Abstract
Various initiatives by the Government are currently being implemented to form core hospitals that conduct quality clinical trials and to reform the Ethics Guidelines to ensure the reliability of clinical research. Important elements in these initiatives are human resource development, quality management and secure conduct of trials. The computerization in clinical research at medical institutions is essential to raise the efficiency in these elements but there are four issues: long term record keeping, raising the efficiency of application to institutional review board and reviewing, the collection and quality management of clinical data, and education and training through e-learning. In particular, electronic data capture (EDC) system is now becoming essential for the conduct and reliability, not only of investigator-initiated clinical trials aimed at approval, but also of numerous clinical researches running in medical institutions. For this purpose, some academic institutions developed their own user-friendly EDC systems. We have also developed our own EDC system that can be easily customized by researchers, titled the UHCT ACReSS, and, recently, the number of trials and participants registered in this system is rapidly increasing. On the other hand, we are also introducing a learning management system in which investigators can ascertain respective learning goals and update their learning history. Thus, computerization in medical institutions plays important role in the conduct and reliability of investigator-initiated clinical research.
