Abstrakt

A System for Managing Clinical Trial Data for Diabetes

Diarta Siburian*

The use of novel medications and strategies to forestall, diagnose, treat, and manage polygenic disease needs confirmation of safety and effectively in an exceedingly welldesigned study before widespread adoption. Polygenic disease clinical trials square measure the studies that examine these problems. The aim of this study was to develop a web-based system for knowledge management in polygenic disease clinical trials. This analysis was a mixed-methods study conducted in 2019. To spot the specified knowledge parts and functions to develop the system, sixty researchers completed a form. The designed system was evaluated victimization 2 strategies. The usability of the system was at first evaluated by a bunch of researchers (n=6) victimization the thinkaloud technique, and once system improvement, the system functions were evaluated by alternative researchers (n=30) employing a form. The most knowledge parts that were needed to develop a case report type enclosed “study knowledge,” “participant’s personal knowledge,” and “clinical knowledge.” The purposeful necessities of the system were “managing the study,” “creating case report forms,” “data management,” “data internal control,” and “data security and confidentiality.” once victimization the system, researchers rated the system functions at a “good” level (6.3±0.73) on a seven-point. Given the quality of the information management processes in polygenic disease clinical trials and therefore the widespread use of data technologies in analysis, the employment of clinical knowledge management systems in polygenic disease clinical trials appears inevitable. The system developed within the current study will facilitate and improve the method of making and managing case report forms similarly as aggregation knowledge in polygenic disease clinical trials.