Selecting the right sites for a radiopharmaceuticals clinical trial is crucial for ensuring seamless study startup, enrollment, and execution. Given the radioactive nature of the investigational medicinal product (IMP), it is important for sponsors and contract research organizations (CROs) to design site feasibility questionnaires that confirm sites have the specialized credentials and capabilities needed to safely conduct these studies. These questionnaires should evaluate various domains of suitability, from previous performance, technical capabilities, and staff qualifications to patient recruitment potential, regulatory compliance, and operations infrastructure.
The following checklist outlines key questions to consider when evaluations potential sites, ensuring that all critical aspects are thoroughly assessed to facilitate informed decision-making.