Common issues and improvements on clinical trial data inspection of medical device / 中华医学科研管理杂志

ABSTRACT

Objective:The authenticity and accuracy of medical device related clinical trial data is crucial for the efficacy and safety of tested products. This article analyzed issues identified during previous data inspections of medical device clinical trials in our hospital, summarized experiences and findings, and proposed solutions.Methods:According to the " Medical Device Clinical Trial Inspection Points and Judgment Principles" , this study retrospectively analyzed the data inspection of medical device clinical trials in our hospital since 2016, summarized and analyzed the common issues identified.Results:A total number of six data inspections on medical device clinical trials were carried out in our hospital, during which 30 findings were identified. These findings include 4 items of pre-trial preparation, 2 items of patient rights protection, 7 items of trial processes, 12 items of records and reporting, as well as 5 items of experimental medical device management.Conclusions:The completeness, accuracy and consistency of clinical trial records in clinical trials of devices in our hospital have a lot space for improvement. And there is still room for improvement in the compliance to the protocol and the management of medical devices during the trial process. Based on the common findings, our drug clinical trial center will strengthen training and quality control, improve informatization and centralized management, and emphasize the importance of records. Through that the accuracy and authenticity of trial data for medical devices, and the credibility and objectiveness of trial results would be assured.