Dear colleagues,

It is a common practice to include data loggers to record temperatures during the transport from Investigator site to central lab; the question is: is this practice mandatory? If the box of transport has been validated to maintain the expected temperature for the expected period of time of transport, is still necessary to include a data logger?

I would appreciate if anyone could indicate a reference document from regulatory authorities (FDA 483, warning letter, MHRA document, etc) that suggests (or confirms) that a deviation could be reported in case of absence of record of temperature.

Many thanks in advance for your wise advice

Best whishes