It should be noted that an IMP must have stability data to support the shelf-life of the product as specified in the IMPD submitted as part of the clinical trial application. Temperature monitoring is to ensure the IMP is being kept within the condictions as stated in the clinical trial applciation (unless there is a good reason this is not required during the risk assessment conducted and documented prior to commencing the trial (i.e. it is market product being stored within it's license conditions, as per the same product that is stored for general use).