Radioactive drug research program audit checklist.

Abstract

Many institutions conduct human research studies that involve the administration of radiopharmaceuticals. The Radiation Safety Officer (RSO) may be the person responsible for ensuring that such studies are performed safely and in compliance with applicable regulations. Sometimes, RSOs assigned this responsibility lack the knowledge and experience necessary to oversee such research activities. In an effort to assist RSOs unfamiliar with radioactive drug research regulations to establish an effective compliance program in this field, the authors developed a comprehensive audit checklist. Periodic use of this checklist may be effective in ensuring compliance with applicable regulations.