臨床研究法の下での技術専門員の運用状況と課題

抄録

According to the Clinical Trials Act, which has been enacted since 2018, the Certified Review Board (CRB) has to refer to written opinions of technical experts. The system of technical experts is new, and its actual state and function are still unclear. Here, we conducted a questionnaire survey with 70 participating CRB offices across the country, and a field survey with 12 CRB offices, attempting to clearly show the actual state and issues the technical experts face. Each research institution performs a variety of operations in relation to existing Academic Research Organization (ARO). In the future, it is required that the operations of technical experts make a high-quality review by a CRB.