Temperature excursions represent a significant concern in clinical trials because exposure to inappropriate temperatures may compromise the stability and potency of investigational products or the integrity of biological specimens. Many investigational products require refrigerated storage, and some biologics require frozen or ultra-cold conditions. Deviation from these requirements, even briefly, may render products unsuitable for use or samples unsuitable for analysis. Prompt detection, documentation, and evaluation of excursions is essential for maintaining trial integrity.

Temperature excursion management begins with prevention through appropriate storage equipment, monitoring systems, and handling procedures. Continuous temperature monitoring with alarm capabilities enables rapid detection of excursions. When an excursion is detected, immediate actions focus on limiting duration and magnitude by transferring affected materials to appropriate storage if possible. Documentation must capture the specific temperatures reached, duration of exposure, products or samples affected, and immediate corrective actions taken.

Evaluation of excursion impact requires comparison of actual exposure conditions against established stability data for the affected materials. Sponsors maintain stability profiles indicating acceptable temperature ranges and duration limits for their investigational products. When excursions fall within acceptable stability margins, products may remain suitable for use. When excursions exceed stability limits or when stability data is insufficient to make a determination, affected products must be quarantined pending sponsor guidance and typically require replacement. The decision regarding product disposition must be documented and approved by the sponsor before products are used or discarded.