Construction and Application of an Information Management Platform for Clinical Audit
A report management system(RMS)was independently designed and developed,which real-ized the management of whole process in clinical trial audit,aiming to explore the application of informa-tion management in clinical trial audit.RMS was designed with the audit workflow as the background,with the audit report as the main part,the audit check-points as the framework,and a port for problem input.The function of multi-role synchronous operation improved audit efficiency.The problems were classified and graded by a dictionary of categories and items,the reports were improved for readability and conve-nience of accessing.Computer retrieval and arithmetic supported multi-dimensional analysis,further im-proved reporting mechanism and achieved continuous improvement of clinical trial quality.In addition,the RMS also safeguarded data security,privacy protection and data modification trajectories.