RESUMEN
PURPOSE: To design and describe a management and control tool and the human resources needed to efficiently manage the imaging process within clinical trials for a better quality of care for the patient. METHODS: A unit was created to efficiently organise the participation of our Medical Imaging Department in clinical trials. This entity was defined and monitored using a customized, flexible and modular software package that provides the necessary information to execute and monitor requests (appointments, protocols, reports, complaints, billing). Various indicators of activity and professional satisfaction were parameterised. RESULTS: From 2016 to 2020, 367 trials were participated and monitored, 50% of all the hospital clinical trials. The budget of the Medical Imaging Department grew by 47% in this period. The coordination with other departments and principal investigators improved, as shown by surveys (62% fluid and 38% very fluid), with a high perception of collaboration (86%). CONCLUSIONS: The implementation of a Medical Imaging Clinical Trials Unit involve identifying the tasks, personnel, organisational needs, workflow, monitoring and invoicing. The creation of this Unit has improved the control and traceability of clinical trials within the Department.