{
  "abstract": "Background and Importance Monitoring and managing storage temperatures during the shipment of investigational products (IPs) in clinical trials is essential to ensure the efficacy and safety of the IP. In accordance with GCP (Good Clinical Practice), temperature control is a critical phase that must be monitored and recorded.Aim and Objectives Prepare a Risk Management Tool (RMT) and assess the clinical risk of experimental studies underway in 2024 at the University Hospital.Material and Methods Literature review was conducted to classify the risk class and complexity of investigational products (IPs). Search terms (investigational product, clinical trial, risk management, risk assessment) was appropriately combined with Boolean operators. An RMT was prepared. Clinical Trial Information was organised in a database: protocol (study design (phase, specific web-based management system, type of IP, route of administration, dosage); IP management (management, therapeutic area, storage temperature (t)); preparation (dose customisation, preparation procedure, customised administration). The application of the RMT to the database made it possible to assign and analyse the respective risk classes.Results The literature review reveals eight studies useful for assigning and stratifying clinical trials into risk classes (high, medium, or low). These were used to structure an RMT as an objective tool for risk classification.In our hospital, 110 experimental trials are active in 2024 (3.63% PHASE I; 16.36% PHASE II; 69.02% PHASE III and 10.99% with medical devices (MD)). The application of the RMT classifies them as follows: 32.33% high risk; 25.62% medium risk; and 34.57% low risk. High-risk clinical trials: dosing once or more times/day = 46.36% and IPs attributable to ATC-L (44.54%). Medium-high risk: storage temperature 2-8°C (55.46%). 13.64% (15/110) of clinical trials were considered high risk due to the simultaneous management of IPs to be stored at 2-8°C and 15-25°C, vs 41.82% at medium risk (t=2-8°C). In relation to the route of administration, the risk was: high (22.72%), medium (35.45%), and low (41.82%). Dose customisation and personalised administration (high risk) accounted for 26.36%.Conclusion and Relevance Pharmacists play an essential role in the multidisciplinary team involved in clinical trials. The assessment, monitoring, and constant review of a predictive risk management model guarantee the quality of the investigational product.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Azienda Ospedaliera Universitaria ‘R. Dulbecco’ – P.O. ‘Mater Domini’, Hospital Pharmacy, Catanzaro, Italy"
      ],
      "name": "M De Fina"
    },
    {
      "affiliations": [
        "Azienda Ospedaliera Universitaria ‘R. Dulbecco’ – P.O. ‘Mater Domini’, Hospital Pharmacy, Catanzaro, Italy"
      ],
      "name": "MC Zito"
    },
    {
      "affiliations": [
        "Azienda Ospedaliera Universitaria ‘R. Dulbecco’ – P.O. ‘Mater Domini’, Hospital Pharmacy, Catanzaro, Italy"
      ],
      "name": "C Monopoli"
    },
    {
      "affiliations": [
        "Azienda Ospedaliera Universitaria ‘R. Dulbecco’ – P.O. ‘Mater Domini’, Hospital Pharmacy, Catanzaro, Italy"
      ],
      "name": "S Esposito"
    },
    {
      "affiliations": [
        "Universita’ Magna Graecia Catanzaro, Dip. Scienze Della Vita, Catanzaro, Italy"
      ],
      "name": "MD Naturale"
    },
    {
      "affiliations": [
        "Universita’ Magna Graecia Catanzaro -Ssfo, Universita’, Catanzaro, Italy"
      ],
      "name": "A Porcelli"
    },
    {
      "affiliations": [
        "Universita’ Magna Graecia Catanzaro, Ssfo, Catanzaro, Italy"
      ],
      "name": "S Sardella"
    },
    {
      "affiliations": [
        "Azienda Ospedaliera Universitaria ‘R. Dulbecco’ – P.O. ‘Mater Domini’, Hospital Pharmacy, Catanzaro, Italy"
      ],
      "name": "A De Francesco"
    }
  ],
  "title": "5PSQ-138 Clinical risk in clinical trials: what role does the pharmacist play in the management of investigational products?",
  "uid": "d4a827c6-8826-5fce-a4e3-ffdc6f436327"
}