Good Clinical Practice Guide
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Thread: Data loggers in sample shipment

  1. #1
    Forum Member
    Join Date
    Feb 2014

    Question Data loggers in sample shipment

    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


  2. #2
    Forum Member
    Join Date
    Jul 2018
    Pennsylvania, USA
    If the shipment container is truly validated there will be extensive documentation to support sample integrity under a wide range of likely shipping conditions. Unless there are exceptional circumstances, such as transportation delays beyond the validation period, weird weather, etc. then I would argue shipping without a data logger this is acceptable.

    However, there are advantages to using a data logger since you have a full record that covers even these exceptional circumstances, this may result in you being able to still use the samples.

    So, firstly I would look at how "validated" the containers are - for what extreme temperature ranges and duration do they provide protection? Then look at the shipping logistics for your samples (time, geographies, climate, transportation mode, etc.).

    In the end you should base your decision on the risk associated with potentially losing your samples.

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