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目的通过对放射诊疗设备临床试验中存在问题的分析和讨论,帮助医疗机构和生产厂家了解法律规定,合法开展临床试验,并为监管部门加强管理提供建议。方法梳理监督管理实践中发现的放射诊疗设备临床试验中存在的各类问题;分析医疗器械临床试验、大型医用设备配置和放射诊疗管理相关法律法规中与放射诊疗设备临床试验相关的法律规定;理清合法开展放射诊疗设备临床试验的要求;进一步探讨加强监管的方法。结果放射诊疗临床试验中存在参与单位对法律法规认识不足、安全和防护未受到足够重视、放射源管理有隐患等问题。结论临床试验的参与单位应加强法律法规学习,合法开展放射诊疗设备的临床试验;监管部门应加强管理,保障合法的临床试验,依法处理违法行为。
OBJECTIVE Through the analysis and discussion of the problems existing in the clinical trials of radiotherapy and treatment equipment, it helps medical institutions and manufacturers to understand the legal provisions, carry out clinical trials legally and provide suggestions for the supervisory departments to strengthen their management. Methods To sort out various problems in the clinical trial of radiotherapy and treatment equipment found in the practice of supervision and management; to analyze the legal provisions related to the clinical trials of radiotherapy and treatment equipment in the clinical trials of medical equipment, the configuration of large-scale medical equipment and the radiodiagnostic management; Clear law to carry out clinical trials of radiotherapy equipment requirements; to further explore ways to strengthen supervision. Results There were some problems in the clinical trials of radiotherapy and treatment, such as lack of understanding of laws and regulations, insufficient attention to safety and protection, and hidden dangers of radioactive sources management. Conclusion Participants in clinical trials should strengthen their study of laws and regulations and legally carry out clinical trials of radiotherapy and treatment equipment. Regulatory authorities should strengthen management, safeguard legal clinical trials and handle illegal activities according to law.