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Background and Importance Regulation No. 1901/2006 of the European Parliament and the Council requires pharmaceutical companies to develop a Paediatric Investigation Plan to ensure the authorisation of medicines in paediatrics . This has led to an increase in paediatric clinical trials (CTs) and greater involvement of the Pharmacy Service (PS) in managing investigational medicinal products.Aim and Objectives The aim of this study is to describe the characteristics of active CTs in the PS of a tertiary paediatric hospital and to classify their complexity using the scale developed by Calvin-Lamas et al.Material and Methods A retrospective observational study was conducted in a paediatric monographic hospital. All active CTs in the PS clinical trial unit in March/2025 were included.Variables collected: trial phase, department, blinding, number of drugs, storage, special conditioning, drug preparation, personnel involved, dispensing method, and use of interactive web response systems (IWRS).Complexity was assessed with the Calvin-Lamas et al. scale: Level 1 (low: 6–10 points), Level 2 (moderate: 11–19), and Level 3 (high: 20–33). Descriptive statistics included mean, standard deviation, and frequency distribution.Results Eighty-three clinical trialswere identified Almost half of the CTs required special conditioning (49%) and drug preparation in the PS (48%), often involving both pharmacists and pharmacy nurses. Direct-to-patient dispensing was reported in 89% of CTs, while 76% used IWRS for drug management.Abstract 6ER-043 Table 1 Trial phase Department Blinding N°drugs Storage Phase III: 42% Oncology: 57% Open-label: 51% ≥3 drugs: 55% Refrigerated: 49% Phase I–II: 23% Neurology: 8% Double-blind: 29% 2 drugs: 27% Room temperature: 46% Phase II: 23% Gastroenterology: 7% Open-label w/commercial drugs:19% 1 drug:18% Frozen: 5% Others: 28% The mean complexity score, according to the Calvin-Lamas et al. scale, was 14.9 points (SD 4.2), classifying most CTs as Level 2 (67%). 19% were classified as Level 1 and 13% as Level 3.Conclusion and Relevance The application of the Calvin-Lamas et al. scale allowed us to quantify the workload of the PS clinical trials unit, with particular impact on drug preparation, dispensing, and monitoring, which in paediatrics require highly individualised attention and rigorous dose control. A validated paediatric-specific scale would be necessary to more robustly confirm the complexity of CTs in this population.References and/or Acknowledgements 1. Calvin-Lamas,Marta, et al. A complexity scale for clinical trials from the perspective of a pharmacy service. European Journal of Hospital Pharmacy 2018.Conflict of Interest No conflict of interest