Establishment of an Automated Laboratory Information System to Support Management of Medical Records in Clinical Trials

Abstract

Background: In clinical trials, traditional methods for monitoring and collecting laboratory data by paper documentation need a lot of efforts and lead to inaccuracies of study informations. To solve the problem, we designated an integrated laboratory information management system to support medical stuffs for collecting various medical records, such as prescription records and laboratory data. Methods: In collaboration with a company of integrated solution provider, we have developed programs collecting not only laboratory data but also prescribed drug informations from databases of the division of clinical laboratory in our hospital. Results:We established an automated laboratory information management system (Clinilan View), and the system can present the required data sequentially as both multiple graph images and digital data.We can set a research period according to the clinical trial. The presented data can be downloaded automatically as CSV/Excel format, and therefore, the data analyses are easily performed. Since the system is simultaneously connected with electric medical recording system, abnormal laboratory data can be compared with other clinical information. Conclusion: A newly established laboratory information system can be harnessed real-time collection and review of clinical information during trials. This system will be a useful tool for reporting of important informations in clinical trial centers.