Clinical OperationsGlossary Term
ICH E6(R3) Section 5.14
An event in which investigational product or biological samples are exposed to temperatures outside the specified storage range, potentially affecting product stability, quality, or sample integrity.
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.
Refrigerator malfunction
"The temperature monitoring system alarmed when the pharmacy refrigerator reached 12 degrees Celsius overnight due to a compressor failure, resulting in quarantine of 24 medication kits pending stability assessment by the sponsor."
Shipping excursion
"Temperature logger data from the shipment showed a two-hour excursion to 28 degrees Celsius during transit; the sponsor reviewed stability data and confirmed the product remained within acceptable limits for the exposure duration."
A systematic approach to identifying, investigating, and addressing the root causes of quality problems or non-conformances, implementing corrections to resolve existing issues, and establishing preventive measures to reduce the likelihood of recurrence.
The documented chronological history of the handling, transfer, and storage of investigational products, biological samples, or other controlled materials, establishing accountability at each step from origin to final disposition.
The system of documentation and procedures that accounts for all investigational product received at a site, dispensed to participants, returned by participants, and remaining in inventory, ensuring complete traceability throughout the trial.
The process of officially registering a qualified participant into a clinical trial after confirming eligibility and obtaining informed consent, marking the point at which the individual becomes a study subject.
A systematic evaluation conducted before trial initiation to determine whether a clinical trial can be successfully conducted at a particular site or in a specific region, considering factors such as patient population, site capabilities, and regulatory environment.
ICH E6(R3) Section 5.14
An event in which investigational product or biological samples are exposed to temperatures outside the specified storage range, potentially affecting product stability, quality, or sample integrity.
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.
Refrigerator malfunction
"The temperature monitoring system alarmed when the pharmacy refrigerator reached 12 degrees Celsius overnight due to a compressor failure, resulting in quarantine of 24 medication kits pending stability assessment by the sponsor."
Shipping excursion
"Temperature logger data from the shipment showed a two-hour excursion to 28 degrees Celsius during transit; the sponsor reviewed stability data and confirmed the product remained within acceptable limits for the exposure duration."
A systematic approach to identifying, investigating, and addressing the root causes of quality problems or non-conformances, implementing corrections to resolve existing issues, and establishing preventive measures to reduce the likelihood of recurrence.
The documented chronological history of the handling, transfer, and storage of investigational products, biological samples, or other controlled materials, establishing accountability at each step from origin to final disposition.
The system of documentation and procedures that accounts for all investigational product received at a site, dispensed to participants, returned by participants, and remaining in inventory, ensuring complete traceability throughout the trial.
The process of officially registering a qualified participant into a clinical trial after confirming eligibility and obtaining informed consent, marking the point at which the individual becomes a study subject.
A systematic evaluation conducted before trial initiation to determine whether a clinical trial can be successfully conducted at a particular site or in a specific region, considering factors such as patient population, site capabilities, and regulatory environment.