Detailed Explanation
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.