医疗器械临床试验准入评估模型构建及应用

依据《医疗器械临床试验质量管理规范》，参考丹麦卫生技术评估中心制定的Mini-卫生技术评估清单，结合医院实际，建立了医疗器械临床试验准入评估模型。该模型主要包括医院评估、器械评估、患者评估、机构评估及经济评估等5项指标、26项内容。实际应用中，确保了所承接的临床试验能在规定时间节点内顺利完成，并保障了试验质量和受益者权益。

Construction and Application of Admittance Evaluation Model for Clinical Trials of Medical Devices

According to the "Quality Management Practice for Clinical Trials of Medical Devices", referring to the Mini Health Technology Assessment List made by the Danish Center for Health Technology Assessment, and combining with the actual situation of the hospital, the admittance evaluation model for clinical trials of medical devices was established. The model mainly included five indexes, namely,hospital evaluation, instrument evaluation, patient evaluation, institution evaluation and economic evaluation,and 26 content. The practical application ensured that the clinical trials undertaken can be successfully completed within the specified time node,and the test quality and the beneficiary's rights were guaranteed.