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The Impact a Site Temperature Excursion Has On a Clinical Trial Study

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By: Shawn Foreman November 24 2016

Tags: Cold Chain, Logistics for Clinical Trials

Thermostat

A temperature excursion occurs when clinical trial material is stored at a temperature outside of the specified temperature range as defined on the label. When temperature fluctuations occur, clinical site personnel are responsible for documenting the storage condition on a temperature log (or comparable documentation). The investigational site is then responsible for notifying their study coordinator within 24 hours of the occurrence, or discovery thereof, and reporting the excursion to the Temperature Excursion Call Center. Temperature excursions outside the established acceptable range can have a substantial impact to a clinical trial study.

An excursion can have a significant impact on quality, efficacy and safety of products. More importantly, an excursion can have significant impact on the quality and safety of the patient if not detected and communicated effectively, creating potential delays in dosing patients.

When an excursion occurs, the affected material must be segregated and dispensing of the impacted material must cease. Although the material is segregated, the material must still remain stored according to the product label. Patient visits must be rescheduled until the effected material is deemed fit for use, or the material is resupplied by the pharmaceutical company. Temperature excursion management is imperative to a robust, timely supply chain. Resupplying material can be costly and storage space at the clinical sites can become a concern.

In either case of material supply to the patient, an excursion can potentially add days to patient visits. A material disposition by the Temperature Excursion Call Center may take 2-5 business days. Likewise, a resupply may take several days to ship to the investigational site in an expedited resupply situation. This leads to patient and site frustration, and more impactful, potential patient drop out.

Some future considerations for discussion around the topic of temperature excursions are apparent. Best practices at sites for managing temperature controlled drugs is one such discussion, while some ideas for best practices around managing temperature excursions and making a disposition decision quickly is another.

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