Temperature Deviation and IRT

IRT Essentials

The ability to track the temperature excursions of an investigational product has taken on an increasing importance in clinical trials. Temp tales and similar devices are used to record the drug’s environmental exposure from the time it is sealed into a shipping container at the warehouse to the time it is unpacked at a clinical site.  The electronically recorded temperature history is available for review by project teams and site personnel on demand.

A robust IRT (IVRIWR) must be able to take into consideration the real-life, logistical issues associated with the issue of temperature deviation, whether ambient, refrigerated, or frozen. Variables that determine whether the drug can be returned to the study inventory to be assigned to subjects, or whether it needs to be permanently excluded, include the nature and intensity of deviation, the length of time outside the allowed temperature range, and the most current scientific knowledge of the drug under study.

When vetting an IRT, be sure it can do the following:

  • Provide easy access on-demand to the temperature excursion data (e.g., temp tale, etc)
  • Permit entire shipments or individual units within the shipment to be given a status of temperature deviation
  • Permit mixtures of ambient, refrigerated, or frozen products within the same study, by drug type
  • Be sure the system is able to ‘quarantine’ or otherwise hold out of circulation drug that has been exposed to a temperature excursion until authorized personnel can review the temp tale data and determine the proper disposition. The range and circumstance of allowable deviation may change during the study as more of the science of the drug is understood.
  • Be able either to return exposed study drug to normal use (easily), or to designate it unusable
  • Permit unusable drug to be returned to the warehouse and/or destroyed
  • Ensure that drug that is under quarantine is NOT reflected in site inventory, and enable its return to inventory tallies if it is re-designated as available for assignment
  • Permit temperature deviation tracking to be separate cost module in IRT setup so when there are no temperature concerns related to the study drug there is no cost incurred.
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