医疗器械临床试验现场检查要点解读-中国药事.PDFVIP

1616 《医疗器械临床试验现场检查要点》解读 * （上海中医药大学附属曙光医院国家药物临床试验机构办公室，上海 201203） 胡薏慧，元唯安 摘要 目的： 方法： 通过解读医疗器械临床试验现场核查要点，以规范医疗器械临床试验过程。 从临 床试验条件与合规性、临床试验部分、临床试验数据管理、受试产品的管理 4 个方面，分析现场检查 的注意事项。结果：目前，我国医疗器械临床试验质量距离“核查要点”还有一定的差距，申办者、 合同研究组织、研究者、临床试验机构都应该进一步学习相关法规，提高临床试验质量，确保上市 后的产品安全。结论：以《医疗器械临床试验现场检查要点》为标准，是保证试验数据真实、完整、 规范的重要途径。 关键词： 医疗器械临床试验；检查要点；解读 R95 A 1002-7777(2018)12-1616-04 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2018.12.005 Interpretation of The Key Points of On-site Inspection of Medical Devices Clinical Trials * Hu Yihui, Yuan Weian (Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine office of National Drug Clinical Trial, Shanghai 201203, China) Abstract Objective: To interpret the key points of on-site inspection of medical devices clinical trials in order to standardize the process of medical devices clinical trials. Methods: The key points of on-site inspection of medical devices clinical trials were analyzed from four aspects, including clinical trial condition and compliance, clinical trial, clinical trial data management and test product management. Results: At present, there is certain disparity between the medical devices clinical trials in China and the strict requirements in the bulletin released by the CFDA, so the sponsors, contract research organizations, investigators, and clinical trial institutions should further study the related regulations so as to improve the quality of clinical trials and ensure the safety of products on the market. Conclusion: Strict implement of The Key Points of On-site Inspection of Medical Devices Clinical Trials is an important approach to guaranteeing the authenticity, integrity and standardization of the clinical trial d