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4CPS-293 Importance and role of the research pharmacist in evaluating the temperature storage report of investigational products

ejhpharm · 2026-03-18 · canonical JSON source

2 visible annotations · policy: published · automated confidence ≥ 75.00%

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Background and Importance Continuous monitoring and management of storage temperature throughout all stages of the life cycle of investigational products (IPs) in clinical trials is essential to ensure their efficacy and safety. In accordance with GCP (Good Clinical Practice), temperature control is a critical phase that must be monitored and recorded from the moment the IPs arrive at the trial site.Aim and Objectives Analyse the reports extracted from the TempTale associated with the shipment of IPs conducted in 2024 at a university hospital.Material and Methods The information extracted from the study protocols (Eudract code, phase, therapeutic area), pharmacy manuals (IP management, storage temperature (t)), and all information extracted from the qualitative and quantitative control of the documentation relating to receipts was collected in a database. The data were stratified according to storage temperature: 2-8 °C vs. 15-25 °C.A search was conducted on current legislation to support the drafting of management procedures requiring quality control of the temperature recorded during transport upon arrival at the pharmacy. Through the extrapolation of data from the continuous monitoring device (data logger), the temperature range settings and alarm values were analysed and evaluated.Results In 2024 110 clinical trials were conducted and 3425 IPs received. Standard procedure was applied to 273 IP receipts (64.10% controlled vs. 35.90% environment). Analysis of temperature traces extrapolated from data loggers was possible in 60.07% of cases. The t range and alarm value settings were correct in 19.41% of cases, while in 40.66% of cases the alarm values set were incorrect, with an error range between -20°C and +60°C. 25.17% of IPs related to clinical studies in the field of oncology. Careful evaluation of the recorded temperature graph revealed four cases of alarm status that were not detected due to an error in the settings.Conclusion and Relevance Simply visually checking a data logger set to an incorrect range would not have triggered the alarm for the temperature increase. TempTales provides essential data, but this data must be interpreted correctly. The qualitative and quantitative checks carried out by the clinical pharmacist are indispensable and important, as they ensure the proper management of the clinical trial and patient safety.Conflict of Interest No conflict of interest