Clinical Research and Radiopharmaceutical Documentation

RACHEL supports the clinical research activities of the Nuclear Medicine department, handling the management and manipulation of experimental radiopharmaceuticals used in clinical studies, which can be of both diagnostic and therapeutic nature. The department is accredited for Phase 1 studies, wherein the laboratory staff authorized for such experiments plays a crucial role in labeling new tracers for diagnostics and in managing (reception, storage, measurement) new therapeutic radiopharmaceuticals.

The section is responsible for order management, accounting, and quality documentation of radiopharmaceuticals used in clinical trials. It validates the personnel operating in the Nuclear Medicine Department by conducting Mediafill Tests, ensures the appropriateness of prescriptions through dispensation in the AIFA (Italian Medicines Agency) Registers of Radiopharmaceuticals subject to intensive monitoring, and manages quality documentation by drafting and publishing Standard Operating Procedures on the hospital's Quality Web.

The structure also benefits from a clinical research coordinator affiliated with the Clinical Trial Center, contributing to data collection and processing.