A Review of Clinical Data Management Systems Used in Clinical Trials

BACKGROUND: Clinical data management system is a software supporting the data management process in clinical trials. In this system, the effective support of clinical data management dimensions leads to the increased accuracy of results and prevention of diversion in clinical trials. The objective of this review article is to investigate the dimensions of data management in clinical data management systems.

METHODS: This study was conducted in 2017. The used databases included Web of Science, Scopus, Science Direct, ProQuest, Ovid Medline and PubMed. The search was conducted over a period of 10 years from 2007 to 2017. The initial number of studies was 101 reaching to 19 in the final stage. The final studies were described and compared in terms of the year, country and dimensions of the clinical data management process in clinical trials.

RESULTS: The research findings indicated that none of the systems completely supported the data management dimensions in clinical trials. Although these systems were developed for supporting the clinical data management process, they were in many cases similar to electronic data capture systems. The most significant dimensions of data management in such systems were data collection or entry, report, validation, and security maintenance.

CONCLUSION: Seemingly, in relation with the performance of data management systems, not sufficient attention was paid to automation all dimensions of the clinical data management process. However, these systems could take positive steps towards changing the manual processes of clinical data management to electronic processes.