sites”
o How are the products transported between sites (e.g., Hand delivered by Primary Investigator, hand delivered by staff, shipped in mail/FedEx)?
Very site dependent but site must have an SOP outlining the process
o How do you maintain appropriate storage conditions during transport?
Site driven based on SOPs (approved by the CRO on the Sponsors behalf)
o What is documented for the transporting process?
Site driven based on SOPs (approved by the CRO on the Sponsors behalf)
o What type of qualification/audit/oversight of the Primary Site is conducted before allowing the transportation of product to additional sites?
Site qualification is completed as well as routine monitoring
o Is the patient data reported to your company under one location or under multiple locations?
Typically through the one primary location
