| Objective: The authenticity and accuracy of medical device related clinical trial data is the essential assurance of efficacy and safety of tested products. This article analyzed issues identified during previous data inspection of medical device clinical trials in our hospital, summarized experience and learnings, and proposed solutions. Method: Retrospective analysis of issues identified during previous data inspection of medical device clinical trials in our hospital, since the implementation of Key points of on-site inspection of medical device clinical trials in 2016. Result: There are a total of 4 medical device trial data inspections took place in our hospital, with 20 issues identified relating to clinical trial conditions, compliance, clinical trial operation, management of clinical trial data, management of test products, etc. Conclusion: In respect to the particularity of medical device clinical trials, we should have more specific quality control and training, enhance the informatization and centralization of management, to ensure a authentic and arrurate clinical trial data, and reliable clinical trial result. |