Interfacing Electronic Health Records With Clinical Trial Databases

Objective:To understand the feasibility of interfacing electronic health record with clinical trial database, and to preliminarily carry out mapping between Chinese electronic medical record standard and CDISC standard regarding demography module and medical history module. Methods:The regulations on demography and medical history in electronic health record standard issued by Ministry of Health of the People’s Republic of China and CDISC standard were investigated. Database was established using Microsoft Access2007, and SAS programming was adopted to achieve data interfacing. Results:We achieved the mapping of data points between electronic health record and clinical trial database regarding demographic data and medical history data. We established a set of process, thereby carrying out interface between electronic health record and clinical trial database. Conclusion:The feasibility and repeatability of the established process were validated by evaluation, and further demonstrating feasibility of interfacing electronic health record with clinical trial database.